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Module 09: Discussion Module 09: DiscussionResearch the National Committee of BioEthics (NCBE) Implementing Regulations of the Law of Ethics of Research on Living Creatures in Saudi Arabia. National Committee of BioEthics (NCBE) Implementing Regulations of the Law of Ethics of Research on Living Creatures in Saudi Arabia. – Alternative FormatsSelect any of the many articles related to your profession or resonate with your student research topic. How could these guidelines be integrated to ensure the researcher’s adherence to these research regulations and protocols?Embed course material concepts, principles, and theories (which require supporting citations) in your initial response along with at least one scholarly, peer-reviewed journal article. Keep in mind that these scholarly references can be found in the Saudi Digital Library by conducting an advanced search specific to scholarly references. Use Saudi Electronic University academic writing standards and APA style guidelines.
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Annotated Bibliography on Patient Safety Culture
Name of Student
Institutional Affiliation
Course
Date
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Annotated Bibliography on Patient Safety Culture
Al‐Shaya, S., Al‐Reshidi, A., Farajat, M., & Elnefiely, A. (2021). The COVID‐19
outbreak in Saudi Arabia and the impact on patient safety incident reports: an
empirical study among the medical facilities of Qassim health cluster. Journal
of Healthcare Risk Management, 41(2), 4045. https://doi.org/10.1002/jhrm.21464
– The influence of COVID-19 on patient safety incident reporting at Saudi
Arabia’s Qassim Health Cluster is investigated in this study. Inpatient
admissions fell by 25% during the pandemic, which resulted in more incident
reports (30.6/100 inpatients). Medication, patient care, infection control, staff,
and facility upkeep are frequently cited problems. Curiously, the analysis
discovers no association between incidence volume and facility size.
-This study provides insightful information about COVID-19’s impact on
patient safety culture. It effectively highlights higher incident reporting rates
during the pandemic using empirical data, highlighting the significance of
active reporting cultures. However, because it needs to examine the underlying
causes thoroughly, healthcare organizations hoping to improve patient safety
in emergencies may find that it has limited practical implications.
Al-Surimi, K., Najjar, S., Al Quidaihi, A., & Masuadi, E. (2021). The impact of a
national accreditation program on patient safety culture in a tertiary hospital:
pre-and post-evaluation study. Global Journal on Quality and Safety in
Healthcare, 4(1), 18-26. https://doi.org/10.36401/JQSH-20-30
– This study examines how a significant public hospital’s patient safety culture
has changed due to Saudi Arabia’s national accrediting program. Three
hundred healthcare professionals participated in surveys performed before and
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after accreditation using a pre-and-post evaluation design. After accreditation,
improvements were seen in hospital handoffs, error communication, and
cooperation. The Patient Safety Culture’s Hospital Survey was used in the
study, which showed improvements in staff awareness and general perceptions
of safety.
-The study uses rigorous statistical analysis, a proven tool, and a careful
research technique. The high reaction rate enhances its dependability. The
single hospital emphasis could limit generalizability, and there are potential
limitations due to the need for long-term data. Despite these drawbacks, the
study contributes to understanding how accreditation affects patient safety
culture, highlighting its critical role in improving patient safety and healthcare
quality.
Ellis, L. A., Churruca, K., Tran, Y., Long, J. C., Pomare, C., & Braithwaite, J. (2020).
An empirical application of “broken windows” and related theories in
healthcare: examining disorder, patient safety, staff outcomes, and collective
efficacy in hospitals. BMC health services research, 20(1), 112. https://doi.org/10.1186/s12913-020-05974-0
– This study explores the use of the Broken Windows Theory in hospitals,
examining how chaos affects staff and patient outcomes. The Disorder and
Collective Efficacy Survey (DaCEs), used in this study’s Australian hospital
settings, is used to gauge disorder and collective efficacy. Findings show a
favorable relationship between staff burnout and social and physical disorder
but a negative relationship between job satisfaction and patient safety.
