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.

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.

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.

Transporters and Their Impact on Drug Disposition

2005 ◽  
Vol 39 (6) ◽  
pp. 1097-1108 ◽  
Author(s):  
Paul M Beringer ◽  
Richard L Slaughter
Keyword(s):  
Patient Outcomes ◽  
Drug Disposition ◽  
Data Extraction ◽  
The Body ◽  
Pertinent Literature ◽  
Data Synthesis ◽  
Medline Search ◽  
Manual Search ◽  
Study Selection ◽  
The Impact

OBJECTIVE: To review the recent advances in knowledge about human transporters and their effect on drug disposition. DATA SOURCES: A MEDLINE search (1996–March 2005) was performed to identify pertinent literature on human transporters and their impact on drug disposition. Additional articles were identified from a manual search of the references of retrieved articles. STUDY SELECTION AND DATA EXTRACTION: Based on the identified studies, data were extracted on the impact of transporters on drug absorption, distribution, and elimination. DATA SYNTHESIS: The pharmacokinetic disposition of drugs is known to be influenced by metabolic enzymes, kidney function, and transporters. Recent research on human transporters has greatly advanced our understanding of their diversity and importance in drug disposition. In particular, members of the multidrug resistance family of transporters (MDR, MRP) are present in organs and tissues throughout the body and are known to significantly affect the absorption, distribution, and elimination of commonly prescribed drugs. A growing number of studies now demonstrate that alterations in transporter function as a result of drug interactions or genetic polymorphisms may explain a significant portion of the variability in treatment response for certain drugs. CONCLUSIONS: Human transporters contribute significantly to the pharmacokinetic disposition of drugs. Knowledge of substrates, inducers, and inhibitors of these transporters is necessary to ensure optimal patient outcomes.

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.

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.

scholarly journals Associations of tobacco retailer density and proximity with adult tobacco use behaviours and health outcomes: a meta-analysis

2021 ◽  
pp. tobaccocontrol-2021-056717
Author(s):  
Joseph G L Lee ◽  
Amanda Y Kong ◽  
Kerry B Sewell ◽  
Shelley D Golden ◽  
Todd B Combs ◽  
...  
Keyword(s):  
Health Outcomes ◽  
Tobacco Use ◽  
Data Extraction ◽  
Meta Analysis ◽  
Grey Literature ◽  
Inclusion Criteria ◽  
Data Synthesis ◽  
Literature Searches ◽  
Adult Participants ◽  
Study Selection

ObjectiveWe sought to conduct a systematic review and meta-analysis of evidence to inform policies that reduce density and proximity of tobacco retailers.Data sourcesTen databases were searched on 16 October 2020: MEDLINE via PubMed, PsycINFO, Global Health, LILACS, Embase, ABI/Inform, CINAHL, Business Source Complete, Web of Science and Scopus, plus grey literature searches using Google and the RAND Publication Database.Study selectionIncluded studies used inferential statistics about adult participants to examine associations between tobacco retailer density/proximity and tobacco use behaviours and health outcomes. Of 7373 studies reviewed by independent coders, 37 (0.5%) met inclusion criteria.Data extractionEffect sizes were converted to a relative risk reduction (RRR) metric, indicating the presumed reduction in tobacco use outcomes based on reducing tobacco retailer density and decreasing proximity.Data synthesisWe conducted a random effects meta-analysis and examined heterogeneity across 27 studies through subgroup analyses and meta-regression. Tobacco retailer density (RRR=2.55, 95% CI 1.91 to 3.19, k=155) and proximity (RRR=2.38, 95% CI 1.39 to 3.37, k=100) were associated with tobacco use behaviours. Pooled results including both density and proximity found an estimated 2.48% reduction in risk of tobacco use from reductions in tobacco retailer density and proximity (RRR=2.48, 95% CI 1.95 to 3.02, k=255). Results for health outcomes came from just two studies and were not significant. Considerable heterogeneity existed.ConclusionsAcross studies, lower levels of tobacco retailer density and decreased proximity are associated with lower tobacco use. Reducing tobacco supply by limiting retailer density and proximity may lead to reductions in tobacco use. Policy evaluations are needed.

Applications of Flow Cytometry and Immunohistochemistry to Diagnostic Hematopathology

2004 ◽  
Vol 128 (9) ◽  
pp. 1004-1022 ◽  
Author(s):  
Cherie H. Dunphy
Keyword(s):  
Data Extraction ◽  
Data Sources ◽  
Data Synthesis ◽  
Flow Cytometric Immunophenotyping ◽  
Advantages And Disadvantages ◽  
Flow Cytometric ◽  
Study Selection ◽  
Molecular Studies ◽  
Reported Data

