east multicenter study data collection tool · perforated appendicitis phlegmon cecal inflammation...

EAST MULTICENTER STUDY

DATA COLLECTION TOOL

Multicenter Study: Appendicitis Enrolling Center: _______________________ Subject ID# _________ Enrolling Co-investigator: _______________________ Demographics: Admit Date: ______________ Admit Time: ______________ Age: _______ Gender:_______ Weight (kg): _________ Body Mass Index (BMI): _____________

History of Present Illness: Duration of symptoms (Single best choice for description of # of hours since symptom onset) < 6 h

6 – 12 h 12 – 18 h 18 – 24 h 24 – 30 h 30 – 36 h 36 – 42 h 42 – 48 h 48 – 54 h 54 – 60 h 60 – 66 h 66 – 72 h 72 – 78 h 78 – 84 h 84 – 90 h 90 – 96 h > 96 h

Nausea? Yes or No Vomiting? Yes or No Anorexia? Yes or No Diarrhea? Yes or No Migration? Yes or No Prior episodes? Yes or No

Past Medical History/Past Surgical History: Diabetes mellitus (DM)? Yes or No If Yes: Type 1 or Type 2 Coronary artery disease (CAD)? Yes or No Hypercholesterolemia? Yes or No Chronic Obstructive Pulmonary Disease (COPD)? Yes or No Charlson Comorbidity Index: _________________ Prior operations: _____________________

Medications: Steroids? Yes or No Chemotherapy? Yes or No Other? Yes or No If Yes: describe (free text)

Admission Physical Exam: Temperature (Celsius): ______ Heart rate: ________ Systolic BP: _________ Right lower quadrant (RLQ) tenderness? Yes or No RLQ rebound tenderness? Yes or No Diffuse abdominal tenderness? Yes or No Rovsing’s sign? Yes or No Obturator’s sign? Yes or No Psoas sign? Yes or No

Admission Lab values: WBC (K/uL): _______ % polymorphonuclear cells: _______ % band cells: _______ C-reactive peptide (CRP), mg/L: _____________ Erythrocyte sedimentation rate (ESR), mm/hr: ___________ Alvarado score: _______________

Radiographic Imaging: Type: None

Ultrasound (US) only Computed tomography (CT) US and CT Magnetic Resonance Imaging (MRI)

US and MRI Other Ultrasound findings (choose all that apply):

Normal appendix Non-compressible blind-ending structure Appendicolith Appendiceal diameter (enter numeric value) Unable to visualize Inconclusive Other: __________________ CT findings (choose all that apply):

Normal appendix Inflammatory changes localized to appendix Appendiceal diameter (enter numeric value) Contrast nonfilling of appendix Appendiceal wall necrosis with contrast nonenhancement Air in appendiceal wall Local periappendiceal fluid Contrast extravasation Regional soft tissue inflammatory changes, phlegmon or abscess Diffuse abdominal or pelvic inflammatory changes Free intraperitoneal fluid or air Perforated appendicitis Phlegmon Cecal inflammation Appendicolith Unable to visualize Inconclusive Other: _________________ MRI findings (choose all that apply):

Normal appendix Inflammatory changes localized to appendix Appendiceal diameter (enter numeric value) Contrast nonfilling of appendix Appendiceal wall necrosis with contrast nonenhancement Air in appendiceal wall Local periappendiceal fluid Contrast extravasation Regional soft tissue inflammatory changes, phlegmon or abscess Diffuse abdominal or pelvic inflammatory changes Free intraperitoneal fluid or air Perforated appendicitis Phlegmon Cecal inflammation Appendicolith Unable to visualize Inconclusive Other: _________________