-This ground-breaking study applies BWT in a novel way to the healthcare
field, using a customized survey method and emphasizing the mediating role
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of collective efficacy. The research offers crucial insights into the complex
dynamics of disorder in hospital settings, notwithstanding its regional focus
and potential difficulties in theoretical translation. This study establishes a
crucial basis for improving patient safety culture and staff satisfaction in
hospitals worldwide by linking theory and healthcare practice.
Garcia, C. D. L., Abreu, L. C. D., Ramos, J. L. S., Castro, C. F. D. D., Smiderle, F. R.
N., Santos, J. A. D., & Bezerra, I. M. P. (2019). Influence of burnout on
patient safety: systematic review and meta-analysis. Medicina, 55(9),
553. https://doi.org/10.3390/medicina55090553
– This comprehensive research and meta-analysis examines the connection
between patient safety and burnout. The analysis of 21 research in the study,
which was done using the PubMed and Web of Science databases, revealed a
clear correlation between high levels of burnout and declining patient safety.
Burnout among health professionals is influenced by things like workload,
long hours, and dysfunctional interpersonal interactions. The meta-analysis
results show a strong correlation, highlighting the negative effects of burnout
on patient safety.
-This study, which uses reliable systematic review techniques, illuminates the
connection between burnout and patient safety, a crucial issue in healthcare. In
order to improve patient safety, it recognizes extrinsic variables that can
contribute to burnout, such as workload, and emphasizes the significance of
resolving professional tiredness. Although the meta-analysis shows a strong
association, the complexity of this relationship is highlighted by noting the
diverse results in the different research.
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Hata, T., Murao, H., Nakagami-Yamaguchi, E., Yamaguchi, Y., Eguchi, H.,
Nishihara, M., … & Katsumata, T. (2022). Factors affecting patient safety
culture in a university hospital under the universal health insurance system: A
cross-sectional study from
Japan. Medicine, 101(45). https://doi.org/10.1097%2FMD.0000000000031603
– This cross-sectional study explores the culture of patient safety in university
hospitals operating under a system of widespread health insurance. The two
topics that received the highest percentage of affirmative votes were
“Teamwork within units” (81%) and “Supervisor/manager expectations
promoting patient safety” (80%), while “Staffing” received the lowest
percentage of votes (36%).
-This study uses rigorous techniques, such as confirmatory factor analysis, to
gain an important understanding of patient safety culture. However, its
exclusive application to a single hospital might make it less generalizable. The
study’s findings highlight the critical link between workload, staffing, and
patient safety culture in the absence of worldwide comparisons, and they offer
crucial advice for healthcare professionals and politicians in universal health
insurance systems.
Haugen, A. S., Sevdalis, N., & Søfteland, E. (2019). Impact of the World Health
Organization surgical safety checklist on patient
safety. Anesthesiology, 131(2), 420425. https://doi.org/10.1097/ALN.0000000000002674
– The surgical safety checklist of WHO is implemented in this article, and its
effects on surgical complications and patient outcomes are investigated. It
highlights the challenges of checklist adoption in actual medical practices and
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emphasizes the requirement of thorough checklist usage and personalized
implementation tactics to improve patient safety in operating rooms.
-The study evaluates surgical safety checklists severely while admitting their
potential to lower mortality and complication rates. It underlines the value of
concentrated implementation efforts and the necessity of a safety-oriented
culture in healthcare settings. The assessment acknowledges achievements and
concerns, providing a balanced viewpoint on using checklist adoption in
raising the safety of patient.
Hessels, A. J., Paliwal, M., Weaver, S. H., Siddiqui, D., & Wurmser, T. A. (2019).
Impact of patient safety culture on missed nursing care and adverse patient
events. Journal of nursing care quality, 34(4), 287294. https://doi.org/10.1097%2FNCQ.0000000000000378
– This cross-sectional study investigates the connection between adverse
patient events, missing nurse care, and hospital patient safety culture (PSC).
The study, which involved 311 nurses in 29 units across five hospitals, found
that certain PSC dimensions substantially impact missing nursing care
associated with falls and adverse outcomes. The findings highlight the critical
link between organizational culture and patient safety and the urgent need to
improve PSC to reduce missed nurse care.
