This readme.txt file was generated on 20191210 by Matthew Jones ------------------- GENERAL INFORMATION ------------------- 1. Effects of user-testing existing guidelines on the safety of intravenous medicines administration: a randomised in-situ simulation study 2. Author Information Principal Investigator Contact Information Name: Dr Matthew D Jones Institution: Department of Pharmacy and Pharmacology, University of Bath Address: Department of Pharmacy and Pharmacology, University of Bath, Bath, BA2 7AY, United Kingdom. Email: M.D.Jones@bath.ac.uk Associate or Co-investigator Contact Information Name: Prof DK Theo Raynor Institution: University of Leeds and Luto Research Ltd, Leeds Address: Dawsons House, Owlcotes Lane, Pudsey, Leeds LS28 6PY, United Kingdom. Email: TRaynor@luto.co.uk Associate or Co-investigator Contact Information Name: Prof Margaret Watson Institution: University of Strathclyde Address: Strathclyde Institute Of Pharmacy And Biomedical Sciences, 161 Cathedral Street, Glasgow, G4 0RE, United Kingdom. Email: margaret.watson@strath.ac.uk Associate or Co-investigator Contact Information Name: Prof Bryony Dean Franklin Institution: UCL School of Pharmacy Address: 29-39 Brunswick Square, London, WC1N 1AX, United Kingdom. Email: bryony.deanfranklin@ucl.ac.uk Associate or Co-investigator Contact Information Name: Dr Anita McGrogan Institution: Department of Pharmacy and Pharmacology, University of Bath Address: Department of Pharmacy and Pharmacology, University of Bath, Bath, BA2 7AY, United Kingdom. Email: am399@bath.ac.uk 3. Date of data collection 20190104 to 20190724 4. Geographic location of data collection (where was data collected?): England 5. Information about funding sources that supported the collection of the data: National Institute for Health Research, Trainees Co-ordinating Centre, Leeds Innovation Centre, 103 Clarendon Road, Leeds, LS2 9DF. TRF-2017-10-006. “Matthew Jones is funded by a National Institute for Health Research (NIHR), Transitional Research Fellowship for this research project. This dataset presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.” --------------------- DATA & FILE OVERVIEW --------------------- 1. File List A. Filename: Phase_2_protocol_v1.2.pdf Short description: Full research protocol describing how the data were collected and analysed. PDF format. Created 190605. -------- Packaged in Data_collection_tools.zip: B. Filename: Data collection form.pdf Short description: Form used to collect participant demographic data, and post-simulation measures of confidence guideline preference. PDF format. Created 20190111 C. Filename: Interview topic guide.pdf Short description: Topic guide used for debrief interviews. PDF format. Created 20180621 D. Filename: Participant written instructions.pdf Short description: Written instructions given to participants at start of in situ simulation. PDF format. Created 20190111 E. Filename: Simulation standard operating procedure.pdf Short description: Standard operating procedure followed by researcher to complete in situ simulation. PDF format. Created 20190111 F. Filename: Structured observation form.pdf Short description: Structured observation forms used to record simulation errors at each research site. PDF format. Created 20190222 to 20190311 ------- Packaged in IMG_guidelines.zip G. Filename: Changes made to IMG guidelines in preparation for in situ simulation.pdf Short description: Record of the changes made to the IMG guidelines (and the reasons for them) between the previous user testing study and this study. The file is in .PDF format. Created 20191115 H. Filename: IMG guidelines.pdf Short description: The current and user tested IMG guidelines used in this study. The file is in .pdf format. Created 20181206 ------- Packaged in Interview_transcriptions.zip: I. Filename: Participant * - checked and anonymised.pdf (where * is participant number (14 files)) Short description: Anonymised transcriptions of debrief interviews with 14 participants. PDF format. Created 20190905 J. Filename: Phase 2 interview lengths.csv Short description: Record of the length of each debrief inteview. CSV format. Created 20191012 ------- Packaged in Numerical_data.zip: K. Filename: Observation records - Final Cleaned Data Set.xlsx Short description: Raw data showing description of every error observed during the in situ simulation. .xlsx format Created 20190910 L. Filename: Participant data.csv Short description: Raw data showing participant demographics and and post-simulation measures of confidence guideline preference. CSV format. Created 20191118 M. Filename: Phase_2_data.sav Short description: Final processed data set, used for statistical analysis. The file is in .sav format created in SPSS version 25 software. Created 20191114 N. Filename: Randomisation key code.csv Short description: Key linking each participant randomimsation code to their allocated IMG guide. CSV format. Created 20191118 O. Filename: Video inter-rater reliability.sav Short description: Raw data used to calculate inter-rater reliability between the live and video observers. The file is in .sav format created in SPSS version 25 software. Created 20191106 ------- Packaged in Severity survey.zip: P. Filename: Severity Analysis Survey Final Results.csv Short description: Raw data from the severity analysis survey sent to an expert panel. CSV format Created 20191012 Q. Filename: Severity survey.pdf Short description: Copy of the severity survey sent to an expert panel via an online survey platform. PDF format. Created 20191210 ------- Packaged in Interview_analysis.zip: R. Filename: Phase 2 interview analysis.nvp Short description: File documenting the final content and thematic analysis of the debrief interview data. It shows the final coding of all interview transcriptions, as well as the final relationship between individual codes, sub-themes and themes. The file is in .nvp format created in Nvivo version 11 software. Created 20191107. S. Filename: Phase 2 debrief interviews thematic description.pdf Short description: Full thematic description of the debrief interview data analysed with thematic analysis. The file is in PDF format. Created 20191210 2. Relationship between files: N/A 3. Additional related data collected that was not included in the current data package: None 4. Are there multiple versions of the dataset? No -------------------------- METHODOLOGICAL INFORMATION -------------------------- 1. Description of methods used for collection/generation of data: See file Phase_2_protocol_v1.2.pdf 2. Methods for processing the data: See Phase_2_protocol_v1.2.pdf 3. Instrument- or software-specific information needed to interpret the data: N/A 4. Standards and calibration information, if appropriate: N/A 5. Environmental/experimental conditions: N/A 6. Describe any quality-assurance procedures performed on the data: Interview transcriptions were double checked and corrected by a second person. Numerical data entry was double checked on a second occasion. 7. People involved with sample collection, processing, analysis and/or submission: All stages performed by Matthew Jones (details above), with the exception of content analysis, which was performed independently by Matthew Jones and Bryony Dean Franklin (details above). Video analysis was performed by a trained researcher. ----------------------------------------- DATA-SPECIFIC INFORMATION FOR: Observation records - Final Cleaned Data Set.xlsx ----------------------------------------- 1. Number of variables: 13 2. Number of cases/rows: 1695 3. Variable List (Data worksheet) A. Name: Part. ID Description: Participant ID number B. Name: Part. Rand. # Description: Participant randomisation number C. Name: Exclude? Description: Whether the participant should be included or excluded in the final analysis D. Name: Exclude reason Description: Description of the reason for the exclusion of a participant E. Name: Videoed? Description: Whether the simulation was videoed F. Name: Time (mins) Description: Length of simulation in completed minutes (to which completed seconds should be added, next data field) G. Name: Time (seconds) Description: Length of simulation in completed seconds (to which completed minutes should be added, previous data field) H. Name: Total time (seconds) Description: The total length of the simulation in seconds (produced by addition of previous two data fields) I. Name: IMG errors? Description: Whether there was an IMG-related error observed during the simulation. Artefact = no IMG-related error was observed, but the infusion rate was based on the participants verbal description of how they would programme an infusion pump (which was not available at the time of the simulation). J. Name: Non-IMG errors? Description: Whether there was a non-IMG-related error observed during the simulation. K. Name: Description of error Description: Description of each observed error L. Name: Error code Description: The error code for the error type associated with the described error (see Answer Options worksheet or protocol for a description of error types) M. Name: Description number Description: The identification number assigned to the observed error description 4. Missing data codes: N/A 5. Specialized formats of other abbreviations used N/A ----------------------------------------- DATA-SPECIFIC INFORMATION FOR: Participant data.csv ----------------------------------------- 1. Number of variables: 22 2. Number of cases/rows: 278 3. Variable List A. Name: Part. Randomisation code Description: Participant randomisation number B. Name: Gender Description: Participant's gender C. Name: Age Description: Participants age in years D. Name: English? Description: Whether English is the participant's first language E. Name: Registered? Description: Whether the participant is a nurse or midwife registered with the NMC F. Name: Years qualified Description: Number of years since the participant qualified as a nurse or midwife G. Name: IV authorised? Description: Whether the participant is authorised to prepare and administer intravenous medicines in their hospital H. Name: Years IV authorised? Description: The number of years for which the participant has been authorised to prepare and administer intravenous medicines I. Name: % IV shifts Description: The percentage of shifts during which the participant prepares and administered intravenous medicines J. Name: Medusa? Description: The participants past experience of the NHS Injectable Medicines Guide (Medusa) K. Name: Hospital Description: The research site number L. Name: mPDPAI1 to mPDPAI8 Description: The participant's response to each of the eight provider decision process assessment instrument questions (see protocol and Data collection form.pdf) M. Name: Satisfaction 1 Description: The participant's rating of the quality of their intravenous medicine preparation and administration (see protocol and Data collection form.pdf) N. Name: Satisfaction 2 Description: The participant's rating of their feelings about their intravenous medicine preparation and administration (see protocol and Data collection form.pdf) M. Name: Preference Description: The participant's preference between the two IMG guidelines being tested. Guide X = current IMG guidelines; Guide Y = user tested IMG guidelines 4. Missing data codes: N/A 5. Specialized formats of other abbreviations used N/A ----------------------------------------- DATA-SPECIFIC INFORMATION FOR: Phase 2 data.sav ----------------------------------------- 1. Number of variables: 120 2. Number of cases/rows: 273 3. Variable List A. Name: Part. Randomcode Description: Participant randomisation number B. Name: Group Description: Randomisation group to which the participant was allocated 1 = user tested guidelines; 2 = current guidelines C. Name: Gender Description: Participant's gender 1 = female; 2 = male D. Name: Age Description: Participant's age in years E. Name: English Description: Whether English is the participant's first language 0 = no; 1 = yes F. Name: Registered Description: Whether the participant is a nurse or midwife registered with the NMC 0 = no; 1 = yes G. Name: Yearsqualified Description: Number of years since the participant qualified as a nurse or midwife H. Name: IVauthorised Description: Whether the participant is authorised to prepare and administer intravenous medicines in their hospital 0 = no; 1 = yes I. Name: YearsIVauthorised Description: The number of years for which the participant has been authorised to prepare and administer intravenous medicines J. Name: YearsIVauthorisedBinary Description: The number of years for which the participant has been authorised to prepare and administer intravenous medicines 1 = less than 5 years; 2 = greater than or equal to five years K. Name: IVshifts Description: The percentage of shifts during which the participant prepares and administered intravenous medicines L. Name: Medusa Description: The participants past experience of the NHS Injectable Medicines Guide (Medusa) 1 = I regularly use it at the moment; 2 = I used it regularly in the past, but not at the moment; 3 = I've seen it before, but not used it often; 4 = I haven't seen it before M. Name: MedusaBinary Description: The participants past experience of the NHS Injectable Medicines Guide (Medusa) 1 = Regularly uses Medusa; 2 = Does not regularly use Medusa N. Name: Hospital Description: The research site number 1 = site 1; 2 = site 2; 3 = site 3; 4 = site 4 O. Name: MaxIMGseverityCategoryBinary Description: The maximum severity IMG-related error observed for the participant 1 = no error or minor error; 2 = moderate-severe error P. Name: MaxNonIMGseverityCategoryBinary Description: The maximum severity non-IMG-related error observed for the participant 1 = no error or minor error; 2 = moderate-severe error Q. Name: IMGerror Description: Did the participant make any IMG-related errors of any severity? 0 = no error; 1 = error R. Name: NonIMGerror Description: Did the participant make any non-IMG-related errors of any severity? 