scholarly journals Risk Management Assessments of Anti-tuberculosis Adverse Drug Reaction: A Systematic Review

2021 ◽  
Vol 319 ◽  
pp. 01042
Author(s):  
Boubacar Traore ◽  
Gladys Tsoumbou Bakana ◽  
Samira Nani ◽  
Samira Hassoune

To improve adherence to treatment, quality of life of patients on anti-tuberculosis drugs, and prevent antibiotic resistance, we conducted this systematic review to support risk minimization actions. Methods: Medline, Scopus, and Web of Science were searched with a focus on adverse drug reactions. Two independent reviewers assessed the methodological quality of the included studies using criteria defined by the Newcastle Ottawa Scale. Results: Seven studies were included, and four risk management strategies were identified (psychological intervention, drug dose reduction with or without prescription of adjunctive drugs, drug switching, permanent or temporary drug discontinuation). The strategies adopted were dependent on the nature and severity of the adverse events. All drugs responsible for serious adverse effects were changed or discontinued. Conclusions: The results highlight the relatively low frequency of adverse events leading to permanent discontinuation of 1st-line anti-tuberculosis drugs, but also emphasize the high incidence of adverse events leading to permanent discontinuation of cycloserine.

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S446-S447
Author(s):  
M Khorshid Fasge ◽  
D Dorgham ◽  
A Sharobim ◽  
M Attia ◽  
M Hussein ◽  
...  

Abstract Background To perform a systematic review and meta-analysis to discuss the efficacy and safety of tofacitinib in patients with moderate to severe ulcerative colitis (UC). Methods We searched PubMed, Scopus, Web of Science, in addition to Cochrane Central, until May 2020 using relevant keywords. We included randomized controlled trials (RCTs) in addition to cohort studies that compared tofacitinib oral treatment versus placebo in patients with active UC, with a moderate to severe degree. Quality of included RCTs was assessed by the Cochrane risk of bias assessment tool, whereas the Newcastle-Ottawa scale was applied to assess for bias sources in included cohort studies. Data were pooled, after being extracted, from eligible articles in the review manager software, or the open meta-analyst software. Dichotomous outcomes were pooled as risk ratios (RR) under the fixed effect model, while continuous outcomes were pooled as standardized mean difference (SMD) under the random-effects model. Results pooling data from seven RCTs and four cohort studies, 2728 patients, showed that tofacitinib therapy was superior to placebo in inducing a clinical response in UC patients after eight weeks (p = 0.0001) and 26 weeks, in a proportion 0.4 of patients who took tofacitinib 10 mg BID. Additionally, tofacitinib treatment was associated with significantly higher events of clinical remission of UC, after eight weeks (RR= 3.12, 95% CI [2.34, 4.16], p < 0.0001). Likewise, endoscopic, deep, in addition to symptomatic remission rates were higher in the tofacitinib group, compared to the group of placebo (p ≤ 0.008). Most of the drug-related adverse events were comparable between tofacitinib and placebo groups. However, tofacitinib treatment was associated with fewer serious adverse events (RR= 0.68, 95% CI [0.48, 0.98], p = 0.04); adverse events that led to drug discontinuation (RR= 0.53, 95% CI [0.39, 0.73], p< 0.0001); and worsening of UC (RR= 0.48, 95% CI [0.38, 0.61], p < 0.00001). On the other hand, the placebo group had fewer overall infections (p = 0.002); and elevation in laboratory parameters, including LDL cholesterol, total cholesterol, and triglycerides. Conclusion Our systematic review and meta-analysis showed that, in patients with active moderate to severe UC, tofacitinib treatment was superior to placebo in inducing clinical response and remission, with less adverse reactions. Additionally, treatment with tofacitinib showed beneficial quality of life and survival benefits for UC patients. Future clinical trials should study the effect of higher doses of tofacitinib in larger RCTs, with longer follow up periods.


2019 ◽  
Vol 19 (1) ◽  
pp. 615-647
Author(s):  
Leonardo Nogueira Melo ◽  
Vera Lúcia Freitas ◽  
Emanuel Pereira dos Santos ◽  
Raphael Dias de Mello Pereira ◽  
Vanessa Silva De Oliveira ◽  
...  

Objetivo: Evaluar, según la literatura, cuáles son los principales factores considerados facilitadores y/o agravantes en la realización del transporte de pacientes en estado crítico.Método: Este estudio se trata de una revisión sistemática realizada con el método PICOResultado: Los periódicos seleccionados comprendían un espacio temporal en los últimos diez años, donde 6 periódicos fueron elegibles, basado en los criterios establecidos. Los resultados relatan que los temas encontrados en esta revisión demuestran una alineación entre la práctica asistencial y la literatura, pero para que el transporte sea realizado sin eventos adversos, es necesario que haya unión entre la gestión y los profesionales involucrados.Conclusión: Aunque los hallazgos demuestren una gran preocupación en relación a la calidad en la asistencia y en la preparación del equipo, los autores creen que más estudios deben ser fomentados una vez que el trabajo en equipo, a pesar de ser complejo, es la clave para la realización de los procedimientos con efectividad. Objective: To evaluate, according to the literature, the main factors considered facilitators and/or aggravating in the transportation of patients in critical condition.Method: This study is a systematic review performed using the PICO method.Results: The selected journals comprised a time space in the last 10 years, with six journals eligible, based on the established criteria. The results report that the themes found in this review demonstrate an alignment between care practice and literature, but, for a transportation without adverse events, there must be a union between the management and the professionals involved.Conclusion: Although the findings demonstrate a great concern regarding the quality of care and team preparation, the authors believe that more studies should be encouraged since teamwork, despite being complex, is the key to performing the procedures with effectiveness. Objetivo: Avaliar segundo a literatura quais são os principais fatores que são considerados facilitadores e/ou agravantes na realização do transporte de pacientes em estado crítico.Método: Este estudo trata-se de uma revisão sistemática realizada com método PICOResultado: Os periódicos selecionados compreendiam um espaço temporal nos últimos dez anos, onde 6 periódicos foram elegíveis, baseado nos critérios estabelecidos. Os resultados relatam que os temas encontrados nesta revisão demonstram um alinhamento entre a prática assistencial e a literatura, porém para que o transporte seja realizado sem eventos adversos, é necessário que haja união entre a gestão e os profissionais envolvidos.Conclusão: Embora os achados demonstrem uma grande preocupação em relação à qualidade na assistência e no preparo da equipe, os autores acreditam que mais estudos devem ser fomentados uma vez que o trabalho em equipe apesar de ser complexo, é a chave para a realização dos procedimentos com efetividade.


BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030713 ◽  
Author(s):  
Dacheng Li ◽  
Li Zhu ◽  
Daming Liu

IntroductionRefractory gastro-oesophageal reflux disease (rGORD) is a common disease, affecting patients’ quality of life. Since conventional medicines have limitations, like low effective rates and adverse events, acupuncture may be a promising therapy for rGORD. While no related systematic review has been published, the present study is designed to evaluate the efficacy and safety of acupuncture for rGORD.Methods and analysisPubMed, the Cochrane Central Register of Controlled Trials and Chinese electronic databases, including China National Knowledge Infrastructure, Wan Fang database, VIP, SinoMed and the Chinese Clinical Trial Registry, will be searched from establishment of the database to 31 August 2019. There will be no limitations on language, and all articles will be screened and collected by two reviewers independently. RevMan V.5.3.5 software will be used for meta-analysis, and the conduction of study will refer to the Cochrane Handbook for Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol guidelines. The efficacy and safety of acupuncture for rGORD will be evaluated based on outcomes, including global symptom improvement, oesophageal sphincter function test measured by high-resolution manometry, quality of life, recurrence rate and adverse events.Ethics and disseminationThere is no necessity for this study to acquire an ethical approval, and this review will be disseminated in a peer-reviewed journal or conference presentation.Trial registration numberCRD42018111912.