-The cross-sectional methodology of this study restricts the ability to draw
causal conclusions, even if it provides essential insights into the dynamics of
patient safety culture and its effect on patient outcomes. The study’s
dependence on self-reporting by nurses raises the possibility of bias.
Additionally, the study’s overall robustness is compromised by the absence of
thorough adjustment for relevant confounders.
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Hunt, J., Gammon, J., Williams, S., Daniel, S., Rees, S., & Matthewson, S. (2022).
Patient safety culture as a space of social struggle: understanding infection
prevention practice and patient safety culture within hospital isolation settingsa qualitative study. BMC Health Services Research, 22(1),
1446. https://doi.org/10.1186/s12913-022-08703-x
– This study examines the relationship between infection prevention in
isolation settings and patient safety culture within NHS hospitals. It examines
how the culture of patient safety is impacted by healthcare professionals’
participation in infection prevention procedures through Bourdieu’s lens.
Focus group interviews in two hospitals reveal various safety cultures amid
healthcare reform, illuminating the challenges of implementing efficient
isolation methods while protecting patient safety.
-This article explores infection control and patient safety culture using
Bourdieu’s theory to provide a new perspective. It adds depth to current
conversations by placing patient safety in social, cultural, and political
contexts. Focusing on isolated environments offers novel insights into a
critical but challenging element of healthcare. Focus group interviews, used in
the study’s qualitative methodology, deepen the analysis. However, the study’s
concentration on a particular geographic region poses a drawback regarding
the generalizability of findings.
Lee, S. E., Scott, L. D., Dahinten, V. S., Vincent, C., Lopez, K. D., & Park, C. G.
(2019). Safety culture, patient safety, and quality of care outcomes: a literature
review. Western journal of nursing research, 41(2), 279304. https://doi.org/10.1177/0193945917747416
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– This comprehensive literature analysis analyzes 17 papers from six databases
to explore the relationship between hospital safety culture and patient
outcomes. The analysis reveals inconsistencies, a need for more theoretical
frameworks, and methodological diversity. Surprisingly, many studies show
weak and erratic relationships between patient outcomes and safety culture,
highlighting the need for reliable frameworks and better research techniques to
further knowledge in this important domain.
-This study is a critical critique, calling for increased precision while
highlighting semantic discrepancies and methodological problems in earlier
research. Its analysis of erratic interactions emphasizes the need for robust
theoretical underpinnings and meticulous research methodologies. By
highlighting flaws, this evaluation transforms into a priceless tool that directs
future researchers toward more thorough studies and guarantees the growth of
patient safety culture studies.
Olsen, E., & Leonardsen, A. C. L. (2021). Use of the Hospital Survey of Patient
Safety Culture in Norwegian hospitals: A systematic review. International
Journal of Environmental Research and Public Health, 18(12),
6518. https://doi.org/10.3390/ijerph18126518
– This analysis of 20 HSOPSC-based research from Norway demonstrates the
difficulties in improving patient safety culture while highlighting HSOPSC
characteristics’ consistency over time. An important study showed that
comprehensive, long-term plans are necessary for successful changes.
Confirmatory factor analysis (CFA) and meticulous criterion-related validity
testing are encouraged by the necessity for methodological rigor. New
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HSOPSC variants that are adapted for various settings and place an emphasis
on strategic, nuanced interventions are suggested by the review.
-The research highlights the need for comprehensive, systemic reforms and
offers useful insights into the intricacies of the patient safety culture in
Norwegian hospitals. Methodological critiques guide upcoming research,
highlighting the value of thorough analysis methods. The review has greater
practical importance now that context-specific HSOPSC versions have been
found. However, the narrow scope raises concerns regarding generalizability,
highlighting the requirement for comparative research beyond Norway’s
healthcare system.
