EEppiicc Developing National Evidence-based Guidelines for Preventing Hospital-acquired Infections – Phase 1 epic – DDeevveellooppiinngg NNaattiioonnaall EEvviiddeennccee--bbaasseedd GGuuiiddeelliinneess ffoorr PPrreevveennttiinngg HHeeaalltthh CCaarree aassssoocciiaatteedd IInnffeeccttiioonnss National evidence-based guidelines – Standard Principles for preventing hospital-acquired infections TECHNICAL REPORT PART B Contents Pages 1 Contents 2 Appendix 1- The Project Team 3 Appendix 2 - The Project Advisory Group 4-13 Appendix 3 - Guideline Development Protocols 14-18 Appendix 4 - National Guidelines retrieved 19-21 Appendix 5 - Hospital Environmental Hygiene references retrieved 22-31 Appendix 6 - Hand Hygiene references retrieved 32-35 Appendix 7a- Personal Protective Equipment (general) references retrieved 36-40 Appendix 7b- Personal Protective Equipment (gloves) references retrieved 41-46 Appendix 8 - Universal Precautions references retrieved 47-55 Appendix 9 - Use and Disposal of Sharps references retrieved 56-59 Appendix 10 – Data Extraction Form - Practice Utility 60-76 Appendix 11a/11b – Data Extraction Forms- Critical Appraisal 77-78 Appendix 12 - Consultation Process 79 Appendix 12a - Organisations Consulted 80-81 Appendix 12b -Consultation Feedback Questionnaire Appendix 1 The Project Team Professor Robert J. Pratt, Professor of Nursing, Project Director, Wolfson Institute of Health Sciences, Thames Valley University Ms. Carol Pellowe, Principal Lecturer, Deputy Project Director, Wolfson Institute of Health Sciences, Thames Valley University Mrs. Heather Loveday, Principal Lecturer, Authoring Manager, Wolfson Institute of Health Sciences, Thames Valley University Dr. Nicky Robinson, Reader, Research & Analysis Manager, Wolfson Institute of Health Sciences, Thames Valley University Dr. Anne Mulhall, Research Consultant, Principal Project Officer Dr. Godfrey Smith, Consultant Medical Microbiologist and Honorary Senior Lecturer in Medical Microbiology and Genito-Urinary Medicine, Royal Liverpool University Hospital Mrs. Sue Privett, Clinical Nurse Specialist - Infection Control, Principal Project Officer Mrs. Barbara Weller, Research Consultant, Principal Project Officer Ms. Lynda J. Taylor, Head of Nursing Unit, Laboratory of Hospital Infection, Central Public Health Laboratory Dr. Mark H. Wilcox, Senior Lecturer, Honorary Consultant in Medical Microbiology, Department of Microbiology, University of Leeds Dr. Stephen P. Barrett , Consultant Medical Microbiologist, Department of Medical Microbiology, Imperial College at St. Mary's Hospital, London Professor Clive Loveday, Professor of Retrovirology, The Royal Free & University College Medical School, University of London. Mrs. Chris McDougall, Senior Infection Control Nurse, St Mary’s Hospital, London Professor Peter G. Davey, Professor of Pharmacoeconomics, Medicines Monitoring Unit, Department of Clinical Pharmacology, Ninewells Hospital Medical School, University of Dundee. Mr. Peter Harper, Senior Lecturer, Wolfson Institute of Health Sciences, Thames Valley University Mrs. Caroline Smales, Senior Lecturer, Wolfson Institute of Health Sciences, Thames Valley University © TVU 2 Appendix 2 Project Advisory Group q Co-Chairpersons Professor Christine Beasley, Director of Nursing, Human Resources & Organisational Development, NHS Executive (London Regional Office) Professor Michael Orme, Director of Education and Training, NHS Executive (North West Office) q Members Mrs. Susan Macqueen, Chairman, Infection Control Nurses Association Ms. Lynda J. Taylor, Head of Nursing Unit, Laboratory of Hospital Infection, Central Public Health Laboratory Dr. Gill Harvey, Head of Quality Improvement, Royal College of Nursing Institute (Oxford) Ms. Rosaline Steele, Director of Education & Practice Development, Royal College of Midwives Dr. Mary Cooke, Specialist Adviser in Infection Control Dr. Mark Farrington, Consultant Microbiologist & Infection Control Doctor, Cambridge Public Health Laboratory Dr. Alison Holmes, Royal College of Physicians Mr. Bernard Ribeiro, Royal College of Surgeons of England Professor Gary French, Chairman, Hospital Infection Society Professor Hillary Humphreys, Professor of Microbiology, Royal College of Surgeons of Ireland Professor Clive Loveday, Professor of Retrovirology, The Royal Free & University College Medical School, University of London, Royal College of Pathologists Professor Peter G. Davey, Professor of Pharmacoeconomics, Medicines Monitoring Unit, Department of Clinical Pharmacology, Ninewells Hospital Medical School, University of Dundee, British Society for Anti-microbial Chemotherapy Dr. Richard C.D. Slack, Association of Medical Microbiologists Dr. Henry K. Fell, Consultant Microbiologist, West Suffolk Hospital, British Medical Association Dr. Nita A. Mitchell-Heggs, Consultant Occupational Health Physician, St. George’s Healthcare NHS Trust Dr. Godfrey W. Smith, Senior Lecturer and Honorary Consultant in Medical Microbiology and Genito-Urinary Medicine, Royal Liverpool University Hospital, University of Liverpool Dr. Stephen P. Barrett , Consultant Medical Microbiologist, Department of Medical Microbiology, Imperial College