This DATSETNAMEreadme.txt file was generated on 2021-01-18 by Claire Yinn Lim GENERAL INFORMATION 1. Title of Dataset: MIS Abx Dataset Complete 2. Author Information A. Principal Investigator Contact Information Name: Jason Abbott Institution: UNSW School of Women's and Children's Health Address: Royal Hospital for Women, Barker St, Randwick, NSW 2031 Email: j.abbott@unsw.edu.au B. Associate or Co-investigator Contact Information Name: Claire Yinn Lim Institution: UNSW School of Women's and Children's Health Address: Royal Hospital for Women, Barker St, Randwick, NSW 2031 Email: claire.lim@student.unsw.edu.au Name: Anais Alonso Institution: UNSW School of Women's and Children's Health Address: Royal Hospital for Women, Barker St, Randwick, NSW 2031 Email: alonso.anais97@gmail.com Name: Yi Ying Koh Institution: UNSW School of Women's and Children's Health Address: Royal Hospital for Women, Barker St, Randwick, NSW 2031 Email: yiying96@gmail.com Name: Stephanie Roydhouse Institution: UNSW School of Women's and Children's Health Address: Royal Hospital for Women, Barker St, Randwick, NSW 2031 Email: steph.roydhouse@gmail.com Name: Lalla McCormack Institution: UNSW School of Women's and Children's Health Address: Royal Hospital for Women, Barker St, Randwick, NSW 2031 Email: lalla_mccormack@hotmail.com Name: Rebecca Deans Institution: UNSW School of Women's and Children's Health Address: Royal Hospital for Women, Barker St, Randwick, NSW 2031 Email: r.deans@unsw.edu.au Name: Erin Nesbitt-Hawes Institution: UNSW School of Women's and Children's Health Address: Royal Hospital for Women, Barker St, Randwick, NSW 2031 Email: erin@alanahealthcare.com.au Name: Archana Rao Institution: Royal Brisbane and Women's Hospital Address: Royal Brisbane and Women's Hospital, Butterfield St, Herston, QLD 4029 Email: archanadrao1@gmail.com Name: Louise Causer Institution: Kirby Institute Address: Wallace Wurth Building, High St, Kensington NSW 2052 Email: Lcauser@kirby.unsw.edu.au 3. Date of data collection: 2019-02-21 to 2021-04-22 4. Geographic location of data collection: Sydney, New South Wales, Australia 5. Information about funding sources that supported the collection of the data: The Australasian Gynaecological Endoscopy & Surgery (AGES) provided a competitive, unrestricted grant for the study. SHARING/ACCESS INFORMATION 1. Licenses/restrictions placed on the data: CC-BY-NC 2. Links to publications that cite or use the data: -NA- 3. Links to other publicly accessible locations of the data: -NA- 4. Links/relationships to ancillary data sets: -NA- 5. Was data derived from another source? No 6. Recommended citation for this dataset: -NA- DATA & FILE OVERVIEW 1. File List: Sheet 1 - Demographics: participant demographics Sheet 2 - DOS: participant day of surgery information, including preoperative and intraoperative information Sheet 3 - Postoperative Data: data pertaining to participant hospital stay until discharge Sheet 4 - 2-Week Follow Up: participant follow up data at 2-weeks post-surgery Sheet 5 - 6-Week Follow Up: participant follow up data at 6-weeks post-surgery (last follow up) 2. Relationship between files, if important: temporal 3. Additional related data collected that was not included in the current data package: 4. Are there multiple versions of the dataset? No METHODOLOGICAL INFORMATION 1. Description of methods used for collection/generation of data: Inclusion Criteria: undergoing elective, non-hysterectomy laparoscopic surgery for benign gynaecological conditions; age over 18 years at the time of surgery; fluency in written and spoken English; and ability to understand the implications of their involvement in the study Exclusion Criteria: suspected or confirmed pregnancy; immunocompromise; documented history of allergy to cephalosporins and/or penicillin; and current involvement in another research project Data was collected via an electronic form stored on an ethics-approved secure database on the day of surgery, during the participant's hospital stay, and at 2- and 6-weeks postoperatively. Brief study design can be obtained from https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373902&isReview=true 2. Methods for processing the data: Dichotomous data were compared using the Chi-square test, or Fisher’s exact test, as indicated. Continuous variables were assessed for normality using the Kolmogorov-Smirnov test with parametric data analysed by Student’s t test and non-parametric data analysed by Mann-Whitney U test. In this study p<.05 is considered statistically significant. 