guidelines development
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2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Naomi Fearns ◽  
Laura Walker ◽  
Karen Graham ◽  
Norman Gibb ◽  
Duncan Service

Abstract Background The Scottish Intercollegiate Guidelines Network (SIGN) is the leading national clinical guideline producer in Scotland. Improved design and dissemination of guidelines produced for the public can empower people to take an active role in self-management and shared decision-making. The public version of the guideline examined covered getting assessed and diagnosed with autism, and approaches that can help. The aim of this study was to test a public version of a guideline for the parents of children and young people with autism, implement improvements, and identify what works in making it usable and accessible. Methods We recruited mothers from across Scotland. User testing involved formal ‘think aloud’ semi-structured interviews that guided users through the booklet. Interviews took place individually and were recorded and transcribed. Key findings were identified and themed using the honeycomb user experience model. Results Fourteen user-testing interviews were conducted. Facilitators for usability and desirability of the guideline included the chunking of text, consistent use of colour and boxes to highlight important information. Simple language, written in a tone of partnership, helped to engage mothers. Value arose from the guidelines ability to explain the process of diagnosis and make mothers feel empowered in their relationships with healthcare professionals. There was a lack of consensus on the usefulness of rating the strength of evidence and recommendations. Conclusion There was a marked similarity between what was important to the mothers and what has been found to be important to other groups. The involvement of service users and carers in the guidelines development was key to its credibility. One size does not fit all in presenting evidence-based recommendations to the public and it is a challenge to provide sufficient information while avoiding information overload. Recommendations and evidence levels are suitable for use in public versions, but these should be kept as simple as possible.


2021 ◽  
Vol 14 (S1) ◽  
Author(s):  
Joseph M. Zulu ◽  
Doreen Sitali ◽  
Zubin Cyrus Shroff ◽  
Geetanjali Lamba ◽  
George Sichone ◽  
...  

Abstract Background The Zambia Medicines Regulatory Authority (ZAMRA) piloted the implementation of Guidelines on Operating Health Shops in Zambia in 2016, with a view to making basic medicines more accessible to communities. The guidelines aim to transform ordinary drug shops into health shops, which are dispensing facilities permitted to sell a ZAMRA-prescribed list of medicines over the counter. However, studies that explore the integration and uptake of guidelines into the health system are lacking. This study aims to inform future improved implementation of these guidelines by examining the current acceptability of guidelines within the Zambian health system, especially in relation to family planning services. Methodology Data collected through documentary review, key informant interviews with district pharmacists, staff from ZAMRA and in-depth interviews with 24 health shop owners and dispensers were analyzed using thematic analysis. A conceptual framework on the integration of health innovations into health systems guided the analysis. Results The Guidelines on Operating Health Shops were implemented to address the problem of inadequate access to quality medicines especially in rural areas. Factors that facilitated the acceptability of the guidelines included their perceived relevance and simplicity, comprehensive training and improved knowledge among health shop operators on the guidelines, development of a governance and reporting structure or steering committee at the national level as well as perceived improved health outcomes at the community level. Factors that hindered acceptability of the guidelines included the high cost of implementing them, a restricted list of drugs which affected consumer choice, limited communication between the local council and the operators of health shops, health shop owners not owning the health shop premises restricting their ability to adapt the building, and cultural norms which constrained uptake of family planning services. Conclusion In addition to training, facilitating the acceptability of the guidelines among health shop owners requires paying attention to operational issues such as location, ownership of the shop, size of infrastructure as well as financial costs of implementing guidelines through decentralizing the registration process and thus reducing the cost of registration. It is also important to have effective communication strategies between operators and the regulators of health shops.


2021 ◽  
Author(s):  
Naomi Fearns ◽  
Laura Walker ◽  
Karen Graham ◽  
Norman Gibb ◽  
Duncan Service