Abstract Objective.—Diagnostic hematopathology depends on the applications of flow cytometric immunophenotyping and immunohistochemical immunophenotyping combined with the cytomorphology and histologic features of each case. Select cases may require additional ancillary cytogenetic and molecular studies for diagnosis. The purpose of this review is to focus on the applications of flow cytometric and immunohistochemical immunophenotyping of paraffin-embedded tissue to diagnostic hematopathology. Advantages and disadvantages of these techniques are examined. Data Sources.—The literature is extensively reviewed (PubMed 1985–2003) with an emphasis on the most recent applications and those that are most useful clinically, both diagnostically and prognostically. Study Selection.—Studies were selected based on statistically significant results in large studies with reported adequate clinical follow-up. Data Extraction.—The methodology was reviewed in the selected studies to ensure reliable comparison of reported data. Data Synthesis.—Flow cytometric immunophenotyping offers the sensitive detection of antigens for which antibodies may not be available for paraffin immunohistochemical immunophenotyping. However, paraffin immunohistochemical immunophenotyping offers preservation of architecture and evaluation of expression of some proteins, which may not be available by flow cytometric immunophenotyping. These techniques should be used as complimentary tools in diagnostic hematopathology. Conclusions.—There are extensive applications of flow cytometric and immunohistochemical immunophenotyping to diagnostic hematopathology. As cytogenetic and molecular findings evolve in diagnostic hematopathology, there may be additional applications of flow cytometric and immunohistochemical immunophenotyping to this field of pathology.

Herbs for Benign Prostatic Hyperplasia

2002 ◽  
Vol 36 (9) ◽  
pp. 1443-1452 ◽  
Author(s):  
Lana Dvorkin ◽  
Kathy Y Song
Keyword(s):  
Benign Prostatic Hyperplasia ◽  
Adverse Effects ◽  
Data Extraction ◽  
Signs And Symptoms ◽  
Prostatic Hyperplasia ◽  
Data Sources ◽  
Data Synthesis ◽  
Study Selection ◽  
Herbal Therapies

OBJECTIVE: To review and evaluate the literature relative to the use of herbal therapies in the treatment of benign prostatic hyperplasia. DATA SOURCES: Literature was identified by MEDLINE, Embase, International Pharmaceutical Abstracts, and the International Bibliographic Information on Dietary Supplements searches and through cross-referencing of selected articles. STUDY SELECTION/DATA EXTRACTION: All articles identified from the data sources were evaluated and all information deemed relevant was included in this review. DATA SYNTHESIS: A large percentage of men >50 years old begin to experience signs and symptoms of benign prostatic hyperplasia (BPH). Herbs hold promise in the treatment of BPH. Serenoa repens, Pygeum africanum, Urtica dioica radix, and Cucurbita peponis semen are some of the botanical therapies used in the treatment of BPH. CONCLUSIONS: There are many European studies examining efficacy, dose, and adverse effects of these plants in the treatment of BPH. However, numerous questions remain. These include issues concerning long-term beneficial and adverse effects of herbal therapy, prevention of complications, standardization of extracts, and concomitant use with “mainstream” medications. Based on the information available today, these botanical therapies can be used for treatment of a number of objective and subjective symptoms in patients with BPH, stages I and II.

Narrative Review of Controversies Involving Vasopressin Use in Septic Shock and Practical Considerations

2020 ◽  
Vol 54 (7) ◽  
pp. 706-714
Author(s):  
Caroline Der-Nigoghossian ◽  
Drayton A. Hammond ◽  
Mahmoud A. Ammar
Keyword(s):  
Septic Shock ◽  
English Language ◽  
Data Extraction ◽  
Initial Therapy ◽  
Renal Protection ◽  
Data Synthesis ◽  
Study Selection ◽  
Consensus Statements ◽  
The Impact ◽  
Higher Doses

Objective: To summarize literature evaluating vasopressin use, focusing on clinical controversies regarding initiation, dosing, and discontinuation and interaction of vasopressin with other therapies in septic shock patients. Data Sources: A PubMed English-language literature search (January 2008 to December 2019) was performed using these terms: arginine vasopressin, septic, shock, and sepsis. Citations, including controlled trials, observational studies, review articles, guidelines, and consensus statements, were reviewed. Study Selection and Data Extraction: Relevant clinical data focusing on specific controversial questions regarding the utility of vasopressin in patients with septic shock were narratively summarized. Data Synthesis: Current literature does not strongly support the use of vasopressin as a first-line initial therapy for septic shock. Additionally, there are conflicting data for weight-based dosing of vasopressin in overweight patients. Evidence for vasopressin renal protection and interaction with corticosteroids is minimal. However, vasopressin has the ability to reduce catecholamine requirements in septic shock patients and may provide a mortality benefit in specific subgroups. Discontinuation of vasopressin last, not second to last, in resolving septic shock may reduce hypotension development. Relevance to Patient Care and Clinical Practice: This review addresses specific clinical controversies that drive vasopressin use in septic shock patients in real-world practice. Conclusion: Vasopressin should remain second-line adjunct to norepinephrine to augment mean arterial pressures. Dosing should be initiated at 0.03 U/min, and higher doses offer minimal benefit. There are conflicting data on the impact of weight on vasopressin response. Studies have failed to show renal benefit with vasopressin use or an interaction with corticosteroid therapy.

Sign in / Sign up

Export Citation Format

Share Document