Management Variables: Initial treatment strategy : Antibiotics only Percutaneous drainage with pre-operative antibiotics > 1 hr before procedure Percutaneous drainage without pre-operative antibiotics > 1 hr before Procedure Appendectomy with pre-operative antibiotics > 1 hr before procedure Appendectomy without pre-operative antibiotics > 1 hr before procedure Other: __________________ Type of antibiotics Free text entry for specific type of antibiotic initiated Generic or trade-name acceptable. If there is not space within the confines of the entry space to write all of the antibiotics utilized, use the study site email to notify the PIs and we will collect this information Time from symptom onset to initial intervention: < 6h


Time from hospital admission to initial intervention: < 6h


Initial operative approach Not applicable (N/A) Laparoscopic single incision Laparoscopic three incision Open Other:______________ Final operative approach N/A Laparoscopic single incision Laparoscopic three incision Open via RLQ incision Open via midline incision Open via other incision Other: _____________ Intraoperative findings (choose all that apply): N/A Normal appearing appendix Acutely inflamed appendix, intact Perforated appendix, with evidence of local contamination Perforated appendix, with abscess or phlegmon in region of appendix Perforated appendix with addition of generalized purulent contamination away from appendix Gangrenous appendix, intact Gangrenous appendix, with evidence of local contamination Gangrenous appendix, with abscess or phlegmon in region of appendix Gangrenous appendix with addition of generalized purulent contamination away from appendix Abscess Serous pelvic fluid Purulent pelvic fluid Other:________________ Intraoperative adverse events (iAE) N/A Yes No iAE grade Single best option for iAE grade. Options include: N/A 1 = Injury requiring no repair within the same procedure (eg,

cauterization, use of prothrombotic material, small vessel ligation)

2 = Injury requiring surgical repair, without organ removal or a change in the planned procedure (eg, any suture repair, patch repair)

3 = Injury requiring tissue or organ removal with completion of the originally planned procedure

4 = Injury requiring a significant change (excluding minimally invasive to open conversions) and/or incompletion of the originally planned procedure

5 = Missed intraoperative injury requiring re-operation within 7 days 6 = intraoperative death Suffix T = Add if injury required transfusion of ≥ 2 u RBCs Operative duration Duration of operation (minutes). Enter -99 if N/A Surgical drains N/A Yes or No

Post-intervention antibiotics: N/A Yes No Post-intervention antibiotics type Free entry for specific type of antibiotic initiated and duration Generic or trade-name acceptable. If there is not space within the confines of the entry space to write all of the antibiotics utilized, use the study site email to notify the PIs and we will collect this information

Pathologic Variables: Microbiologic diagnosis: Check if applies. Free entry for organism. If there is not space within the confines of the entry space to write all of the antibiotics utilized, use the study site email to notify the PIs and we will collect this information Final pathologic diagnosis (single best answer): N/A Normal appendix Acute appendicitis Acute on chronic appendicitis Chronic appendicitis Perforated appendicitis Gangrenous appendicitis Adenocarcinoma Neuroendocrine tumor Other: ___________________ AAST Grade Single best answer for AAST grade. In cases where the grade differs

between the four categories, the highest grade will apply. Options include: 1 2 3 4

1 – Description: acutely inflamed appendix, intact Clinical: pain, leukocytosis and RLQ tenderness Imaging: inflammatory changes localized to appendix +/- appendiceal dilation +/- contrast nonfilling Operative: acutely inflamed appendix, intact Pathologic: presence of neutrophils at the base of crypts, submucosa +/- in muscular wall 2 – Description: gangrenous appendix, intact Clinical: pain, leukocytosis, and RLQ tenderness Imaging: appendiceal wall necrosis with contrast nonenhancement +/- air in appendiceal wall Operative: gangrenous appendix, intact Pathologic: mucosa and muscular wall digestion; not identifiable on hematoxylin-eosin stain 3 – Description: perforated appendix with local contamination Clinical: pain, leukocytosis, and RLQ tenderness Imaging: above with local periappendiceal fluid +/- contrast extravasation Operative: above, with evidence of local contamination

