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1 MedView record for The Ora-Stem Study. Date for this version: 090604 Prerequisites: - Special Multicenter MedView study file that can be reached via Internet. - Each patient coded. Each patient identification to be kept by treating center until the patient has passed through the whole study, then destroyed. The patient can not be identified by others. - For some questions we have fixed answers, for some we can answer in our own words and for some questions we can make new answers that will end up in a drop down list. QUESTIONS PHASE I. BASELINE DATA Pre-Tx examination (8 weeks – 1 day before Tx) Demographics What age is the patient at first visit? What gender? What race? Medical diagnosis and treatment Medical diagnosis requiring transplant? WHO diagnosis by International Classification of Diseases (ICD-10) - in around 40 languages What oncology treatment is planned? SPECIFICATIONS/CHOICES Drop down list 18-90 years Male Female White or caucasian Black or African American East Asia West Asia Pacific Islander Other race Drop down list: Acute lymphatic leukaemia (ALL); Recurrent ALL; Acute myeloid leukaemia (AML); Recurrent AML; Myelodysplastic syndrome (MDS); Myeloma Hodgkin Lymphoma, Non-Hodgkin Lymphoma -Indolent (lågmaligna) lymphoma -Aggressive (högmaligna) lymphoma Conditioning regimen? Drop down list: Allogeneic, unrelated donor Allogeneic, related donor Autologous Cord blood transplant Write down the regimen Total Body Irradiation regimen? No Yes 2 Earlier chemotherapy within last year Earlier RT to Head & Neck? Notes Patient history of oral problems during cancer therapy preceding BMT Past medical history (general medical problems) based on patient report and medical record Past medical conditions Current medical conditions Current medication (Observe, only list Generics) Environmental allergies Drug allergies Current bleeding problems/disturbances (list can be extended) Smoking habits Smoking habits, frequency Smokeless tobacco (snuff) use Alcohol habits No No Yes Yes Drop down list Start by filling in text – leading to drop down list eventually Start by filling in text – leading to drop down list eventually Drop down list of generic names Long list of allergens Long list of drugs No Yes, due to: (drop down list) Cancer chemotherapy Haemophilia Liver cirrhoses Anticoagulants Thrombocytopenia No, never # years ago (Previous smoker) Not daily Yes, daily # cigarettes/day # cigars/days # years No never Not daily # doses/day, packed # doses/day, unpacked No, never use alcohol Yes # alcohol equivalents/week (1 alcohol equivalent = 1½ ounce (4.4 cl) distilled spirits or 1 glass (5 ounces=15 cl) wine or 1 glass (12 ounces=35 cl) beer Pack years be calculated later 3 Patient reports of general oral problems How does your mouth feel right now? Ok, no symptoms. Do you have oral symptoms right now? Not ok, having (List can be extended). symptoms List as below Have you had any other symptoms from the oral No Yes cavity for the last 6 months (history)? (List can be extended). How often do you routinely brush your mouth? How often do you see a dentist or dental therapist? Complete full oral exam including Dental charting (restorations, caries, Periodontal charting (such as pocket depths if possible) Radiographs For how long have they lasted? (separate answer for each symptom) Teeth: Mucosa: Decay to Tenderness: dentin Mucositis; (caries); Bleeding Food (gingival); impaction; Bleeding Grinding (other (Bruxism); mucosal); Sensitive Blisters/ulcer teeth (e.g. s; hot or cold Canker sore sensitivity), (Aphthae); Filling Cold sore fracture; (Herpes Tooth labialis); ache, Intraoral Tooth herpes; infection; Coated toothfract- tongue; ures; Haematoma, Oral Thrush swelling (fungal from infection); infected Burning tooth, sensation; Pericoro“Sand paper nitis feeling” 3 or more times/day Twice/day Once/day < once/day – once/week < once/week Routinely Only for acute problems Never Others: Allergic reaction; Bad taste; Hoarseness; Taste changes; Vomiting reflexes, Dry Mouth; Diffuse pain ---- 4 Photos taken Pictures with dates added 5 PHASE II Admission clinical examination (sometimes in the ward) (days -7 to -1) Day before transplantation? Oral examination MUCOSA Mucosal disease, tentative (preliminary) clinical diagnosis WHO Mucositis Score (only WHO scale at