0 = no error; 1 = error S. Name: AdminTime Description: Time to complete the simulation in minutes T. Name: SimulationComplete Description: Did the participant complete the simulation, or were they unable to do this? 0 = no (censored data); 1 = yes, completed U. Name: DCS Description: The participant's modified decisional conflict score (see protocol for calculation method) V. Name: Preference Description: The participants preference between the two guides being tested 1 = I strongly prefer original; 2 = I prefer original; 3 = I somewhat prefer original; 4 = Same preference; 5 = I somewhat prefer revised; 6 = I prefer revised; 7 = I strongly prefer revised W. Name: mPDPAI1 to mPDPAI8 Description: The participant's response to each of the eight provider decision process assessment instrument questions (see protocol and Data collection form.pdf) 1 = Strongly agree; 2 = Agree; 3 = Neither agree nor disagree; 4 = Disagree; 5 = Strongly disagree X. Name: mPDPAI1R, mPDPAI2R, mPDPAI4R and mPDPAI5R Description: The participant's REVERSED response to each provider decision process assessment instrument questions 1, 2, 4 and 5 (see protocol and Data collection form.pdf, used for calculation of decisional conflict score) 1 = Strongly disagree; 2 = Disagree; 3 = Neither agree nor disagree; 4 = Agree; 5 = Strongly agree Y. Name: Satisfaction1 Description: The participant's rating of the quality of their intravenous medicine preparation and administration (see protocol and Data collection form.pdf) Z. Name: Satisfaction2 Description: The participant's rating of their feelings about their intravenous medicine preparation and administration (see protocol and Data collection form.pdf) 1 = Terrible; 2 = Unhappy; 3 = Dissatisfied; 4 = Neutral; 5 = Satisfied; 6 = Pleased; 7 = Delighted AA. Name: DCSminus1 to DCSminus8 Description: The participant's decisional conflict score minus either mPDPAI1R, mPDPAI2R, mPDPAI3, mPDPAI4R, mPDPAI5R, mDPAI6, mPDPAI7 or mPDPAI8 AB. Name: I1 to I11, and N1 to N5 Description: The number of errors of each error type observed during each participant's simulation. See protocol for description of error type numbers. AC. Name: TotalIMG Description: The total number of IMG-related errors made by the participant AD. Name: TotalNonIMG Description: The total number of non-IMG-related errors made by the participant AE. Name: TotalErrors Description: The total number of errors made by the participant AC. Name: AnyError Description: Did the participant make any errors of any type or severity? 0 = no; 1 = yes AD. Name: MaxIMGseverityScore Description: The mean panel severity score of the most serious IMG-related error made by the participant AE. Name: MaxNonIMGseverityScore Description: The mean panel severity score of the most serious non-IMG-related error made by the participant AF. Name: MaxIMGseverityCategory Description: The severity category of the most serious IMG-related error made by the participant 0 = no error; 1 = minor; 2 = moderate; 3 = severe AG. Name: MaxNonIMGseverityCategory Description: The severity category of the most serious non-IMG-related error made by the participant 0 = no error; 1 = minor; 2 = moderate; 3 = severe AH. Name: MaxIMGerrorCode Description: The error type for the most severe IMG-related error made by the participant (see protocol for definitions of each error type) 1 = I1; 2 = I2; 3 = I3; 4 = I4; 5 = I5; 6 = I6; 7 = I7; 8 = I8; 9 = I9; 10 = I10; 11 = I11 AI. Name: SevereIMGerror Description: Did the participant make a severe IMG-related error? 0 = no; 1 = yes AJ. Name: Debrief Description: Did the participant take part in a debrief interview? 0 = no; 1 = yes AK. Name: SimCompleteDilute Description: Did the participant complete the simulation and dilute the reconsitituted solution 0 = no; 1 = yes AL. Name: I1 minor, I1 moderate, I1 severe through to I11 minor, I11 moderate, I11 severe; N1 minor, N1 moderate, N1 severe through to N5 minor, N5 moderate, N5 severe; Description: Number of observed errors made by the participant of the stated error type and severity 4. Missing data codes: 99 5. Specialized formats of other abbreviations used N/A ----------------------------------------- DATA-SPECIFIC INFORMATION FOR: Video inter-rater reliability.sav ----------------------------------------- 1. Number of variables: 3 2. Number of cases/rows: 730 3. Variable List A. Name: Part. Randomisation Description: Participant randomisation number B. Name: Live Description: Live observer's record 0 = no error; 1 = error C. Name: Video Description: Video observer's record 0 = no error; 1 = error 4. Missing data codes: 99 5. Specialized formats of other abbreviations used N/A ----------------------------------------- DATA-SPECIFIC INFORMATION FOR: Severity Analysis Survey Final Results.csv ----------------------------------------- 1. Number of variables: 86 2. Number of cases/rows: 7 3. Variable List A. Name: Each variable name is the question (see severity survey.pdf) Description: Expert panel's severity score for each described error (range 0-10) 4. Missing data codes: N/A 5. Specialized formats of other abbreviations used N/A