Relevant bibliographies by topics / Health decision-making process

Academic literature on the topic 'Health decision-making process'

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Published: 10 December 2022
Last updated: 19 February 2023

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Journal articles on the topic "Health decision-making process"

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VLAICU, Claudia. "DECISION MAKING PROCESS IN THE PANDEMIC CONTEXT. PSYCHOLOGICAL APPROACH." International Multidisciplinary Scientific Conference on the Dialogue between Sciences & Arts, Religion & Education 4, no. 1 (December 7, 2020): 142–47. http://dx.doi.org/10.26520/mcdsare.2020.4.142-147.

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The world is dealing with a health crisis unparalleled in this era that underscores a negative side of globalization. People have to face economic and psychological changes. The paper is intended to draw attention upon the importance of building emotional resilience to handle the actual crisis and its development. Thus, it analyses what the emotional reactions of people are when making decisions in such difficult contexts as this pandemic crisis. Specifically, each of the seven steps of the decision-making process are described along with the subsequent emotional reactions of the people (both as individuals and as part of an organization or team) involved in the process. The conclusion of the paper is that all reports that have been issued by governments of all countries rather urges to further decisions that should be made in three areas: economic support, Covid-19 testing and the lockdown. Therefore, the decisionmaking process seems to be rather a work in progress within this pandemic context. At the emotional level, every step is experienced differently. There is still a common emotion that seems to appear at all stages of the process and that is anxiety. Up to some point, anxiety is functional and useful. It is human and adaptive for a while. But beyond certain reasonable limits, however, it becomes exhausting and devastating
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Ikram, Krit, and Aftiss Ahmed. "The Role of Accounting Information in the Company’s Decision-Making Process." International Journal of Psychosocial Rehabilitation 24, no. 03 (February 18, 2020): 645–56. http://dx.doi.org/10.37200/ijpr/v24i3/pr200821.

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Frączkiewicz-Wronka, Aldona, Katarzyna Dyaczyńska, Karolina Szymaniec, and Przemysław Kotowski. "THE IMPACT AND IMPORTANCE OF STAKEHOLDERS OF THE HEALTH UNITS TO THE MANAGERIAL DECISION-MAKING PROCESS." Economics & Sociology 4, no. 1a (July 20, 2011): 148–65. http://dx.doi.org/10.14254/2071-789x.2011/4-1a/10.

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King, Barbara Lee. "Decision Making in the Intervention Process." Alcoholism Treatment Quarterly 3, no. 3 (December 19, 1986): 5–23. http://dx.doi.org/10.1300/j020v03n03_02.

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Benfield, Angela, and Robert B. Krueger. "Making Decision-Making Visible—Teaching the Process of Evaluating Interventions." International Journal of Environmental Research and Public Health 18, no. 7 (March 31, 2021): 3635. http://dx.doi.org/10.3390/ijerph18073635.

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Significant efforts in the past decades to teach evidence-based practice (EBP) implementation has emphasized increasing knowledge of EBP and developing interventions to support adoption to practice. These efforts have resulted in only limited sustained improvements in the daily use of evidence-based interventions in clinical practice in most health professions. Many new interventions with limited evidence of effectiveness are readily adopted each year—indicating openness to change is not the problem. The selection of an intervention is the outcome of an elaborate and complex cognitive process, which is shaped by how they represent the problem in their mind and is mostly invisible processes to others. Therefore, the complex thinking process that support appropriate adoption of interventions should be taught more explicitly. Making the process visible to clinicians increases the acquisition of the skills required to judiciously select one intervention over others. The purpose of this paper is to provide a review of the selection process and the critical analysis that is required to appropriately decide to trial or not trial new intervention strategies with patients.
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LOBONT, Oana Ramona, Sorana VATAVU, Daniel BRINDESCU OLARIU, Andrei PELIN, and Codruta CHIS. "E-Health Adoption Gaps in the Decision-Making Process." Revista de Cercetare si Interventie Sociala 65 (June 18, 2019): 389–403. http://dx.doi.org/10.33788/rcis.65.24.

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Castillo, Jonathan, Heidi Castillo, Lisa Ayoub-Rodriguez, Jeanine E. Jennings, Kareen Jones, Sara Oliver, Charles J. Schubert, and Thomas DeWitt. "The Resident Decision-Making Process in Global Health Education." Clinical Pediatrics 51, no. 5 (January 25, 2012): 462–67. http://dx.doi.org/10.1177/0009922811433555.

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Dolan, James G. "Medical Decision Making Using the Analytic Hierarchy Process." Medical Decision Making 9, no. 1 (February 1989): 51–56. http://dx.doi.org/10.1177/0272989x8900900109.

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Koyama, Fumiko, and Kumi Suzuki. "Process of Decision-Making of Anti-Cancer Treatment in Elderly Patients with Advanced Lung Cancer." Health 09, no. 12 (2017): 1644–59. http://dx.doi.org/10.4236/health.2017.912121.

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Simmons, M. B., and P. M. Gooding. "Spot the difference: shared decision-making and supported decision-making in mental health." Irish Journal of Psychological Medicine 34, no. 4 (October 23, 2017): 275–86. http://dx.doi.org/10.1017/ipm.2017.59.

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Respecting a person’s choices about the mental health services they do or do not use is a mark of quality support, and is often pursued for moral reasons, as a rights imperative and to improve outcomes. Yet, providing information and assistance for people making decisions about the mental health services can be a complex process, and has been approached in various ways. Two prominent approaches to this end are ‘shared decision-making’ and ‘supported decision-making’. This article considers each of these approaches, discussing points of similarity and difference and considering how the two might complement one another. By exploring the contribution that each approach can make, we conclude by proposing how future application of these approaches can account for the broader context of decisions, including support for ongoing decision-making; the multitude of service settings where decision-making occurs; and the diversity in supportive practices required to promote active involvement.
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Dissertations / Theses on the topic "Health decision-making process"

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Tzafettas, Marilena. "Women's decision making process regarding prenatal diagnostic testing." Thesis, London Metropolitan University, 2017. http://repository.londonmet.ac.uk/1244/.