Abstract Background: The Scottish Intercollegiate Guidelines Network (SIGN) is the leading national clinical guideline producer in Scotland. Improved design and dissemination of guidelines produced for the public can empower people to take an active role in self-management and shared decision-making. The aim of this study was to test a public version of a guideline with the parents of children and young people with autism, implement improvements, and identify what works in making it usable and accessible. Methods: Parents were recruited from across Scotland. User testing involved a formal ‘think aloud’ process and semi-structured interview that guided users through the booklet. Sessions took place individually and were recorded and transcribed. Key findings were identified and themed using the honeycomb user experience model.Results: Fourteen user-testing sessions were conducted. Key facilitators for usability and desirability of the guideline included the chunking of text, consistent use of colour and the use of boxes to highlight important information. Simple language, written in a tone of partnership, helped to engage parents. Value arose from the guidelines ability to explain the process of diagnosis and make parents feel empowered in their relationship with healthcare professionals. There was a lack of consensus on the usefulness of rating the strength of evidence and recommendations. Conclusion: There was a marked similarity between what was important to the parents and what is important for other groups. The involvement of patients and carers in the guidelines development was key to its credibility. One size does not fit all in presenting evidence-based recommendations to the public and it is a challenge to provide sufficient information while avoiding information overload. Recommendations and evidence levels are suitable for use in public versions, but these should be kept as simple as possible.


2021 ◽  
Vol 11 (7) ◽  
pp. 322-338
Author(s):  
Sangeeta Kumari

Background: The entire planet is now under significant threat of a terrible CoVid-19 epidemic Because of small clandestine organisms known as viruses. Only 1% of the population has been discovered, leaving the other 95% unexplored. The most difficult aspect of dealing with these minuscule organisms is their unpredictability, as viruses mutate quickly. Poliomyelitis, smallpox, measles, meningitis, and a few other deadly viral and bacterial diseases were successfully eradicated as a result of the immunisation push. The goal of this review article is to look at both the positive and negative aspects of vaccines. In order to improve the production, examine the quality of WHO vaccine recommendations in clinical practise guidelines (CPGs). Methods: A systematic review of available microbial agent vaccines and pipelines (WHO, 2020) as well as the National Centre for Complementary and Integrative Health's websites was conducted. The US Department of Health and Human Services' Assessment of Guidance, Study, and Evaluation was compared to the Eligible WHO and FDA guidelines providing treatment and/or management recommendations. Approval stage for vaccination products. Food and Drug Administration, United States of America. Understanding vaccine research: How are AIDS vaccines tested? IAVI Article, first volume, 2003. WHO,1998 Recommendations for the quality control of 26 DNA vaccine volumes [17] Vaccines, 3rd Edition, Shock 12th Edition, and “History of Vaccination” in 111 volumes of proceedings are also recommended. Vaccines against almost 27 microbes are approved and ongoing research on vaccines against almost 130 microbial agents is ongoing (WHO, 2020; FDA, 2017). The decision to move to ART (Anti-Retroviral Treatment) regimens is based on the recommendations for clinical, immunological, and virological failure. Assay style output using DBS as opposed to plasma using a 1000 copies / mL viral load threshold [30]. Conclusion: The high-scoring suggestions could be used as a foundation for future vaccine use in the context of various microbial illnesses in vaccine development. In addition to the graphical representation of the vaccine plan, various tools for designing guidance are being used to get insight. Key words: Vaccines, WHO Guidelines, Development stages, Challenges, COVID Vaccines


Author(s):  
Vladimir E. Kriyt ◽  
Yuliya N. Sladkova ◽  
Olga V. Volchkova

Human health and efficiency are largely determined by the microclimate conditions and the air quality in residential, public and industrial buildings in which people spend a significant amount of time. The existing methods of measuring microclimate indicators largely do not correspond to the changed regulatory framework, do not fully reflect all the stages of measurements, have contradictions and inaccuracies, which leads to errors in the measurement and evaluation of the results obtained. The purpose of this study was to develop guidelines for measuring microclimate indicators in residential and public buildings, leveling the existing contradictions in the current documents and meeting modern requirements. The analysis of the current methodological documents regulating the requirements for measuring microclimate indicators was carried out, the main problems encountered by specialists during measurements and evaluation of laboratory and instrumental studies of the microclimate were identified and systematized. To date, the only methodological document in the field of microclimate for residential and public buildings is GOST 30494-2011 "Residential and public buildings. Indoor microclimate parameters". This standard sets the requirements for the organization of control and allows to measure and evaluate the microclimate in almost any residential and public building. However, the standard presents requirements for measurement conditions that are practically unrealizable for many regions of Russia, unreasonably high requirements for measuring instruments (MI), which do not allow to take measurements by MI included in the State Register and having the appropriate scope of application, insufficient requirements for the criteria for the selection of premises and their preparation for an objective assessment of the microclimate parameters, inaccuracies in the presented formulas for calculating the resulting room temperature and inconsistencies in individual paragraphs of the document. There are also no requirements for processing and presenting measurement results. In this situation, the development of a methodology for measuring microclimate indicators in residential and public buildings is extremely relevant. This paper presents the main provisions of the developed draft methodology for measuring microclimate indicators in residential and public buildings at different stages of operation of research objects. The developed procedural guidelines determine the order, conditions for carrying out and minimum scope of instrumental control required for microclimate parameters in residential and public buildings that meet the requirements of sanitary legislation. In the process of procedural guidelines development inconsistencies and discrepancies of current procedural documents were considered as much as possible.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Elisangela da Costa Lima ◽  
Thais de Barros Fernandes ◽  
Adair Freitas ◽  
Juliana Freire de Lima Sias ◽  
Marcelo Gerardin Poirot Land ◽  
...  

