scholarly journals Prioritising recommendations following analyses of adverse events in healthcare: a systematic review

2020 ◽  
Vol 9 (4) ◽  
pp. e000843
Author(s):  
Kelly Bos ◽  
Maarten J van der Laan ◽  
Dave A Dongelmans
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Data Extraction ◽  
Data Sources ◽  
Cochrane Library ◽  
High Quality ◽  
Data Synthesis ◽  
Study Selection ◽  
Personal Opinion ◽  
User Friendly

PurposeThe purpose of this systematic review was to identify an appropriate method—a user-friendly and validated method—that prioritises recommendations following analyses of adverse events (AEs) based on objective features.Data sourcesThe electronic databases PubMed/MEDLINE, Embase (Ovid), Cochrane Library, PsycINFO (Ovid) and ERIC (Ovid) were searched.Study selectionStudies were considered eligible when reporting on methods to prioritise recommendations.Data extractionTwo teams of reviewers performed the data extraction which was defined prior to this phase.Results of data synthesisEleven methods were identified that are designed to prioritise recommendations. After completing the data extraction, none of the methods met all the predefined criteria. Nine methods were considered user-friendly. One study validated the developed method. Five methods prioritised recommendations based on objective features, not affected by personal opinion or knowledge and expected to be reproducible by different users.ConclusionThere are several methods available to prioritise recommendations following analyses of AEs. All these methods can be used to discuss and select recommendations for implementation. None of the methods is a user-friendly and validated method that prioritises recommendations based on objective features. Although there are possibilities to further improve their features, the ‘Typology of safety functions’ by de Dianous and Fiévez, and the ‘Hierarchy of hazard controls’ by McCaughan have the most potential to select high-quality recommendations as they have only a few clearly defined categories in a well-arranged ordinal sequence.

Recovery and Return to Activity Following Exertional Heat Stroke: Considerations for the Sports Medicine Staff

2007 ◽  
Vol 16 (3) ◽  
pp. 163-181 ◽  
Author(s):  
Brendon P. McDermott ◽  
Douglas J. Casa ◽  
Susan W. Yeargin ◽  
Matthew S. Ganio ◽  
Lawrence E. Armstrong ◽  
...  
Keyword(s):  
Data Extraction ◽  
Heat Stroke ◽  
Data Sources ◽  
Exertional Heat Stroke ◽  
Data Synthesis ◽  
Residual Symptoms ◽  
Study Selection ◽  
Initial Care ◽  
Type Data ◽  
Return To Activity

Objective:To describe the current scientific evidence of recovery and return to activity following exertional heat stroke (EHS).Data Sources:Information was collected using MEDLINE and SPORTDiscus databases in English using combinations of key words, exertional heat stroke, recovery, rehabilitation, residual symptoms, heat tolerance, return to activity, and heat illness.Study Selection:Relevant peer-reviewed, military, and published text materials were reviewed.Data Extraction:Inclusion criteria were based on the article’s coverage of return to activity, residual symptoms, or testing for long-term treatment. Fifty-two out of the original 554 sources met these criteria and were included in data synthesis.Data Synthesis:The recovery time following EHS is dependent on numerous factors, and recovery length is individually based and largely dependent on the initial care provided.Conclusion:Future research should focus on developing a structured return-to-activity strategy following EHS.

Effectiveness of Physical Therapy Treatments on Lateral Epicondylitis

2008 ◽  
Vol 17 (2) ◽  
pp. 119-136 ◽  
Author(s):  
Mohamed Kohia ◽  
John Brackle ◽  
Kenny Byrd ◽  
Amanda Jennings ◽  
William Murray ◽  
...  
Keyword(s):  
Physical Therapy ◽  
Treatment Options ◽  
Lateral Epicondylitis ◽  
Data Sources ◽  
Cochrane Library ◽  
Future Research ◽  
Data Synthesis ◽  
Study Selection ◽  
Type Data ◽  
Therapy Interventions