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Objective: Expanding the original scope of the study, which was to explore the decision-making process of pregnant women in the uptake of invasive diagnostic tests - amniocentesis and Chorionic Villus Sampling (CVS) – and taking into account the latest emergence of a Noninvasive Prenatal Testing, NIPT, the primary goal of this study was to explore factors that influence women’s decision to have an invasive, a non-invasive or no further testing at all. Design and sample: The Prenatal Decision Making Questionnaire (PDMQ) developed for the purposes of this study. Following a pilot test and factor analysis, it was distributed to a population of pregnant women (N=421) prior to them receiving their combined screening results. The total sample was divided into three sub-groups according to their risk status (low-intermediate-high) for the analysis. Results. Logistic regression analysis using the R version 3.0.3 revealed that none of the PDMQ factors had a significant impact on women’s decision to have an invasive test (CVS), whereas the following three factors had a significant impact on the decision to have a non-invasive test (NIPT): negative attitude to doctors and an internal locus of control were associated with the uptake of NIPT, whereas a negative attitude to medicine was associated with rejection of NIPT When risk status was included in the model it was found that uptake of NIPT was predicted by the presence of some level of risk for T21 or T13/T18. On the contrary, uptake of CVS was only predicted by an increased risk for T21. Conclusion(s): Women’s decision making process in prenatal diagnosis is affected by several factors with personalised risk being one of the key determinants. The findings of this study can be used by healthcare professionals in providing the appropriate support and information and facilitating an informed decision during this stage of pregnancy.
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Bell, Mary Ann 1953. "Losing connections: A process of decision-making in late life suicidality." Diss., The University of Arizona, 2000. http://hdl.handle.net/10150/284294.

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Late life suicide is a major public health problem in the U.S. with elderly white men at highest risk of completed suicide. This grounded theory study explored individual perspectives of suicidality with men aged 67 to 83 years. A basic social psychological process, Losing Connections, was identified from interviews. Three stages of this process were identified during which the effect of cumulative losses culminated in depression, prompted suicidal ideation, and led to a decision point for the individual. Loss was the key theme in stage one. Relationship, health, and role losses were identified with professional role loss being the most prominent. The second stage was characterized by depression and despair during which suicidal ideation was prominent. Progressive alienation and the resolution to die characterized this phase. In stage three, the struggle between wanting to die and deciding to do so presented a decision point. The decision point was surrounded by a balance of triggers and barriers, which was modulated by ambivalence. The informant perceived they had reasons to die (triggers), but made the decision not to die because of perceived consequences (barriers). Triggers prompting the decision point were thoughts of a deceased spouse, emotional pain, health problems, and feelings of uselessness and/or hopelessness. The most common barrier to suicide was consequences to family members. Religion was not a significant barrier. Instead, there was a general lack of religious connections among informants. Likewise, social isolation was not prominent, as informants retained connections with family members, friends, and community.
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Mapis, Gachomo Joanne. "The Dietary Decision-Making Process of Women in Nigeria." ScholarWorks, 2020. https://scholarworks.waldenu.edu/dissertations/7696.

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Nigerians have been opting for a more processed Western diet. These changes in dietary choices have aligned with obesity and undernutrition, attributable to micronutrient deficiencies or malnutrition. Many scholars have presented varying intervention strategies ranging from consumption of a variety of foods containing the necessary micronutrients to food fortification. The purpose of this grounded theory study was to explore the perceptions of women in an urban city in Nigeria on indigenous foods and Western dietary influences to determine social interactions, the consequence of the interactions, and the women’s current perceptions of food choices. The social-ecological model was used to explore the interaction between a woman and her environment. Women between the ages of 20 to 30 from the urban city of Jos, Nigeria, constituted the population of interest, and 12 women were chosen for the sample. From the in-depth interviews, a thematic analysis was employed to provide sociocontextual reasoning for changes in diet that have led to the loss of interest in traditional foods and cultures. This study found that Jos has a variety of foods, yet women choose the same staple foods to feed their families. Additionally, despite a marginal understanding of the health impact of diet, most women choose the convenience and palatability of Western options, citing cost as the rationale for choosing to cook staple Western-inspired meals at home. Understanding media, convenience, and cost can impact social change by enlightening communities on the interconnectedness of human health, cultures, and industrialization. Health care providers can monitor the outcomes of those who consume a variety of indigenous foods to see how such a practice could influence the overall health status of Nigerian families.
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Quinonez, Bonnie. "Influence of Dual Process Decision-Making Theory in Patients Diagnosed With Cancer." Thesis, Walden University, 2017. http://pqdtopen.proquest.com/#viewpdf?dispub=10639411.

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Each year millions of people face the medical decision-making cycle that comes with a diagnosis of cancer. For patients and their families, this can be a rollercoaster of confusion and fear. Researchers have indicated that the complexity of the decision-making process is underrepresented in the current approach of informed decision-making. The purpose of this study was to add to scientifically-validated research expanding the identification of factors that influence decision-making for individuals diagnosed with cancer. Fuzzy trace theory (FTT) is the dual process memory theory used as the framework for this study. Qualitative data were collected using semistructured interviews with 10 participants. The sampling strategy included purposeful sampling and snowball or chain sampling. The audio-recorded interviews were transcribed and analyzed. Software tools were used to aid in the creation of word mapping and clusters and a naming structure emerged. A comprehensive thematic analysis was completed. Participants detailed experiences with family and social dynamics, psychological or emotional stress, external influencing factors to the decision-making process, and experiences with cancer advertising. This research can create positive social change through the advancement of scientifically-validated research to support patients during the decision-making process.

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Eisenberg, Dana J. "Information Amount and Patient Empowerment: Participation in the HPV Vaccination Decision-Making Process." Columbus, Ohio : Ohio State University, 2009. http://rave.ohiolink.edu/etdc/view?acc%5Fnum=osu1243830226.

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Greener, Judith Robin. "Contralateral Prophylactic Mastectomy: An Exploratory Approach to Understanding the Decision Making Process." Diss., Temple University Libraries, 2015. http://cdm16002.contentdm.oclc.org/cdm/ref/collection/p245801coll10/id/354121.

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Public Health
Ph.D.
The rate at which women choose mastectomy has grown dramatically, and of particular note is the increase in contralateral prophylactic mastectomy (CPM). For women with no history of breast cancer or genetic risk, CPM represents a treatment decision that does not offer better long-term outcomes than the decision not to remove a healthy breast and may be associated with increased surgical risk and interventions, increased cost to the healthcare system, and potential adverse psycho-social outcomes. To better understand the decision making process regarding the election of CPM among women with early stage unilateral breast cancer, with no family history or genetic risk, a three-phase exploratory study was conducted. Qualitative in-depth interviews were conducted with healthcare providers who have close interaction with women during the decision making process (N=3) and patients who made a surgical decision about breast cancer treatment within the past three years (N=11). These two phases informed the design of the quantitative internet survey, conducted among women diagnosed with early stage breast cancer in the process of making a surgical decision (N=336). The survey design was also guided by an existing model for treatment decision making which uses a social ecological framework (Revenson & Pranikoff, 2005). In addition to descriptive analyses, perceptual mapping was utilized to understand patients’ conceptualizations of the relative importance of factors considered during the decision making process, and AdSAM® was used to gauge emotional response. Results suggest that women more likely to elect CPM demonstrate an emotional response to a generalized fear of cancer, along with the need to take control of their situation. In addition, retrospective interviews emphasized somewhat different reasons for electing CPM, highlighting the importance of prospective research in studying the decision making process.
Temple University--Theses
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Quinonez, Bonnie D. "Influence of Dual Process Decision-Making Theory in Patients Diagnosed With Cancer." ScholarWorks, 2017. https://scholarworks.waldenu.edu/dissertations/4402.

