Risk management and safety in the use of patient-controlled analgesia (PCA) pump : a scoping review protocol.
Creators: name: da Silva, Thamires
Publisher: name: Open Science Framework
Year: 2022
Subjects: subject: Medicine and Health Sciences

description: Introduction Pain is an unpleasant sensory and emotional experience associated with, or similar to, that associated with actual or potential tissue damage that causes suffering and reduces the quality of life. The perception of pain is individual and depends on the emotional, cognitive state, circumstances, and factors such as memory, attention, language, and expectations.1,2 It is important to assess pain in its multidimensional context, to manage it with pharmacological and non-pharmacological approaches, and to reassess it. Treatment must be patient-centered and consider its current presentation, professional clinical judgment, potential risks, and benefits. Adequate pain management should be a priority in the quality of care in health institutions.2,3 Patient-controlled analgesia (PCA) is a method that consists of self-administration of analgesic doses for pain treatment. PCA pumps are computerized systems, programmed for individual use. The effectiveness of PCA in controlling pain is proven, as it improves patient satisfaction, reduces opioid consumption, and as a need for nursing care. The prescriber defines the drug, usually, morphine or another opioid, orders the dose, demand, dose range, and block as proposed by the guidelines of the Current American Pain Society. The term PCA goes beyond the pump, as it encompasses a whole process that includes the patient, nurse, pharmacist, and doctor. Therefore, if any component is failing, security is compromised. Be careful with patient selection, education, proper prescription, and patient monitoring, the method becomes safer and more effective.4-8 Patient safety practice reduces the likelihood of drug-related adverse events, defined as health care complications that may be due to errors or an adverse reaction.9 Unsafe health care causes serious damage to the health of patients, in addition to serious damage financially and loss of confidence in the health system.10 Security is closely related to high-quality care since it produces the best health results.9 It is essential to think about pain as an adverse event when it is undertreated, poorly controlled, and due to surgical, drug, and diagnostic interventions. The creation of protocols that stand out from the contexts where pain management may fail is a way to identify risk factors and integrated approaches to prevention and control. Adequate pain management is one of the aspects associated with ensuring patient safety, which aims to reduce the risk of unnecessary damage associated with health care. According to the WHO, investments in a safe care practice can generate related savings and the best results for patients. Promote proactive risk management implying how a process can fail, identifying risk trends to explore mandatory mitigations to reduce risk before bad results occur. 11,12,13 Studies estimate that clinical incidents related to PCA occur more commonly in surgical services and are more associated with drugs provided via PCA.5 Such a process involves several components, as doses must be prescribed, prepared, administered and their effects monitored. The administration was the stage most marked by errors: rates, configuration, dose, medication, solution, interruption, and violation of the policy or protocol. Failures in monitoring, in responding to the patient's clinical condition, documents, labeling, knowledge and skills, equipment, communication, and selection of patients.5 Therefore, incident analysis is the first step for the risks to be identified and managed, allowing the building security improvement practices in ACP, as it is a highly error-prone process.6 There are publications involving some primary studies on risk management and safety measures in the use of the patient-controlled analgesia pump. Preliminary research was carried out on the bases: PROSPERO, MEDLINE (PubMed), JBI Database of Systematic Reviews and Implementation Reports. No scoping or systematic reviews were found on the topic. A scoping review can identify research gaps in the scope of actions to promote safety. In this sense, it was decided to conduct a scoping review, guided by the methodology proposed by the Joanna Briggs Institute for Scoping Reviews.14 A review will aim to map the available evidence on the risks of adverse events associated with the PCA technique and to identify patient safety actions. This review seeks to answer the following question: What is the evidence about the risks of adverse events and safety actions in the use of PCA (patient-controlled analgesia). Review question(s) The research question was guided by the PCC strategy (P: population, C: concept, and C: context). The “P” Corresponds to patients using ACP pumps (population),“ C ”to the risks of adverse events and safety actions (concept), and“ C ”to hospitals (context). This review seeks to answer the following question: What is the evidence about the risks of adverse events and safety actions in the use of PCA (patient-controlled analgesia). Inclusion criteria Participants This review will consider studies that include adult patients, 18 years or older, using PCA pumps