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  1. Article ; Online: Adherence of systematic reviews to Cochrane RoB2 guidance was frequently poor: a meta epidemiological study.

    Minozzi, Silvia / Gonzalez-Lorenzo, Marien / Cinquini, Michela / Berardinelli, Daniela / Cagnazzo, Celeste / Ciardullo, Stefano / De Nardi, Paola / Gammone, Mariarosaria / Iovino, Paolo / Lando, Alex / Rissone, Marco / Simeone, Giovanni / Stracuzzi, Marta / Venezia, Giovanna / Moja, Lorenzo / Costantino, Giorgio

    Journal of clinical epidemiology

    2022  Volume 152, Page(s) 47–55

    Abstract: ... adherence and the methodological quality of the reviews assessed by AMSTAR2 (p-for-trend 0.007 ...

    Abstract Objectives: To assess whether the use of the revised Cochrane risk of bias tool for randomized trials (RoB2) in systematic reviews (SRs) adheres to RoB2 guidance.
    Methods: We searched MEDLINE, Embase, Cochrane Library from 2019 to May 2021 to identify SRs using RoB2. We analyzed methods and results sections to see whether risk of bias was assessed at outcome measure level and applied to primary outcomes of the SR as per RoB2 guidance. The relation between SR characteristics and adequacy of RoB2 use was examined by logistic regression analysis.
    Results: Two hundred-eight SRs were included. We could assess adherence in 137 SRs as 12 declared using RoB2 but actually used RoB1 and 59 did not report the number of primary outcomes. The tool usage was adherent in 69.3% SRs. Considering SRs with multiple primary outcomes, adherence dropped to 28.8%. We found a positive association between RoB2 guidance adherence and the methodological quality of the reviews assessed by AMSTAR2 (p-for-trend 0.007). Multivariable regression analysis suggested journal impact factor [first quartile vs. other quartiles] was associated with RoB2 adherence (OR 0.34; 95% CI: 0.16-0.72).
    Conclusions: Many SRs did not adhere to RoB2 guidance as they applied the tool at the study level rather than at the outcome measure level. Lack of adherence was more likely among low and very low quality reviews.
    MeSH term(s) Humans ; Systematic Reviews as Topic ; Bias ; Epidemiologic Studies ; Research Design ; Research Report
    Language English
    Publishing date 2022-09-23
    Publishing country United States
    Document type Journal Article
    ZDB-ID 639306-8
    ISSN 1878-5921 ; 0895-4356
    ISSN (online) 1878-5921
    ISSN 0895-4356
    DOI 10.1016/j.jclinepi.2022.09.003
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Reimbursement models to tackle market failures for antimicrobials: Approaches taken in France, Germany, Sweden, the United Kingdom, and the United States.

    Gotham, Dzintars / Moja, Lorenzo / van der Heijden, Maarten / Paulin, Sarah / Smith, Ingrid / Beyer, Peter

    Health policy (Amsterdam, Netherlands)

    2020  Volume 125, Issue 3, Page(s) 296–306

    Abstract: Introduction: The pipeline of new antibacterials remains limited. Reasons include low research investments, limited commercial prospects, and scientific challenges. To complement existing initiatives such as research grants, governments are exploring ... ...

    Abstract Introduction: The pipeline of new antibacterials remains limited. Reasons include low research investments, limited commercial prospects, and scientific challenges. To complement existing initiatives such as research grants, governments are exploring policy options for providing new market incentives to drug developers.
    Materials and methods: Reimbursement interventions for antibacterials in France, Germany, Sweden, US, and UK were reviewed and analysed by the authors.
    Results: In France, Germany, and the US, implemented interventions centre on providing exceptions in cost-containment mechanisms to allow higher prices for certain antibacterials. In the US, also, certain antibacterials are granted additional years of protection from generic competition (exclusivity) and faster regulatory review. The UK is piloting a model that will negotiate contracts with manufacturers to pay a fixed annual fee for ongoing supply of as many units as needed. Sweden is piloting a model that will offer manufacturers of selected antibacterials contracts that would guarantee a minimum annual revenue. A similar model of guaranteed minimal annual revenues is under consideration in the US (PASTEUR Act).
    Conclusions: The UK and Sweden are piloting entirely novel procurement and reimbursement models. Existing interventions in the US, France, and Germany represent important, but relatively minor interventions. More countries should explore the use of novel models and international coordination will be important for 'pull' incentives to be effective. If adopted, the PASTEUR legislation in the US would constitute a significant 'pull' incentive.
    MeSH term(s) Anti-Infective Agents ; Drug Costs ; France ; Germany ; Humans ; Sweden ; United Kingdom ; United States
    Chemical Substances Anti-Infective Agents
    Language English
    Publishing date 2020-12-01
    Publishing country Ireland
    Document type Journal Article
    ZDB-ID 605805-x
    ISSN 1872-6054 ; 0168-8510
    ISSN (online) 1872-6054
    ISSN 0168-8510
    DOI 10.1016/j.healthpol.2020.11.015
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Trivalent and quadrivalent seasonal influenza vaccine in adults aged 60 and older: a systematic review and network meta-analysis.