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Each year millions of people face the medical decision-making cycle that comes with a diagnosis of cancer. For patients and their families, this can be a rollercoaster of confusion and fear. Researchers have indicated that the complexity of the decision-making process is underrepresented in the current approach of informed decision-making. The purpose of this study was to add to scientifically-validated research expanding the identification of factors that influence decision-making for individuals diagnosed with cancer. Fuzzy trace theory (FTT) is the dual process memory theory used as the framework for this study. Qualitative data were collected using semistructured interviews with 10 participants. The sampling strategy included purposeful sampling and snowball or chain sampling. The audio-recorded interviews were transcribed and analyzed. Software tools were used to aid in the creation of word mapping and clusters and a naming structure emerged. A comprehensive thematic analysis was completed. Participants detailed experiences with family and social dynamics, psychological or emotional stress, external influencing factors to the decision-making process, and experiences with cancer advertising. This research can create positive social change through the advancement of scientifically-validated research to support patients during the decision-making process.
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Puski, Athena Joy Bowen. "The Surgical and Management Decision-Making Process of BRCA1 and BRCA2 Mutation Carriers." The Ohio State University, 2016. http://rave.ohiolink.edu/etdc/view?acc_num=osu1459588788.

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Kier, Karen Leigh. "A study of the adaptive decision making ability of pharmacists' when patient counseling using a process-tracing technique /." The Ohio State University, 2000. http://rave.ohiolink.edu/etdc/view?acc_num=osu1488193665236376.

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Shi, Zhenzhen. "A MARKOV DECISION PROCESS EMBEDDED WITH PREDICTIVE MODELING: A MODELING APPROACH FROM SYSTEM DYNAMICS MATHEMATICAL MODELS, AGENT-BASED MODELS TO A CLINICAL DECISION MAKING." Diss., Kansas State University, 2015. http://hdl.handle.net/2097/20578.

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Doctor of Philosophy
Department of Industrial & Manufacturing Systems Engineering
David H. Ben-Arieh
Chih-Hang Wu
Patients who suffer from sepsis or septic shock are of great concern in the healthcare system. Recent data indicate that more than 900,000 severe sepsis or septic shock cases developed in the United States with mortality rates between 20% and 80%. In the United States alone, almost $17 billion is spent each year for the treatment of patients with sepsis. Clinical trials of treatments for sepsis have been extensively studied in the last 30 years, but there is no general agreement of the effectiveness of the proposed treatments for sepsis. Therefore, it is necessary to find accurate and effective tools that can help physicians predict the progression of disease in a patient-specific way, and then provide physicians recommendation on the treatment of sepsis to lower risk for patients dying from sepsis. The goal of this research is to develop a risk assessment tool and a risk management tool for sepsis. In order to achieve this goal, two system dynamic mathematical models (SDMMs) are initially developed to predict dynamic patterns of sepsis progression in innate immunity and adaptive immunity. The two SDMMs are able to identify key indicators and key processes of inflammatory responses to an infection, and a sepsis progression. Second, an integrated-mathematical-multi-agent-based model (IMMABM) is developed to capture the stochastic nature embedded in the development of inflammatory responses to a sepsis. Unlike existing agent-based models, this agent-based model is enhanced by incorporating developed SDMMs and extensive experimental data. With the risk assessment tools, a Markov decision process (MDP) is proposed, as a risk management tool, to apply to clinical decision-makings on sepsis. With extensive computational studies, the major contributions of this research are to firstly develop risk assessment tools to identify the risk of sepsis development during the immune system responding to an infection, and secondly propose a decision-making framework to manage the risk of infected individuals dying from sepsis. The methodology and modeling framework used in this dissertation can be expanded to other disease situations and treatment applications, and have a broad impact to the research area related to computational modeling, biology, medical decision-making, and industrial engineering.
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Books on the topic "Health decision-making process"

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McDermott, Rose. Presidential leadership, illness, and decision making. New York: Cambridge University Press, 2007.

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Policy making in Bangladesh: A study of the health policy process. Dhaka: A.H. Development Pub. House, 2004.

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Tribunals on trial: A study of decision-making under the Mental Health Act 1983. Oxford [England]: Clarendon Press, 1989.

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Insider's guide to environmental negotiation. Boca Raton, Fla: CRC Press, 1992.

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Gorczynski, Dale M. Insider's guide to environmental negotiation. Chelsea, MI: Lewis Publishers, 1991.

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1956-, Mace Chris, ed. The art and science of assessment in psychotherapy. London: Routledge, 1995.

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United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health. Scientific opportunities and public needs: Balancing NIH's priority setting process : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Eighth Congress, second session, June 2, 2004. Washington: U.S. G.P.O., 2004.

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Successful community leadership: A skills guide for volunteers and professionals. Washington, DC: National Association of Social Workers, 1997.

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H, Gustafson David, ed. Decision analysis for healthcare managers. Chicago: Health Administration Press, 2007.

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Blows, William T. The biological basis of nursing: Mental health. London: Routledge, 2003.

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Book chapters on the topic "Health decision-making process"

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Mason, Tom. "Decision-making process in seclusion practice." In Seclusion and Mental Health, 82–94. Boston, MA: Springer US, 1994. http://dx.doi.org/10.1007/978-1-4899-2969-3_6.

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Anchin, Jack C., and Jefferson A. Singer. "A dual process perspective on the value of theory in psychotherapeutic decision making." In Clinical decision making in mental health practice., 61–103. Washington: American Psychological Association, 2016. http://dx.doi.org/10.1037/14711-003.

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Sexton, Thomas L., and Adam R. Fisher. "Integrating ongoing measurement into the clinical decision-making process with measurement feedback systems." In Clinical decision making in mental health practice., 223–44. Washington: American Psychological Association, 2016. http://dx.doi.org/10.1037/14711-009.

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Narayanasamy, Melanie. "Handling Role Boundaries: A Basic Social Process Underpinning Decision-Making in Mental Health Teams." In Mental Health Uncertainty and Inevitability, 199–220. Cham: Springer International Publishing, 2017. http://dx.doi.org/10.1007/978-3-319-43970-9_8.