Abstract Background Children are more vulnerable to adverse drug reactions (ADRs) due to complex changes in the body during the growth process and lack specific pharmacoepidemiologic studies. Causality and Avoidability assessment of ADRs are relevant to clinical guidelines development and pharmacovigilance. This study aimed to translate and transcultural adapt two new tools—Liverpool Causality Assessment Tool (LCAT) and the Liverpool Avoidability Assessment Tool (LAAT)—to Brazilian-Portuguese and evaluate the psychometric properties of these tools to analyse ADRs in Brazilian children. Methods The validation of the cross-cultural adaptation of tools was obtained by the functional (conceptual, semantic, operational, and measurement) equivalence between the original and translated versions of each instrument. The translated version of LCAT and LAAT was applied to assessing the twenty-six case reports of suspected adverse drug reactions in a Brazilian teaching paediatric hospital. The inter-rater reliability (a pharmacist and a physician) was evaluated using Cronbach’s alpha. The exact agreement percentages (%EA) and extreme disagreement (%ED) were computed. Overall Kappa index was calculated with a 95% confidence interval. Results There was a need to modify some terms translated into Portuguese for semantic and conceptual equivalence. The Cronbach’s alpha coefficient values obtained were 0.95 and 0.85, and the weighted Kappa (95% confidence interval) were 0.82 (0.67–0.97) and 0.68 (0.45–0.91) for LCAT and LAAT, respectively. The Brazilian-Portuguese versions of the LCAT and LAAT showed reliable and valid tools for the diagnosis and follow-up of ADRs in children. Conclusion The methodological approach allowed the translation, transcultural adaptation, and validation to Brazilian-Portuguese of two easy and quick to perform tools for causality and avoidability of ADRs in children by a multidisciplinary expert specialist committee, including the authors of original tools. We believe these versions may be applied by professionals (patient safety teams) and researchers in Brazil in groups or by a single reviewer. Trial registration This study was evaluated and approved by the Research Ethics Committee (Instituto de Pediatria e Puericultura Martagão Gesteira – Federal University of Rio de Janeiro – Number: 3.264.238.


2021 ◽  
Author(s):  
Arit Udoh ◽  
Mary Akpan ◽  
Umar Idris Ibrahim ◽  
Basira Kankia Lawal ◽  
Kamilu Sarki Labaran ◽  
...  

Background: Studies show that clinical pharmacy services are effective in optimizing medicines use and patients outcomes. This study aimed to determine the clinical pharmacy services provided in public sector hospitals in Nigeria. Methods: This was an online survey of 296 primary, secondary and tertiary care hospitals sampled purposively across the 36 States and Federal Capital Territory in Nigeria. Data analysis was conducted descriptively, and via Chi-square test and multivariate analysis of variance (MANOVA). Key findings: Complete responses were obtained from 272 hospitals in the country with a survey completion rate of 88%. This included 55 tertiary, 72 secondary, and 145 primary healthcare centres (PHCs). Pharmacists provided pharmaceutical care services in all the tertiary care hospitals, 94% of the secondary, and in only 6% of the PHCs surveyed. The composition of the pharmacy department per level of care was similar across the six geopolitical regions (V = 0.383, F = 1.453, p = 0.06) with more pharmacy staff employed in the tertiary care hospitals compared to the secondary care facilities. The majority (>=75%) of the tertiary and secondary care hospitals in the survey provided medicines information, patient education and counselling, alongside in- and outpatient dispensing services. However, fewer than 30% reported routine pharmacist involvement in multidisciplinary ward rounds, medication chart review, therapeutic guidelines development, antibiotic stewardship programmes, and drug therapy monitoring. Pharmacists routinely provided medication error reporting services in only about half of the hospitals in the sample, and this was not associated with the level of care (p>0.05). Conclusions: The findings of this study demonstrate disparity in clinical pharmacy service availability across the various levels of care in Nigeria. It also highlights the need to scale up and prioritize their integration within the primary care sector.