at St. Mary's Hospital, London Dr. Mark H. Wilcox, Senior Lecturer, Honorary Consultant in Medical Microbiology, Department of Microbiology, University of Leeds q Secretariat Ms. Meg Morse, Senior Administrator, Wolfson Institute of Health Sciences, Thames Valley University q Observer Ms. Carole Fry, Nursing Officer, Department of Health © TVU 3 Appendix 3 Protocols for Phase 1 Protocol 1 Retrieval of UK Prevention/Control Guidance This stage focused on the current guidelines available for preventing HAI. All current guideline documents were retrieved and were independently examined by two reviewers against the following inclusion criteria: A. Does the document contain guidance, i.e., guidelines, statements of good practice, recommendations, advice, standards, policy statements If YES, the document is accepted for continuing review. If NO, it is referenced as reviewed and is not examined further. B. Is the guidance in the document focused on: the general principles of preventing hospital-acquired infections and/or preventing nosocomial infections from either indwelling urethral catheters or central intravascular devices? If YES, the document is accepted for continuing review. If NO, it is referenced as reviewed and is not examined further. C. Does the document contain current guidance issued by a key UK player (Royal Colleges, Learned Socities, Professional Organisations and Consumer Groups. See Appendix 4)? If YES, the document is accepted for continuing review. If NO, it is referenced as reviewed and is not examined further. D. Is the document referenced? If YES, the document is accepted into Stage 2 of the main evidence search and analysis protocol, i.e., guideline review, content analysis and data extraction. If NO, reviewers will make appropriate enquiries to the originator of the document to ascertain if references were used and are available but were not published. If YES, references will be retrieved and the documented accepted into Stage 2. If NO, documents will be referenced and not examined further. This procedure resulted in the retrieval of 103 sets of guidelines. © TVU 4 Protocol 2a Content Analysis: UK Guidelines All documents retrieved will be independently examined by two reviewers against the following inclusion criteria. 1. Each document accepted into the review in Stage 1 will be referenced according to its project identification number. 2. Guidance statements will be extracted and documented verbatim on the appropriate pro forma (on disc), i.e., general principles, central intravascular devices and indwelling urethral catheters. 3. Guidance statements will be coded as: 3.1. Guidelines 3.2. Statements of good practice 3.3. Recommendations 3.4. Advice 3.5. Standards 3.6. Policy 3.7. Other (specify) 4. References cited for each guidance statement will be listed (first author, year, Journal/Book). 5. Officers will generate provisional categories for each guidance statement. 6. At the end of Stage 2, categories will be agreed by the Project Management Team. Protocol 2b Fast-tracking New Documents into the Study This protocol describes the process to be followed for reviewing UK Guidelines received after 31 December 1998. This will ensure that relevant new material will continue to inform guideline development. Two reviewers will independently examine all documents. q All guidelines received after 31 December 1998 will be sifted using Protocol 1: retrieval of UK prevention/control guidance. q Each document accepted into the review will be referenced according to its project identification number. q Guidance statements will be highlighted and reviewed against the composite statements for each field of study, i.e., general principles, central intravascular devices and indwelling urethral catheters, as identified in Stage 5. q Statements considered to be new or in conflict with the composite statements for the appropriate field of study will only be entered onto Microsoft®Access 2000 if there are supporting references Guidance statements will be coded as: q Guidelines q Statements of good practice q Recommendations q Advice q Standards q Policy q Other (specify) q References cited in support of new or conflicting statements will be listed (first author, year, Journal/Book). © TVU 5 q Supporting references will be retrieved and included in the analysis. Protocol 3 Category Review Process: UK Guidelines 1. A team of two or more reviewers will independently review each Category Report. 2. Guideline statements within each category will be: 2.1 examined and coded for relevance to the study field; 2.2 examined and coded for consistency (conflict or agreement identified); 3. Reviewers will prioritise all relevant and consistent guideline statements in relation to their importance in preventing HAI in that category. Prioritisation of statements within categories will be based on collective professional expertise. 4. Reviewing the indexes of Guideline Originators and UK Guidelines retrieved, categories will be examined for perceived completeness, i.e., gaps and omissions, within the study field. 