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References
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1
Vaccines: COVID-19 Vaccines and their Effects on Different Trial Groups globally
Annotated Bibliography
Ghady Alayad
Colorado State University – Global Campus, and Saudi Electronic University
HCM 505: Research Methodology in Health Care Management
Dr. Mary Moor
13 October, 2023
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Vaccines: COVID-19 Vaccines and their Effects on Different Trial Groups globally
Annotated Bibliography
Chemaitelly, H., AlMukdad, S., Ayoub, H. H., Altarawneh, H. N., Coyle, P., Tang, P., Yassine,
H. M., Al-Khatib, H. A., Smatti, M. K., Hasan, M. R., Al-Kanaani, Z., Al-Kuwari, E.,
Jeremijenko, A., Kaleeckal, A. H., Latif, A. N., Shaik, R. M., Abdul-Rahim, H. F.,
Nasrallah, G. K., Al-Kuwari, M. G., & Al-Romaihi, H. E. (2022). Covid-19 Vaccine
Protection among Children and Adolescents in Qatar. New England Journal of Medicine,
387(20), 1865–1876. https://doi.org/10.1056/nejmoa2210058
The authors of this study used three groups of retrospectives, and target-trial
methods to collect data, to compare the prevalence of COVID-19 in the vaccinated group
and the unvaccinated group in Qatar. The aim of this research study is to assess the
effectiveness of the BNT162b2 vaccine against Covid 19 in children 5 to 11 years old
and adolescents 12 to 17 years old. In the research, the first group was children 5 to 11
years old after the B.1.1.529 (omicron) variant spread. The second group is adolescents
12 to 17 years of age before the spread of the omicron variant, and the third group is
adolescents 12 to 17 years of age after the spread of the omicron variant. The vaccinated
group received a 10-μg dose of the BNT162b2 vaccine among children and a 30-μg dose
of the BNT162b2 vaccine among adolescents. The Cox proportional-hazards regression
model was used to compare percentages and statistics among the three trial groups.
Chin, E. T., Leidner, D., Lamson, L., Lucas, K., Studdert, D. M., Goldhaber-Fiebert, J. D.,
Andrews, J. R., & Salomon, J. A. (2022). Protection against Omicron from Vaccination
and Previous Infection in a Prison System. New England Journal of Medicine, 387(19),
1770–1782. https://doi.org/10.1056/nejmoa2207082
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The authors of this paper used a retrospective cohort design research to conduct
their study by collecting data from December 24, 2021, through April 14, 2022, which is
the period of the omicron outbreak. The research was focused on two high-risk groups:
the staff and residents of California State Prison. The aim of this study is to evaluate the
protection level by vaccination and previous infection against the omicron variant of
COVID-19. The Weighted Cox models were used to compare the effectiveness of
protection between the group who had a previous infection, secondly, the group who was
vaccinated before with two doses, and lastly the group who was vaccinated with a third
booster dose. Also, a rolling matched-cohort design was used as a secondary analysis
method to compare the effectiveness of two, and three doses of vaccination.
Dai, L., Gao, L., Tao, L., Hadinegoro, S. R., Erkin, M., Ying, Z., He, P., Girsang, R. T., Vergara,
H., Akram, J., Satari, H. I., Khaliq, T., Sughra, U., Celi, A. P., Li, F., Li, Y., Jiang, Z.,
Dalimova, D., Tuychiev, J., & Turdikulova, S. (2022). Efficacy and Safety of the RBDDimer–Based Covid-19 Vaccine ZF2001 in Adults. New England Journal of Medicine.
https://doi.org/10.1056/nejmoa2202261
The method used by researchers in this study was a randomized, double-blind,
placebo-controlled, phase 3 trial to investigate the efficacy and safety of the ZF2001
vaccine against COVID-19. The research was conducted at 31 clinical centers across
Uzbekistan, Indonesia, Pakistan, and Ecuador, and additionally, a center in China was
included in the safety analysis only. A random allocation of three 25 g doses, 30 days
apart from ZF2001 or placebo, was given to adult participants 18 years of age or older in
a 1:1 ratio. Symptomatic symptoms of the Covid19 that were confirmed in a polymerase
chain reaction assay not less than 7 days after initiation of 3 doses, were an important
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endpoint. Serious to critical COVID-19 events at least seven days after administration of
the 3rd dose were a crucial second efficacy endpoint.
Halasa, N. B., Olson, S. M., Staat, M. A., Newhams, M. M., Price, A. M., Pannaraj, P. S., Boom,
J. A., Sahni, L. C., Chiotos, K., Cameron, M. A., Bline, K. E., Hobbs, C. V., Maddux, A.
B., Coates, B. M., Michelson, K. N., Heidemann, S. M., Irby, K., Nofziger, R. A., Mack,
E. H., & Smallcomb, L. (2022). Maternal Vaccination and Risk of Hospitalization for
Covid-19 among Infants. New England Journal of Medicine.
https://doi.org/10.1056/nejmoa2204399
The method used by researchers in this study is a case-control test-negative design
to assess the effectiveness of maternal vaccination in pregnancy against hospitalization
for COVID-19 among infants aged less than 6 months; as they are considered at high risk
for Covid 19 and not eligible for vaccination. Researchers are trying to test if the
transplacental transfer of antibodies in vaccinated pregnant ladies can offer protection
against COVID-19 for infants. Researchers included infants hospitalized for COVID-19
(case infants) and infants hospitalized without COVID-19 (control infants) at 30 hospitals
in 22 states between July 1, 2021, and March 8, 2022. Researchers calculated vaccine
efficiency by comparing the likelihood of full maternal immunization (two doses of
mRNA vaccine) among case and control newborns during the B.1.617.2 (delta) and
B.1.1.529 (omicron) variants’ circulation.
Muñoz, F. M., Sher, L. D., Sabharwal, C., Gurtman, A., Xu, X., Kitchin, N., Lockhart, S.,
Riesenberg, R., Sexter, J. M., Czajka, H., Paulsen, G. C., Maldonado, Y., Walter, E. B.,
Talaat, K. R., Englund, J. A., Sarwar, U. N., Hansen, C., Iwamoto, M., Webber, C., &
Cunliffe, L. (2023). Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger
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than 5 Years of Age. New England Journal of Medicine, 388(7), 621–634.
https://doi.org/10.1056/nejmoa2211031
The method used by researchers in this study is an ongoing phase 2-3,
randomized, placebo-controlled trial to investigate the efficacy, safety, and
immunogenicity of the BNT162b2 vaccination in children aged 6 months to 4 years. The
BNT 162b2 vaccine (three dosages, 3 μg) was given as 2:1 ratio to give two injections,
21 days apart, to 1776 children aged 6 months to 2 years and 2750 children aged 2 to 4
years. A third dose was given at or after 60 days from the second dose. To check the
effectiveness of the vaccine, the ratio of the geometric mean titer (GMT) of neutralizing
antibodies against COVID-19 was used to compare children at 1 month after the third
vaccine dosage as opposed to the GMT at 1 month after the second dose of 30 μg for
people aged 16 to 25.
Pavord, S., Scully, M., Hunt, B. J., Lester, W., Bagot, C., Craven, B., Rampotas, A., Ambler, G.,
& Makris, M. (2021). Clinical Features of Vaccine-Induced Immune Thrombocytopenia
and Thrombosis. The New England Journal of Medicine.
https://doi.org/10.1056/NEJMoa2109908
The method used by researchers in this paper is a prospective cohort study. An
anonymous electronic method was used to collect data from hospitals in the United
Kingdom between March 22 and June 6, 2021. The aim of this research is to provide risk
factors, indicators, course of treatment, and information about the prognosis of VaccineInduced Immune Thrombocytopenia and Thrombosis (VITT) which is a new syndrome
associated with the Oxford-AstraZeneca Covid19 vaccine. Based on predetermined
criteria, incidents were classified as either definite or probable VITT. Researchers found
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170 definite and 50 probable cases of VITT among the 294 individuals that were
assessed. All of the patients showed up 5 to 48 days (median, 14) after receiving the first
dose of the ChAdOx1 nCoV-19 vaccine. There was no sex predominance and no clearcut medical risk factors, and the age range was 18 to 79 years (median, 48).