Objective:To analyze research literature that has examined the effectiveness of various physical therapy interventions on lateral epicondylitis.Data Sources:Evidence was compiled with data located using the PubMed, EBSCO, The Cochrane Library, and the Hooked on Evidence databases from 1994 to 2006 using the key words lateral epicondylitis, tennis elbow, modalities, intervention, management of, treatment for, radiohumeral bursitis, and experiment.Study Selection:The literature used included peer-reviewed studies that evaluated the effectiveness of physical therapy treatments on lateral epicondylitis. Future research is needed to provide a better understanding of beneficial treatment options for people living with this condition.Data Synthesis:Shockwave therapy and Cyriax therapy protocol are effective physical therapy interventions.Conclusions:There are numerous treatments for lateral epicondylitis and no single intervention has been proven to be the most efficient. Therefore, future research is needed to provide a better understanding of beneficial treatment options for people living with this condition.

Intranasal Glucagon: A New Way to Treat Hypoglycemic Emergencies

2020 ◽  
Vol 54 (8) ◽  
pp. 780-787
Author(s):  
Rachel N. Lowe ◽  
Jennifer M. Trujillo
Keyword(s):  
Adverse Events ◽  
English Language ◽  
Data Extraction ◽  
Severe Hypoglycemia ◽  
Data Synthesis ◽  
Language Studies ◽  
Study Selection ◽  
Free Treatment ◽  
Patients With Diabetes ◽  
Data Source

Objective: To review the safety, efficacy, and administration of intranasal (IN) glucagon for the management of hypoglycemia. Data Source: A literature search of PubMed/MEDLINE (1995 to November 2019) using the terms intranasal glucagon, nasal glucagon, glucagon, hypoglycemia treatment, and hypoglycemia management was completed. Study Selection and Data Extraction: English-language studies evaluating IN glucagon were evaluated. Data Synthesis: IN glucagon is a newly approved product for the treatment of hypoglycemia in patients with diabetes, 4 years and older. Administered as a 3-mg dose, it was shown to be noninferior to intramuscular (IM) glucagon. In comparison trials, more than 98% of hypoglycemic events were treated successfully with IN glucagon in both pediatric and adult patients. In simulated and real-world studies, IN glucagon was administered in less than a minute for the majority of scenarios. IM glucagon took longer to administer, ranging from 1 to 4 minutes, and often, patients did not receive the intended full dose. Nausea and vomiting, known adverse events for glucagon, as well as local adverse events were most commonly reported with IN glucagon. Relevance to Patient Care and Clinical Practice: IN glucagon is safe, effective, easy to use, and does not require reconstitution prior to use, which can lead to faster delivery in a severe hypoglycemic event. It does not require age- or weight-based dosing. This delivery method offers an option for someone who fears needles or is uncomfortable with injections. Conclusion: IN glucagon is a safe, effective, easy to use, needle-free treatment option for severe hypoglycemia.

Isoniazid-Associated Psychosis: Case Report and Review of the Literature

1993 ◽  
Vol 27 (2) ◽  
pp. 167-170 ◽  
Author(s):  
Karen A. Pallone ◽  
Morton P. Goldman ◽  
Matthew A. Fuller
Keyword(s):  
Case Report ◽  
English Language ◽  
Case Reports ◽  
Data Extraction ◽  
Data Sources ◽  
Review Of The Literature ◽  
Data Synthesis ◽  
Medline Search ◽  
Study Selection ◽  
Language Literature

Objective To describe a case of isoniazid-associated psychosis and review the incidence of this adverse effect. Data Sources Information about the patient was obtained from the medical chart. A MEDLINE search of the English-language literature published from 1950 to 1992 was conducted and Index Medicus was manually searched for current information. Study Selection All case reports describing isoniazid-associated psychosis were reviewed. Data Extraction Studies were evaluated for the use of isoniazid, symptoms of psychosis, onset of symptoms, and dosage of isoniazid. Data Synthesis The case report is compared with others reported in the literature. The incidence of isoniazid-associated psychosis is rare. Conclusions The mechanism of isoniazid-associated psychosis is uncertain. It appears that isoniazid was associated with the psychosis evident in our patient and in the cases reviewed.

