Has the patient incurred bleeding          
            Skin:   General instructions  
  In the Skin?  
    petechiae, ecchymoses, subcutaneous haematomas, bleeing from minor wounds   Grading is based on physical examination at the time of the visit by the physician or expert nurse or on patient’s history supplemented by available medical reports.
Each type of bleeding should be graded based on the worst bleeding manifestation that occurred during each observation period or in the 15 days preceding the first visit.
Bleeding manifestations reported by the patient but not visible at the time of data collection are graded 1.
To receive a grade > 1, all non-overt skin and non-overt mucosal bleeding (petechiae, ecchymoses,
subcutaneous hematomas, vescicles/bullae subconjunctival bleeding) should be visible at the time of visit for grading by the physician or expert nurse taking the history.
For bleeding from minor wounds and overt-mucosal bleeding (epistaxis, gum, bleeding from bites to lips and tongue or after deciduous teeth loss/extraction) and all organ bleeding, a medical record describing the symptom or indicating a specific intervention/prescription should be also taken into account for grading.
 
Patient’s own palm size is commonly considered to be proportional to body surface area.
Palm = The inner surface of the hand stretching between the distal crease of the wrist and the bases of the fingers (fingers surface excluded).
Body areas include: face, neck, right and left upper limbs (considered separately), right and left lower limbs (considered separately), trunk, abdomen, and recumbent areas (for the ambulatory patient means the area below the knees)
 
Intracranial bleeding should always be reported, irrespective of its grade. For example, if a woman had S2 (subcutaneous hematoma) M2 (epistaxis) O3 (menorrhagia) and an intracranial bleeding grade 2 (post trauma, requiring hospitalization), the SMOG index is S2M2O3 (intracranial 2). If the same patient also had intracranial bleeding grade 3, the SMOG index is S2M2O3 (intracranial 3).
 
Grade 5 is assigned to fatal bleeding. "

 
            Mucosae:    
  In the Mucosae?  
    epistaxis, gum bleeding, oral haemorragic bullae or blisters, bleeding from bites to lips and tongue or after deciduous tooth loss, subconjunctival hemorrhage (not due to congiuntival disease)    
            Organs:    
  In the Organs or Internal Mucosae?
    gastrointestinal bleeding not explained by visible mucosal bleeding or lesion (hematemesis, melena, hematochexia, rectorrhagia), lung bleeding (hemoptysis, tracheobronchial bleeding), hematuria, menorrhagia (compared to pre-ITP or to a phase of disease with normal platelet count), intramuscolar haematoma (only if diagnosed by a physician with an objective method), hemarthrosis (only if diagnosed by a physician with an objective method), ocular bleeding (only if diagnosed by a physician with an objective method), intracranial bleeding (intracerebral, intraventricular, subarachnoidal, subdural, extradural only if diagnosed with an opbjective method or described in  a medical report)    
               
               
    Skin Mucosae Organs      
  CALCOLA SMOG      
           
  References     
  1. Rodeghiero F, Stasi R, Gernsheimer T, et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009;113(11): 2386-2393.  8.Ruggeri M, Fortuna S, Rodeghiero F. Heterogeneity of terminology and clinical definitions in adult idiopathic thrombocytopenic purpura: a critical appraisal from a systematic review of the literature. Haematologica. 2008; 93(1):98-103.     
  2. Provan D, Stasi R, Newland AC, et al. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010;115(2):168-186.  9.Cheng G, Saleh MN, Marcher C, et al. Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study. Lancet. 2011; 377(9763):393-402.     
  3. Neunert C, Lim W, Crowther M, et al. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011;117(16): 4190-4207.  10.Kuter DJ, Bussel JB, Lyons RM, et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008; 371(9610):395-403.     
  4. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer. 1981;47(1):207-214.  11.Bussel JB, Kuter DJ, Pullarkat V, et al. Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP. Blood. 2009;113(10):2161-2171.     
  5. Koreth R, Weinert C, Weisdorf DJ, et al. Measurement of bleeding severity: a critical review. Transfusion. 2004;44(4):605-617.  12.Gernsheimer TB, George JN, Aledort LM, et al. Evaluation of bleeding and thrombotic events during long-term use of romiplostim in patients with chronic immune thrombocytopenia (ITP). J Thromb Haemost. 2010;8(6):1372-1382.    
  6. Rodeghiero F, Tosetto A, Abshire T, et al; ISTH/SSC joint VWF and Perinatal/Pediatric 6. Rodeghiero F, Tosetto A, Abshire T, et al; Hemostasis Subcommittees Working Group. ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders. J Thromb Haemost. 2010;8(9): 2063-2065. 13. Zeng Y, Duan X, Xu J, et al. TPO receptor agonist for chronic idiopathic thrombocytopenic purpura. Cochrane Database Syst Rev. 2011;(7): CD008235.     
  14.Khellaf M, Michel M, Quittet P, et al. Romiplostim safety and efficacy for immune thrombocytopenia in clinical practice: 2-year results of 72 adults in a romiplostim compassionate-use program. Blood. 2011;118(16):4338-4345.     
  7.Rodeghiero F, Tosetto A, Castaman G. How to  estimate bleeding risk in mild bleeding disorders. J Thromb Haemost. 2007;5(Suppl 1):157-166.  15.Khellaf M, Michel M, Schaeffer A, et al. Assessment of a therapeutic strategy for adults with severe autoimmune thrombocytopenic purpura based on a bleeding score rather than platelet count. Haematologica. 2005;90(6): 829-832.     
                   