Pathologic: gross perforation or focal dissolution of muscular wall 4 – Description: perforated appendix with periappendiceal phlegmon or abscess Clinical: pain, leukocytosis, and RLQ tenderness; may have palpable mass Imaging: regional soft tissue inflammatory changes, phlegmon or abscess Operative: above, with abscess or phlegmon in region of appendix Pathologic: gross perforation 5 – Description: Perforated appendix with generalized peritonitis Clinical: generalized peritonitis Imaging: diffuse abdominal or pelvic inflammatory changes +/- free intraperitoneal fluid or air Operative: above, with addition of generalized purulent contamination away from appendix Pathologic: gross perforation

Outcomes: Complications (circle all that apply and list hospital day encountered) NOTE = for calculation of all complication days, day of admission = hospital day (HD) #1 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Definitions of complications included in this section:

Infectious Surgical site infection (SSI) HD:______ Defined as: signs and symptoms of infection (redness, tenderness,

warmth, purulent drainage) requiring treatment (either incisional opening or antibiotic prescription). May be categorized as organ space, deep incisional, or superficial.

CTCAE Grade 2 Defined as: localized, local intervention indicated Grade 3 Defined as: IV antibiotic, antifungal, or antiviral intervention indicated;

interventional radiology or operative intervention indicated Grade 4 Defined as: life-threatening consequences (e.g., septic shock,

hypotension, acidosis, necrosis) Grade 5 Defined as: death secondary to infection Intra-abdominal abscess: HD:______ Defined as signs and symptoms of deep infection (abdominal

tenderness, obstruction, nausea, diarrhea) confirmed by imaging (ultrasound or CT) and requiring treatment (either open or percutaneous drainage or antibiotic prescription)

Hospital Acquired Pneumonia: HD:_________ Definition below Hospital Acquired Pneumonia: Confirmed by the presence of the following after 48 hours of hospitalization:

1. purulent sputum 2. associated systemic evidence of infection:

a. WBC > 11,000 or < 4,000 b. Fever > 100.4 degrees F / 38 degrees Celsius

3. Two or more serial chest radiographs with new or progressive and persistent infiltrate, consolidation or cavitation.

4. BAL, mini-BAL or sterile endotracheal specimen with: a. Limited number of epithelial cells b. WBC (2-3+) c. Dominant organism(s) identified on gram stain or culture with quantitative culture > 100,000

cfu/mL CTCAE Grade 2 Defined as: localized, local intervention indicated Grade 3 Defined as: IV antibiotic, antifungal, or antiviral intervention indicated;


hypotension, acidosis, necrosis) Grade 5 Defined as: death secondary to infection

Blood stream infection: HD:__________ Defined as positive cultures obtained from blood culture. CTCAE Grade 2 Defined as: localized, local intervention indicated Grade 3 Defined as: IV antibiotic, antifungal, or antiviral intervention indicated;


hypotension, acidosis, necrosis) Grade 5 Defined as: death secondary to infection Catheter-associated UTI: UTI = Urinary Tract Infection HD:__________ Definition below: Catheter-associated UTI: All criteria must be met: 1. Patient has had an indwelling urinary catheter within 7 days before urinary culture. 2. Positive urine culture, that is ≥ 10

5 microorganisms/ml of urine with no

more than two species of microorganisms 3. Urine culture has 10wbc/hpf CTCAE Grade 2 Defined as: localized, local intervention indicated Grade 3 Defined as: IV antibiotic, antifungal, or antiviral intervention indicated;


hypotension, acidosis, necrosis) Grade 5 Defined as: death secondary to infection C. difficile infection: HD:__________ Defined as confirmed C. difficile toxin with or without evidence of diarrhea CTCAE Grade 1 Defined as: asymptomatic, pathologic or radiographic findings only Grade 2 Defined as: localized, local intervention indicated Grade 3 Defined as: IV antibiotic, antifungal, or antiviral intervention indicated;


hypotension, acidosis, necrosis) Grade 5 Defined as: death secondary to infection Sepsis: HD:__________ Definition below. Sepsis: Has a confirmed infectious process AND two or more of the following: 1. fluid-unresponsive hypotension 2. serum lactate level >2 mmol/L 3. need for vasopressors to maintain mean arterial pressure >65 mmHg