Pittet, L. F., Messina, N. L., Orsini, F., Moore, C. L., Abruzzo, V., Barry, S., Bonnici, R.,
Bonten, M., Campbell, J., Croda, J., Dalcolmo, M., Gardiner, K., Gell, G., Germano, S.,
Gomes-Silva, A., Goodall, C., Gwee, A., Jamieson, T., Jardim, B., & Kollmann, T. R.
(2023). Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care
Workers. New England Journal of Medicine, 388(17), 1582–1596.
https://doi.org/10.1056/nejmoa2212616
In this publication, the researchers’ method that was used is a multinational,
double-blind, randomized, placebo-controlled trial to assess the efficacy of the BCG
Denmark Vaccine against COVID-19 in Health Care Workers. A total of 3988
individuals were randomly assigned of which 1703 were in the BCG group and 1683
were in the placebo group. These healthcare workers have never tested positive for
COVID-19 and were assigned to receive a (0.1 ml) of BCG Denmark Vaccine
intradermally, be assessed after 6 months, and followed for 12 months.
Polack, F. P., Thomas, S. J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L.,
Pérez Marc, G., Moreira, E. D., Zerbini, C., Bailey, R., Swanson, K. A., Roychoudhury,
S., Koury, K., Li, P., Kalina, W. V., Cooper, D., Frenck, R. W., Hammitt, L. L., &
Türeci, Ö. (2020). Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. New
England Journal of Medicine, 383(27), 2603–2615.
https://doi.org/10.1056/nejmoa2034577
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The method used by researchers in this study is a multinational, placebocontrolled, observer-blinded, pivotal efficacy, randomized trial, in which people 16 years
of age or older were assigned in a 1:1 ratio to receive two doses, 21 days apart, of either
placebo or the BNT162b2 vaccine (30 μg per dose). There were 43,448 participants who
received intramuscular injections: 21,720 with BNT162b2 and 21,728 with placebo and
were followed for around 2 months to assess the efficacy of the vaccine.
Tan, S. H. X., Cook, A. R., Heng, D., Ong, B., Lye, D. C., & Tan, K. B. (2022). Effectiveness of
BNT162b2 Vaccine against Omicron in Children 5 to 11 Years of Age. New England
Journal of Medicine, 387(6), 525–532. https://doi.org/10.1056/nejmoa2203209
The method conducted by researchers in this study is data analysis from January
21, 2022, through April 8, 2022, for 255,936 children who were between the ages of 5 to
11 in Singapore during an outbreak of the omicron strain. The objective of this study is to
report on the efficacy of the BNT162b2 messenger RNA (mRNA) vaccine (PfizerBioNTech) against COVID-19 in 5 to 11-year-old children. Data were collected and
assessed among all, unvaccinated children, partially vaccinated, and fully vaccinated
children. From the incidence rate ratio of outcomes, the Poisson regression model was
utilized to evaluate vaccine effectiveness.
Winokur, P., Gayed, J., Fitz-Patrick, D., Thomas, S. J., Diya, O., Lockhart, S., Xu, X., Zhang,
Y., Bangad, V., Schwartz, H. I., Denham, D., Cardona, J. F., Usdan, L., Ginis, J., Mensa,
F. J., Zou, J., Xie, X., Shi, P.-Y., Lu, C., & Buitrago, S. (2023). Bivalent Omicron BA.1–
Adapted BNT162b2 Booster in Adults Older than 55 Years. New England Journal of
Medicine, 388(3), 214–227. https://doi.org/10.1056/nejmoa2213082
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The method used in this research is phase 3, a randomized trial to evaluate the
effectiveness of different sequences of BNT162b2 Booster vaccine against Omicron
BA.1 in Adults Older than 55 Years. 1846 participants were assigned to six treatment
groups to receive their fourth dose, and all participants had previously received three 30μg doses of the BNT162b2 vaccine. The six groups will receive the fourth dose as follow:
either 30 μg or 60 μg of BNT162b2, 30 μg or 60 μg of (monovalent BA.1 which is a new
adaptive vaccine), 30 μg or 60 μg of (bivalent BA.1 which is also new and adaptive
vaccine).
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