Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: A Mixed Methods Study. (Preprint)

BACKGROUND Existing systems to document adverse drug events often use free text data entry, producing non-standardized, unstructured data prone to misinterpretation. Standardized terminology may improve data quality, but it is unclear which data standard is most appropriate to document adverse drug event symptoms and diagnoses. OBJECTIVE Our objective was to compare the utility, strengths, and weaknesses of different data standards for documenting adverse drug event symptoms and diagnoses. METHODS We performed a mixed-methods sub-study of a multicenter retrospective chart review. We reviewed research records of prospectively diagnosed adverse drug events at 5 Canadian hospitals. Two pharmacy research assistants independently entered symptoms and/or diagnoses for adverse drug events using 4 standards: MedDRA, SNOMED CT, SNOMED Adverse Reaction, and ICD-11. Disagreements between research assistants regarding case-specific utility of data standards were discussed until reaching consensus. We used consensus ratings to determine proportion of adverse drug events covered by a data standard, and coded and analyzed field notes from consensus sessions. RESULTS We reviewed 573 adverse drug events and found MedDRA and ICD-11 had excellent coverage of adverse drug event symptoms and/or diagnoses. While MedDRA had the highest number of matches between the research assistants, ICD-11 had the fewest. SNOMED ADR had the lowest proportion of adverse drug event coverage. Research assistants were most likely to encounter terminological challenges with SNOMED ADR and usability challenges with ICD-11, and least likely with MedDRA. CONCLUSIONS Usability, comprehensiveness, and accuracy are important features of data standards for documenting ADE symptoms and diagnoses. Based on our results, we would recommend the use of MedDRA.

Download Full-text

Adverse Drug Event Reporting From Clinical Care: Mixed-Methods Analysis for a Minimum Required Dataset (Preprint)

10.2196/preprints.10248 ◽

2018 ◽

Author(s):

David Peddie ◽

Serena S Small ◽

Katherin Badke ◽

Chantelle Bailey ◽

Ellen Balka ◽

...

Keyword(s):

Systematic Review ◽

Patient Safety ◽

Mixed Methods ◽

Adverse Drug Event ◽

Improve Patient Safety ◽

Clinical Care ◽

Drug Event ◽

Care Providers ◽

Event Reporting ◽

Improve Patient

BACKGROUND Patients commonly transition between health care settings, requiring care providers to transfer medication utilization information. Yet, information sharing about adverse drug events (ADEs) remains nonstandardized. OBJECTIVE The objective of our study was to describe a minimum required dataset for clinicians to document and communicate ADEs to support clinical decision making and improve patient safety. METHODS We used mixed-methods analysis to design a minimum required dataset for ADE documentation and communication. First, we completed a systematic review of the existing ADE reporting systems. After synthesizing reporting concepts and data fields, we conducted fieldwork to inform the design of a preliminary reporting form. We presented this information to clinician end-user groups to establish a recommended dataset. Finally, we pilot-tested and refined the dataset in a paper-based format. RESULTS We evaluated a total of 1782 unique data fields identified in our systematic review that describe the reporter, patient, ADE, and suspect and concomitant drugs. Of these, clinicians requested that 26 data fields be integrated into the dataset. Avoiding the need to report information already available electronically, reliance on prospective rather than retrospective causality assessments, and omitting fields deemed irrelevant to clinical care were key considerations. CONCLUSIONS By attending to the information needs of clinicians, we developed a standardized dataset for adverse drug event reporting. This dataset can be used to support communication between care providers and integrated into electronic systems to improve patient safety. If anonymized, these standardized data may be used for enhanced pharmacovigilance and research activities.

Download Full-text

The Role of the Clinical Pharmacist in an Irish University Teaching Hospital: A Mixed-Methods Study

Pharmacy ◽

10.3390/pharmacy8010014 ◽

2020 ◽

Vol 8 (1) ◽

pp. 14

Author(s):

Sarah Ronan ◽

Nicola Shannon ◽

Katie Cooke ◽

Trish McKeon ◽

Elaine K. Walsh ◽

...

Keyword(s):

Mixed Methods ◽

Cost Benefit ◽

Mixed Methods Study ◽

Drug Event ◽

Benefit Ratio ◽

Cost Avoidance ◽

Cost Benefit Ratio ◽

The Cost ◽

The Impact

Medication review (MR) is a vital part of the pharmacist’s role in hospital. However, in the South Infirmary Victoria University Hospital (SIVUH), Cork, Ireland, this has not been fully implemented due to resource issues. In addition, the cost of providing this service has not been evaluated. Moreover, it is not clear how other members of the multidisciplinary team e.g., Nurses, value any interventions made as a result of the MR. This mixed methods study assessed the impact of MR in terms of (i) potential clinical harm, (ii) cost avoidance and (iii) the views of nursing staff on the role of the pharmacist. The setting is a 192-bed, voluntary, acute hospital, in the Munster region of Ireland. Study I: The pharmacist provided MR to patients conventionally once a week. Any interventions were then assessed for potential clinical harm and to calculate cost avoidance. Study II: Semi-structured interviews, guided by a topic guide were completed with 12 nurses (11 female). Thematic analysis was used to code the main themes. Main outcome measure: To estimate the cost, cost avoidance, and the net cost benefit ratio of MR provided by pharmacists. Study I: Of 128 patients who received the MR, 113 interventions were made. The estimated cost of providing the MR was €2559 (senior pharmacist). Using €1084 as the cost of an adverse drug event (ADE), the cost avoidance was calculated at €42,330. This led to a net cost benefit of €39,771 (senior pharmacist) which equated to a net cost benefit ratio of 16.5:1. Study II: The main themes were (i) perceptions of pharmacy services, (ii) the role of the pharmacist—past, present and future, and (iii) teamwork and communication. Nurses expressed a desire to have more pharmacists present on the wards.