Gastrointestinal Post-operative ileus: HD:_________ Defined as functional inability to tolerate enteral or oral intake requiring

prolongation of hospitalization. CTCAE Grade 1 Defined as: asymptomatic, radiographic findings only Grade 2 Defined as: symptomatic; altered GI function (e.g., altered dietary

habits); IV fluids indicated for <24 h Grade 3 Defined as: symptomatic and severely altered GI function; IV fluids, tube

feeding, or TPN indicated for ≥ 24 h Grade 4 Defined as: life-threatening consequences Grade 5 Defined as: death secondary to ileus GI Obstruction: Defined as inability to tolerate enteral or oral intake secondary to an

anatomic obstruction and requiring hospital admission or prolongation of hospitalization

HD:_________ CTCAE Grade 1 Defined as: asymptomatic, radiographic findings only Grade 2 Defined as: symptomatic; altered GI function (e.g., altered dietary

habits); IV fluids indicated for <24 h Grade 3 Defined as: symptomatic and severely altered GI function; IV fluids, tube

feeding, or TPN indicated for ≥ 24 h Grade 4 Defined as: life-threatening consequences Grade 5 Defined as: death secondary to obstruction

Cardiac Supraventricular and nodal arrhythmia: HD:________ Defined as: atrial fibrillation, atrial flutter, atrial tachycardia/paroxysmal

atrial tachycardia, nodal/junctional, sinus arrhythmia, sinus bradycardia, sinus tachycardia, supraventricular arrhythmia NOS, supraventricular extrasystoles (premature atrial contractions; premature nodal/junctional contractions), supraventricular tachycardia

CTCAE Grade 1 Defined as: asymptomatic, intervention not indicated Grade 2 Defined as: non-urgent medical intervention indicated Grade 3 Defined as: incompletely controlled medically or controlled with device (e.g. pacemaker) Grade 4 Defined as: life-threatening (e.g., arrhythmia associated with CHF, hypotension, syncope, shock) Grade 5 Defined as: death

Ventricular arrhythmia: HD:________________ Defined as: bigeminy, idioventricular rhythm, PVCs, torsade de pointes, trigeminy, ventricular arrhythmia NOS, ventricular fibrillation, ventricular flutter, ventricular tachycardia CTCAE Grade 1 Defined as: asymptomatic, intervention not indicated Grade 2 Defined as: non-urgent medical intervention indicated Grade 3 Defined as: incompletely controlled medically or controlled with device (e.g. pacemaker) Grade 4 Defined as: life-threatening (e.g., arrhythmia associated with CHF, hypotension, syncope, shock) Grade 5 Defined as: death Cardiac ischemia/infarction: HD:________________ CTCAE Grade 1 Defined as: asymptomatic arterial narrowing (on angiography) without ischemia Grade 2 Defined as: asymptomatic and testing suggesting ischemia; stable angina Grade 3 Defined as: Symptomatic and testing consistent with ischemia; unstable angina; intervention indicated Grade 4 Defined as: acute myocardial infarction Grade 5 Defined as: death

Vascular

DVT / PE: HD:__________ DVT = Deep Vein Thrombosis PE = Pulmonary embolism. Diagnosis must be confirmed radiographically (Ultrasound, Computed tomography, venography, etc.) CTCAE Grade 2 Defined as: intervention (e.g., anticoagulation, lysis, filter, invasive procedure) not indicated. Grade 3 Defined as: intervention (e.g., anticoagulation, lysis, filter, invasive procedure) indicated. Grade 4 Defined as: embolic event including pulmonary embolism or life- threatening thrombus Grade 5 Defined as: death Hemorrhage/Bleeding: CTCAE Grade 1 Defined as hematoma with minimal symptoms, invasive intervention not