scholarly journals Bevacizumab Treatment of Radiation-Induced Brain Necrosis: A Systematic Review

2021 ◽  
Vol 11 ◽  
Author(s):  
Guixiang Liao ◽  
Muhammad Khan ◽  
Zhihong Zhao ◽  
Sumbal Arooj ◽  
Maosheng Yan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Improvement ◽  
Data Extraction ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Gadolinium Enhancement ◽  
Brain Necrosis ◽  
Study Selection ◽  
Bevacizumab Treatment ◽  
Radiation Induced

BackgroundRadiation brain necrosis (RBN) is a serious complication in patients receiving radiotherapy for intracranial disease. Many studies have investigated the efficacy and safety of bevacizumab in patients with RBN. In the present study, we systematically reviewed the medical literature for studies reporting the efficacy and safety of bevacizumab, as well as for studies comparing bevacizumab with corticosteroids.Materials and MethodsWe searched PubMed, Cochrane library, EMBASE, and ClinicalTrials.gov from their inception through 1 March, 2020 for studies that evaluated the efficacy and safety of bevacizumab in patients with RBN. Two investigators independently performed the study selection, data extraction, and data synthesis.ResultsOverall, the present systematic review included 12 studies (eight retrospective, two prospective, and two randomized control trials [RCTs]) involving 236 patients with RBN treated who were treated with bevacizumab. The two RCTs also had control arms comprising patients with RBN who were treated with corticosteroids/placebo (n=57). Radiographic responses were recorded in 84.7% (200/236) of patients, and radiographic progression was observed in 15.3% (36/236). Clinical improvement was observed in 91% (n=127) of responding patients among seven studies (n=113). All 12 studies reported volume reduction on T1 gadolinium enhancement MRI (median: 50%, range: 26%–80%) and/or T2 FLAIR MRI images (median: 59%, range: 48%–74%). In total, 46 responding patients (34%) had recurrence. The two RCTs revealed significantly improved radiographic response in patients treated with bevacizumab (Levin et al.: p = 0.0013; Xu et al.: p < 0.001). Both also showed clinical improvement (Levin et al.: NA; Xu et al.: p = 0.039) and significant reduction in edema volume on both T1 gadolinium enhancement MRI (Levin et al.: p=0.0058; Xu et al.: p=0.027) and T2 FLAIR MRI (Levin et al.: p=0.0149; Xu et al.: p < 0.001). Neurocognitive improvement was significantly better after 2 months of treatment in patients receiving bevacizumab than in those given corticosteroids, as assessed by the MoCA scale (p = 0.028). The recurrence rate and side effects of the treatments showed no significant differences.ConclusionsPatients with RBN respond to bevacizumab, which can improve clinical outcomes and cognitive function. Bevacizumab appears to be more efficacious than corticosteroid-based treatment. The safety profile was comparable to that of the corticosteroids.

Mental Tools for Thinking About DNA Technologies in New Ways

2002 ◽  
Vol 126 (3) ◽  
pp. 263-265
Author(s):  
Robert Root-Bernstein ◽  
Michele Root-Bernstein
Keyword(s):  
Creative Thinking ◽  
Data Extraction ◽  
Data Sources ◽  
Biomedical Science ◽  
Biomedical Sciences ◽  
Data Synthesis ◽  
Recognition Pattern ◽  
The Arts ◽  
Study Selection ◽  
Pattern Forming

