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Ben Steffen Presented to the Maryland Health Quality and Cost Council September 19, 2014.
Background. Maryland’s approach to monitoring comprehensive adverse events monitoring OHCQ
MHCC, HSCRC Maryland Patient Safety Center. AE were categorized according to the discrete
time intervals during which the unintended outcome occurred. For example, the data evaluation was
conducted in two groups. Therefore, whether enrolled in a trial or not, ICU patients are particularly
likely to experience clinical events that fall within the definition of a serious adverse event. Gender
was limited to females in 10 studies and males in 1 study. Three types of victims of patient-related
adverse events can be identified. Prophylaxis of ThromboEmbolism in Critical Care Trials
(PROTECT): a pilot study. This article is an open access article distributed under the terms and
conditions of the Creative Commons Attribution (CC BY) license ( ). The labelling of a serious
adverse event should largely be limited to serious events that are not already labelled as primary,
secondary or tertiary outcomes yet which might reasonably occur as a consequence of the study
drug. For non-interventional or observational studies, events that are not serious need not be
reported. The research question is: What are the key elements of action immediately after AEs in
HCOs? 2. The PI must submit any reports regarding the event to the IRB, once available. The action
for second victims theme consisted of the following elements: second victim support types, coping
strategies, support protocols, changes after AEs and learning about AE phenomena ( Table 2 ).
Action after Adverse Events in Healthcare: An Integrative Literature Review. Int. J. Environ. Res.
Public Health 2020, 17, 4717. Khurshid Ahmad School of Computer Science and Statistics, Trinity
College Dublin, Ireland Wednesday 7 th April 2009 PALC 2009 Lodz, POLAND. 1.
Acknowledgements. AEs consist of complex systems of problems which often interact; thus, it is
important to deal with the phenomenon as a whole. The emotional responses were: feelings of guilt,
anxiety, re-living the event, tiredness, insomnia and persistent feelings of insecurity. When and how
should the information be provided to the HTA. After discussing relevant evaluation areas for a
comprehensive quality assessment, the research group added a further area: (10) strengths and
limitations. Constructive actions after an event can have a positive impact on the safety culture,
effectiveness of services and financial situation of the HCOs. Only peer reviewed research papers
were used in this review. Aims and outcomes. Provide definitions of Serious Adverse Events and
Reactions (SAEARs) What are the criteria for reporting SAEARs. The aims of the study, research
methods, findings, scores and scope of the action after AEs were presented. In this literature review,
we compared adverse effects from the HPV vaccine versus control injection from a compilation of
published randomized controlled trials. Almost 40% of the respondents had previously heard the
term second victim; 30% have had personal problems within the past 12 months, such as anxiety,
depression or concerns about their ability to perform their jobs. Most of them experienced more
support from colleagues than from their manager or department chair. Do not give any personal
information because we cannot reply to you directly. Do not give any personal information because
we cannot reply to you directly. Manual for Expedited Reporting of Adverse Events to DAIDS
(Version 2.0) DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events,
Corrected Version 2.1, dated July 2017.
Liukka, Mari, Alison Steven, M Flores Vizcaya Moreno, Arja M Sara-aho, Jayden Khakurel, Pauline
Pearson, Hannele Turunen, and Susanna Tella. System-wide developments are needed regarding
action after AEs, along with the implementation of evidence-based organisational infrastructures and
strategies which could ameliorate the suffering of patients, their families and healthcare providers, as
well as help healthcare organisations (and ultimately nations) to use resources effectively. Years of
clinical trials by the pharmaceutical companies have materialized into two Food and Drug
Administration (FDA)-approved HPV vaccine. SUSAR- Serious Unexpected Serious Adverse
Reaction Definition. The aim is to identify the underlying elements required for damage preventing
and ameliorating actions following AEs in order to provide direction for development and future
investigation. The strategy and infrastructure of HCOs are crucial to managing action after AEs as
part of healthcare delivery. Rocha MD Find this author on Google Scholar Find this author on
PubMed Search for this author on this site Mary Jane Sayles RN Find this author on Google Scholar
Find this author on PubMed Search for this author on this site Simon Finfer MD Find this author on
Google Scholar Find this author on PubMed Search for this author on this site. SAEs Defined. Any
untoward medical occurrence that at any dose results in: Death Is life-threatening. Journal of Low
Power Electronics and Applications (JLPEA). Fisher Published by: NYU Press Series:
Anthropologies of American Medicine: Culture, Power, and Practice Imprint: NYU Press.
Governments should build a network of researchers and healthcare managers for developing the
study protocols and shared understanding of developing first, second and third victim support
system in healthcare organisations. In terms of the quality of the protocols, only a minority followed
part of the international resources. 16 Second and third victim. All articles published by MDPI are
made immediately available worldwide under an open access license. No special. Office of Research
Education and Regulatory Management. Objectives. Recognize Adverse Events and serious adverse
events Review FDA inspection findings related to adverse events Review regulations related to
adverse events. Editor’s Choice articles are based on recommendations by the scientific editors of
MDPI journals from around the world. Department of Health and Human Services Centers for
Disease Control and Prevention February 2003. The search, for example, from Scopus included
search terms “adverse event” AND “aftermath” OR “disclosure” with limits “in article, title,
keywords”, “published 2009 to 2018”, “article or review”, “English language” and “in journals”. We
advocate that academic trials involving medications commonly used in practice, whether or not for
an approved indication, should be considered differently than industry trials. In brief, no statistically
significant difference was observed between the vaccine group and control group. Elizabeth Dayag
IRB Administrator Naval Medical Center Portsmouth. Overview. Important definitions Review key
features of the NMCP Serious Adverse Events (SAE) Reporting Policy Questions and discussion. As
such, none of the events is definitively related to the study drug. Health-care professionals need more
clarity in policies. What to report? (you do not need to be certain, just suspicious!) ADRAC
encourages the reporting of all suspected adverse reactions to medicines, including vaccines, OTC
medicines, herbal, traditional or alternative remedies. Investigators have to report to their IRB,
sponsors and others. Bleeding during critical illness: a prospective cohort study using a new
measurement tool. Liukka, M.; Steven, A.; Vizcaya Moreno, M.F.; Sara-aho, A.M.; Khakurel, J.;
Pearson, P.; Turunen, H.; Tella, S. Safety and immunogenicity of a quadrivalent human
papillomavirus (types 6, 11, 16, and 18) vaccine in HIV-infected children 7 to 12 years old. Managing
the aftermath of AEs well can be assumed to have positive consequences for first and second
victims’ health, behaviour and economic well-being. The articles retrieved were distributed evenly,
and two researchers independently scored each paper using the tool.
HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. The DIRECT
(Dalteparin's Influence on REnally Compromised anti-Ten-A) Study. The strengths of this study
include an international researcher group involved with strong patient safety research, management
and education experience. Search methods, inclusion and exclusion criteria and search outcomes are
presented in Figure 1. The patient says that this is distressing and has been getting more severe.
Liukka M, Steven A, Vizcaya Moreno MF, Sara-aho AM, Khakurel J, Pearson P, Turunen H, Tella S.
Managers reported that a change in behaviour is necessary to improve patient safety culture.
Occurrence of vaccine and non-vaccine human papillomavirus types in adolescent Finnish females 4
years post-vaccination. The third victim elements consist of organisational action after adverse
events, strategy, infrastructure and training and open communication about adverse events. Error
reporting to patients was carried out by those with the strongest safety culture, under 50 years of age
and primary care staff. For example, the data evaluation was conducted in two groups. Dix etudes
impliquaient les femmes et une les hommes. We advocate that academic trials involving medications
commonly used in practice, whether or not for an approved indication, should be considered
differently than industry trials. With a compilation of previously published RCTs, we compared
adverse effects from the HPV vaccine versus control injection. The research question is: What are
the key elements of action immediately after AEs in HCOs? 2. After making a medical error nurses
had emotional responses, such as fear and disappointment. Attention to revealing an AE, open and
emphatic communication and complete, authentic apology to, and support of, first victims were
essential after AEs. Effect of intravenous corticosteroids on death within 14 days in 10 008 adults
with clinically significant head injury (MRC CRASH trial): randomised placebo controlled trial.
Thus, comprehensive preparation is important both to minimise harm to victims and to maintain the
functionality of HCOs. None of these experiences were liked with the injections. Online survey with
multiple-choice and open-ended items were sent to 842 resent nursing graduates 168 responses were
received. Thus, the vaccinations are safe preventative measures for both males and females. Clearly,
context is important; thus, the interpretation of serious adverse events will differ for trials of primary
prevention involving healthy citizens, for trials in the outpatient clinic setting and for trials involving
hospital inpatients. Please let us know what you think of our products and services. SAEs Defined.
Any untoward medical occurrence that at any dose results in: Death Is life-threatening. Articles
about AE reports were excluded when they were only about frequency of reports, or near misses and
did not present the whole process from AE to disclosure. Tropical Medicine and Infectious Disease
(TropicalMed). The evaluation areas included: (1) background; (2) aim and research questions; (3)
sample; (4) data collection; (5) data analysis; (6) results; (7) ethical issues; (8) reliability; and (9)
usefulness of the results. HPV types 16 and 18 have been implicated in cervical, anal, vaginal, and
vulvar cancers, while types 6 and 11 cause anogenital warts. An institutional review board dilemma:
responsible for safety monitoring but not in control.
HCPs perceived that information on measures for preventing another adverse event is inaccessible.
Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. The third victim
theme consisted of organisational action after AEs, strategy, infrastructure and training and open
communication about AEs. We advocate that academic trials involving medications commonly used
in practice, whether or not for an approved indication, should be considered differently than industry
trials. You will be told what to eat, when to eat, and when to sleep. NOTE: We only request your
email address so that the person you are recommending the page to knows that you wanted them to
see it, and that it is not junk mail. In this integrative review, second victim support programs were
under development work. These highly controlled studies bear little resemblance to real-world
conditions, and everyone involved is incentivized to game the system, ultimately making new drugs
appear safer than they really are. Use of this template is not required and other formats may be
acceptable. Three types of victims of patient-related adverse events can be identified. Launched in
1996 UK-wide confidential, voluntary anonymised scheme which aims to collect data on adverse
events of transfusion of blood and blood components, and to make recommendations to improve
transfusion safety Based at Manchester Blood Centre. Start-up Meeting March 25, 2010 Kingston,
ON. Procedures. Using Pfizer Products MUST follow Pfizer SAE reporting policies. Only peer
reviewed research papers were used in this review. Department of Health and Human Services
Centers for Disease Control and Prevention February 2003. First, the studies were read several times
and listed in a table to gain an understanding of the whole and the characteristics of the actions taken
after an AE. The PI must submit any reports regarding the event to the IRB, once available. When
and how should the information be provided to the HTA. Local adverse events are those experienced
by subjects enrolled by the investigator(s) at this institution or in the local community area. Close
attention was also given to the avoidance of double counting in order to avoid “skewing” the
findings. ISPRS International Journal of Geo-Information (IJGI). The coping strategies used by
second victims have an impact on their patients, colleagues and themselves. Submission of
Supporting Documents for VAERS Reports. Conclusion Following PRISMA guidelines, the
literature review rendered 13 randomized controlled trials comparing HPV vaccine to control. The
purpose of this integrative review is to synthesise existing knowledge on actions following AEs in
HCOs such as hospitals and primary care units. Organisational support services perceived as helpful,
especially peers, but there were fears over confidentiality. Marcelo Rocha, Mary Jane Sayles and
Francois Lauzier contributed substantially to the conception and design. These three themes
interweave tightly together, and we approach the themes from a healthcare organisation’s perspective
to outline the needs of first and second victims and how HCOs could respond to these. The search
strategy may have affected the number of different victim phenomena found vary. Thus,
communication is fundamental to occupational and patient safety. Abnormal laboratory values
should not be reported as adverse events; although any clinical consequences of the abnormality
should be reported as adverse events.
Veteran nurses were more likely to make constructive changes. Health-care professionals need more
clarity in policies. The effects of an AE on first, second and third victims include health-related,
functional and economic consequences. Defensive as well as constructive changes have been
reported in practice after adverse events. Kang LW, Crawford N, Tang ML, Buttery J, Royle J, Gold
M, et al. Start-up Meeting March 25, 2010 Kingston, ON. Procedures. Using Pfizer Products MUST
follow Pfizer SAE reporting policies. Strategies included support organised at the individual,
organisational, national or international levels. The diagram below shows the process steps for
submitting an adverse event report. An “action after AE” strategy needs to include a comprehensive
plan which attends to the interlinked complexity which often exists. The investigator had not
expected that such reactions would be triggered by the survey questions. Prophylactic quadrivalent
human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a
randomised double-blind placebo-controlled multicentre phase II efficacy trial. The DIRECT
(Dalteparin's Influence on REnally Compromised anti-Ten-A) Study. Editor’s Choice articles are
based on recommendations by the scientific editors of MDPI journals from around the world. Thus,
comprehensive preparation is important both to minimise harm to victims and to maintain the
functionality of HCOs. Managing the aftermath of AEs well can be assumed to have positive
consequences for first and second victims’ health, behaviour and economic well-being. The purpose
of this integrative review is to synthesise existing knowledge on actions following AEs in HCOs
such as hospitals and primary care units. Both authors read and approved the final manuscript. We
use cookies on our website to ensure you get the best experience. Events that are part of the natural
history of the primary disease process or expected complications of critical illness should not be
reported as serious adverse events. Results A search of PubMed articles for “human papillomavirus
vaccine” was used to identify all-type HPV clinical studies prior to October 2014. For example, if a
patient fulfilling an exclusion criterion was inadvertently enrolled in a trial and experienced a serious
adverse event, the event report should outline the circumstances, consequences and strategies put in
place to avoid such an error in the future. Marcelo Rocha, Mary Jane Sayles and Francois Lauzier
contributed substantially to the conception and design. Quadrivalent vaccine against human
papillomavirus to prevent anogenital diseases. Cause-specific mortality is usually assessed by central
adjudication, using calibrated duplicate independent data review by experts blinded to treatment
allocation. The first type includes patients and their families, the second type includes healthcare
professionals involved in an adverse event and the third type includes healthcare organisations in
which an adverse event occurs. Healthcare professionals reported a pattern of inadequate social
support after adverse event. Who are you, and why would you choose to take part in this kind of
study. For non-interventional or observational studies, events that are not serious need not be
reported. The most common AE was injection-site reactions, such as pain, erythema, and induration.
It is important not to forget the first victims outside this support.