    Veroniki, Areti Angeliki / Thirugnanasampanthar, Sai Surabi / Konstantinidis, Menelaos / Dourka, Jasmeen / Ghassemi, Marco / Neupane, Dipika / Khan, Paul / Nincic, Vera / Corry, Margarita / Robson, Reid / Parker, Amanda / Soobiah, Charlene / Sinilaite, Angela / Doyon-Plourde, Pamela / Gil, Anabel / Siu, Winnie / Moqueet, Nasheed / Stevens, Adrienne / English, Kelly /
    Florez, Ivan D / Yepes-Nuñez, Juan J / Hutton, Brian / Muller, Matthew / Moja, Lorenzo / Straus, Sharon / Tricco, Andrea C

    BMJ evidence-based medicine

    2024  

    Abstract: Objectives: To compare the efficacy of influenza vaccines of any valency for adults 60 years and older.: Design and setting: Systematic review with network meta-analysis (NMA) of randomised controlled trials (RCTs). MEDLINE, EMBASE, JBI Evidence- ... ...

    Abstract Objectives: To compare the efficacy of influenza vaccines of any valency for adults 60 years and older.
    Design and setting: Systematic review with network meta-analysis (NMA) of randomised controlled trials (RCTs). MEDLINE, EMBASE, JBI Evidence-Based Practice (EBP) Database, PsycINFO, and Cochrane Evidence -Based Medicine database were searched from inception to 20 June 20, 2022. Two reviewers screened, abstracted, and appraised articles (Cochrane Risk of Bias (ROB) 2.0 tool) independently. We assessed certainty of findings using Confidence in Network Meta-Analysis and Grading of Recommendations, Assessment, Development and Evaluations approaches. We performed random-effects meta-analysis and network meta-analysis (NMA), and estimated odds ratios (ORs) for dichotomous outcomes and incidence rate ratios (IRRs) for count outcomes along with their corresponding 95% confidence intervals (CIs) and prediction intervals.
    Participants: Older adults (≥60 years old) receiving an influenza vaccine licensed in Canada or the USA (vs placebo, no vaccine, or any other licensed vaccine), at any dose.
    Main outcome measures: Laboratory-confirmed influenza (LCI) and influenza-like illness (ILI). Secondary outcomes were the number of vascular adverse events, hospitalisation for acute respiratory infection (ARI) and ILI, inpatient hospitalisation, emergency room (ER) visit for ILI, outpatient visit, and mortality, among others.
    Results: We included 41 RCTs and 15 companion reports comprising 8 vaccine types and 206 032 participants. Vaccines may prevent LCI compared with placebo, with high-dose trivalent inactivated influenza vaccine (IIV3-HD) (NMA: 9 RCTs, 52 202 participants, OR 0.23, 95% confidence interval (CI) (0.11 to 0.51), low certainty of evidence) and recombinant influenza vaccine (RIV) (OR 0.25, 95%CI (0.08 to 0.73), low certainty of evidence) among the most efficacious vaccines. Standard dose trivalent IIV3 (IIV3-SD) may prevent ILI compared with placebo, but the result was imprecise (meta-analysis: 2 RCTs, 854 participants, OR 0.39, 95%CI (0.15 to 1.02), low certainty of evidence). Any HD was associated with prevention of ILI compared with placebo (NMA: 9 RCTs, 65 658 participants, OR 0.38, 95%CI (0.15 to 0.93)). Adjuvanted quadrivalent IIV (IIV4-Adj) may be associated with the least vascular adverse events, but the results were very uncertain (NMA: eight 8 RCTs, 57 677 participants, IRR 0.18, 95%CI (0.07 to 0.43), very low certainty of evidence). RIV on all-cause mortality may be comparable to placebo (NMA: 20 RCTs, 140 577 participants, OR 1.01, 95%CI (0.23 to 4.49), low certainty of evidence).
    Conclusions: This systematic review demonstrated efficacy associated with IIV3-HD and RIV vaccines in protecting older persons against LCI. RIV vaccine may reduce all-cause mortality when compared with other vaccines, but the evidence is uncertain. Differences in efficacy between influenza vaccines remain uncertain with very low to moderate certainty of evidence.
    Prospero registration number: CRD42020177357.
    Language English
    Publishing date 2024-04-10
    Publishing country England
    Document type Journal Article
    ISSN 2515-4478
    ISSN (online) 2515-4478
    DOI 10.1136/bmjebm-2023-112767
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Effectiveness of a Hospital-Based Computerized Decision Support System on Clinician Recommendations and Patient Outcomes: A Randomized Clinical Trial.