Download Full-text

Adverse Drug Event Reporting From Clinical Care: Mixed-Methods Analysis for a Minimum Required Dataset

JMIR Medical Informatics ◽

10.2196/10248 ◽

2018 ◽

Vol 6 (2) ◽

pp. e10248 ◽

Cited By ~ 4

Author(s):

David Peddie ◽

Serena S Small ◽

Katherin Badke ◽

Chantelle Bailey ◽

Ellen Balka ◽

...

Keyword(s):

Mixed Methods ◽

Adverse Drug Event ◽

Clinical Care ◽

Drug Event ◽

Event Reporting

Download Full-text

Determining Emotional Tone and Verbal Behavior in Patients With Tinnitus and Hyperacusis: An Exploratory Mixed-Methods Study

American Journal of Audiology ◽

10.1044/2019_aja-18-0136 ◽

2019 ◽

Vol 28 (3) ◽

pp. 660-672

Author(s):

Suzanne H. Kimball ◽

Toby Hamilton ◽

Erin Benear ◽

Jonathan Baldwin

Keyword(s):

Mixed Methods ◽

Verbal Behavior ◽

Coping Strategies ◽

Mixed Methods Study ◽

Self Report ◽

Anxiety And Depression ◽

Negative Consequences ◽

Emotional Tone ◽

Explanatory Mixed Methods ◽

Quantitative Results

Purpose The purpose of this study was to evaluate the emotional tone and verbal behavior of social media users who self-identified as having tinnitus and/or hyperacusis that caused self-described negative consequences on daily life or health. Research Design and Method An explanatory mixed-methods design was utilized. Two hundred “initial” and 200 “reply” Facebook posts were collected from members of a tinnitus group and a hyperacusis group. Data were analyzed via the LIWC 2015 software program and compared to typical bloggers. As this was an explanatory mixed-methods study, we used qualitative thematic analyses to explain, interpret, and illustrate the quantitative results. Results Overall, quantitative results indicated lower overall emotional tone for all categories (tinnitus and hyperacusis, initial and reply), which was mostly influenced by higher negative emotion. Higher levels of authenticity or truth were found in the hyperacusis sample but not in the tinnitus sample. Lower levels of clout (social standing) were indicated in all groups, and a lower level of analytical thinking style (concepts and complex categories rather than narratives) was found in the hyperacusis sample. Additional analysis of the language indicated higher levels of sadness and anxiety in all groups and lower levels of anger, particularly for initial replies. These data support prior findings indicating higher levels of anxiety and depression in this patient population based on the actual words in blog posts and not from self-report questionnaires. Qualitative results identified 3 major themes from both the tinnitus and hyperacusis texts: suffering, negative emotional tone, and coping strategies. Conclusions Results from this study suggest support for the predominant clinical view that patients with tinnitus and hyperacusis have higher levels of anxiety and depression than the general population. The extent of the suffering described and patterns of coping strategies suggest clinical practice patterns and the need for research in implementing improved practice plans.

Download Full-text

Self-contradicting attitudes and beliefs by emerging teachers on textbook use: A sequential explanatory mixed methods study

PsycEXTRA Dataset ◽

10.1037/e522252014-015 ◽

2014 ◽

Author(s):

Abel Diaz

Keyword(s):

Mixed Methods ◽

Mixed Methods Study ◽

Attitudes And Beliefs ◽

Textbook Use ◽

Explanatory Mixed Methods ◽

Sequential Explanatory

Download Full-text

Efficacy of the flipped classroom to teach play therapy: A mixed-methods study.

International Journal of Play Therapy ◽

10.1037/pla0000076 ◽

2018 ◽

Vol 27 (3) ◽

pp. 146-156 ◽

Cited By ~ 3

Author(s):

Elisabeth A. Counselman-Carpenter

Keyword(s):

Mixed Methods ◽

Play Therapy ◽

Flipped Classroom ◽

Mixed Methods Study

Download Full-text

EXPERIENCES, FRUSTRATIONS, AND BARRIERS, OF IPAD USAGE IN THE SPECIAL EDUCATION: LIFE SKILLS CLASSROOM FROM EDUCATORS PERSPECTIVE

Informatics and Education ◽

10.32517/0234-0453-2018-33-8-61-67 ◽

2018 ◽

pp. 61-67

Author(s):

D. J. Sullivan ◽

S. Labby ◽

A. Koptelov ◽

S. L. Sullivan

Keyword(s):

Special Education ◽

Mixed Methods ◽

Communication Systems ◽

Life Skills ◽

Mixed Methods Study ◽

Educational Tool ◽

Special Educator ◽

Communications Systems ◽

Communication Device ◽

Communication Devices

The purpose of this mixed methods study was to determine the barriers that special educator teachers encounter when using iPads within the Life Skills classroom. The research investigates the experiences, frustrations, and barriers through educators’ perceptions of iPad implementation. The influence of these issues suggests why iPad usage is not a device that special education classrooms are using in a widespread daily manner. Exploration of iPads as an educational tool and as a communication device is also discussed, along with considerations of other communications systems such as Picture Exchange Communication Systems and Alternative and Augmented Communication Devices is considered. Recommendations for further possible research are also discussed.

Download Full-text