indicated Grade 2 Defined as hematoma with minimally invasive evacuation or aspiration

indicated Grade 3 Defined as requiring transfusion, interventional radiology, or operative

intervention Grade 4 Defined as bleeding with life-threatening consequences or major urgent

intervention Grade 5 Defined as death secondary to hemorrhage

Renal/Genitourinary Urinary retention HD:____________ CTCAE Grade 1 Defined as: hesitancy or dribbling, no significant residual urine; retention occurring during the immediate postoperative period Grade 2 Defined as: hesitancy requiring medication; or operative bladder atony requiring indwelling catheter beyond immediate postoperative period but for <6 weeks Grade 3 Defined as: more than daily catheterization indicated; urological intervention indicated (e.g., TURP, suprapubic tube, urethrotomy) Grade 4 Defined as: life-threatening consequences; organ failure (e.g., bladder rupture); operative intervention requiring organ resection indicated Grade 5 Defined as: death Acute Kidney Injury (AKI): Defined as twofold increase in the serum creatinine or glomerular

filtration rate (GFR) decrease by 50% or urine output < 0.5 mL/kg/h for 12 hours (RIFLE criteria)

HD:___________ CTCAE Grade 1 Defined as: creatinine between upper limit of normal (ULN) and 1.5 x ULN Grade 2 Defined as: creatinine between 1.5 to 3.0 x ULN Grade 3 Defined as: creatinine between 3.0 to 6.0 x ULN Grade 4 Defined as: creatinine > 6.0 x ULN Grade 5 Defined as: death

Pulmonary ARDS: HD:___________ ARDS = Acute respiratory distress syndrome. Definition(s) below: Berlin criteria definitions will be utilized Timing: Must develop symptoms within 1 week of a known clinical insult Chest imaging: bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules Origin of edema: Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective

assessment (eg, echocardiography) to exclude hydrostatic edema if no risk factor present)

Oxygenation Mild ARDS: PaO2/FiO2 = 201-300 with PEEP or CPAP ≥ 5 cm H20 Moderate ARDS: PaO2/FiO2 =101-200 with PEEP ≥ 5 cm H20 Severe ARDS: PaO2/FiO2 ≤ 100 with PEEP ≥ 5 cm H20

Clavien-Dindo Complications Yes or No If yes, what grade (if more than one, Numerical value (1-5) choose highest grade)

Dindo. Classification of Surgical Complications: A New Proposal With Evaluation in a Cohort of 6336 Patients and Results of a Survey. Ann Surg 2004;240:205-213. Index Hospital LOS (days): _________ Free text entry for number of consecutive days patient hospitalized at initial admission (Day of admission = hospital day #1) LOS = Length of Stay 1-year hospital LOS (days):_________ Free text entry for number of days patient was hospitalized for 365 days after initial admission. Refers only to abdominal symptom-related admissions. (Day of admission = hospital day #1) Hospital readmission within 365 days after initial hospitalization? Yes or No ICU LOS (days): ___________ Free text entry of number of consecutive days patient required ICU admission (ICU = Intensive Care Unit, LOS = Length of Stay) - Day of ICU admission = ICU day #1 1-year ICU LOS (days): _______ Free text entry for number of days patient required ICU admission for 365 days after initial admission. Refers only to abdominal symptom- related admissions. (Day of ICU admission = ICU day #1) Secondary intervention: Yes or No Did patient require an additional intervention beyond the initially chosen

treatment strategy during initial hospitalization? 1-year secondary intervention:Yes or No Did patient require an additional intervention beyond the initially

chosen treatment strategy in the 365 days after initial hospitalization (includes interventions during initial hospitalization).

Type of secondary intervention Choose all that apply. N/A Antibiotics only Percutaneous drainage Appendectomy (laparoscopic) Appendectomy (open) Lysis of adhesions Small bowel resection Surgical repair of enteric or appendiceal stump leak Incisional hernia repair (includes port-site hernias) Other: _________________ Mortality? Yes or No Did patient expire during initial hospitalization? 1-year mortality? Yes or No Did patient expire in the 365 days after initial hospitalization?