3. Instrument- or software-specific information needed to interpret the data: -NA- 4. Standards and calibration information, if appropriate: 5. Environmental/experimental conditions: 6. Describe any quality-assurance procedures performed on the data: 7. People involved with sample collection, processing, analysis and/or submission: Dr Claire Lim, Dr Stephanie Roydhouse, Ms Anais Alonso, Ms Yi Ying Koh, Dr Lalla McCormack, Dr Rebecca Deans, Dr Erin Nesbitt-Hawes, Prof Jason Abbott DATA-SPECIFIC INFORMATION FOR: MIS Abx Dataset Complete 1. Number of variables: Sheet 1 (Demographics) - 15 Sheet 2 (DOS) - 22 Sheet 3 (Postoperative Data) - 10 Sheet 4 (2-Weeks Follow Up) - 26 Sheet 5 (6-Weeks Follow Up) - 44 2. Number of cases/rows: Sheet 1 (Demographics) - 117 Sheet 2 (DOS) - 117 Sheet 3 (Postoperative Data) - 117 Sheet 4 (2-Weeks Follow Up) - 117 Sheet 5 (6-Weeks Follow Up) - 117 3. Variable List: Sheet 1 (Demographics) - blind_id: deidentified study participant number trial_drug_allocation: 1 - antibiotic, 2 - placebo age ethnicity: 1 - white, 2 - asian, 3 - others marital_status: 1 - single, 2 - married, 3 - de facto, 4 - others current_occupation: 1 - clerical, 2 - home duties, 3 - professional, 4 - trade, 5 - others, 6 - not currently employed body_mass_index smoking_status: 1 - yes, 2 - no alcohol_consumption: 1 - yes, 2 - no previous_abdominal_surgery: 1 - yes, 2 - no existing_medical_conditions: 1 - yes, 2 - no regular_prescription_medication: 1 - yes, 2 - no non_prescription_medication: 1 - yes, 2 - no antibiotic_reactions: 1 - yes, 2 - no drug_allergies: 1 - yes, 2 - no Sheet 2 (DOS) - dos_blind_id: deidentified study participant number date: date of surgery baseline_temp_celsius: temperature at time of hospital admission on day of surgery, ˚C baseline_heart_rate_bpm: heart rate at time of hospital admission on day of surgery, beats per minute blood_pressure_mmHg: blood pressure at time of hospital admission on day of surgery, mmHg total_operating_time_min: total time from first to last incision, minutes administration_trial_drug_within_1h: 1 - yes, 2 - no primary_procedure: 1 - endometriosis surgery, 2 - others uterine_elevator_insertion: 1 - yes, 2 - no idc_insertion: indwelling urinary catheter insertion; 1 - yes, 2 - no duration_catheterisation_hours: duration of urinary catheter insertion, hours method_of_entry: 1 - closed (Veress), 2 - open, 3 - direct, 4 - others number_of_ports: 1 - 4 ports, 2 - 3 ports primary_pathology: 1 - endometriosis, 2 - others, 3 - none found laparotomy_conversion: 1 - yes, 2 - no intraoperative_complications: 1 - yes, 2 - no description_postoperative_complications: type of postoperative complication experience estimated_blood_loss_ml: estimated blood loss during surgery, mL intraoperative_blood_transfusion: 1 - yes, 2 - no intraoperative_antibiotic_administration: 1 - yes, 2 - no intraoperative_drug_reaction: 1 - yes, 2 - no drain_insertion: 1 - yes, 2 - no Sheet 3 (Postoperative Data) - postop_blind_id: deidentified study participant number allocation_trial_drug: 1 - antibiotic, 2 - placebo postoperative_catheterisation_duration_hours: duration of urinary catheter insertion, hours duration_drain_insitu_hours: duration of drain insertion, hours suspected_drug_reaction_prior_discharge: any suspected drug reactions prior to participant discharge drug_reaction_specified: description of drug reaction experienced drug_reaction_days_postop: number of days postoperatively the drug reaction was experienced postoperative_complication_prior_discharge: postoperative complication experience prior to discharge complication_description: description of postoperative complication experienced length_of_stay_hours: total length of stay in hospital from time of return to ward to time of discharge, hours Sheet 4 (2-Weeks Follow Up) - 2_blind_id: deidentified study participant number 2_allocation: 1 - antibiotic, 2 - placebo 2_infection_requiring_antibiotics: participant developed an infection within 2-weeks postoperatively; 1 - yes, 2 - no 2_infection_site: site of infection 2_days_since_index_surgery: number of days postoperatively the infection started 2_microbiological_testing_undertaken: any microbiological tests ordered; 1 - yes, 2 - no 2_tests_ordered_results: microbiological tests ordered and test results 2_antibiotic_prescribed: type of antibiotic prescribed 2_antibiotic_dose: dose of antibiotic prescribed 2_antibiotic_route: route of antibiotic administration, including oral (PO), intravenous (IV) and topical 2_antibiotic_frequency: frequency of antibiotic administration, including once daily (OD), twice daily (BD), thrice daily (TDS) or four times daily (QID) 2_antibiotic_total_duration_course_days: total duration of antibiotic course 2_need_for_readmission: need for readmission into hospital following infection; 1 - yes, 2 - no 2_antibiotic_prescriber: prescriber 2_infection_requiring_antibiotics_2: participant developed an