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Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care.

ABSTRACT: PURPOSE:Little is known about adverse drug events (ADEs) experienced over time during chronic drug use. The purpose of this study was to assess ADE patterns experienced by patients with diabetes. METHODS:Patients who received an oral glucose-lowering drug completed a daily diary for 13 weeks. The diary asked for experienced symptoms and whether patients related these symptoms to any drug they used. Summaries of Product Characteristics were used to check whether the ADEs were known adverse drug reactions (ADRs) of the drugs used. Patterns of weekly occurring ADEs were assessed with descriptive statistics. RESULTS:We included 78 patients. Almost half of them reported at least one ADE (N = 36; 46%). In total, 80 ADEs were reported. Of these ADEs, 71 (90%) were known ADRs. ADEs lasted less than 1 week in 27 cases (34%) and between 2 and 12 weeks in 15 cases (19%). The remaining ADEs fluctuated (16 cases; 20%) or persisted (22 cases; 28%) during the entire study period. CONCLUSIONS:ADEs experienced by patients with diabetes can fluctuate or persist over long periods of drug use.

SUBMITTER: Denig P

PROVIDER: S-EPMC6771843 | biostudies-other | 2019 Sep

REPOSITORIES: biostudies-other

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Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care.

Denig Petra P van Puijenbroek Eugène P EP Soliman Nashwa N Mol Peter G M PGM de Vries Sieta T ST

Pharmacoepidemiology and drug safety 20190617 9

<h4>Purpose</h4>Little is known about adverse drug events (ADEs) experienced over time during chronic drug use. The purpose of this study was to assess ADE patterns experienced by patients with diabetes.<h4>Methods</h4>Patients who received an oral glucose-lowering drug completed a daily diary for 13 weeks. The diary asked for experienced symptoms and whether patients related these symptoms to any drug they used. Summaries of Product Characteristics were used to check whether the ADEs were known ...[more]

PMID: 31209934

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Project description:BackgroundThere is a high degree of variability in assessing the preventability of adverse drug events, limiting the ability to compare rates of preventable adverse drug events across different studies. We compared three methods for determining preventability of adverse drug events in emergency department patients and explored their strengths and weaknesses.MethodsThis mixed-methods study enrolled emergency department patients diagnosed with at least one adverse drug event from three prior prospective studies. A clinical pharmacist and physician reviewed the medical and research records of all patients, and independently rated each event's preventability using a "best practice-based" approach, an "error-based" approach, and an "algorithm-based" approach. Raters discussed discordant ratings until reaching consensus. We assessed the inter-rater agreement between clinicians using the same assessment method, and between different assessment methods using Cohen's kappa with 95% confidence intervals (95% CI). Qualitative researchers observed discussions, took field notes, and reviewed free text comments made by clinicians in a "comment" box in the data collection form. We developed a coding structure and iteratively analyzed qualitative data for emerging themes regarding the application of each preventability assessment method using NVivo.ResultsAmong 1356 adverse drug events, a best practice-based approach rated 64.1% (95% CI: 61.5-66.6%) of events as preventable, an error-based approach rated 64.3% (95% CI: 61.8-66.9%) of events as preventable, and an algorithm-based approach rated 68.8% (95% CI: 66.1-71.1%) of events as preventable. When applying the same method, the inter-rater agreement between clinicians was 0.53 (95% CI: 0.48-0.59), 0.55 (95%CI: 0.50-0.60) and 0.55 (95% CI: 0.49-0.55) for the best practice-, error-, and algorithm-based approaches, respectively. The inter-rater agreement between different assessment methods using consensus ratings for each ranged between 0.88 (95% CI 0.85-0.91) and 0.99 (95% CI 0.98-1.00). Compared to a best practice-based assessment, clinicians believed the algorithm-based assessment was too rigid. It did not account for the complexities of and variations in clinical practice, and frequently was too definitive when assigning preventability ratings.ConclusionThere was good agreement between all three methods of determining the preventability of adverse drug events. However, clinicians found the algorithmic approach constraining, and preferred a best practice-based assessment method.

Project description:BackgroundDiabetes mellitus is highly prevalent and associated with huge economic burden globally. The conventional care and management of diabetes mellitus is highly fragmented and complex, warranting the need for a comprehensive Collaborative Care Model (CCM). Little is known about the perception of patients with diabetes and their healthcare providers about CCM, its barriers and facilitators. This study aimed to explore the value of CCM in diabetes care at a primary healthcare (PHC) setting from the perspective of patients with diabetes and healthcare professionals (HCPs), in an effort to expand our current knowledge on collaborative care in diabetes at primary care level for the purpose of quality improvement and service expansion.MethodsUsing an exploratory case study approach, semi-structured interviews were conducted among patients and HCPs who encountered CCM in Qatar during 2019 and 2020. The semi-structured interviews were transcribed verbatim and the data were analysed and interpreted using a deductive-inductive thematic analysis approach.ResultsTwelve patients and 12 HCPs at a diabetes clinic participated in one-to-one interviews. The interviews resulted in five different themes: the process and components of collaborative care model (four subthemes), current organizational support and resources (three subthemes), impact of collaborative care model on diabetes outcomes (three subthemes), enablers of collaborative care model (three subthemes), and barriers to collaborative care model (three subthemes). The participants indicated easy access to and communication with competent and pleasant HCPs. The patients appreciated the extra time spent with HCPs, frequent follow-up visits, and health education, which empowered them to self-manage diabetes. HCPs believed that successful CCM provision relied on their interest and commitment to care for patients with diabetes. Generally, participants identified barriers and facilitators that are related to patients, HCPs, and healthcare system.ConclusionsThe providers and users of CCM had an overall positive perception and appreciation of this model in PHC settings. Barriers to CCM such as undesirable attributes of HCPs and patients, unsupportive hospital system, and high workload must be addressed before implementing the model in other PHC settings.

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Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care.

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Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care.

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