regardless of sex, diagnosis, type, and severity of pain. Concept This review will consider studies that explore the risks of adverse events and safety actions. Context This review will consider studies that performed on hospitalized patients, regardless of geographic region and level of care. Types of sources The information source will be “open” to provide greater sensitivity and, consequently, a broad mapping that includes all existing literature and all types of evidence. To this end, it will consider quantitative, qualitative, and mixed methods study designs, reviews, experimental, quasi-experimental, observational, descriptive, and analytical studies, in addition to theses, texts, and opinion articles. Do not limit the language restriction and data publishing limitations. Methods The proposed scoping review will be conducted following the JBI methodology for scoping reviews 14. The choice for this method is due to its main objectives: mapping available evidence, analyzing gaps in existing literature, identifying, reporting, and discussing as main related characteristics to a concept. From this synthesis, it will be possible to develop a review with a broader scope on security actions for the safe handling of ACP, and, in the future, it may contribute to the construction of a systematic review. Search strategy The search strategy will take place in three stages. An initial limited search at MEDLINE via Pubmed and at CINAHL via Ebsco was undertaken to identify articles on the topic. The text words contained in the titles and abstracts of relevant articles, and the index terms used to describe the articles were used to develop a full search strategy for MEDLINE via Pubmed (see Appendix I). The keywords and research expressions identified were: “patient-controlled analgesia”, “Risk management” and “Patient safety”. The search strategy, including all identified keywords and index terms, will be adapted for each included information source. In the second step, a complete search will be performed in all databases included using all keywords and index terms identified in the initial search. The search will be adapted for each included information source. Appendix I contains a detailed search strategy for MEDLINE (PubMed). The third step will be screened for additional papers in the reference lists of all publications included in the review, and to obtain more information, if necessary, the reviewers appear in contact with the authors of the included materials. There will be no language restriction or publication date A librarian will be contacted to refine the strategy. The databases to be searched include MEDLINE (Medical Literature Analysis and Retrieval System Online / PubMed); EMBASE (Elsevier); CINAHL (Cumulative Index to Nursing and Allied Health Literature / EBSCOhost); CENTRAL (The Cochrane Central Register of Controlled Trials The Cochrane Library); LILACS (Scientific and Technical Literature of Latin America and the Caribbean / VHL - Virtual Health Library); SCOPUS; Web of Science; Capes Portal (Coordination for the Improvement of Higher Education Personnel); Academic Google; TRIP (Turning Research into Practice) database. Sources of unpublished studies and gray literature to be searched include sites of pain and patient safety organizations such as The Agency for Healthcare Research and Quality; The Institute for Healthcare Improvement; NICE (National Institute for Health and Care Excellence); The Institute for safe medication practices and other sources such as ProQuest Dissertations and Theses Database. Study/Source of evidence selection Following the search, all identified records will be collated and uploaded into EndNote (Clarivate Analytics, PA, USA), and duplicates removed. Following a pilot test, titles and abstracts will then be screened according to the inclusion criteria with the support of Rayyan, a web and mobile app for systematic reviews that makes it possible to include and exclude citations imported from EndNote independently and blinded by two reviewers.15 The full text of the selected citations will be evaluated in detail about the inclusion criteria. The reasons for excluding full-text articles that do not meet the inclusion criteria will be recorded and reported in the scoping review. Any disagreements that arise between the reviewers at each stage of the selection process will be resolved through discussion or with a third reviewer. There will be no analysis of the methodological quality of the sources of evidence because it is a scoping review. The research results will be reported in full in the final scope review and presented in a flow chart of Preferred Reporting Items for Systematic Reviews and Meta-analyzes for Scope Reviews (PRISMA-SCR).16 Data extraction Data will be extracted from papers included in the scoping review by two independent reviewers using a data extraction tool developed by the reviewers. The data extracted will include specific details about the adult patients using PCA pumps, risk management, safety actions, and the hospital institution relevant to the review question. A draft extraction tool is provided with the objective and question of review (see Appendix II). The draft data extraction tool is preliminary, so it can be modified and revised as necessary during the process of extracting data if new relevant information is identified