5. A Category Report will be prepared by using Protocol 4, documenting all of the above. Protocol 4 Prioritisation of Categories and Themes: UK Guidelines Category Review Teams will refine categories against the following protocol: 1. All guideline statements in each category agreed to be either irrelevant to the study field or a statutory requirement will be excluded. 2. From the list of remaining Guideline Statements, provisional omissions and gaps will be identified and listed. 3. The remaining guideline statements in each category, along with the identified gaps and omissions, will be grouped into themes, e.g., Category: Sharps, Theme: disposal of sharps. 4. Categories, and the themes within them, will be assigned to appropriate study fields and their priority discussed and agreed by the Project Advisory Group. Protocol 5 Generation and Review of Composite Statements: UK Guidelines The purpose of this process is to generate a series of statements that best describe the key issues in preventing hospital-acquired infection in each of the fields of study and their related categories in order to establish a focus for the search strategy and the construction of the search (review) questions. 1. Two or more project managers/ project officers will be involved in producing the composite statements. 2. Similar guideline statements/recommendations within the each database category e.g. general principles – hand preparation, will be grouped together and composite statements generated to avoid repetition. The following process will be used to generate the composite statements: © TVU 6 2.1 Category reports (Protocol 4) will be used to group the statements within the themes identified by the review teams e.g., Hand preparation (How), Hand Preparation (When), Hand Preparation (What with), Use of gloves. In some cases the themes may be too broad to facilitate grouping. Where this is the case the team may identify and agree additional themes or sub-themes. 2.2 Reviewers will agree the allocation of statements to themes or sub- themes. Where disagreement arises this should be resolved through discussion and the process documented. 2.3 A composite statement will be generated which most closely represents the content and meaning of the statements within each theme or sub-theme. (A list of record numbers for the statements contributing to each composite statement will be made) 2.4 Against each of the composite statements, a list of the key words used in the statements within each grouping will be made. These will be used in developing the subject search terms. 2.5 Project Managers will agree composite statements. Any disagreements will be resolved through discussion and the rationale for changes to the statement documented. 2.6 The composite statements will be independently reviewed by two project advisers and either accepted or rejected. Those statements rejected by project advisers will be rewritten and further reviewed. Copies of all the documentation will be sent to the project adviser(s) for confirmation. 3. The purpose of the expert review is to ensure that the project team has produced composite statements that most closely represent the content and meaning of the original statements. The project advisers will use the following process: 3.1 The grouping of statements into themes or sub-themes will be reviewed as described and documented on the category report. Agreement or disagreement with the grouping will be documented. Where disagreement exists a full written comment will be provided and a suggestion made as to how the statement(s) should be grouped. 3.2 Composite statements will be reviewed and a judgement made about whether it accurately represents the content and meaning of the statements within the group from which it was derived? 3.3 Acceptance or rejection of each composite statement will be documented. Where a statement is rejected a full written comment should be made with suggestions as to how it may be re-worded. 3.4 Finally, any important issues, which in the advisers expert opinion, have not been covered by the composite statements will be identified and documented. Protocol 6 Evidence Search Strategy A stratified search strategy will be used and will concentrate on identifying potential evidence from well designed and robust studies with generalisable conclusions which can be strongly recommended for most hospitals. A systematic search for each field of © TVU 7 study. The following electronic databases will be accessed to identify and retrieve evidence for analysis: q Medline; q Cochrane Database of Systematic Reviews (CDSR); q Database of Abstracts of Reviews of Effectiveness (DARE); q Cochrane Controlled Trials Register (CCTR); q Embase; q Cumulative Index of Nursing and Allied Health Literature (CINAHL); q Paradigm. The key concepts associated with each category /theme will be identified. A list of synonyms will be generated for each of the key concepts. These will be used to develop the subject searches. A comprehensive subject search, employing thesaurus and free text search approaches, will be constructed in Medline for each of the areas within the fields of study. Methodological filters for randomised controlled trials and other study designs, will be applied to identify evidence for analysis. (1,2,3,) The Medline search will provide the template that is adapted and applied to the other databases detailed above. References 1. NHS Centre for Reviews and Dissemination. Undertaking Systematic Reviews on Research on Effectiveness: CRD Guidelines for those carrying out or commissioning reviews. CRD Report No. 4, January 1996. 