this point) Description of mucosal disease, not mucositis (multiple diseases should be described separately) - Location of mucosal disease - Colour - Mucosal texture -7, -6, -5, -4, -3, -2, -1 Dropdown list: Lichen planus, Leukoplakia, unknown cause, Lesion from smokeless tobacco Geographic tongue, Coated tongue; Hairy tongue, Cancer sore (aphthae), Pemphigoid, Mucositis; Haematoma, Herpes Simplex Viral infection, other Fungal infection Bacterial infection other… Grade 0: No findings or erythema only Grade 1: soreness present with or without erythema Grade 2: Ulcers present but able to take solid food Grade 3: Ulcers present and only able to take liquids Grade 4: Ulcers present/not able to take anything orally Drop down list Normal Pale Blue Brown Grey Yellow Dark Red White Blister Bleeding Petecciae 6 Subcutaneous bleeding Exostosis Fissure Fistula Granuloma Hyperplasia Scalloping Leukoedema Necrosis Pigmentation Striae Ulcer Swollen Vesical Scaring - size Diagnostic tests completed at today’s appointment Drop down list Bacterial Viral Fungal Biopsy Results ORAL SYMPTOMS FORM See special form TEETH Total number of remaining teeth with natural root (with or without crown) # Total number of dental implants # Total number of teeth with manifest caries (D3; decayed to dentine) left untreated (calibration between centers needed) None 1-3 teeth 4-6 teeth >6 teeth # teeth (0,1,2,3,4,5,6,7,8,9,10,11, 12, >12) # teeth (0,1,2,3,4,5,6,7,8,9,10,11, 12, >12) Total number of teeth decayed to pulp left untreated Total number of completed root canal treated teeth, regardless of quality Total number of teeth with root canal treatment started but not completed Total number and asymptomatic teeth with radiographic evidence of periapical lesions (apical periodontitis) Please indicate tooth number position by nonUS standard (18 for upper right wisdom tooth) Tooth number positions *Can be scare or active processes 7 Total number and symptomatic teeth with radiographic evidence of periapical lesions (apical periodontitis) Please indicate tooth number position by nonUS standard (18 for upper right wisdom tooth) Fully impacted teeth (covered with bone; fully covered with mucosa) Tooth number positions No Tooth numbers European Partially Impacted teeth (can be seen or felt with a probe) PERIODONTIUM Total number of remaining teeth with at least one pocket depth ≥ 6 mm (based on periodontal exam within previous 8 weeks) Debris Index simplified (DI-S) according to Greene and Vermillion, 1964) The 6 surfaces examined are selected from 4 posterior and 2 anterior teeth. - In the posterior portion of the dentition, the first fully erupted tooth distal to the second bicuspid (15), usually the first molar (16), but sometimes the second molar (17) or third molar (18) is examined. The buccal surfaces of the selected upper molar and the lingual surfaces of the selected lower molars are inspected. - In the anterior portion of the mouth, the labial surfaces of the upper right (11) and the lower left central incisors (13) are scored. In the absence of either of these anterior teeth, the central incisor (21 or 41, respectively) on the opposite side of the midline is substituted. Calculus Index simplified (CI-S) according to Greene and Vermillion, 1964 http://www.whocollab.od.mah.se/expl/ohisgv64. html The 6 surfaces examined are selected from 4 posterior and 2 anterior teeth. - In the posterior portion of the dentition, the first fully erupted tooth distal to the second bicuspid (15), usually the first molar (16), but sometimes the second molar (17) or third molar (18) is (translated to American) No Tooth numbers European Yes Yes (translated to American) Grade 0 = No debris or stain present Grade 1 = Soft debris covering not more than 1/3 of the tooth surface or presence of extrinsic stains without other debris regardless of surface area covered. Grade 2 = Soft debris covering more than 1/3 but not more than 2/3 of the exposed tooth surface. Grade 3 = Soft debris covering more than 2/3 of the exposed tooth surface. Grade 0 = No calculus present Grade 1 = Supragingival calculus covering not more than one third of the exposed tooth surface. Grade 2 = Supragingival calculus covering more than one third but not more than two thirds of the exposed tooth surface or the presence of individual flecks of subgingival calculus around the cervical 8 - examined. The buccal surfaces of the selected upper molar and the lingual surfaces of the selected lower molars are inspected. In the anterior portion of the mouth, the labial surfaces of the upper right (11) and the lower left central incisors (13) are scored. In the absence of either of these anterior teeth, the central incisor (21 or 41, respectively) on the opposite side of the midline is substituted. portion of the tooth or both. Grade 3 = Supragingival calculus covering more than two third of the exposed tooth surface or a continuos heavy band of subgingival calculus around the cervical portion of the tooth or both. Total number of teeth with mobility grade III # of teeth (>1 mm displacement horizontally from a central position combined with displacement in vertical direction (intrusion)) Notes (Example: Other radiographic pathology except caries, perio, periapical lesions) Dental treatment plan Other chronic dental disease recommended to be left untreated prior to transplantation text 9 Acute oral problems Drop down list can be extended Oral care regimen Is institution specific standard oral care regimen reviewed to patient? List special oral care recommendation to this patient that supplements institution specific standard oral care regimen Medication Complete list of current medication To be filled in by medical personal if possible Most recent lab test values Blood-HGB (ref. 116-166 g/L or 12-17 d/dL) Total white blood cell count – WBC (Ref. 3.5 – 9.0 x 109/L) Total trombocyte count, Blood - PTL (Rev. 150350 x 109 /L Notes (e.g. other significant lab. abnormalities) Weight, Height Teeth: Decay to dentin (caries); Food impaction; Grinding (Bruxism); ‘Sensitive teeth (e.g. hot or cold sensitivity), Filling fracture; Tooth ache, Tooth infection; tooth fracture; Oral swelling from infected tooth, Chronice apical lesions; Abscess; Pericoronitis Other tissues Pain with muscles and mastication (e.g. Masseter) No Yes, by dentist or dental hygienist Yes, by nursing staff text acyclovir, valacyclovir CMV-prophylaxis fluconazole, nystatin rinse, amphotericin B local, amphotericin B systemic Cephalosporin Bactrim V-penicillin Others (fill in) Value Days old Presc ript. durati on 10 Temp. Photos taken Pictures with dates added 11 PHASE III Visit by dentist Monday, Wednesday, Friday during Inpatient Treatment period in the ward: 1) Until “take” (bone marrow recovery) if no oral problems then or 2) until resolution of oral problems up to 6 weeks after Tx (day 0) Day before/after transplantation? Type of examination Symptoms/Open questions Do you have any symptoms/anything that bothers you in the oral cavity today? Please describe! What is the worst/most bothersome oral symptom right now? In general (overall), how difficult are the oral symptoms now? Objectively (dentist) Are symptoms in the oral cavity better/worse than at last visit? (indicate if patient is deteriorating or healing) Subjectively (patient) Are symptoms in the oral cavity better/worse than at last visit? (indicate if patient is deteriorating or healing) Do you have any symptoms/anything that bothers you in the throat? Please describe! What is the worst/most bothersome symptom in your throat right now? In general (overall), how difficult are the symptoms from the throat now? ORAL SYMPTOMS FORM Symptoms/Validated symptoms scales -7, -6, -5, -4, -3, -2, -1, 1,2,3,4,5,7,8,9,10,11,12,13,14,15,16, - Study bed-side visits (i.e. 3 days a week Monday-Wednesday-Friday) - Not study visit No Yes Drop down list bleeding, saliva thick, saliva “sticky”, “sand paper/raw feeling”, swollen, dryness, teeth tenderness/sensitivity, tenderness/sensitivity in mucosa tooth ache pain VAS 1-10 0 = none 10 = unbearable Better worse completely healed unchanged Better worse completely healed unchanged VAS 0-10 0 = none 10 = unbearable See special form 12 Asked by dentist or nursing staff Monday, Wednesday, Friday (Pain, Xerostomia, Dysgeusia, Dysphagia) Oral examination Mucosal disease, tentative clinical diagnosis Can the patient eat? WHO Mucositis Score (Please observe: It has to be because of problems with the mouth) OMAS Mucositis Score Dropdown list: Lichen planus, geographic tongue, leukoplakia from unknown cause, lesion from smokeless tobacco, pemphigoid, aphthae, other… herpes simplex Viral infection, other Fungal infection Bacterial infection GVH Solid food Liquid food (passerad kost) Would be able to eat solid food if not due to - stomach - throat - loss of appetite - nausea - mouth? Would be able to eat liquid food if not due to - stomach - throat - loss of appetite - nausea - mouth? Grade 0: No findings or erythema only Grade 1: soreness present with or without erythema Grade 2: Ulcers present but able to take solid food Grade 3: Ulcers present and only able to take liquids Grade 4: Ulcers present/not able to take anything orally Ulceration/pseudomembrane 0 (no lesion) 1 (≤ 1 cm2) 2 (1-3 cm2) 3 (≥ 3 cm2) Erythema 13 Sonis et al Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. Cancer 1999 May 15;85(10):2103-13. 0 (None) 1 (not severe) 2 (severe) Location ORAL SYMPTOMS FORM GVHD Description of mucosal disease Location of mucosal disease Colour Mucosal texture - Size? Management of dental/oral problems New drug treatment for oral problems now? (by dentist or physician) Se special form Yes No Normal Pale Blue Brown Grey Yellow Dark Red White Drop down list Blister Bleeding Petecciae Submucosal hemorrhage Exostosis Fissure Fistula Granuloma Hyperplasia Scalloping Leukoedema Necrosis Pigmentation Striae Ulcer Swollen Vescical Scaring Long list of dental/oral treatments (drop down) Rinsing for pericoronitis Grinding of sharp of edges Xxxx Xx Long list of medications (e.g. fluconazole for fungal, acyclovir for viral infection, morphine for oral pain, antibiotics for oral bacterial infection) 14 Diagnostic tests completed at today’s appointment Oral care regimen List special recommendation above institution specific standard oral care regimen) Medication Complete list of current medication To be filled in by medical personal if possible Drop down list bacterial virus test fungal biopsy Results Discontinue brushing due to oral pain Discontinue brushing due to nausea Chlorhexidine others acyclovir, valacyclovir CMV-prophylaxis others (fill in) fluconazole, nystatin rinse, amphotericin B local, amphotericin B systemic Cephalosporin Bactrim V-penicillin Documented each time ? Most recent lab test values Blood-HGB (ref. 116-166 g/L or 12-17 d/dL) Total white blood cell count – WBC (Ref. 3.5 – 9.0 x 109/L) Absolute neutrophil count (Ref. >1.5 x 109/L or - Value 1500/microL) - Missing Total trombocyte count, Blood – PTL (Rev. 150350 x 109 /L Notes (e.g. other significant laboratory abnormalities) Weight (Kg) Temperature (C) (Medical personal) Note Photos taken Pictures with dates added to the record 15 PHASE IV – UNSCHEDULED FOLLOWUP FOR ORAL PROBLEMS From 6 weeks after Tx if: 1) the patient has ongoing oral problems (out- or inpatient) <3 months 2) if the patient develops new oral problems Cause for present visit? Current oral care regimens used by patient PATIENT HISTORY Specify main oral complaint How does your mouth feel right now? Do you have symptoms right now? How difficult are the oral symptoms? For how long have you had you problems? Objectively (dentist) better/worse symptoms in the oral cavity than at last visit? (indicates if patient is deteriorating or healing) Subjectively (patient) better/worse symptoms in the oral cavity than at last visit? EXAMINATION WHO Mucositis Score 1) Extended Examination of ongoing oral problems close to Tx <3 months 2) Acute problems Current oral care regimens used by patient Acute dental care; acute examination; Biopsy; Excision; Extraction; Focal Infection Investigation; GVH; infection investigation, check-up after SCT, other research check up, Pain invest, Sutures, Dental treatment, investigation due to new or recurrent haematologic malignancy, etc Blisters Bleeding Bad taste Taste changes Filling fracture Sensitive teeth Burning sensation Dry mouth sand paper/raw feeling Pain Tenderness Diffuse swelling VAS 1-10 0 = none 10 = unbearable Better, worse, completely healed, unchanged (is this referring to previous invasive dental procedures?) See above Grade 0: No findings or erythema 16 (Please observe: It has to be because of problems with the mouth) OMAS Mucositis Score Sonis et al Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. Cancer 1999 May 15;85(10):2103-13. only Grade 1: soreness present with or without erythema Grade 2: Ulcers present but able to take solid food Grade 3: Ulcers present and only able to take liquids Grade 4: Ulcers present/not able to take anything orally Ulceration/pseudomembrane 0 (no lesion) 1 (≤ 1 cm2) 2 (1-3 cm2) 3 (≥ 3 cm2) Erythema 0 (None) 1 (not severe) 2 (severe) Location ORAL SYMPTOMS FORM Location of mucosal/dental disease Colour Mucosal texture See special form Normal Pale Blue Brown Grey Yellow Dark Red White Drop down list Blister Bleeding Petecciae Submucosal hemorrhage Exostosis Fissure Fistula Granuloma Hyperplasia Scalloping Leukoedema Necrosis Pigmentation Striae Ulcer Swollen 17 Tentative (preliminary) diagnosis Diagnosis Treatment type? Diagnostic tests completed at today’s appointment GVHD Symptoms If patients has GVHD symptoms, please feel in the symptoms document. Current medication (NB! Don’t forget GVH-prophylaxis, Antiviral prophylaxis, Antifungal prophylaxis) To be filled in by medical personal if possible Most recent lab test values Blood-HGB (ref. 116-166 g/L or 12-17 d/dL) Total white blood cell count – WBC (Ref. 3.5 – 9.0 x 109/L) Absolute neutrophil count (Ref. >1.5 x 109/L or 1500/microL) Total trombocyte count, Blood - PTL (Rev. 150350 x 109 /L Recommend new drug treatment for oral problems now? (by dentist or physician) SYMPTOMS Photos taken Next visit Note Vescical Scaring Long list of dental/oral diagnoses Tooth no Long list of dental/oral diagnoses Tooth number Long list of dental/oral treatments Tooth no Treatment Drop down list Results Bacterial Viral Fungal Biopsy Yes No acyclovir, valacyclovir CMV-prophylaxis others (fill in) fluconazole, nystatin rinse, amphotericin B local, amphotericin B systemic Cephalosporin Bactrim V-penicillin ? Long list of medications (e.g. fluconazole for fungal, acyclovir for viral infection, morphine for oral pain, antibiotics for oral bacterial infection) SEE SEPARATE SHEET Pictures with dates added 18 PHASE V 3, 6, 12 months after transplant Months after Tx Current status of cancer Current oral care regimens used by patient List any symptoms from the oral cavity or teeth today (current oral complaints)? Describe any symptoms from the oral cavity or teeth since last visit? Have had any fungal infect. in oral mucosa after Tx/since last oral check up here? Have had any viral infect. in oral mucosa after Tx/ since last oral check up here? Have had any bact. infect. in oral mucosa after Tx/ since last oral check up here? ORAL SYMPTOMS FORM GVHD SYMPTOMS FORM (for allogeneic transplant patients only) EXAMINATION Mucosal disease/lesion Location of mucosal disease Colour Mucosal texture Drop down list of the number months after Tx that the patient comes in Drop down (remission; recurrence; new primary cancer) Drop down None No, yes, extraoral, intraoral? No, intraoral, labial, CMV Se separate form Dropdown list: Lichen planus, geographic tongue, leukoplakia from unknown cause, lesion from smokeless tobacco, pemphigoid, aphthae, other… gingival hyperplasia Viral infection Fungal infection Bacterial infection GVH Normal Pale Blue Brown Grey Yellow Dark Red White Drop down list Blister Bleeding Important that it allows multiple 19 Have you had dental problems since last dental visit? Diagnostic tests taken Have oral complications been identified as a cause of additional hospital visits, prolonged Petecciae Submucosal hemorrhage Exostosis Fissure Fistula Granuloma Hyperplasia Scalloping Leukoedema Necrosis Pigmentation Striae Ulcer Swollen Vescical Scaring Long list of dental diagnoses Drop down list Bacterial Viral Fungal Biopsy Yes Results No If yes, which oral complication? hospital stays or death? How many visits? / How long were the visits? Most recent lab test values Blood-HGB (ref. 116-166 g/L or 12-17 d/dL) Total white blood cell count – WBC (Ref. 3.5 – 9.0 x 109/L) Absolute neutrophil count (Ref. >1.5 x 109/L or 1500/microL) Total trombocyte count, Blood - PTL (Rev. 150-350 x 109 /L Type of treatment for each dental problems? ? Long list (include. treatm., referrals etc) Recommend new drug treatment for non-dental Long list of medications (e.g. oral problems now? (by dentist or physician) fluconazole for fungal, acyclovir for viral infection, morphine for oral pain, antibiotics for oral bacterial infection) Medication for dry mouth etc Next appointment 20 Notes Photos taken PHASE VI Patient deceased Pictures with dates added Days after transplantation 1) Measurements for poor clinical and economic outcomes; including days of hospitalization for SCT will be discussed with dr Jan-Erik Johansson.