2012 ◽  
Vol 12 (3) ◽  
pp. 243-260 ◽  
Author(s):  
Mark Wever ◽  
Nel Wognum ◽  
Jacques Trienekens ◽  
Onno Omta

The present study examines the management of transaction risks in supply chains. Risk management studies often ignore the wider supply chain context in which individual transactions take place. However, risk management strategies which are suitable to use when only a single transaction is considered may be inappropriate when other transactions in the supply chain are taken into account. This study addresses this issue by examining: (1) how risks arise as a result of interdependencies between the various transactions making up the supply chain; and (2) what types of contractual-based strategies actors can use to manage their risk exposure. To realize these aims, the study applies an extended Transaction Cost Economics (TCE) framework with a supply chain orientation. The framework illustrates how different types of interdependencies - pooled, sequential and reciprocal - expose companies to different sources of risk. Three strategies companies can use when facing barriers to risk minimization in sequentially interdependent supply chains are analyzed: risk transferring, risk altering and risk sharing. Examples from the agri-food sector are discussed to demonstrate the functioning of these strategies.


2019 ◽  
Vol 3 (1) ◽  
Author(s):  
Kevin Phan ◽  
Olivia Charlton ◽  
Saxon D. Smith

Abstract Background Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder which involves painful nodules and draining abscesses in flexural areas. Acne vulgaris and its more severe variants including acne conglobata and acne fulminans are also disorders involving the follicular unit. Given that follicular obstruction, dilatation and inflammation feature in both HS and acne vulgaris/conglobata, it has been suggested that HS is associated with acne vulgaris/conglobata. Methods The present systematic review and meta-analysis was performed according to recommended PRISMA guidelines. All eligible case-control studies comparing patients with HS vs non-HS were included in the present review. All studies must have included either the proportion of patients with acne vulgaris/conglobata in each group, or the summary effect size for association between HS and acne vulgaris/conglobata. The odds ratio (OR) was used as a summary statistic. Results From pooled unadjusted meta-analysis, we found a significantly higher proportion of patients with acne vulgaris/conglobata in HS cases compared to controls (OR 3.44, 95% CI 1.95–6.07, P < 0.0001, I2 = 100%). Pooled meta-analysis was also performed with adjusted effect sizes. This demonstrated that HS was significantly associated with acne vulgaris/conglobata after adjustment for potential confounders (OR 3.44, 95% CI 2.43–4.87, P < 0.00001, I2 = 99%). Conclusions In summary, a significant association was found between HS and acne vulgaris/conglobata. This has implications in terms of understanding the burden of disease on patient quality of life as well as consideration of optimal management strategies to target both disorders. Physicians taking care of patients with HS should be aware of this association.


BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015712 ◽  
Author(s):  
D Scott Kehler ◽  
Andrew N Stammers ◽  
Navdeep Tangri ◽  
Brett Hiebert ◽  
Randy Fransoo ◽  
...  

ObjectivesThe objective of this systematic review was to study the impact of preoperative physical activity levels on adult cardiac surgical patients’ postoperative: (1) major adverse cardiac and cerebrovascular events (MACCEs), (2) adverse events within 30 days, (3) hospital length of stay (HLOS), (4) intensive care unit length of stay (ICU LOS), (5) activities of daily living (ADLs), (6) quality of life, (7) cardiac rehabilitation attendance and (8) physical activity behaviour.MethodsA systematic search of MEDLINE, Embase, AgeLine and Cochrane library for cohort studies was conducted.ResultsEleven studies (n=5733 patients) met the inclusion criteria. Only self-reported physical activity tools were used. Few studies used multivariate analyses to compare active versus inactive patients prior to surgery. When comparing patients who were active versus inactive preoperatively, there were mixed findings for MACCE, 30 day adverse events, HLOS and ICU LOS. Of the studies that adjusted for confounding variables, five studies found a protective, independent association between physical activity and MACCE (n=1), 30-day postoperative events (n=2), HLOS (n=1) and ICU LOS (n=1), but two studies found no protective association for 30-day postoperative events (n=1) and postoperative ADLs (n=1). No studies investigated if activity status before surgery impacted quality of life or cardiac rehabilitation attendance postoperatively. Three studies found that active patients prior to surgery were more likely to be inactive postoperatively.ConclusionDue to the mixed findings, the literature does not presently support that self-reported preoperative physical activity behaviour is associated with postoperative cardiac surgical outcomes. Future studies should objectively measure physical activity, clearly define outcomes and adjust for clinically relevant variables.RegistrationTrial registration numberNCT02219815. PROSPERO number CRD42015023606.


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