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Helmer, Axel, Frerk Müller, Okko Lohmann, Andreas Thiel, Friedrich Kretschmer, Marco Eichelberg, and Andreas Hein. "Integration of Smart Home Health Data in the Clinical Decision Making Process." In Biomedical Engineering Systems and Technologies, 354–66. Berlin, Heidelberg: Springer Berlin Heidelberg, 2014. http://dx.doi.org/10.1007/978-3-662-44485-6_24.

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Smith, Susan Anne. "Modelling the Discharge Decision-Making Process in the Domain of Mental Health Care." In Systems for Sustainability, 625–30. Boston, MA: Springer US, 1997. http://dx.doi.org/10.1007/978-1-4899-0265-8_103.

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Lefebvre, Patrick, Marie-Hélène Lafeuille, and Sean Tiggelaar. "Perspectives on the Common Drug Review Process at the Canadian Agency for Drugs and Technologies in Health." In Decision Making in a World of Comparative Effectiveness Research, 167–79. Singapore: Springer Singapore, 2017. http://dx.doi.org/10.1007/978-981-10-3262-2_13.

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Bortot, Silvia, and Mario Fedrizzi. "Medical Decision Making as a Group Choice Process: Consensual Dynamics in Fuzzy Diagnosis." In Fuzziness and Medicine: Philosophical Reflections and Application Systems in Health Care, 313–22. Berlin, Heidelberg: Springer Berlin Heidelberg, 2013. http://dx.doi.org/10.1007/978-3-642-36527-0_21.

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Vankova, Desislava, Sotir Sotirov, and Lyubka Doukovska. "An Application of Neural Network to Health-Related Quality of Life Process with Intuitionistic Fuzzy Estimation." In Uncertainty and Imprecision in Decision Making and Decision Support: Cross-Fertilization, New Models and Applications, 183–89. Cham: Springer International Publishing, 2017. http://dx.doi.org/10.1007/978-3-319-65545-1_17.

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Pelletier, Patrice M., François-Baptiste Cartiaux, and Valeria Fort. "Structural Health Monitoring at the Heart of the Decision-Making Process for Structural Asset Management." In Lecture Notes in Civil Engineering, 23–32. Cham: Springer International Publishing, 2021. http://dx.doi.org/10.1007/978-3-030-91877-4_3.

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Conference papers on the topic "Health decision-making process"

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Zhou, Yifan, Lin Ma, Joseph Mathew, Yong Sun, and Rodney Wolff. "Maintenance decision-making using a continuous-state partially observable semi-Markov decision process." In 2010 Prognostics and System Health Management Conference (PHM). IEEE, 2010. http://dx.doi.org/10.1109/phm.2010.5413427.

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Hummel, Marjan, and Maarten IJzerman. "THE PAST AND FUTURE OF THE AHP IN HEALTH CARE DECISION MAKING." In The International Symposium on the Analytic Hierarchy Process. Creative Decisions Foundation, 2011. http://dx.doi.org/10.13033/isahp.y2011.079.

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Max, Maximum. "Rapporteur summary: the potential for modeling the health care decision-making process." In SPIE Proceedings, edited by Warren S. Grundfest. SPIE, 1994. http://dx.doi.org/10.1117/12.195337.

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Teles, Germanno, Carina Oliveira, Reinaldo Braga, Luiz Andrade, Ronaldo Ramos, Paulo Cunha, and Mauro Oliveira. "Using Bayesian networks to improve the decision-making process in public health systems." In 2014 IEEE 16th International Conference on e-Health Networking, Applications and Services (Healthcom 2014). IEEE, 2014. http://dx.doi.org/10.1109/healthcom.2014.7001904.

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Marquard, Jenna L., Stefan C. Christov, Philip L. Henneman, Lori A. Clarke, Leon J. Osterweil, George S. Avrunin, Donald L. Fisher, et al. "Studying Rigorously Defined Health Care Processes Using a Formal Process Modeling Language, Clinical Simulation, Observation, and Eye Tracking." In 9th Bi-annual International Conference on Naturalistic Decision Making (NDM9). BCS Learning & Development, 2009. http://dx.doi.org/10.14236/ewic/ndm2009.32.

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Dohou, AM, A. Aynaz, VH Thierry, VB Françoise, D. Francis Moise, and D. Olivia. "4CPS-017 The decision-making process in health policy impacts clinical practices: a qualitative study." In 26th EAHP Congress, Hospital pharmacists – changing roles in a changing world, 23–25 March 2022. British Medical Journal Publishing Group, 2022. http://dx.doi.org/10.1136/ejhpharm-2022-eahp.69.

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Leite, Carla, and Ana Almeida. "e-Health Services to Support the Perinatal Decision-making Process: An Analysis of Digital Solutions to Create Birth Plans." In 15th International Conference on Health Informatics. SCITEPRESS - Science and Technology Publications, 2022. http://dx.doi.org/10.5220/0010814600003123.

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Худолеев, А. Ф., И. П. Акулич, М. М. Тихонов, and С. В. Акулич. "On the issue of improving the management decision-making process in emergency situations at the Belarusian nuclear power plant." In III International Scientific Forum "Health And Safety At The Workplace". Polikraft, 2019. http://dx.doi.org/10.31089/978-985-7153-76-3-2019-1-3-335-339.

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Petrone, Annamaria, Paolo Cherubin, and Luciano Scataglini. "A powerful approach for decision making in Risk Management process: BART tool and AHP methodology for ALARP demonstration." In International Conference on Health, Safety and Environment in Oil and Gas Exploration and Production. Society of Petroleum Engineers, 2012. http://dx.doi.org/10.2118/156521-ms.

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Xiaocui, Li, Wang Wei, Zhang Guanhong, and Pan Qunli. "A risk ranking method based on intuitionistic fuzzy group decision-making model in the process of risk management in equipment projects." In 2014 Prognostics and System Health Management Conference (PHM-2014 Hunan). IEEE, 2014. http://dx.doi.org/10.1109/phm.2014.6988207.

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Reports on the topic "Health decision-making process"

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Zachry, Anne, J. Flick, and S. Lancaster. Tune Up Your Teaching Toolbox! University of Tennessee Health Science Center, 2016. http://dx.doi.org/10.21007/chp.ot.fp.2016.0001.

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Occupational therapy (OT) educators strive to prepare entry-level practitioners who have the expertise to meet the diverse health care needs of society. A variety of instructional methods are used in the University of Tennessee Health Science Center (UTHSC) MOT program, including traditional lecture-based instruction (LBI), problem-based learning (PBL), team-based learning (TBL), and game-based learning (GBL). Research suggests that active learning strategies develop the critical thinking and problem-solving skills that are necessary for effective clinical reasoning and decision-making abilities. PBL, TBL, GBL are being successfully implemented in the UTHSC MOT Program to enhance the learning process and improve student engagement.
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Lenhardt, Amanda. Progress Towards Meaningful Women’s Participation in Conflict Prevention and Peacebuilding Decision-makingt prevention and peacebuilding decision-making. Institute of Development Studies, December 2021. http://dx.doi.org/10.19088/k4d.2022.044.

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The Women, Peace and Security or Gender Peace and Security (WPS/GPS) agenda has expanded significantly over the 20+ years of concerted efforts at many levels to expand the role of women in conflict resolution and peacebuilding. Yet many authors note that the expansion of international agreements and national plans to support greater women’s participation in decision-making have yet to translate into concrete changes. This report examines progress in promoting women’s meaningful participation in decision making processes in conflict prevention and peacebuilding, with a focus on changes since 2018. Evidence on women’s meaningful participation in decision-making tends to focus on a small range of measurable outcomes with some studies considering the outcomes of women’s involvement in those processes to determine the extent to which they might be ‘meaningful’. Few studies examine differential outcomes of such initiatives for different groups of women, and most data does not allow for the disaggregation of intersecting identities between gender, ethnicity, race, disability, migration status and other key factors. Evidence collected for this report suggests that policies and programmes seeking to support greater women’s participation in decision-making in conflict prevention and peacebuilding often struggle to address the broader structural factors that inhibit women’s empowerment. Tackling longstanding and often deeply embedded harmful social norms has proven challenging across sectors, and in conflict or post-conflict settings with highly complex social dynamics, this can be especially difficult. Many of the issues highlighted in the literature as hindering progress on the WPS agenda relate to cross-cutting issues at the heart of gender inequality. Multiple authors from within women’s movements in conflict and post-conflict settings emphasise the need for policies and programmes that support women to act as agents of change in their own communities and which amplify their voices rather than speak on their behalf. Recent achievements in South Sudan and the Pacific region are indicative of the potential of women’s movements to affect change in conflict prevention and peacebuilding and suggest progress is being made in some areas, though gender equality in these processes may be a long way off.
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Nitz, Peter, and Jürgen Fluch. Collection of available solar process heat related national and trans-national research and funding programs. IEA SHC Task 64, April 2021. http://dx.doi.org/10.18777/ieashc-task64-2021-0001.

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Within Task 64/IV Solar Process Heat, Subtask E Guideline to Market is aiming to support a wider penetration of solar thermal technologies in the supply of heating (and cooling) in industry, demonstrating Solar Heat for Industrial Processes (SHIP) to be an important contribution to the decarbonisation of the industrial sector. This requires not only to overcome technical and/or technological barriers, but it is crucial to also address on technical barriers. Whereas well suited system integration strategies, design tools, standardized procedures or modular components are all in all paramount for the development of reliable and prompt off the shelve solutions, experience shows that often non-technological barriers might have a critical role in the decision making process. Above all, competitiveness and investment/financing related barriers prove in many cases to be the bottleneck for the adoption of solar thermal technologies in the industrial framework.
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Vingre, Anete, Peter Kolarz, and Billy Bryan. On your marks, get set, fund! Rapid responses to the Covid-19 pandemic. Fteval - Austrian Platform for Research and Technology Policy Evaluation, April 2022. http://dx.doi.org/10.22163/fteval.2022.538.

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This paper presents findings from an analysis of seven multidisciplinary national research funders’ responses to COVID-19. We posit that while some parts of research and innovation funding responses to COVID-19 were ‘pandemic responses’ in the conventional biomedical sense, other parts were thematically far broader and are better termed ‘societal emergency’ funding. This type of funding activity was unprecedented for many funders. Yet, it may signal a new/additional mission for research funders, which may be required to tackle future societal emergencies, medical or otherwise. Urgency (i.e., the need to deploy funding quickly) is a key distinguishing theme in these funding activities. This paper explores the different techniques that funders used to substantially speed up their application and assessment processes to ensure research on COVID-19 could commence as quickly as possible. Funders used a range of approaches, both before application submission (call design, application lengths and formats) and after (review and decision-making processes). Our research highlights a series of trade-offs, at the heart of which are concerns around simultaneously ensuring the required speed as well as the quality of funding-decisions. We extract some recommendations for what a generic ‘societal emergency’ funding toolkit might include to optimally manage these tensions in case national research funders are called upon again to respond to future crises.
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Kwon, Jaymin, Yushin Ahn, and Steve Chung. Spatio-Temporal Analysis of the Roadside Transportation Related Air Quality (STARTRAQ) and Neighborhood Characterization. Mineta Transportation Institute, August 2021. http://dx.doi.org/10.31979/mti.2021.2010.

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To promote active transportation modes (such as bike ride and walking), and to create safer communities for easier access to transit, it is essential to provide consolidated data-driven transportation information to the public. The relevant and timely information from data facilitates the improvement of decision-making processes for the establishment of public policy and urban planning for sustainable growth, and for promoting public health in the region. For the characterization of the spatial variation of transportation-emitted air pollution in the Fresno/Clovis neighborhood in California, various species of particulate matters emitted from traffic sources were measured using real-time monitors and GPS loggers at over 100 neighborhood walking routes within 58 census tracts from the previous research, Children’s Health to Air Pollution Study - San Joaquin Valley (CHAPS-SJV). Roadside air pollution data show that PM2.5, black carbon, and PAHs were significantly elevated in the neighborhood walking air samples compared to indoor air or the ambient monitoring station in the Central Fresno area due to the immediate source proximity. The simultaneous parallel measurements in two neighborhoods which are distinctively different areas (High diesel High poverty vs. Low diesel Low poverty) showed that the higher pollution levels were observed when more frequent vehicular activities were occurring around the neighborhoods. Elevated PM2.5 concentrations near the roadways were evident with a high volume of traffic and in regions with more unpaved areas. Neighborhood walking air samples were influenced by immediate roadway traffic conditions, such as encounters with diesel trucks, approaching in close proximity to freeways and/or busy roadways, passing cigarette smokers, and gardening activity. The elevated black carbon concentrations occur near the highway corridors and regions with high diesel traffic and high industry. This project provides consolidated data-driven transportation information to the public including: 1. Transportation-related particle pollution data 2. Spatial analyses of geocoded vehicle emissions 3. Neighborhood characterization for the built environment such as cities, buildings, roads, parks, walkways, etc.
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Herbert, Sian. Women’s Meaningful Participation in Water Security. Institute of Development Studies, May 2022. http://dx.doi.org/10.19088/k4d.2022.063.

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This rapid literature review explores gender transformative practices and the meaningful participation of women in water security. There is large and growing literature base on gender and water, with most of it coming from a health, or sanitation and hygiene perspective, and most focussing on access, quality, and women as vulnerable water users and or women and water in rural communities (de Silva, Veilleux & Neal, 2018). There has been a growth in focus on women’s participation in water governance, and particularly a more recent focus on meaningful participation. However, as yet, the literature is much more limited in this latter area, and the practical advances in women’s meaningful participation (“gender transformative processes”) in water security have also been more limited than progress in other areas (Ozano, et al., 2022). This rapid review found a lot of literature focusses on a few countries including: Kenya, India, and Nepal. As de Silva, et al. (2018, p.212) explain in their work on transboundary water, there is limited evidence on “the role of women as agents of change within a decision-making, transboundary water context and almost every paper that promised to do so in some way, ended up focusing on specific developing countries and women as direct water users”. As for the effectiveness of certain practices over others, and over different timeframes, there is little empirical information on this, yet there are a lot of critical reflections in the literature on the broad barriers to meaningful participation. And there are general recommendations for how to make progress on this agenda. This rapid review is indicative of the most commonly discussed issues in the literature, but is not inclusive of all of the many related issues.
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Newman-Toker, David E., Susan M. Peterson, Shervin Badihian, Ahmed Hassoon, Najlla Nassery, Donna Parizadeh, Lisa M. Wilson, et al. Diagnostic Errors in the Emergency Department: A Systematic Review. Agency for Healthcare Research and Quality (AHRQ), December 2022. http://dx.doi.org/10.23970/ahrqepccer258.

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Objectives. Diagnostic errors are a known patient safety concern across all clinical settings, including the emergency department (ED). We conducted a systematic review to determine the most frequent diseases and clinical presentations associated with diagnostic errors (and resulting harms) in the ED, measure error and harm frequency, as well as assess causal factors. Methods. We searched PubMed®, Cumulative Index to Nursing and Allied Health Literature (CINAHL®), and Embase® from January 2000 through September 2021. We included research studies and targeted grey literature reporting diagnostic errors or misdiagnosis-related harms in EDs in the United States or other developed countries with ED care deemed comparable by a technical expert panel. We applied standard definitions for diagnostic errors, misdiagnosis-related harms (adverse events), and serious harms (permanent disability or death). Preventability was determined by original study authors or differences in harms across groups. Two reviewers independently screened search results for eligibility; serially extracted data regarding common diseases, error/harm rates, and causes/risk factors; and independently assessed risk of bias of included studies. We synthesized results for each question and extrapolated U.S. estimates. We present 95 percent confidence intervals (CIs) or plausible range (PR) bounds, as appropriate. Results. We identified 19,127 citations and included 279 studies. The top 15 clinical conditions associated with serious misdiagnosis-related harms (accounting for 68% [95% CI 66 to 71] of serious harms) were (1) stroke, (2) myocardial infarction, (3) aortic aneurysm and dissection, (4) spinal cord compression and injury, (5) venous thromboembolism, (6/7 – tie) meningitis and encephalitis, (6/7 – tie) sepsis, (8) lung cancer, (9) traumatic brain injury and traumatic intracranial hemorrhage, (10) arterial thromboembolism, (11) spinal and intracranial abscess, (12) cardiac arrhythmia, (13) pneumonia, (14) gastrointestinal perforation and rupture, and (15) intestinal obstruction. Average disease-specific error rates ranged from 1.5 percent (myocardial infarction) to 56 percent (spinal abscess), with additional variation by clinical presentation (e.g., missed stroke average 17%, but 4% for weakness and 40% for dizziness/vertigo). There was also wide, superimposed variation by hospital (e.g., missed myocardial infarction 0% to 29% across hospitals within a single study). An estimated 5.7 percent (95% CI 4.4 to 7.1) of all ED visits had at least one diagnostic error. Estimated preventable adverse event rates were as follows: any harm severity (2.0%, 95% CI 1.0 to 3.6), any serious harms (0.3%, PR 0.1 to 0.7), and deaths (0.2%, PR 0.1 to 0.4). While most disease-specific error rates derived from mainly U.S.-based studies, overall error and harm rates were derived from three prospective studies conducted outside the United States (in Canada, Spain, and Switzerland, with combined n=1,758). If overall rates are generalizable to all U.S. ED visits (130 million, 95% CI 116 to 144), this would translate to 7.4 million (PR 5.1 to 10.2) ED diagnostic errors annually; 2.6 million (PR 1.1 to 5.2) diagnostic adverse events with preventable harms; and 371,000 (PR 142,000 to 909,000) serious misdiagnosis-related harms, including more than 100,000 permanent, high-severity disabilities and 250,000 deaths. Although errors were often multifactorial, 89 percent (95% CI 88 to 90) of diagnostic error malpractice claims involved failures of clinical decision-making or judgment, regardless of the underlying disease present. Key process failures were errors in diagnostic assessment, test ordering, and test interpretation. Most often these were attributed to inadequate knowledge, skills, or reasoning, particularly in “atypical” or otherwise subtle case presentations. Limitations included use of malpractice claims and incident reports for distribution of diseases leading to serious harms, reliance on a small number of non-U.S. studies for overall (disease-agnostic) diagnostic error and harm rates, and methodologic variability across studies in measuring disease-specific rates, determining preventability, and assessing causal factors. Conclusions. Although estimated ED error rates are low (and comparable to those found in other clinical settings), the number of patients potentially impacted is large. Not all diagnostic errors or harms are preventable, but wide variability in diagnostic error rates across diseases, symptoms, and hospitals suggests improvement is possible. With 130 million U.S. ED visits, estimated rates for diagnostic error (5.7%), misdiagnosis-related harms (2.0%), and serious misdiagnosis-related harms (0.3%) could translate to more than 7 million errors, 2.5 million harms, and 350,000 patients suffering potentially preventable permanent disability or death. Over two-thirds of serious harms are attributable to just 15 diseases and linked to cognitive errors, particularly in cases with “atypical” manifestations. Scalable solutions to enhance bedside diagnostic processes are needed, and these should target the most commonly misdiagnosed clinical presentations of key diseases causing serious harms. New studies should confirm overall rates are representative of current U.S.-based ED practice and focus on identified evidence gaps (errors among common diseases with lower-severity harms, pediatric ED errors and harms, dynamic systems factors such as overcrowding, and false positives). Policy changes to consider based on this review include: (1) standardizing measurement and research results reporting to maximize comparability of measures of diagnostic error and misdiagnosis-related harms; (2) creating a National Diagnostic Performance Dashboard to track performance; and (3) using multiple policy levers (e.g., research funding, public accountability, payment reforms) to facilitate the rapid development and deployment of solutions to address this critically important patient safety concern.
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Rankin, Nicole, Deborah McGregor, Candice Donnelly, Bethany Van Dort, Richard De Abreu Lourenco, Anne Cust, and Emily Stone. Lung cancer screening using low-dose computed tomography for high risk populations: Investigating effectiveness and screening program implementation considerations: An Evidence Check rapid review brokered by the Sax Institute (www.saxinstitute.org.au) for the Cancer Institute NSW. The Sax Institute, October 2019. http://dx.doi.org/10.57022/clzt5093.

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Background Lung cancer is the number one cause of cancer death worldwide.(1) It is the fifth most commonly diagnosed cancer in Australia (12,741 cases diagnosed in 2018) and the leading cause of cancer death.(2) The number of years of potential life lost to lung cancer in Australia is estimated to be 58,450, similar to that of colorectal and breast cancer combined.(3) While tobacco control strategies are most effective for disease prevention in the general population, early detection via low dose computed tomography (LDCT) screening in high-risk populations is a viable option for detecting asymptomatic disease in current (13%) and former (24%) Australian smokers.(4) The purpose of this Evidence Check review is to identify and analyse existing and emerging evidence for LDCT lung cancer screening in high-risk individuals to guide future program and policy planning. Evidence Check questions This review aimed to address the following questions: 1. What is the evidence for the effectiveness of lung cancer screening for higher-risk individuals? 2. What is the evidence of potential harms from lung cancer screening for higher-risk individuals? 3. What are the main components of recent major lung cancer screening programs or trials? 4. What is the cost-effectiveness of lung cancer screening programs (include studies of cost–utility)? Summary of methods The authors searched the peer-reviewed literature across three databases (MEDLINE, PsycINFO and Embase) for existing systematic reviews and original studies published between 1 January 2009 and 8 August 2019. Fifteen systematic reviews (of which 8 were contemporary) and 64 original publications met the inclusion criteria set across the four questions. Key findings Question 1: What is the evidence for the effectiveness of lung cancer screening for higher-risk individuals? There is sufficient evidence from systematic reviews and meta-analyses of combined (pooled) data from screening trials (of high-risk individuals) to indicate that LDCT examination is clinically effective in reducing lung cancer mortality. In 2011, the landmark National Lung Cancer Screening Trial (NLST, a large-scale randomised controlled trial [RCT] conducted in the US) reported a 20% (95% CI 6.8% – 26.7%; P=0.004) relative reduction in mortality among long-term heavy smokers over three rounds of annual screening. High-risk eligibility criteria was defined as people aged 55–74 years with a smoking history of ≥30 pack-years (years in which a smoker has consumed 20-plus cigarettes each day) and, for former smokers, ≥30 pack-years and have quit within the past 15 years.(5) All-cause mortality was reduced by 6.7% (95% CI, 1.2% – 13.6%; P=0.02). Initial data from the second landmark RCT, the NEderlands-Leuvens Longkanker Screenings ONderzoek (known as the NELSON trial), have found an even greater reduction of 26% (95% CI, 9% – 41%) in lung cancer mortality, with full trial results yet to be published.(6, 7) Pooled analyses, including several smaller-scale European LDCT screening trials insufficiently powered in their own right, collectively demonstrate a statistically significant reduction in lung cancer mortality (RR 0.82, 95% CI 0.73–0.91).(8) Despite the reduction in all-cause mortality found in the NLST, pooled analyses of seven trials found no statistically significant difference in all-cause mortality (RR 0.95, 95% CI 0.90–1.00).(8) However, cancer-specific mortality is currently the most relevant outcome in cancer screening trials. These seven trials demonstrated a significantly greater proportion of early stage cancers in LDCT groups compared with controls (RR 2.08, 95% CI 1.43–3.03). Thus, when considering results across mortality outcomes and early stage cancers diagnosed, LDCT screening is considered to be clinically effective. Question 2: What is the evidence of potential harms from lung cancer screening for higher-risk individuals? The harms of LDCT lung cancer screening include false positive tests and the consequences of unnecessary invasive follow-up procedures for conditions that are eventually diagnosed as benign. While LDCT screening leads to an increased frequency of invasive procedures, it does not result in greater mortality soon after an invasive procedure (in trial settings when compared with the control arm).(8) Overdiagnosis, exposure to radiation, psychological distress and an impact on quality of life are other known harms. Systematic review evidence indicates the benefits of LDCT screening are likely to outweigh the harms. The potential harms are likely to be reduced as refinements are made to LDCT screening protocols through: i) the application of risk predication models (e.g. the PLCOm2012), which enable a more accurate selection of the high-risk population through the use of specific criteria (beyond age and smoking history); ii) the use of nodule management algorithms (e.g. Lung-RADS, PanCan), which assist in the diagnostic evaluation of screen-detected nodules and cancers (e.g. more precise volumetric assessment of nodules); and, iii) more judicious selection of patients for invasive procedures. Recent evidence suggests a positive LDCT result may transiently increase psychological distress but does not have long-term adverse effects on psychological distress or health-related quality of life (HRQoL). With regards to smoking cessation, there is no evidence to suggest screening participation invokes a false sense of assurance in smokers, nor a reduction in motivation to quit. The NELSON and Danish trials found no difference in smoking cessation rates between LDCT screening and control groups. Higher net cessation rates, compared with general population, suggest those who participate in screening trials may already be motivated to quit. Question 3: What are the main components of recent major lung cancer screening programs or trials? There are no systematic reviews that capture the main components of recent major lung cancer screening trials and programs. We extracted evidence from original studies and clinical guidance documents and organised this into key groups to form a concise set of components for potential implementation of a national lung cancer screening program in Australia: 1. Identifying the high-risk population: recruitment, eligibility, selection and referral 2. Educating the public, people at high risk and healthcare providers; this includes creating awareness of lung cancer, the benefits and harms of LDCT screening, and shared decision-making 3. Components necessary for health services to deliver a screening program: a. Planning phase: e.g. human resources to coordinate the program, electronic data systems that integrate medical records information and link to an established national registry b. Implementation phase: e.g. human and technological resources required to conduct LDCT examinations, interpretation of reports and communication of results to participants c. Monitoring and evaluation phase: e.g. monitoring outcomes across patients, radiological reporting, compliance with established standards and a quality assurance program 4. Data reporting and research, e.g. audit and feedback to multidisciplinary teams, reporting outcomes to enhance international research into LDCT screening 5. Incorporation of smoking cessation interventions, e.g. specific programs designed for LDCT screening or referral to existing community or hospital-based services that deliver cessation interventions. Most original studies are single-institution evaluations that contain descriptive data about the processes required to establish and implement a high-risk population-based screening program. Across all studies there is a consistent message as to the challenges and complexities of establishing LDCT screening programs to attract people at high risk who will receive the greatest benefits from participation. With regards to smoking cessation, evidence from one systematic review indicates the optimal strategy for incorporating smoking cessation interventions into a LDCT screening program is unclear. There is widespread agreement that LDCT screening attendance presents a ‘teachable moment’ for cessation advice, especially among those people who receive a positive scan result. Smoking cessation is an area of significant research investment; for instance, eight US-based clinical trials are now underway that aim to address how best to design and deliver cessation programs within large-scale LDCT screening programs.(9) Question 4: What is the cost-effectiveness of lung cancer screening programs (include studies of cost–utility)? Assessing the value or cost-effectiveness of LDCT screening involves a complex interplay of factors including data on effectiveness and costs, and institutional context. A key input is data about the effectiveness of potential and current screening programs with respect to case detection, and the likely outcomes of treating those cases sooner (in the presence of LDCT screening) as opposed to later (in the absence of LDCT screening). Evidence about the cost-effectiveness of LDCT screening programs has been summarised in two systematic reviews. We identified a further 13 studies—five modelling studies, one discrete choice experiment and seven articles—that used a variety of methods to assess cost-effectiveness. Three modelling studies indicated LDCT screening was cost-effective in the settings of the US and Europe. Two studies—one from Australia and one from New Zealand—reported LDCT screening would not be cost-effective using NLST-like protocols. We anticipate that, following the full publication of the NELSON trial, cost-effectiveness studies will likely be updated with new data that reduce uncertainty about factors that influence modelling outcomes, including the findings of indeterminate nodules. Gaps in the evidence There is a large and accessible body of evidence as to the effectiveness (Q1) and harms (Q2) of LDCT screening for lung cancer. Nevertheless, there are significant gaps in the evidence about the program components that are required to implement an effective LDCT screening program (Q3). Questions about LDCT screening acceptability and feasibility were not explicitly included in the scope. However, as the evidence is based primarily on US programs and UK pilot studies, the relevance to the local setting requires careful consideration. The Queensland Lung Cancer Screening Study provides feasibility data about clinical aspects of LDCT screening but little about program design. The International Lung Screening Trial is still in the recruitment phase and findings are not yet available for inclusion in this Evidence Check. The Australian Population Based Screening Framework was developed to “inform decision-makers on the key issues to be considered when assessing potential screening programs in Australia”.(10) As the Framework is specific to population-based, rather than high-risk, screening programs, there is a lack of clarity about transferability of criteria. However, the Framework criteria do stipulate that a screening program must be acceptable to “important subgroups such as target participants who are from culturally and linguistically diverse backgrounds, Aboriginal and Torres Strait Islander people, people from disadvantaged groups and people with a disability”.(10) An extensive search of the literature highlighted that there is very little information about the acceptability of LDCT screening to these population groups in Australia. Yet they are part of the high-risk population.(10) There are also considerable gaps in the evidence about the cost-effectiveness of LDCT screening in different settings, including Australia. The evidence base in this area is rapidly evolving and is likely to include new data from the NELSON trial and incorporate data about the costs of targeted- and immuno-therapies as these treatments become more widely available in Australia.
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Lessons Learned from the Cambodia Enterprise Infirmary Guidelines development process. Population Council, 2018. http://dx.doi.org/10.31899/sbsr2018.1002.

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Women of reproductive age in Cambodia, and many other developing countries, comprise a large part of factories’ workforce. Integrating family planning and reproductive health information and services into factories can improve workers’ health and help countries achieve FP2020 commitments. This case study looks at the process of how the Cambodian Ministry of Labor and Vocational Training launched, as formal policy, a set of workplace health infirmary guidelines for enterprises. What made this policy process unique for Cambodia—and what can be replicated by health advocates elsewhere—is that a group of organizations typically focused on public health policy successfully engaged on labor policy with a labor ministry. This case study describes the policy process, which was underpinned by the strategic use of evidence in decision-making and has been hailed by government, donors, civil society and industry as a success. The learnings presented in this case study should be useful to health advocates, labor advocates, and program designers.
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Evidence Synthesis and Meta-Analysis for Drug Safety. Council for International Organizations of Medical Sciences (CIOMS), 2016. http://dx.doi.org/10.56759/lela7055.

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At any point in the drug development process, systematic reviews and meta-analysis can provide important information to guide the future path of the development programme and any actions that might be needed in the post-marketing setting. This report gives the rationale for why and when a meta-analysis should be considered, all in the context of regulatory decision-making, and the tasks, data collection, and analyses that need to be carried out to inform those decisions. -- There is increasing demand by decision-makers in health care, the biopharmaceutical industry, and society at large to have access to the best available evidence on benefits and risks of medicinal products. The best strategy will take an overview of all the evidence and where it is possible and sensible, combine the evidence and summarize the results. For efficacy, the outcomes generally use the same or very similar predefined events for each of the trials to be included. Most regulatory guidance and many Cochrane Collaboration reviews have usually given more attention to assessment of benefits, while issues around combining evidence on harms have not been as well-covered. However, the (inevitably) unplanned nature of the data on safety makes the process more difficult. -- Combining evidence on adverse events (AEs), where these were not the focus of the original studies, is more challenging than combining evidence on pre-specified benefits. This focus on AEs represents the main contribution of the current CIOMS X report. The goal of the CIOMS X report is to provide principles on appropriate application of meta-analysis in assessing safety of pharmaceutical products to inform regulatory decision-making. This report is about meta-analysis in this narrow area, but the present report should also provide conceptually helpful points to consider for a wider range of applications, such as vaccines, medical devices, veterinary medicines or even products that are combinations of medicinal products and medical devices. -- Although some of the content of this report describes highly technical statistical concepts and methods (in particular Chapter 4), the ambition of the working group has been to make it comprehensible to non-statisticians for its use in clinical epidemiology and regulatory science. To that end, Chapters 3 and 4, which contain the main technical statistical aspects of the appropriate design, analysis and reporting of a meta-analysis of safety data are followed by Chapter 5 with a thought process for evaluating the findings of a meta-analysis and how to communicate these.
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