2. Dickersin K, Larson K. Optimal search strategy for RCTs. From Establishing and maintaining an international register of RCTs. In: The Cochrane Library. Oxford: Update Software, 1996. 3. Swedish Council on Technology Assessment in Health Care. Literature Searching and Evidence Interpretation for Accessing Health Care Practices. 1993. Protocol 7 Assessing the Evidence Four stages will be used during this protocol to assess the evidence. © TVU 8 Protocol 7a Initial on screen assessment 1. The abstracts (or full text articles) will be examined on screen against specified inclusion criteria. Included studies must have been: q primary research, or q secondary research that was either a: - systematic review; - review of effectiveness; - literature review with described methodology; - other (justified by reviewer); q relevant to the prevention of hospital-acquired infections. 2. Full text articles will be retrieved for those identified as having potential clinical and methodological relevance to the study fields. Protocol 7b Assessment of retrieved articles 1. Two reviewers will independently examine each retrieved study for its relevance to the study fields and review questions and the appropriateness of the study design and decide to either accept or reject it for continuing review and appraisal. 2. Additional references will be located from the cited references of accepted retrieved studies and subjected to the Stage 7a/7b processes. 3. Citations for all studies retrieved will be entered onto Reference Manager®. Protocol 7c Assessment of practice relevance/utility 1. In this stage, all evidence meeting the inclusion criteria for continuing appraisal in Stage 7b will be referred to expert advisers in infection prevention/control or microbiology for review. 2. Using a data extraction form (DEF1) (Appendix 11a) reviewers will assess the potential clinical utility of the findings for practical infection prevention in the real world. They will examine the aims and general setting of the study and focus on: q the key claims arising from research that investigators rated as important and determine if those claims demonstrated: - a positive finding, i.e., showing a significant difference between modalities or interventions; - a negative finding, i.e., showing no evidence in favour of a particular modality/intervention; q the review question(s) that were addressed by the study; q identifying any further references cited by investigators that are felt to be crucial; q validating key claims; q determining the clinical importance of the differences in outcome measures; q the validity of any microbiological or laboratory tests used by study investigators; © TVU 9 q identifying any other results (detailed or alluded to in the evidence but not highlighted by investigators) that may be notable for providing additional evidence relevant to any other epic study field. 3. Reviewers will grade studies as: q Grade A: having definite or potential utility q Grade B: unsure but probably having some or limited potential utility q Grade C: having little or no potential utility 4. All graded studies will then be returned to Project Managers. Grade A and B studies All Grade A and B studies will be referred for critical appraisal. Grade C studies All Grade C studies will be excluded from further review unless the reviewers judgement was equivocal or their grading was inconsistent with their comments. In these circumstances a second review was undertaken. Protocol 7d Critical Appraisal 1. All included studies from Protocol 7c will be subjected to critical appraisal. This involves an assessment by experts who are experienced and skilled in critical appraisal, study design and statistical analysis. 2. Project Managers will review the design of all studies and allocate them to appropriate methodological appraisers. 3. Using data extraction forms (DEF2/3/4) (Appendix 11b), appraisers will grade studies as: Category 1: well designed and robust study; conclusions generalisable to and can be strongly recommended for most hospitals Category 2: acceptable study; conclusions may be generalisable to most hospitals; in the absence of Category 1 evidence (either experimental or observational), study may be accepted into the review; Category 3: study methodology fatally flawed and conclusions and recommendations cannot be relied upon; study is rejected; and decide on the studies' inclusion in the review based on its methodological validity. Those graded as 3 were sent for second appraisal as part of quality monitoring. 4. Where needed, studies with complex statistical analyses will be further reviewed by a statistician experienced in critical appraisal. 5. Project Managers will randomly select 10 percent of all completed appraisals and submit them for double review by external appraisers. © TVU 10
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