                   
                   
                   
                   
                   
                   
                   
  Which bleeding has the patient incurred?
  SKIN         Score  
  Petechiae?
   
LEGENDA:
0=NO
1=Less than or equal to 10 in a patient's palm-size area in the most affectd body area Any numer if reported by the patient
2=more than 10 in a patient's palm-sized area or more than 5 in at least 2 patient's pal-sized areas located in at least 2 different body areas on above and one below the belt (in the most affected body areas)
3=More then 50, if scattered both above and delow the belt
4= --
 
               
  Ecchymoses?
   
LEGENDA:
0=None or up to 2 in the same body area, but smaller than a patient's palm-sized area, if (a) spontaneous or (b) disproportionate to trauma/constriction
1=3 or more in the same body area, but smaller than a patient's palm-sized area, if (a) spontaneous or (b) disproportionate to trauma/constriction. At least 2 in two different body areas, smaller than a patient's palm-size area, if (a) spontaneous or (b) disproportionate to trauma/constriction. Any number and size if reported by the patient.
2=From 1 to 5 larger then a patient's palm-sized area, if (a) spontaneous or (b) disproportionate to trauma/constriction with or without smaler ones
3=More than 5 larger than a patient's palm-sized area, if (a) spontaneous or (b) disproportionate to trauma/constrictions
4=--
 
               
  Subcutaneos haematoma?
   
LEGENDA:
0=NO
1=Smaller than a patient's palm-sized area.Any number and size if reported by the patient
2=Smaler than a patient's palm-sized area, spontaneous. Smaller than a patient's palm-sized area, disproportionate to trauma
3=More than 2 smaller or at least 1 larger than a patient's palm-sized area,spontaneous. More than 2 smaller or at least 1 larger than a patient's palm-sized area, dispoportionate
4=--
 
               
  Bleeing from minor wounds?
   
LEGENDA:
0=NO
1=Lasting ≤5 min. Any episode if reported by the patient
2=Lasting >5 min or interfering with daily activities
3=Requiring protracted medical observation at the time of this visit. Medical report describing patient's evaluation by a physician
4=--
 
               
               
    Skin Mucosae Organs      
  CALCOLA SMOG      
  Which bleeding has the patient incurred?
  Mucosae         Score  
  Epistaxis
   
LEGENDA:
0= NO
1= Lasting ≤5 min. Any episode if reported by the patient
2= Lasting >5 min or interfering with daily activities
3= Packing or cauterization or in-hospital evaluation at the time of this visit. Medical report describing packing or cauterization or in-hospital evaluation
4= RBC transfusion or Hb drop>2 g/dL
 
               
  Oral Cavity, gum bleeding
   
LEGENDA:
0= NO
1= Lasting ≤5 min. Any episode if reported by the patient
2= Lasting >5 min or interfering with daily activities
3= Requiring protracted medial observation at the time of this visit. Medical report describign pationt's evaluation by a physician.
4= --
 
               
  Oral Cavity Hemorhagic bullae or blisters
   
LEGENDA:
0= NO
1= Less than 3. Any episode if reported by the patient
2= From 3 to 10 but no difficulty with mastication
3= More than 10 or more than 5 if difficulty with mastication
4= --
 
               
  Oral Cavity, bleeding from bites to lips and tongue or after deciduous tooth loss
   
LEGENDA:
0= NO
1= Lasting ≤ 5 min. Any episode if reported by the patient
2= Lasting >5 min or interfering with daily activities
3= Interventions to ensure hemostasis or in-hospital evaluation at the time of this visit. Medical report describing inerventions to ensure hemostasis or in-hospital evaluation.
4=--
 
               
  Subconjunctival hemorrhage (not due to conjunctival disease)  
   
LEGENDA:
0= NO
1= Petechiae/hemorrhage partially involving 1 eye. Any episode if reported by the patient.
2= Petechiae/hemorrhage partially involving both eyes, or diffuse hemorrhage in 1 eye
3= Diffuse hemorrhage in goth eyes
4=--
 
               
               
    Skin Mucosae Organs      
  CALCOLA SMOG      
  Which bleeding has the patient incurred?
  Organ (and internal mucosae)         score  
  GI bleeding not explained by visible mucosal bleeding or lesion:hematemesis, melena, hematochezia, rectorrhagia
   