Abstract Objective.—To investigate the nature of creative thinking in biomedical science with specific applications to molecular pathologies and DNA technologies. Data Sources.—Accounts of breakthroughs and inventions contained in autobiographies, biographies, interviews, and archival sources. Study Selection.—Discoveries that have altered, or may yet alter, basic textbook accounts of biomedical sciences for which appropriate data sources exist. Data Extraction.—Approximately 1000 data sources were analyzed, both within appropriate sciences and in other creative fields, such as the arts. Data Synthesis.—The current analysis is based on a framework described in our previous book, Sparks of Genius, which outlines a general approach to understanding creative thinking. Conclusions.—Creative thinking in all disciplines depends on a common mental “toolkit” that consists of 13 fundamental tools: observing, imaging, abstracting, pattern recognition, pattern forming, analogizing, body thinking, empathizing, dimensional thinking, modeling, playing, transforming, and synthesizing. Scientists recognize and solve problems by observing data that break the patterns established by theories; exploring a system by creating an abstract model with which they can play; and transforming data into feelings, sounds, and other forms that create surprising analogies to already-understood principles. The result of such personal thinking is knowledge combined with sensation and emotion—feeling and understanding synthesized into complete awareness. We illustrate some of these modes of thinking with reference to recent breakthroughs in DNA-related areas and suggest ways in which the use of “tools for thinking” can increase the probability of making further discoveries in the biomedical sciences.

Neuromuscular Excercise in Children with Down Syndrome. A Systematic Review

2022 ◽  
Author(s):  
Eliana-Isabel Rodríguez-Grande ◽  
Olga-Cecilia Vargas-Pinilla ◽  
Martha-Rocio Torres-Narvaez ◽  
Nelcy Rodríguez-Malagón
Keyword(s):  
Muscle Strength ◽  
Randomized Clinical Trials ◽  
Data Extraction ◽  
Cochrane Library ◽  
Exercise Frequency ◽  
Data Synthesis ◽  
Children With Down Syndrome ◽  
Maximum Resistance ◽  
Effective Interventions ◽  
Study Selection

Abstract Objective to evaluate the effects of neuromuscular exercise, specifying the parameters and characteristics of effective interventions to improve balance, muscle strength and flexibility in children with DS between the ages of 4 and 18 years. Data Sources: A search was carried out on PubMed, PEDro, EMBASE, SCIELO, Lilacs, Cochrane library. Study Selection: The search yielded 1384 eligible articles. Randomized clinical trials were selected, and that would have reported the effectiveness in the outcomes. Data Extraction: The methodology and results of the studies were critically appraised in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes guidelines. Data Synthesis: Ten studies were included. The interventions included mechanotherapy, vibration, and use of different unstable surfaces. The exercise frequency ranged from three days to five days a week, and the duration of each session was between six and 15 minutes. The frequency was between two and three times a week for 6 and 12 weeks and the intensity was between 60% and 80% of maximum resistance (MR). Conclusion neuromuscular exercise appears to be effective for the improvement of both lower limb and chest muscle strength and balance in children over 8 years of age.

scholarly journals Blinding Measured: A Systematic Review of Randomized Controlled Trials of Acupuncture

2013 ◽  
Vol 2013 ◽  
pp. 1-12 ◽  
Author(s):  
Alex Moroz ◽  
Brian Freed ◽  
Laura Tiedemann ◽  
Heejung Bang ◽  
Melanie Howell ◽  
...  
Keyword(s):  
Systematic Review ◽  
Data Extraction ◽  
Quantitative Measure ◽  
Data Synthesis ◽  
Study Selection ◽  
Potential Association ◽  
Number Of Patients ◽  
Study Characteristics ◽  
The Subject ◽  
Study Participants

Background.There is no agreement among researchers on viable controls for acupuncture treatment, and the assessment of the effectiveness of blinding and its interpretation is rare.Purpose.To systematically assess the effectiveness of blinding (EOB) in reported acupuncture trials; to explore results of RCTs using a quantitative measure of EOB.Data Sources.A systematic review of published sham RCTs that assessed blinding.Study Selection.Five hundred and ninety studies were reviewed, and 54 studies (4783 subjects) were included.Data Extraction.The number of patients who guessed their treatment identity was extracted from each study. Variables with possible influence on blinding were identified.Data Synthesis.The blinding index was calculated for each study. Based on blinding indexes, studies were congregated into one of the nine blinding scenarios. Individual study characteristics were explored for potential association with EOB.Limitations.There is a possibility of publication or reporting bias.Conclusions.The most common scenario was that the subjects believed they received verum acupuncture regardless of the actual treatment received, and overall the subject blinding in the acupuncture studies was satisfactory, with 61% of study participants maintaining ideal blinding. Objectively calculated blinding data may offer meaningful and systematic ways to further interpret the findings of RCTs.