Author(s):  
Amelia T. Rogers ◽  
Rebecca Dirks ◽  
Holly Ann Burt ◽  
Stephen Haggerty ◽  
Geoffrey P. Kohn ◽  
...  

2021 ◽  
Vol 96 (2) ◽  
pp. 116-138
Author(s):  
Jung Hwan Oh ◽  
Joong Goo Kwon ◽  
Hye-Kyung Jung ◽  
Chung Hyun Tae ◽  
Kyung Ho Song ◽  
...  

Background/Aims: Functional dyspepsia (FD) is a chronic upper gastrointestinal symptom complex that routine diagnostic work-up, such as endoscopy, blood laboratory analysis, or radiological examination, fails to identify a cause for. It is highly prevalent in the Korean population, and its response to the various available therapeutic strategies is only modest because of the heterogeneous nature of its pathogenesis. We constituted a guidelines development committee to review the existing guidelines on the management of FD.Methods: This committee drafted statements and conducted a systematic review and meta-analysis of various studies, guidelines, and randomized control trials. External review was also conducted by selected experts. These clinical practice guidelines for FD were developed based on evidence recently accumulated with the revised version of FD guidelines released in 2011 by the Korean Society of Neurogastroenterology and Motility.Results: These guidelines apply to adults with chronic symptoms of FD and include the diagnostic role of endoscopy, <i>Helicobacter pylori</i> screening, and systematic review and meta-analyses of the various treatment options for FD (proton pump inhibitors, <i>Helicobacter pylori</i> eradication, and tricyclic antidepressants), especially according to the FD subtype.Conclusions: The purpose of these new guidelines is to aid understanding, diagnosis, and treatment of FD, and the targets of the guidelines are clinicians, healthcare workers at the forefront of patient care, patients, and medical students. The guidelines will continue to be revised and updated periodically.


2021 ◽  
Vol 15 (3) ◽  
pp. e0009175
Author(s):  
Bishoy Kamel ◽  
Martina R. Laidemitt ◽  
Lijun Lu ◽  
Caitlin Babbitt ◽  
Ola Liota Weinbaum ◽  
...  

Background We were tasked by the World Health Organization (WHO) to address the following question: What techniques should be used to diagnose Schistosoma infections in snails and in the water in potential transmission sites? Our goal was to review and evaluate the available literature and provide recommendations and insights for the development of WHO’s Guidelines Development Group for schistosomiasis control and elimination. Methodology We searched several databases using strings of search terms, searched bibliographies of pertinent papers, and contacted investigators who have made contributions to this field. Our search covered from 1970 to Sept 2020. All papers were considered in a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) framework, and retained papers were grouped by technique and subjected to our GRADE (Grading of Recommendations, Assessment, Development and Evaluations) evidence assessment profile determined in consultation with WHO. We also considered issues of sensitivity, specificity, coverage, cost, robustness, support needs, schistosome species discrimination, and relevant detection limits. Principal findings Our PRISMA process began with the perusal of 949 articles, of which 158 were retained for data extraction and evaluation. We identified 25 different techniques and for each applied a GRADE assessment considering limitations, inconsistency, imprecision, indirectness, and publication bias. We also provide advantages and disadvantages for each category of techniques. Conclusions Our GRADE analysis returned an assessment of moderate quality of evidence for environmental DNA (eDNA), qPCR and LAMP (Loop-mediated isothermal amplification). No single ideal diagnostic approach has yet been developed, but considerable recent progress has been made. We note a growing trend to use eDNA techniques to permit more efficient and replicable sampling. qPCR-based protocols for follow-up detection offer a versatile, mature, sensitive, and specific platform for diagnosis though centralized facilities will be required to favor standardization. Droplet digital PCR (ddPCR) can play a complementary role if inhibitors are a concern, or more sensitivity or quantification is needed. Snail collection, followed by shedding, is encouraged to provide specimens for sequence verifications of snails or schistosomes. LAMP or other isothermal detection techniques offer the prospect of less expensive and more distributed network of analysis but may face standardization and verification challenges related to actual sequences amplified. Ability to detect schistosome infections in snails or in the water is needed if control and elimination programs hope to succeed. Any diagnostic techniques used need to be regularly verified by the acquisition of DNA sequences to confirm that the detected targets are of the expected species. Further improvements may be necessary to identify the ideal schistosome or snail sequences to target for amplification. More field testing and standardization will be essential for long-term success.


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