LEGENDA:
0= NO
1= Any episode if reported by the patient
2= Present at the visit. Described in a medical report.
3= Requiring endoscopy or other therapeutic procedures or in-hospital evauation at the time of this visit. Medical report prescribing or other therapeutic procedures or in-hospital evaluation.
4= RBC transfusion or Hb drop>2 g/dL
 
               
  Lung bleeding (Hemoptysis, Trachobornchial bleeding)
   
LEGENDA:
0= NO
1= Any episode if reported by the patient
2= Present at this visit
3= Requiring bronchoscopy or other therapeutic procedures or in-hospital evaluation at the time of this visit
4= RBC transfusion or Hb drop>g/dL
 
               
  Hematuria  
   
LEGENDA:
0= NO
1= Any episode if reported by the patient. Microscopic (laboratory analysis)
2= Macroscopic. Descrideb in a medical report
3= Macroscopic, and requiring cystoscopy or other therapeutic procedures or in-hospital evaluation at the time of this visit. An equivalent episode if descrideb ina a medical report.
4=RBC transfusion or Hb drop>2 g/dL
 
               
  Menorrhagia (compared with pre-ITP or to a phase of disease with normal platelet count)
   
LEGENDA:
0= NO
1= Doublign number of pads or tampons in last cycle compared with pre-ITP or to a phase of disease with normal platelet count. Score>100 using PBAC in the last cycle, if normal score in pre-ITP cycles or in a phase of disease with normal platelet count.
2= Changing pads more frequently than every 2 h or clot and flooding. Requiring combined treatment with antifibrinolytics and hormonal therapy or gynecologic investigation (either at this visit or described in a medical report)
3= Acute menorrhagia requiring hospital admission or endometrial ablation (either at this visit or descrideb in a medical report)
4=RBC transfusion or Hb drop>2 g/dL
 
               
  Intramuscular hematomas (only if diagnosed by a physician with an objective method)
   
LEGENDA:
0= NO
1= Post trauma, diagnosed at this visit, if judged disproportionate to trauma. An equivalent episode if descrideb in a medical report.
2= Spontaneous, diagnosed at this visit. An equivalent episode if descrideb in a medical report.
3= Spontaneous or post trauma (if judged disproportionate to trauma) diagnosed at this visit and requiring hospital admission or sugical intervention. An equivalent episode if descrideb in a mediacl report.
4=RBC transfusion or Hb drop>2 g/dL
 
               
  Hemarthrosis (only if diagnosed by a physician with an objective method)
   
LEGENDA:
0= NO
1= Post trauma, diagnosed at this visit, funcion conserved or minimally impaired, if judged disproportionate to trauma. An equivalent episode if described in a medical report.
2= Spontaneous, diagnosed at this visit, funcion conserved or minimally impaired. An equivalent episode if described in a medical report.
3= Spontaneous or post trauma (if judged disproportionate to trauma), diagnosed at this visit and requiring immobilization or joint aspiration. An equivalent episode if descrideb in a medical report.
4= Spontaneous or post trauma (if judged disproportionate to trauma) diagnosed at this visit and requiring surgical intervetion. An equivalent episode if descrideb in a medical report.
 
               
  Ocular bleeding  for subconjunctival hemorrhage see mucosal section (only if diagnosed by a physician with an objective method)
   
LEGENDA:
0= NO
1= --
2= Any post trauma vitreous or retinal hemorrhage involving one or both eyes with or without impaired/blurred vision present at this visit if judged dispoportionate to trauma. An equivalent episode if descrideb in a medical report.
3= Spontaneous vitreous or retinal hemorrhage involving one or both eyes with impaired/blurred vision present at this visit. An equivalent episode if descrideb in a medical report.
4=Spontaneous vitreous or retinal hemorrhage with loss of vision in one or both eyes present at this visit. An equivalent epoisode if descrideb in a medical report.
 
               
  Intracranial bleeding: intracerebral, intraventricular, subarachnoidal, sudbura, extradural (only if diagnosed with an objective method at the visit or described in a medical report provided by the patient)
   
LEGENDA:
0= NO
1= --
2= Any post trauma event requiring hospitalization
3= Any spontaneous event requiring hospitalization in the presence of an underlying intracranical lesion.
4= Any spontaneous event requiring hospitalization without an underlying intracranical lesion.
 
           
  Other internal bleeding: hemoperitoneum, hemopericardium, hemothorax, retroperitoneal bleeding, hepatic and splenic peliosis with organ rupture, retro-orbital bleeding metrorrhagia (only if diagnosed with an objective method at the visit or descrideb in a medical report provided by the patient)
   
LEGENDA:
0= NO
1= --
2= --
3= Any event requiring hospitalization <48h
4= Any event requiring hospitalization >48h or RBC transfusion or Hb drop>2 g/dL
 
           
               
               
    Skin Mucosae Organs      
  CALCOLA SMOG