infection within 2-weeks postoperatively; 2nd entry; 1 - yes, 2 - no 2_infection_site_2: site of infection; 2nd entry 2_days_since_index_surgery_2: number of days postoperatively the infection started; 2nd entry 2_microbiological_testing_undertaken_2: any microbiological tests ordered; 2nd entry; 1 - yes, 2 - no 2_tests_ordered_results_2: microbiological tests ordered and test results; 2nd entry 2_antibiotic_prescribed_2: type of antibiotic prescribed; 2nd entry 2_antibiotic_dose_2: dose of antibiotic prescribed; 2nd entry 2_antibiotic_route_2: route of antibiotic administration, including oral (PO), intravenous (IV) and topical; 2nd entry 2_antibiotic_frequency_2: frequency of antibiotic administration, including once daily (OD), twice daily (BD), thrice daily (TDS) or four times daily (QID); 2nd entry 2_antibiotic_total_duration_course_days_2: total duration of antibiotic course; 2nd entry 2_need_for_readmission_2: need for readmission into hospital following infection 2nd entry; 1 - yes, 2 - no 2_antibiotic_prescriber_2: prescriber; 2nd entry Sheet 5 (6-Week Follow Up) - 6_blind_id: deidentified study participant number 6_allocation: 1 - antibiotic, 2 - placebo 6_infection_requiring_antibiotics: participant developed an infection within 6-weeks postoperatively; 1 - yes, 2 - no 6_infection_site: site of infection 6_days_since_index_surgery: number of days postoperatively the infection started 6_microbiological_testing_undertaken : any microbiological tests ordered; 1 - yes, 2 - no 6_tests_ordered_results: microbiological tests ordered and test results 6_antibiotic_prescribed: type of antibiotic prescribed 6_antibiotic_dose: dose of antibiotic prescribed 6_antibiotic_route: route of antibiotic administration, including oral (PO), intravenous (IV) and topical 6_antibiotic_frequency: frequency of antibiotic administration, including once daily (OD), twice daily (BD), thrice daily (TDS) or four times daily (QID) 6_antibiotic_total_duration_course_days: total duration of antibiotic course 6_need_for_readmission: need for readmission into hospital following infection; 1 - yes, 2 - no 6_antibiotic_prescriber: prescriber 6_infection_requiring_antibiotics_2: participant developed an infection within 6-weeks postoperatively; 2nd entry; 1 - yes, 2 - no 6_infection_site_2: site of infection; 2nd entry 6_days_since_index_surgery_2: number of days postoperatively the infection started; 2nd entry 6_microbiological_testing_undertaken_2: any microbiological tests ordered; 2nd entry; 1 - yes, 2 - no 6_tests_ordered_results_2: microbiological tests ordered and test results; 2nd entry 6_antibiotic_prescribed_2: type of antibiotic prescribed; 2nd entry 6_antibiotic_dose_2: dose of antibiotic prescribed; 2nd entry 6_antibiotic_route_2: route of antibiotic administration, including oral (PO), intravenous (IV) and topical; 2nd entry 6_antibiotic_frequency_2: frequency of antibiotic administration, including once daily (OD), twice daily (BD), thrice daily (TDS) or four times daily (QID); 2nd entry 6_antibiotic_total_duration_course_days_2: total duration of antibiotic course; 2nd entry 6_need_for_readmission_2: need for readmission into hospital following infection; 2nd entry; 1 - yes, 2 - no 6_antibiotic_prescriber_2: prescriber; 2nd entry 6_infection_requiring_antibiotics_3: : participant developed an infection within 6-weeks postoperatively; 3rd entry; 1 - yes, 2 - no 6_infection_site_3: site of infection; 3rd entry 6_tests_ordered_results_3: microbiological tests ordered and test results; 3rd entry 6_antibiotic_prescribed_3: type of antibiotic prescribed; 3rd entry 6_antibiotic_dose_3: dose of antibiotic prescribed; 3rd entry 6_antibiotic_route_3: route of antibiotic administration, including oral (PO), intravenous (IV) and topical; 3rd entry 6_antibiotic_total_duration_course_days_3: total duration of antibiotic course; 3rd entry 6_need_for_readmission_3: need for readmission into hospital following infection; 3rd entry; 1 - yes, 2 - no 6_antibiotic_prescriber_3: prescriber; 3rd entry 6_suspected_drug_reaction: suspected drug reaction of duration of study; 1 - yes, 2 - no 6_description_reaction: description of drug reaction 6_days_postop_drug_reaction: number of days postoperative the drug reaction was experienced 6_drug_name: suspected causative drug 6_drug_route: route of administration of suspected drug 6_drug_frequency: frequency of administration of suspected drug 6_anaphylaxis: anaphylactic reaction to drug; 1 - yes, 2 - no 6_referral_allergy_testing: any referral made for allergy testing; 1 - yes, 2 - no 6_drug_identification: identification of causative drug; 1 - yes, 2 - no 4. Missing data codes: all missing data codes were left empty 5. Specialized formats or other abbreviations used: