Development and Inter-Rater Reliability of the Liverpool Adverse Drug Reaction Causality Assessment Tool

Gallagher, Ruairi M; Kirkham, Jamie J; Mason, Jennifer; Bird, Kim A; Williamson, Paula; Nunn, Anthony J; Turner, Mark A.; Smyth, Rosalind L; Pirmohamed, Munir

doi:10.1371/journal.pone.0028096

Cited by 184 publications

(225 citation statements)

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“…We found that families' accounts of how they linked symptoms to a medicine resembled the logic that underpins tools for assessing ADRs 53,188 in research and clinical practice. Participants noted temporal associations between a medicine's administration and the onset of symptoms, the receding of symptoms between doses and the absence of alternative explanations for symptoms.…”

Section: Perspectives On Communication About Adverse Drug Reactionsmentioning

confidence: 86%

“…53 Three investigators (RMG, JRB, KAB) independently assessed causality for all possible ADR cases. Agreement on causality category between all three investigators was taken as accepted consensus.…”

Section: Methodsmentioning

confidence: 99%

“…For ADRs with a high or uncertain probability that the reaction is due to an underlying disease, the causality outcome is 'possible' unless objective evidence of the causal ADR mechanism is available. 53 Our estimate for the overall incidence was based on the sum of probable and definite ADRs only, as these ADRs are deemed to have a low probability of the underlying disease being responsible for the reaction. Severity of ADRs was assessed by the researcher compiling the case report using the Hartwig scale.…”

Section: Adverse Drug Reactions In Hospitalised Childrenmentioning

confidence: 99%

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ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods

Smyth

Peak

Turner

et al. 2014

Programme Grants for Applied Research

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AimsTo comprehensively investigate the incidence, nature and risk factors of adverse drug reactions (ADRs) in a hospital-based population of children, with rigorous assessment of causality, severity and avoidability, and to assess the consequent impact on children and families. We aimed to improve the assessment of ADRs by development of new tools to assess causality and avoidability, and to minimise the impact on families by developing better strategies for communication.Review methodsTwo prospective observational studies, each over 1 year, were conducted to assess ADRs in children associated with admission to hospital, and those occurring in children who were in hospital for longer than 48 hours. We conducted a comprehensive systematic review of ADRs in children. We used the findings from these studies to develop and validate tools to assess causality and avoidability of ADRs, and conducted interviews with parents and children who had experienced ADRs, using these findings to develop a leaflet for parents to inform a communication strategy about ADRs.ResultsThe estimated incidence of ADRs detected in children on admission to hospital was 2.9% [95% confidence interval (CI) 2.5% to 3.3%]. Of the reactions, 22.1% (95% CI 17% to 28%) were either definitely or possibly avoidable. Prescriptions originating in the community accounted for 44 out of 249 (17.7%) of ADRs, the remainder originating from hospital. A total of 120 out of 249 (48.2%) reactions resulted from treatment for malignancies. Off-label and/or unlicensed (OLUL) medicines were more likely to be implicated in an ADR than authorised medicines [relative risk (RR) 1.67, 95% CI 1.38 to 2.02;p < 0.001]. When medicines used for the treatment of oncology patients were excluded, OLUL medicines were not more likely to be implicated in an ADR than authorised medicines (RR 1.03, 95% CI 0.72 to 1.48;p = 0.830). For children who had been in hospital for > 48 hours, the overall incidence of definite and probable ADRs based on all admissions was 15.9% (95% CI 15.0 to 16.8). Opiate analgesic drugs and drugs used in general anaesthesia (GA) accounted for > 50% of all drugs implicated in ADRs. The odds ratio of an OLUL drug being implicated in an ADR compared with an authorised drug was 2.25 (95% CI 1.95 to 2.59;p < 0.001). Risk factors identified were exposure to a GA, age, oncology treatment and number of medicines. The systematic review estimated that the incidence rates for ADRs causing hospital admission ranged from 0.4% to 10.3% of all children [pooled estimate of 2.9% (95% CI 2.6% to 3.1%)] and from 0.6% to 16.8% of all children exposed to a drug during hospital stay. New tools to assess causality and avoidability of ADRs have been developed and validated. Many parents described being dissatisfied with clinician communication about ADRs, whereas parents of children with cancer emphasised confidence in clinician management of ADRs and the way clinicians communicated about medicines. The accounts of children and young people largely reflected parents’ accounts. Clinicians described using all of the features of communication that parents wanted to see, but made active decisions about when and what to communicate to families about suspected ADRs, which meant that communication may not always match families’ needs and expectations. We developed a leaflet to assist clinicians in communicating ADRs to parents.ConclusionThe Adverse Drug Reactions In Children (ADRIC) programme has provided the most comprehensive assessment, to date, of the size and nature of ADRs in children presenting to, and cared for in, hospital, and the outputs that have resulted will improve the management and understanding of ADRs in children and adults within the NHS. Recommendations for future research: assess the values that parents and children place on the use of different medicines and the risks that they will find acceptable within these contexts; focusing on high-risk drugs identified in ADRIC, determine the optimum drug dose for children through the development of a gold standard practice for the extrapolation of adult drug doses, alongside targeted pharmacokinetic/pharmacodynamic studies; assess the research and clinical applications of the Liverpool Causality Assessment Tool and the Liverpool Avoidability Assessment Tool; evaluate, in more detail, morbidities associated with anaesthesia and surgery in children, including follow-up in the community and in the home setting and an assessment of the most appropriate treatment regimens to prevent pain, vomiting and other postoperative complications; further evaluate strategies for communication with families, children and young people about ADRs; and quantify ADRs in other settings, for example critical care and neonatology.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