during the reading of the publications. Modifications will be detailed in the full scoping review. Any disagreements that arise between the reviewers will be resolved through discussion or with a third reviewer. A pilot test will be carried out on publications for what is necessary to familiarize reviewers with the instrument. Data analysis and presentation The extracted data will be presented in tabular and diagrammatic form for scope review. A narrative summary will accompany the tabulated and mapped results and describe how they relate to the research objective and question. These tools will elucidate the different contexts of PCA use, types of errors, and associated risks, in addition to actions for risk management and the promotion of patient safety. The risks to be listed may involve aspects related to the pump, patient, prescriber, pharmacist, nursing, and medication such as errors in programming, operation, and configuration of the PCA pump, drug selection, dose and blocking periods, patient choice, and monitoring. References 1. Raja SN et al. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. International Association for the Study of Pain. 2020;00(00):1-7. 2. Williams AC, Craig KD. Updating the definition of pain. 2016;157(11):2420–3. 3. Baker DW. Statement on pain management: understanding how Joint Commission standards address pain. Jt Comm Perspect 2016;36(6):10–2. 4. D’Arcy Y et al. Keep your patient safe during PCA. Nursing 2008. 2007; 38(1):50-5. 5. Clinical Excellence Commission. Clinical Focus Report Patient Controlled Analgesia [Internet]. Sidney South; 2013 [cited 2020 Nov 11]. Available from: https://www.cec.health.nsw.gov.au/__data/assets/pdf_file/0009/259209/patient-safety-report-pca-web.pdf 6. San Diego Patient Safety Council. Patient Controlled Analgesia (PCA) Guidelines of Care [Internet]. San Diego; 2009 [cited 2020 Nov 22]. Available from: https://www.hqinstitute.org/post/patient-controlled-analgesia-pca-guidelines-care. 7. Institute for safe medication practices. Safety Issues with PCA Part I - How Errors Occur [Internet]. Horsham; 2003 [cited 2020 Nov 22]. Available from: https://www.ismp.org/resources/safety-issues-pca-part-i-how-errors-occur. 8. Morello RT, Lowthian AJ, Barker AL, McGinnes R, Dunt Dm, Brand C. Strategies for improving patient safety culture in hospitals: a systematic review. BMJ Qual Saf. 2013;22: 11-18. 9. World Health Organization. Patient Safety Global action on patient safety [Internet]. WHO; 2018 [cited 2020 Nov 22]. Available from: https://apps.who.int/iris/handle/10665/327526. 10. Chorney JM, McGrath P, Finley GA. Pain as the neglected adverse event. CMAJ 2010;182(7):732. 11. Sheikh A, Kumar ND, Kelley E, Kieny MP, Donaldson LJ. The third global patient safety challenge: tackling medication-related harm. WHO 2017;95:546-54A. 12. World Health Organization. Patient Safety [Internet]. WHO; 2019 [cited 2020 Nov 21]. Available from: https://www.who.int/news-room/fact-sheets/detail/patient-safety. 13. Yarmohammadian MH, Abadi TNB, Tofighi S, Esfahani SS. Performance improvement through proactive risk assessment: Using failure modes and effects analysis. J Edu Health Promot 2014; 3:28. 14. Aromataris E, Munn Z (Editors). JBI Manual for Evidence Synthesis [Internet]. JBI; 2020 [cited 2020 Nov 21]. Available from: https://synthesismanual.jbi.global.https://doi.org/10.46658/JBIMES-20-01. 15. Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan — a web and mobile app for systematic reviews. BioMed Central. (2016); 5:210. 16. Tricco AC, Lillie E, Zarin W, O’Brien KK, Colquhoun H, Levac D, et al. PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation. The PRISMA-ScR Statement. Ann Intern Med. 2018;169(7):467-73. Appendix I: Search strategy The search was conducted in MEDLINE (via Pubmed) in November 2020. Search #1 Query: “Analgesia, Patient-Controlled” [MESH] OR “Analgesia, Patient Controlled” [tw] OR “Patient-Controlled Analgesia” [tw] OR “Patient Controlled Analgesia” [tw] Records retrieved: 6,590 Search #2 Query: “Risk Management” [MESH] OR “Management, Risk” [tw] OR “Management, Risks” [tw] OR “Risks Management” [tw] OR “Reporting, Hospital Incident” [tw] OR “reporting, Hospital Incident” [tw] OR “reporting, Hospital Risk” [tw] OR “Hospital Risk Reporting” [tw] OR “hospital risk reporting” [tw] OR “Reporting, Hospital Risk” [tw] OR “Risk Reporting, Hospital” [tw] OR “risk reporting, Hospital” [tw] OR “incident reporting, Hospital” [tw] OR “Incident Reporting, Hospital” [tw] OR “hospital incident reporting” [tw] OR “Voluntary Patient Safety Event Reporting” [tw] OR “Hospital Incident Reporting” [tw] OR “Incident Reporting” [tw] OR “incident reporting” [tw] OR “Reporting, Incident” [tw] OR “reporting, Incident” [tw] Records retrieved: 311,735 Search #3 Query: “Patient Safety” [MESH] OR “Patient Safeties” [tw] OR “Safeties, Patient” [tw] OR “Safety, Patient” [tw] Records retrieved: 21,663 Search #4 Query: Search #1 AND #2 AND #3 Records retrieved: 1,766 Appendix II: Data extraction instrument A. Responsible for extraction B: Bibliographic data Year of publication C: Study Type Place Objective D: Population Patient profile Type of pathology Medicinal characteristics Pump characteristics E: Concept Adverse events (errors or adverse reactions) Risk stage Security actions F: Context Hospital institution G: References Relevant bibliographic