scholarly journals Using ActionADE to create information continuity to reduce re-exposures to harmful medications: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jeffrey P. Hau ◽  
Penelope M. A. Brasher ◽  
Amber Cragg ◽  
Serena Small ◽  
Maeve Wickham ◽  
...  

Abstract Background Repeat exposures to culprit medications are a common cause of preventable adverse drug events. Health information technologies have the potential to reduce repeat adverse drug events by improving information continuity. However, they rarely interoperate to ensure providers can view adverse drug events documented in other systems. We designed ActionADE to enable rapid documentation of adverse drug events and communication of standardized information across health sectors by integrating with legacy systems. We will leverage ActionADE’s implementation to conduct two parallel, randomized trials: patients with adverse drug reactions in the main trial and those diagnosed with non-adherence in a secondary trial. Primary objective of the main trial is to evaluate the effects of providing information continuity about adverse drug reactions on culprit medication re-dispensations over 12 months. Primary objective of the secondary trial is to evaluate the effect of providing information continuity on adherence over 12 months. Methods We will conduct two parallel group, triple-blind randomized controlled trials in participating hospitals in British Columbia, Canada. We will enroll adults presenting to hospital with an adverse drug event to prescribed outpatient medication. Clinicians will document the adverse drug event in ActionADE. The software will use an algorithm to determine patient eligibility and allocate eligible patients to experimental or control. In the experimental arm, ActionADE will transmit information to PharmaNet, where adverse drug event information will be displayed in community pharmacies when re-dispensations are attempted. In the control arm, ActionADE will retain information in the local record. We will enroll 3600 adults with an adverse drug reaction into the main trial. The main trial’s primary outcome is re-dispensation of a culprit or same-class medication within 12 months; the secondary trial’s primary outcome will be adherence to culprit medication. Secondary outcomes include health services utilization and mortality. Discussion These studies have the potential to guide policy decisions and investments needed to drive health information technology integrations to prevent repeat adverse drug events. We present an example of how a health information technology implementation can be leveraged to conduct pragmatic randomized controlled trials. Trial registration ClinicalTrials.gov NCT04568668, NCT04574648. Registered on 1 October 2020.

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Xiao-Li Chen ◽  
Bei-Lei Zhang ◽  
Chang Meng ◽  
Hui-Bin Huang ◽  
Bin Du

Abstract Objective Conservative oxygen strategy is recommended in acute illness while its benefit in ICU patients remains controversial. Therefore, we sought to conduct a systematic review and meta-analysis to examine such oxygen strategies’ effect and safety in ICU patients. Methods We searched PubMed, Embase, and the Cochrane database from inception to Feb 15, 2021. Randomized controlled trials (RCTs) that compared a conservative oxygen strategy to a conventional strategy in critically ill patients were included. Results were expressed as mean difference (MD) and risk ratio (RR) with a 95% confidence interval (CI). The primary outcome was the longest follow-up mortality. Heterogeneity, sensitivity analysis, and publication bias were also investigated to test the robustness of the primary outcome. Results We included seven trials with a total of 5265 patients. In general, the conventional group had significantly higher SpO2 or PaO2 than that in the conservative group. No statistically significant differences were found in the longest follow-up mortality (RR, 1.03; 95% CI, 0.97–1.10; I2=18%; P=0.34) between the two oxygen strategies when pooling studies enrolling subjects with various degrees of hypoxemia. Further sensitivity analysis showed that ICU patients with mild-to-moderate hypoxemia (PaO2/FiO2 >100 mmHg) had significantly lower mortality (RR, 1.24; 95% CI, 1.05–1.46; I2=0%; P=0.01) when receiving conservative oxygen therapy. These findings were also confirmed in other study periods. Additional, secondary outcomes of the duration of mechanical ventilation, the length of stay in the ICU and hospital, change in sequential organ failure assessment score, and adverse events were comparable between the two strategies. Conclusions Our findings indicate that conservative oxygen therapy strategy did not improve the prognosis of the overall ICU patients. The subgroup of ICU patients with mild to moderate hypoxemia might obtain prognosis benefit from such a strategy without affecting other critical clinical results.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Wynne E. Norton ◽  
Kirsty Loudon ◽  
David A. Chambers ◽  
Merrick Zwarenstein

Abstract Background First articulated by Schwartz and Lellouch (1967), randomized controlled trials (RCTs) can be conceptualized along a continuum from more explanatory to more pragmatic. The purpose and intent of the former is to test interventions under ideal contexts, and the purpose and intent of the latter is to test interventions in real-world contexts. The PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) is a validated tool that helps researchers make decisions about the elements of the trial to match the overall purpose and intent of the trial along the continuum. The PRECIS-2 tool has guided the design of hundreds of RCTs. However, a few aspects of the tool would benefit from greater clarity, including its application to provider-focused implementation trials rather than patient-focused intervention trials. Main text We describe the newly developed PRECIS-2-Provider Strategies (PRECIS-2-PS) tool, an extension of the PRECIS-2 tool, which has been adapted for trials testing provider-focused strategies. We elaborate on nine domains that can make a provider-focused trial more explanatory or more pragmatic, including eligibility, recruitment, setting, implementation resources, flexibility of provider strategies, flexibility of intervention, data collection, primary outcome, and primary analysis. We detail the complementary roles that researchers and stakeholders play in the trial design phase, with implications for generalizability of trial results to the contexts in which they are intended to be applied. Conclusions The PRECIS-2-PS tool is designed to help research and practice teams plan for provider-focused trials that reflect the overall intent and purpose of the trial. The tool has potential to help advance the science of provider-focused strategies across a range of trials, with the ultimate goal of facilitating the adoption, integration, and sustainability of provider-focused strategies outside the context of trials.


Author(s):  
Ahmad Shamabadi ◽  
Shahin Akhondzadeh

Abstract Pharmacotherapy is the conventional treatment for depression, with only half of the patients responding to the first trial of monotherapy with first-line medicines. One way to overcome this resistance is to use complementary and alternative medicine. The antidepressant effects of Lavandula angustifolia, which is commonly called lavender, have been investigated in previous studies. This study aims to provide the first systematic review of lavender in treating patients with depression diagnosis. ISI Web of Science, Scopus, PubMed, Embase, PsycINFO, Google Scholar, and three trial registries were searched until May 2020 to find randomized controlled trials on lavender for depressed patients. The primary outcome was difference between the intervention and control groups in changing depression scores from baseline to endpoint. The included studies were assessed for effect size and methodological quality. Seven clinical trials were identified, in which 852 patients were studied. In six trials, the effectiveness of lavender in treating depression was reported, as being more pronounced adjunct to a typical antidepressant in one study. Significant reported side effects include headaches and eructation. Lavender is beneficial, tolerable, and safe in treating depression. Despite obtaining promising results, they are not enough to recommend prescribing lavender to depressed patients. Further high-quality, large-scale studies for rectifying the shortcomings of existing studies are recommended.


2021 ◽  
Vol 13 (3) ◽  
pp. 75-81
Author(s):  
A. A. Tappakhov ◽  
T. E. Popova ◽  
A. I. Vasilev ◽  
T. G. Govorova ◽  
Yu. I. Khabarova ◽  
...  

Objective: to assess the predictors and prevalence of adverse drug reactions (ADRs) associated with antiparkinsonian drugs.Materials and methods. 18 clinical studies and randomized controlled trials were included in the analysis. We combined all registered ADRs for each drug and made direct comparisons with odds ratio (OR) and 95% confidence interval (95% CI) calculation.Results and discussion. Levodopa/benserazide (LB) had the best safety profile among levodopa drugs. Levodopa/carbidopa (LC) compared with LB was associated with more frequent development of nausea (OR=2.8; 95% CI: 1.51–5.21), aggravation of parkinsonism (OR=4.44; 95% CI: 2.12–9.28) and dizziness (OR=3.32; 95% CI: 1.5–7.33; p=0.002). Piribedil had the lowest number of ADRs among dopamine receptor agonists. Dizziness was more common with pramipexole and ropinirole than with levodopa (OR=1.82; 95% CI: 1.21–2.74 and OR=1.65; 95% CI: 1.11–2.44 respectively). Increased daytime sleepiness and peripheral edema have also been associated with pramipexole. Arterial hypertension was present in 9.6% of patients prescribed with piribedil. Amantadine compared with pramipexole was associated with a higher risk of hallucinations (OR=2.27; 95% CI: 1.24–4.12) and constipation (OR=2.40; 95% CI: 1.14–5.05). Patients prescribed with selegeline had higher odds of dizziness (OR=3.40; 95% CI: 1.76–6.55) and hallucinations (OR=4.30; 95% CI: 1.83–10.09) compared to rasagiline.Conclusion. Based on the results, we propose a diagram of the relationship between ADRs and their frequency with antiparkinsonian drugs. We hope that the study will find clinical application and allow neurologists to consider the effectiveness and the expected risks of ADRs in the treatment of PD.


2021 ◽  
Author(s):  
Erina Chan ◽  
Serena S Small ◽  
Maeve E Wickham ◽  
Vicki Cheng ◽  
Ellen Balka ◽  
...  

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.


2020 ◽  
pp. 107815522094193
Author(s):  
Eric P Borrelli ◽  
Conor G McGladrigan

Background Four new agents (elotuzumab, ixazomib, panobinostat, and daratumumab) were approved by the US Food and Drug Administration (FDA) in 2015 for the treatment of multiple myeloma. Our objective was to compare the safety profiles of these new medications in real-world settings and their randomized controlled trial(s). Material and methods An analysis was conducted of the FDA Adverse Event Reporting System (FAERS) for each drug consisting of the quarter that the drug received its FDA approval and the eight subsequent quarters. Reporting odds ratios and corresponding 95% confidence intervals were then calculated for each drug for each of the 10 most frequent adverse drug reactions. The randomized controlled trials that led to initial FDA approval for these medications were subsequently reviewed to assess the 10 most frequently reported adverse drug reactions in these trials. Results There were only two adverse drug reactions in the top 10 of both FAERS and its randomized controlled trials for elotuzumab (anaemia, diarrhoea) and for daratumumab (cough, back pain), five for ixazomib (diarrhoea, constipation, fatigue, nausea, peripheral neuropathy), and four panobinostat (diarrhoea, fatigue, nausea, constipation). Ixazomib had two adverse drug reactions with a significant reporting odds ratios greater than a 10-fold increased risk (plasma cell myeloma, peripheral neuropathy); elotuzumab had three adverse drug reactions (infusion site reaction, malignant neoplasm progression, deep vein thrombosis); daratumumab had three adverse drug reactions (infusion site reaction, bronchospasm, chills), while panobinostat had four (malignant neoplasm progression, decreased platelet count, diarrhoea, increased blood creatinine). Conclusion This analysis helps to highlight the importance of conducting postmarketing pharmacovigilance studies to better understand the potential adverse reactions of these medications.


2020 ◽  
Vol 100 (3) ◽  
pp. 523-542 ◽  
Author(s):  
Kristin L Campbell ◽  
Kendra Zadravec ◽  
Kelcey A Bland ◽  
Elizabeth Chesley ◽  
Florian Wolf ◽  
...  

Abstract Background Cancer-related cognitive impairment (CRCI), often called “chemo-brain” or “chemo-fog,” is a common side effect among adults with cancer, which can persist well after treatment completion. Accumulating evidence demonstrates exercise can improve cognitive function in healthy older adults and adults with cognitive impairments, suggesting exercise may play a role in managing CRCI. Purpose The purpose was to perform a systematic review of randomized controlled trials (RCTs) to understand the effect of exercise on CRCI. Data Sources Relevant literature was retrieved from CINAHL, Medline (Ovid), and EMBASE. Study Selection Eligible articles were RCTs that prescribed aerobic, resistance, combined aerobic/resistance, or mind-body (eg, yoga or Qigong) exercise during or following cancer treatment and included cognitive function outcome measures. Data Extraction Descriptive information and Cohen d effect sizes were directly extracted or calculated for included trials. Data Synthesis Twenty-nine trials were included in the final analysis. A statistically significant effect of exercise on self-reported cognitive function, both during and postadjuvant treatment, was reported in 12 trials (41%) (Cohen d range: 0.24–1.14), most commonly using the EORTC QLQ-C30. Ten trials (34%) performed neuropsychological testing to evaluate cognitive function; however, only 3 trials in women with breast cancer reported a significant effect of exercise (Cohen d range: 0.41–1.47). Limitations Few RCTs to date have evaluated the effect of exercise on CRCI as a primary outcome. Twenty-six trials (90%) in this review evaluated CRCI as secondary analyses. Conclusions Evidence supporting exercise as a strategy to address CRCI is limited. Future research evaluating CRCI as a primary outcome, including self-reported and objective measures, is needed to confirm the possible role of exercise in preventing and managing cognitive impairments in adults with cancer.


2019 ◽  
Vol 26 (3) ◽  
pp. 595-602
Author(s):  
Esra Kucuk ◽  
Aygin Bayraktar-Ekincioglu ◽  
Mustafa Erman ◽  
Saadettin Kilickap

Background Some studies in the literature describe drug-related problems in patients with cancer, although few studies focused on patients receiving targeted chemotherapy and/or immunotherapy. To identify the incidence of drug-related problems in patients receiving targeted chemotherapy and/or immunotherapy, and demonstrate the impact of a clinical pharmacist in an outpatient oncology care setting. Methods Prospective study was conducted in a hospital outpatient oncology clinic between October 2015 and March 2016. Patients greater than 18 years old receiving cetuximab, nivolumab, ipilimumab, or pembrolizumab were included in the study and monitored over a three-month period by a clinical pharmacist. Drug-related problems were analyzed using the Pharmaceutical Care Network Europe classification system. The main outcome measures were the frequency and causes of drug-related problems and the degree of resolution achieved through the involvement of a clinical pharmacist. Results A total of 54 patients (mean age: 57 ± 12 years) were included. There were 105 drug-related problems and 159 associated causes. Among the planned interventions (n = 149), 92 interventions were at the patient-level with 88 (96%) being accepted by the doctors. This resulted in 68 (65%) drug-related problems being completely resolved and 9 (8.6%) being partially resolved. The most common drug-related problem identified was “adverse drug event” (n = 38, 36%). Of the 105 drug-related problems, 63 (60%) related to targeted chemotherapy and/or immunotherapy with 34 (54%) classified as an “adverse drug event.” Conclusion Adverse drug events were the most common drug-related problems in patients with cancer. The involvement of a clinical pharmacist improved the identification of drug-related problems and helped optimize treatment outcomes in patients receiving targeted chemotherapy/immunotherapy.


Sign in / Sign up

Export Citation Format

Share Document