EAST MULTICENTER STUDY

DATA COLLECTION TOOL

Multicenter Study: Appendicitis Enrolling Center: _______________________ Subject ID# _________ Enrolling Co-investigator: _______________________ Demographics: Admit Date: ______________ Admit Time: ______________ Age: _______ Gender:_______ Weight (kg): _________ Body Mass Index (BMI): _____________ History of Present Illness: Duration of symptoms (Single best choice for description of # of hours since symptom onset) < 6 h


Nausea? Yes or No Vomiting? Yes or No Anorexia? Yes or No Diarrhea? Yes or No Migration? Yes or No Prior episodes? Yes or No

Past Medical History/Past Surgical History: Diabetes mellitus (DM)? Yes or No If Yes: Type 1 or Type 2 Coronary artery disease (CAD)? Yes or No Hypercholesterolemia? Yes or No Chronic Obstructive Pulmonary Disease (COPD)? Yes or No Charlson Comorbidity Index: _________________ Prior operations: _____________________ Medications: Steroids? Yes or No Chemotherapy? Yes or No Other? Yes or No If Yes: describe (free text) Admission Physical Exam: Temperature (Celsius): ______ Heart rate: ________ Systolic BP: _________ Right lower quadrant (RLQ) tenderness? Yes or No RLQ rebound tenderness? Yes or No Diffuse abdominal tenderness? Yes or No Rovsing’s sign? Yes or No Obturator’s sign? Yes or No Psoas sign? Yes or No Admission Lab values: WBC (K/uL): _______ % polymorphonuclear cells: _______ % band cells: _______ C-reactive peptide (CRP), mg/L: _____________ Erythrocyte sedimentation rate (ESR), mm/hr: ___________ Alvarado score: _______________

Radiographic Imaging: Type: None

Ultrasound (US) only Computed tomography (CT) US and CT Magnetic Resonance Imaging (MRI)

US and MRI Other Ultrasound findings (choose all that apply):

Normal appendix Non-compressible blind-ending structure Appendicolith Appendiceal diameter (enter numeric value) Unable to visualize Inconclusive Other: __________________ CT findings (choose all that apply):

Normal appendix Inflammatory changes localized to appendix Appendiceal diameter (enter numeric value) Contrast nonfilling of appendix Appendiceal wall necrosis with contrast nonenhancement Air in appendiceal wall Local periappendiceal fluid Contrast extravasation Regional soft tissue inflammatory changes, phlegmon or abscess Diffuse abdominal or pelvic inflammatory changes Free intraperitoneal fluid or air Perforated appendicitis Phlegmon Cecal inflammation Appendicolith Unable to visualize Inconclusive Other: _________________ MRI findings (choose all that apply):

Normal appendix Inflammatory changes localized to appendix Appendiceal diameter (enter numeric value) Contrast nonfilling of appendix Appendiceal wall necrosis with contrast nonenhancement Air in appendiceal wall Local periappendiceal fluid Contrast extravasation Regional soft tissue inflammatory changes, phlegmon or abscess Diffuse abdominal or pelvic inflammatory changes Free intraperitoneal fluid or air Perforated appendicitis Phlegmon Cecal inflammation Appendicolith Unable to visualize Inconclusive Other: _________________

Management Variables: Initial treatment strategy : Antibiotics only Percutaneous drainage with pre-operative antibiotics > 1 hr before procedure Percutaneous drainage without pre-operative antibiotics > 1 hr before Procedure Appendectomy with pre-operative antibiotics > 1 hr before procedure Appendectomy without pre-operative antibiotics > 1 hr before procedure Other: __________________ Type of antibiotics Free text entry for specific type of antibiotic initiated Generic or trade-name acceptable. If there is not space within the confines of the entry space to write all of the antibiotics utilized, use the study site email to notify the PIs and we will collect this information Time from symptom onset to initial intervention: < 6h