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Section: Perspectives On Communication About Adverse Drug Reactionsmentioning

confidence: 86%

Section: Methodsmentioning

confidence: 99%

Section: Adverse Drug Reactions In Hospitalised Childrenmentioning

confidence: 99%

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ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods

Smyth

Peak

Turner

et al. 2014

Programme Grants for Applied Research

Self Cite

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“…Desta forma, apesar do algoritmo ser o indicado pela Organização Mundial de Saúde (OMS) para as análises de causalidade, seu uso em oncologia apresenta importantes limitações. Recentemente, outra ferramenta para analisar causalidade de RAM vem sendo utilizada, parecendo ser mais adequada para pacientes oncológicos [41][42][43] , porém, até o momento, o mesmo ainda não está validado para uso no Brasil.…”

Section: Discussionunclassified

Adverse drug reaction: a comparative analysis of protocols used for treatment of colorectal cancer

Melo¹,

Cardoso²,

Silva³

2017

Medicina (Ribeirão Preto)

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Modelo do estudo: Estudo de coorte. Objetivo: Analisar as reações adversas ocorridas em pacientes brasileiros com câncer colorretal submetidos ao tratamento quimioterápico com dois protocolos distintos, visando identificar os tipos e a severidade das alterações mais frequentes. Método: Foram avaliados 63 pacientes, que iniciaram tratamento entre junho de 2014 a maio de 2015 em uma instituição do Rio de Janeiro, subdivididos em dois grupos: protocolo mFOLFOX6 (esquema contendo oxaliplatina 85mg/m2, ácido folínico 400mg/m2 e 5-fluorouracil em infusão em bolus 400mg/m2 e contínua 2.400mg/ m2, n= 40) e protocolo FOLFIRI (esquema contendo irinotecano 180mg/m2, ácido folínico 400mg/m2 e 5-fluorouracil em infusão em bolus 400mg/m2 e contínua 2.400mg/m2, n= 23). Foram coletados do prontuário dados relacionados ao perfil demográfico e clínico dos pacientes, além de informações do tratamento realizado e das toxicidades manifestadas. As toxicidades foram classificadas quanto à gravidade (graus 1, 2, 3 e 4) e causalidade (definida, provável, possível e duvidosa). Resultados: Foi observada alta frequência de toxicidades em ambos os grupos, atingindo 92,5% dos pacientes com protocolo mFOLFOX6 e 95,6% com protocolo FOLFIRI. As toxicidades gastrointestinais e neurológicas foram as mais frequentes, independente do grupo. Ao comparar a ocorrência das reações intergrupos, houve diferença apenas para as toxicidades gastrointestinais (p=0,035). Em 17,5% dos pacientes do grupo mFOLFOX6 (n= 7) e em 8,7% do grupo FOLFIRI (n= 2) se observou toxicidades dos tipos 3 e 4, sendo estas classificadas como provável reação adversa aos medicamentos. Conclusão: As toxicidades foram mais variadas e frequentes no grupo mFOLFOX6 em comparação ao grupo FOLFIRI. Entretanto, não se observou diferença na severidade e na causalidade das reações ocorridas em ambos os grupos.

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“…The remainder of this article attempts to suggest a research agenda for the future of psychiatry. The recommendations for practicing clinicians are described in Table 5 (59)(60)(61)(62)(63)(64)(65)(66)(67)(68)(69)(70)(71).…”

Section: Learning From the Pastmentioning

confidence: 99%

Is psychiatry only neurology? Or only abnormal psychology? Déjà vu after 100 years

León

2014

Acta Neuropsychiatr.

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Forgetting history, which frequently repeats itself, is a mistake. In General Psychopathology, Jaspers criticised early 20th century psychiatrists, including those who thought psychiatry was only neurology (Wernicke) or only abnormal psychology (Freud), or who did not see the limitations of the medical model in psychiatry (Kraepelin). Jaspers proposed that some psychiatric disorders follow the medical model (Group I), while others are variations of normality (Group III), or comprise schizophrenia and severe mood disorders (Group II). In the early 21st century, the players’ names have changed but the game remains the same. The US NIMH is reprising both Wernicke’s brain mythology and Kraepelin’s marketing promises. The neo-Kraepelinian revolution started at Washington University, became pre-eminent through the DSM-III developed by Spitzer, but reached a dead end with the DSM-5. McHugh, who described four perspectives in psychiatry, is the leading contemporary representative of the Jaspersian diagnostic approach. Other neo-Jaspersians are: Berrios, Wiggins and Schwartz, Ghaemi, Stanghellini, Parnas and Sass. Can psychiatry learn from its mistakes? The current psychiatric language, organised at its three levels, symptoms, syndromes, and disorders, was developed in the 19th century but is obsolete for the 21st century. Scientific advances in Jaspers’ Group III disorders require collaborating with researchers in the social and psychological sciences. Jaspers’ Group II disorders, redefined by the author as schizophrenia, catatonic syndromes, and severe mood disorders, are the core of psychiatry. Scientific advancement in them is not easy because we are not sure how to delineate between and within them correctly.

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Development and Inter-Rater Reliability of the Liverpool Adverse Drug Reaction Causality Assessment Tool

Cited by 184 publications

References 21 publications

ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods

ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods

Adverse drug reaction: a comparative analysis of protocols used for treatment of colorectal cancer

Is psychiatry only neurology? Or only abnormal psychology? Déjà vu after 100 years

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