    Moja, Lorenzo / Polo Friz, Hernan / Capobussi, Matteo / Kwag, Koren / Banzi, Rita / Ruggiero, Francesca / González-Lorenzo, Marien / Liberati, Elisa G / Mangia, Massimo / Nyberg, Peter / Kunnamo, Ilkka / Cimminiello, Claudio / Vighi, Giuseppe / Grimshaw, Jeremy M / Delgrossi, Giovanni / Bonovas, Stefanos

    JAMA network open

    2019  Volume 2, Issue 12, Page(s) e1917094

    Abstract: ... corresponding to an odds ratio of 1.21 (95% CI, 1.11-1.32; P < .001). The length of hospital stay did not differ ... time of 8 days (IQR, 5-14 days) for the control group (P = .36). In-hospital all-cause mortality also ... did not differ between groups (odds ratio, 0.95; 95% CI, 0.77-1.17; P = .59). Alert fatigue did not ...

    Abstract Importance: Sophisticated evidence-based information resources can filter medical evidence from the literature, integrate it into electronic health records, and generate recommendations tailored to individual patients.
    Objective: To assess the effectiveness of a computerized clinical decision support system (CDSS) that preappraises evidence and provides health professionals with actionable, patient-specific recommendations at the point of care.
    Design, setting, and participants: Open-label, parallel-group, randomized clinical trial among internal medicine wards of a large Italian general hospital. All analyses in this randomized clinical trial followed the intent-to-treat principle. Between November 1, 2015, and December 31, 2016, patients were randomly assigned to the intervention group, in which CDSS-generated reminders were displayed to physicians, or to the control group, in which reminders were generated but not shown. Data were analyzed between February 1 and July 31, 2018.
    Interventions: Evidence-Based Medicine Electronic Decision Support (EBMEDS), a commercial CDSS covering a wide array of health conditions across specialties, was integrated into the hospital electronic health records to generate patient-specific recommendations.
    Main outcomes and measures: The primary outcome was the resolution rate, the rate at which medical problems identified and alerted by the CDSS were addressed by a change in practice. Secondary outcomes included the length of hospital stay and in-hospital all-cause mortality.
    Results: In this randomized clinical trial, 20 563 patients were admitted to the hospital. Of these, 6480 (31.5%) were admitted to the internal medicine wards (study population) and randomized (3242 to CDSS and 3238 to control). The mean (SD) age of patients was 70.5 (17.3) years, and 54.5% were men. In total, 28 394 reminders were generated throughout the course of the trial (median, 3 reminders per patient per hospital stay; interquartile range [IQR], 1-6). These messages led to a change in practice in approximately 4 of 100 patients. The resolution rate was 38.0% (95% CI, 37.2%-38.8%) in the intervention group and 33.7% (95% CI, 32.9%-34.4%) in the control group, corresponding to an odds ratio of 1.21 (95% CI, 1.11-1.32; P < .001). The length of hospital stay did not differ between the groups, with a median time of 8 days (IQR, 5-13 days) for the intervention group and a median time of 8 days (IQR, 5-14 days) for the control group (P = .36). In-hospital all-cause mortality also did not differ between groups (odds ratio, 0.95; 95% CI, 0.77-1.17; P = .59). Alert fatigue did not differ between early and late study periods.
    Conclusions and relevance: An international commercial CDSS intervention marginally influenced routine practice in a general hospital, although the change did not statistically significantly affect patient outcomes.
    Trial registration: ClinicalTrials.gov identifier: NCT02577198.
    MeSH term(s) Aged ; Decision Support Systems, Clinical ; Electronic Health Records ; Evidence-Based Medicine/methods ; Female ; Hospital Information Systems ; Hospital Mortality ; Hospitals, General ; Humans ; Italy ; Length of Stay ; Male ; Middle Aged ; Outcome Assessment, Health Care ; Practice Patterns, Physicians'/statistics & numerical data ; Precision Medicine/methods
    Language English
    Publishing date 2019-12-02
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2019.17094
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Epilepsy-associated stigma from the perspective of people with epilepsy and the community in Italy.

    Tombini, Mario / Assenza, Giovanni / Quintiliani, Livia / Ricci, Lorenzo / Lanzone, Jacopo / De Mojà, Roberta / Ulivi, Martina / Di Lazzaro, Vincenzo

    Epilepsy & behavior : E&B

    2019  Volume 98, Issue Pt A, Page(s) 66–72

    Abstract: ... were significantly higher in NES with respect to PWE (respectively 47.1 vs 39.5, p < .001). Forty-two ...

    Abstract Objective: The objective of this study was to assess the stigma related to epilepsy from the perspective of people with epilepsy (PWE) and from the Italian community (Rome and central Italy); moreover, the impact of the perceived stigma on the mood and quality of life of patients was also evaluated.
    Materials and methods: We consecutively enrolled 100 PWE and 202 nonepileptic subjects (NES). Both PWE and NES completed an Italian version of the Stigma Scale of Epilepsy (SSE), a 24-items questionnaire that has been demonstrated to allow the quantification of the stigma perception by patients and people from the community. Moreover, the PWE fulfilled a 3-item Jacoby's Stigma Scale, the Quality of Life in Epilepsy-31 (QOLIE-31 [Q3])), and Beck Depression Inventory II (BDI-II) questionnaires for the evaluation of the quality of life and depressive symptoms. The results of the SSE were correlated with clinical and demographic details of PWE and NES, as well as the Q31 and BDI-II scores in PWE.
    Results: The SSE scores were significantly higher in NES with respect to PWE (respectively 47.1 vs 39.5, p < .001). Forty-two percent of PWE reported feeling stigmatized, with 5% reporting feeling highly stigmatized. In PWE, the perceived stigma was not correlated with seizure frequency but was significantly associated with worse quality of life, more severe depressive symptoms, and higher number of AEDs. The multiple regression analysis showed that the quality-of-life overall score and Q31 subscale exploring "social function" are the most significant predictors of stigma.
    Conclusions: By using an Italian translation of the SSE questionnaire, even if we cannot consider our sample representative of the whole Italian community our study evidenced higher rates of stigma related to epilepsy in NES than in PWE. The PWE still experience feelings of stigmatization strongly correlated with higher depressive symptoms and worse quality of life that has proven to be the most significant predictor of stigma. Finally, seizure frequency does not affect the perceived stigma, which is instead significantly influenced by antiepileptic therapy.
    MeSH term(s) Adult ; Aged ; Anticonvulsants/therapeutic use ; Depression/epidemiology ; Depression/psychology ; Epilepsy/drug therapy ; Epilepsy/epidemiology ; Epilepsy/psychology ; Female ; Humans ; Independent Living/psychology ; Italy/epidemiology ; Male ; Middle Aged ; Quality of Life/psychology ; Seizures/drug therapy ; Seizures/epidemiology ; Seizures/psychology ; Social Adjustment ; Social Stigma ; Stereotyping ; Surveys and Questionnaires ; Young Adult
    Chemical Substances Anticonvulsants
    Language English
    Publishing date 2019-07-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2010587-3
    ISSN 1525-5069 ; 1525-5050
    ISSN (online) 1525-5069
    ISSN 1525-5050
    DOI 10.1016/j.yebeh.2019.06.026
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Decision criteria for selecting essential medicines and their connection to guidelines: an interpretive descriptive qualitative interview study.

    Piggott, Thomas / Moja, Lorenzo / Akl, Elie A / Lavis, John N / Cooke, Graham / Kredo, Tamara / Hogerzeil, Hans V / Huttner, Benedikt / Alonso-Coello, Pablo / Schünemann, Holger

    Journal of clinical epidemiology

    2022  Volume 154, Page(s) 146–155

    Abstract: Background and objectives: The World Health Organization Model List of Essential Medicines has led to at least 137 national lists. Essential medicines should be grounded in evidence-based guideline recommendations and explicit decision criteria. ... ...

    Abstract Background and objectives: The World Health Organization Model List of Essential Medicines has led to at least 137 national lists. Essential medicines should be grounded in evidence-based guideline recommendations and explicit decision criteria. Essential medicines should be available, accessible, affordable, and the supporting evidence should be accompanied by a rating of the certainty one can place in it. Our objectives were to identify criteria and considerations that should be addressed in moving from a guideline recommendation regarding a medicine to the decision of whether to add, maintain, or remove a medicine from an essential medicines list. We also seek to explore opportunities to improve organizational processes to support evidence-based health decision-making more broadly.
    Methods: We conducted a qualitative study with semistructured interviews of key informant stakeholders in the development and use of guidelines and essential medicine lists (EMLs). We used an interpretive descriptive analysis approach and thematic analysis of interview transcripts in NVIVO v12.
    Results: We interviewed 16 key informants working at national and global levels across all WHO regions. We identified five themes: three descriptive/explanatory themes 1) EMLs and guidelines, the same, but different; 2) EMLs can drive price reductions and improve affordability and access; 3) Time lag and disconnect between guidelines and EMLs; and two prescriptive themes 4) An "evidence pipeline" could improve coordination between guidelines and EMLs; 5) Facilitating the link between the WHO Model List of Essential Medicines (WHO EML) and national EMLs could increase alignment.
    Conclusion: We found significant overlap and opportunities for alignment between guideline and essential medicine decision processes. This finding presents opportunities for guideline and EML developers to enhance strategies for collaboration. Future research should assess and evaluate these strategies in practice to support the shared goal of guidelines and EMLs: improvements in health.
    MeSH term(s) Humans ; Drugs, Essential ; World Health Organization ; Qualitative Research ; Forecasting
    Chemical Substances Drugs, Essential
    Language English
    Publishing date 2022-12-27
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 639306-8
    ISSN 1878-5921 ; 0895-4356
    ISSN (online) 1878-5921
    ISSN 0895-4356
    DOI 10.1016/j.jclinepi.2022.12.007
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Barriers toward epilepsy surgery. A survey among practicing neurologists.

    Erba, Giuseppe / Moja, Lorenzo / Beghi, Ettore / Messina, Paolo / Pupillo, Elisabetta

    Epilepsia

    2012  Volume 53, Issue 1, Page(s) 35–43

    Abstract: ... of patients referred for surgery (p < 0.01) and the geographical region where specialty was attained (p < 0.01 ...

    Abstract Purpose: Guidelines for refractory epilepsy recommend timely referral of potential surgical candidates to an epilepsy center for evaluation. However, this approach is seldom a priority for treating neurologists, possibly because of inertia of previous practice and personal attitudes, leading to a buildup of psychosocial disabilities and increased risk of morbidity and mortality. The aim of this study was to assess knowledge and attitudes toward epilepsy surgery among practicing neurologists and identify the barriers that delay the treatment.
    Methods: We surveyed 183 Italian adult and child neurologists with an ad hoc questionnaire exploring physicians' willingness to refer patients for epilepsy surgery when such treatment may be indicated. Thirteen of 14 questions had graded answers ranging from 1 (unfavorable to surgery) to 10 (favorable). We compared the overall scores and per-question scores of the neurologists versus a group of academic and clinical leaders in the field.
    Key findings: The neurologists gave responses characterized by extreme variability (i.e., wide response interquartile range) around intermediate scores. Experts had higher and less variable scores favoring surgery. The two groups differed significantly on issues such as how long to pursue pharmacologic treatment and information about indications and outcome of surgery. Multivariate analysis indicated that neurologists' attitudes correlated with the number of patients referred for surgery (p < 0.01) and the geographical region where specialty was attained (p < 0.01). Other variables such as years in practice, number of patients treated for epilepsy, or type of specialty had no predictive value on physicians' behavior.
    Significance: The majority of Italian neurologists have highly variable attitudes toward epilepsy surgery, reflecting ambivalence and uncertainty toward this type of treatment. About two thirds of responders are nonaligned with the opinion leaders, mainly due to differences in handling pharmacologic treatment and information regarding epilepsy surgery, which affect their attitudes and ultimately patient management. Strategies that may solve the lack of agreement include reinforcing the concept of pharmacoresistance and associated risks, as opposed to the safety and potential benefits of surgery, the use of epilepsy quality measures during follow-up, and the adoption of structured referral sheets and greater involvement of patients in decision making. These measures should facilitate the referral of potential candidates for surgical evaluation and improve overall quality of care.
    MeSH term(s) Adult ; Epilepsy/surgery ; Female ; Humans ; Male ; Middle Aged ; Neurology/methods ; Physicians/psychology ; Practice Patterns, Physicians'/standards ; Surveys and Questionnaires ; Treatment Outcome
    Language English
    Publishing date 2012-01
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 216382-2
    ISSN 1528-1167 ; 0013-9580
    ISSN (online) 1528-1167
    ISSN 0013-9580
    DOI 10.1111/j.1528-1167.2011.03282.x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Tough decisions on essential medicines in 2015.

    Magrini, Nicola / Robertson, Jane / Forte, Gilles / Cappello, Bernadette / Moja, Lorenzo P / de Joncheere, Kees / Kieny, Marie-Paule

    Bulletin of the World Health Organization

    2015  Volume 93, Issue 4, Page(s) 283–284

    MeSH term(s) Chronic Disease/drug therapy ; Drugs, Essential/economics ; Drugs, Essential/supply & distribution ; Drugs, Essential/therapeutic use ; Humans ; Public Health ; World Health Organization
    Chemical Substances Drugs, Essential
    Language English
    Publishing date 2015-03-12
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 80213-x
    ISSN 1564-0604 ; 0042-9686 ; 0366-4996 ; 0510-8659
    ISSN (online) 1564-0604
    ISSN 0042-9686 ; 0366-4996 ; 0510-8659
    DOI 10.2471/BLT.15.154385
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: User-experience testing of an evidence-to-decision framework for selecting essential medicines.

    Thomas Piggott / Lorenzo Moja / Carlos A Cuello Garcia / Elie A Akl / Rita Banzi / Benedikt Huttner / Tamara Kredo / John N Lavis / Holger J Schünemann

    PLOS Global Public Health, Vol 4, Iss 1, p e

    2024  Volume 0002723

    Abstract: Essential medicine lists (EMLs) are important medicine prioritization tools used by the World Health Organization (WHO) EML and over 130 countries. The criteria used by WHO's Expert Committee on the Selection and Use of Essential Medicines has parallels ... ...

    Abstract Essential medicine lists (EMLs) are important medicine prioritization tools used by the World Health Organization (WHO) EML and over 130 countries. The criteria used by WHO's Expert Committee on the Selection and Use of Essential Medicines has parallels to the GRADE Evidence-to-Decision (EtD) frameworks. In this study, we explored the EtD frameworks and a visual abstract as adjunctive tools to strengthen the integrate evidence and improve the transparency of decisions of EML applications. We conducted user-experience testing interviews of key EML stakeholders using Morville's honeycomb model. Interviews explored multifaceted dimensions (e.g., usability) on two EML applications for the 2021 WHO EML-long-acting insulin analogues for diabetes and immune checkpoint inhibitors for lung cancer. Using a pre-determined coding framework and thematic analysis we iteratively improved both the EtD framework and the visual abstract. We coded the transcripts of 17 interviews with 13 respondents in 103 locations of the interview texts across all dimensions of the user-experience honeycomb. Respondents felt the EtD framework and visual abstract presented complementary useful and findable adjuncts to the traditional EML application. They felt this would increase transparency and efficiency in evidence assessed by EML committees. As EtD frameworks are also used in health practice guidelines, including those by the WHO, respondents articulated that the adoption of the EtD by EML applications represents a tangible mechanism to align EMLs and guidelines, decrease duplication of work and improve coordination. Improvements were made to clarify instructions for the EtD and visual abstract, and to refine the design and content included. 'Availability' was added as an additional criterion for EML applications to highlight this criterion in alignment with WHO EML criteria. EtD frameworks and visual abstracts present additional important tools to communicate evidence and support decision-criteria in EML applications, which have global ...
    Keywords Public aspects of medicine ; RA1-1270
    Subject code 306
    Language English
    Publishing date 2024-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  10. Article ; Online: Comparison of antibiotics included in national essential medicines lists of 138 countries using the WHO Access, Watch, Reserve (AWaRe) classification: a cross-sectional study.

    Adekoya, Itunuoluwa / Maraj, Darshanand / Steiner, Liane / Yaphe, Hannah / Moja, Lorenzo / Magrini, Nicola / Cooke, Graham / Loeb, Mark / Persaud, Nav

    The Lancet. Infectious diseases

    2021  Volume 21, Issue 10, Page(s) 1429–1440

    Abstract: ... p=0·025).: Interpretation: Our findings highlight potential changes to the antibiotics included ...

    Abstract Background: The WHO Model List of Essential Medicines classified antibiotics into Access, Watch, and Reserve (AWaRe) categories for the treatment of 31 priority bacterial infections as a tool to facilitate antibiotic stewardship and optimal use. We compared the listing of antibiotics on national essential medicines lists (NEMLs) to those in the 2019 WHO Model List and the AWaRe classification database to determine the degree to which NEMLs are in alignment with the AWaRe classification framework recommended by WHO.
    Methods: In this cross-sectional study, we obtained up-to-date (data after 2017) NEMLs from our Global Essential Medicines (GEM) database, WHO online resources, and individual countries' websites. From the 2019 WHO Model List we extracted, as a reference standard, a list of 37 antibiotics (44 unique antibiotics after accounting for combination drugs or therapeutically equivalent drugs as specified by WHO) that were considered essential in treating 31 of the most common and severe clinical infectious syndromes (priority infections). From the WHO AWaRe Classification Database, which contains commonly used antibiotics globally, we extracted a list of 122 AWaRe antibiotics listed by at least one country in the GEM database. We then assessed individual countries' NEMLs for listing of the 44 essential and 122 commonly used antibiotics, overall and according to AWaRe classification group. We also evaluated and summarised the listing of both first-choice and second-choice treatments for the 31 priority infections. A total coverage score was calculated for each country by assigning a treatment score of 0-3 for each priority infection on the basis of whether first-choice and second-choice treatments, according to the 2019 WHO Model List, were included in the country's NEML. Coverage scores were then compared against the score of the 2019 WHO Model List and across World Bank income groups and WHO regions.
    Findings: As of July 7, 2020, we had up-to-date NEMLs for 138 countries. Of the 44 unique essential antibiotics, 24 were Access, 15 were Watch, and five were Reserve. The median number of total essential antibiotics listed across the 138 NEMLs was 26 (IQR 21-32). 102 (74%) countries listed at least 22 (50%) of the 44 essential antibiotics. The median number of total AWaRe antibiotics listed by the 138 countries was 35 (IQR 29-46), of Access antibiotics was 18 (16-21), of Watch antibiotics was 16 (11-22), and of Reserve antibiotics was one (0-2). 56 (41%) countries did not list any essential Reserve antibiotics. 131 (95%) countries had coverage scores of at least 60, equivalent to at least 75% of the score of the 2019 WHO Model List, which was 80. Nine (7%) countries listed fewer than 12 of 24 essential Access antibiotics, and seven (5%) did not list sufficient first-choice and second-choice treatments for priority infections (ie, they had coverage scores lower than 60). Of the 31 priority infections, acute neonatal meningitis and high-risk febrile neutropenia did not have enough listed treatments, with 82 (59%) countries listing no treatment for acute neonatal meningitis and 84 (61%) countries listing only a first-choice treatment, only a second-choice treatment, or no treatment for high-risk febrile neutropenia. Coverage scores differed between countries on the basis of World Bank income groups (p=0·025).
    Interpretation: Our findings highlight potential changes to the antibiotics included in NEMLs that would increase adherence to international guidance aimed at effectively treating infectious diseases while addressing antimicrobial resistance.
    Funding: Canadian Institutes of Health Research and Ontario Strategy for Patient Oriented Research Support Unit.
    MeSH term(s) Anti-Bacterial Agents/classification ; Anti-Bacterial Agents/therapeutic use ; Antimicrobial Stewardship ; Bacterial Infections/drug therapy ; Cross-Sectional Studies ; Databases, Pharmaceutical ; Drugs, Essential/classification ; Drugs, Essential/therapeutic use ; Humans ; World Health Organization
    Chemical Substances Anti-Bacterial Agents ; Drugs, Essential
    Language English
    Publishing date 2021-07-29
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2061641-7
    ISSN 1474-4457 ; 1473-3099
    ISSN (online) 1474-4457
    ISSN 1473-3099
    DOI 10.1016/S1473-3099(20)30854-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

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