Time from hospital admission to initial intervention: < 6h


Initial operative approach Not applicable (N/A) Laparoscopic single incision Laparoscopic three incision Open Other:______________ Final operative approach N/A Laparoscopic single incision Laparoscopic three incision Open via RLQ incision Open via midline incision Open via other incision Other: _____________ Intraoperative findings (choose all that apply): N/A Normal appearing appendix Acutely inflamed appendix, intact Perforated appendix, with evidence of local contamination Perforated appendix, with abscess or phlegmon in region of appendix Perforated appendix with addition of generalized purulent contamination away from appendix Gangrenous appendix, intact Gangrenous appendix, with evidence of local contamination Gangrenous appendix, with abscess or phlegmon in region of appendix Gangrenous appendix with addition of generalized purulent contamination away from appendix Abscess Serous pelvic fluid Purulent pelvic fluid Other:________________ Intraoperative adverse events (iAE) N/A Yes No iAE grade Single best option for iAE grade. Options include: N/A 1 = Injury requiring no repair within the same procedure (eg,

cauterization, use of prothrombotic material, small vessel ligation)

2 = Injury requiring surgical repair, without organ removal or a change in the planned procedure (eg, any suture repair, patch repair)

3 = Injury requiring tissue or organ removal with completion of the originally planned procedure

4 = Injury requiring a significant change (excluding minimally invasive to open conversions) and/or incompletion of the originally planned procedure

5 = Missed intraoperative injury requiring re-operation within 7 days 6 = intraoperative death Suffix T = Add if injury required transfusion of ≥ 2 u RBCs Operative duration Duration of operation (minutes). Enter -99 if N/A Surgical drains N/A Yes or No

Post-intervention antibiotics: N/A Yes No Post-intervention antibiotics type Free entry for specific type of antibiotic initiated and duration Generic or trade-name acceptable. If there is not space within the confines of the entry space to write all of the antibiotics utilized, use the study site email to notify the PIs and we will collect this information Pathologic Variables: Microbiologic diagnosis: Check if applies. Free entry for organism. If there is not space within the confines of the entry space to write all of the antibiotics utilized, use the study site email to notify the PIs and we will collect this information Final pathologic diagnosis (single best answer): N/A Normal appendix Acute appendicitis Acute on chronic appendicitis Chronic appendicitis Perforated appendicitis Gangrenous appendicitis Adenocarcinoma Neuroendocrine tumor Other: ___________________ Outcomes: Complications (circle all that apply and list hospital day encountered) NOTE = for calculation of all complication days, day of admission = hospital day (HD) #1 Definitions of complications included in this section: Surgical site infection (SSI) HD:______ Defined as signs and symptoms of infection (redness, tenderness,

warmth, purulent drainage) requiring treatment (either incisional opening or antibiotic prescription). May be categorized as organ space, deep incisional, or superficial.

Intra-abdominal abscess: HD:______ Defined as signs and symptoms of deep infection (abdominal

tenderness, obstruction, nausea, diarrhea) confirmed by imaging (ultrasound or CT) and requiring treatment (either open or percutaneous drainage or antibiotic prescription)

Post-operative ileus: HD:_________ Defined as inability to tolerate enteral or oral intake requiring

prolongation of hospitalization.

Hospital Acquired Pneumonia: HD:_________ Definition below Hospital Acquired Pneumonia: Confirmed by the presence of the following after 48 hours of hospitalization:

1. purulent sputum 2. associated systemic evidence of infection:

a. WBC > 11,000 or < 4,000 b. Fever > 100.4 degrees F / 38 degrees Celsius

3. Two or more serial chest radiographs with new or progressive and persistent infiltrate, consolidation or cavitation.

4. BAL, mini-BAL or sterile endotracheal specimen with: a. Limited number of epithelial cells b. WBC (2-3+) c. Dominant organism(s) identified on gram stain or culture with quantitative culture > 100,000

cfu/mL Blood stream infection: HD:__________ Defined as positive cultures obtained from blood culture. Catheter-associated UTI: UTI = Urinary Tract Infection HD:__________ Definition below: Catheter-associated UTI: All criteria must be met: 1. Patient has had an indwelling urinary catheter within 7 days before urinary culture. 2. Positive urine culture, that is ≥ 10

5 microorganisms/ml of urine with no

more than two species of microorganisms 3. Urine culture has 10wbc/hpf C. difficile infection: HD:__________ Defined as confirmed C. difficile toxin with or without evidence of diarrhea Sepsis: HD:__________ Definition below. Sepsis: Has a confirmed infectious process AND two or more of the following: 1. fluid-unresponsive hypotension 2. serum lactate level >2 mmol/L 3. need for vasopressors to maintain mean arterial pressure >65 mmHg DVT / PE: HD:__________ DVT = Deep Vein Thrombosis PE = Pulmonary embolism. Diagnosis must be confirmed radiographically (Ultrasound, Computed tomography, venography, etc.)

Acute Kidney Injury (AKI): HD:___________ Defined as twofold increase in the serum creatinine or glomerular

filtration rate (GFR) decrease by 50% or urine output < 0.5 mL/kg/h for 12 hours (RIFLE criteria)

ARDS: HD:___________ ARDS = Acute respiratory distress syndrome. Definition(s) below: Berlin criteria definitions will be utilized Timing: Must develop symptoms within 1 week of a known clinical insult Chest imaging: bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules Origin of edema: Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective

assessment (eg, echocardiography) to exclude hydrostatic edema if no risk factor present)

Oxygenation Mild ARDS: PaO2/FiO2 = 201-300 with PEEP or CPAP ≥ 5 cm H20 Moderate ARDS: PaO2/FiO2 =101-200 with PEEP ≥ 5 cm H20 Severe ARDS: PaO2/FiO2 ≤ 100 with PEEP ≥ 5 cm H20

Clavien-Dindo Complications Yes or No If yes, what grade (if more than one, Numerical value (1-5) choose highest grade)

Dindo. Classification of Surgical Complications: A New Proposal With Evaluation in a Cohort of 6336 Patients and Results of a Survey. Ann Surg 2004;240:205-213. Index Hospital LOS (days): _________ Free text entry for number of consecutive days patient hospitalized at initial admission (Day of admission = hospital day #1) LOS = Length of Stay 1-year hospital LOS (days):_________ Free text entry for number of days patient was hospitalized for 365 days

after initial admission. Refers only to abdominal symptom-related admissions. (Day of admission = hospital day #1) Hospital readmission within 365 days after initial hospitalization? Yes or No ICU LOS (days): ___________ Free text entry of number of consecutive days patient required ICU admission (ICU = Intensive Care Unit, LOS = Length of Stay) - Day of ICU admission = ICU day #1 1-year ICU LOS (days): _______ Free text entry for number of days patient required ICU admission for 365 days after initial admission. Refers only to abdominal symptom- related admissions. (Day of ICU admission = ICU day #1) Secondary intervention: Yes or No Did patient require an additional intervention beyond the initially chosen

treatment strategy during initial hospitalization? 1-year secondary intervention: Yes or No Did patient require an additional intervention beyond the initially

chosen treatment strategy in the 365 days after initial hospitalization (includes interventions during initial hospitalization).

Type of secondary intervention Choose all that apply. N/A Antibiotics only Percutaneous drainage Appendectomy (laparoscopic) Appendectomy (open) Lysis of adhesions Small bowel resection Surgical repair of enteric or appendiceal stump leak Incisional hernia repair (includes port-site hernias) Other: _________________ Mortality? Yes or No Did patient expire during initial hospitalization? 1-year mortality? Yes or No Did patient expire in the 365 days after initial hospitalization?

east multicenter study data collection tool · perforated appendicitis phlegmon cecal inflammation...

Documents