FDA Policy on Unapproved Drug Products: Past, Present, and Future

2005 ◽  
Vol 39 (7-8) ◽  
pp. 1260-1264 ◽  
Author(s):  
Renu Chhabra ◽  
Mary E Kremzner ◽  
Brenda J Kiliany
Keyword(s):  
Data Extraction ◽  
Drug Regulation ◽  
Data Sources ◽  
Federal Regulations ◽  
Data Synthesis ◽  
Safety And Efficacy ◽  
Drug Products ◽  
The Past ◽  
Study Selection ◽  
History Of

OBJECTIVE To review the history of drug regulation by the Food and Drug Administration (FDA) as it relates to unapproved drugs and FDA policy, along with the FDA's efforts to avoid future incidents by amending and enforcing those policies that are already in place. DATA SOURCES Data from FDA history documents, FDA guidances, Code of Federal Regulations Title 21, and presentations by the FDA's Office of Compliance were gathered. STUDY SELECTION AND DATA EXTRACTION All information identified from the data sources was evaluated, and all information deemed relevant was included for this review. DATA SYNTHESIS Contrary to popular belief, there are drugs on the market that have not been evaluated for safety or efficacy by the FDA. For almost a century, the FDA has taken action against public health threats posed by unapproved drug products, and today's drugs and vaccines are required to demonstrate both safety and efficacy prior to marketing. The FDA has taken great strides to ensure the welfare of Americans by reacting to disasters that have occurred in the past and being proactive by setting regulations that will prevent such catastrophes from occurring in the future. CONCLUSIONS The FDA recognizes that drug regulation is an ongoing process and that, although we have come a long way, there is still much to be done.

Impact on Decisions to Start or Continue Medicines of Providing Information to Patients about Possible Benefits and/or Harms

2011 ◽  
Vol 31 (5) ◽  
pp. 767-777 ◽  
Author(s):  
Rachel A. Crockett ◽  
Stephen Sutton ◽  
Fiona M. Walter ◽  
Megan Clinch ◽  
Theresa M. Marteau ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Odds Ratio ◽  
Data Extraction ◽  
Decisional Conflict ◽  
Mean Difference ◽  
Data Sources ◽  
Inclusion Criteria ◽  
Data Synthesis ◽  
Study Selection ◽  
The Impact

Background. The impact of providing information about medicines to patients on decisions about starting or continuing them is unknown. Purpose. To estimate the impact on decisions to start or continue medicines, of providing information to patients about possible benefits and/or harms. Data Sources. Electronic searches from 1980 to October 2010; reference and citation searches of included studies. Study Selection. Two investigators assessed studies' eligibility against inclusion criteria: randomized or pseudorandomized trials; participants older than 16 years and deciding for themselves; one group received information about possible benefits and/or harms of a potentially beneficial medicine, compared with another who did not; d) a measure of decision about starting or continuing a medicine. Data Extraction. One investigator extracted all data, checked by a second. Data Synthesis. Eight studies were included, covering a range of medicines. There was no consistent impact of interventions on decisions about whether to start or continue medicines (pooled odds ratio 1.08; 95% confidence interval [CI], 0.69–1.70; P = 0.74). Among those who received more information, knowledge was increased (pooled mean difference 8.47; 95% CI 2.17–14.77; P = 0.008), and decisional conflict was reduced (pooled mean difference -0.15; 95% CI -0.24 to -0.06; P = .001). Limitations. A small number of studies across different clinical contexts, of uncertain heterogeneity, were included. Conclusions. Providing information to patients about possible benefits and/or harms has no consistent effect on the number who decide to start or continue medicines, although it increases patients' knowledge and reduces their decisional conflict.

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