Figure : Form C – MASCC/ISOO Oral Care Systematic Review

DESCRIPTIVE INFORMATION ABOUT THE STUDY / NOTES
1 / Study Identification / Include author, title, reference and year of publication (if available) and the study timeframe.
2 / Time Frame / Date range when data was collected
(e.g. 1999-2005)
3 / Study population / List cancer diagnoses and stage of disease as well as other characteristics if applicable (elderly, pediatric, mean age (SD), gender, rural, community, teaching, cancer center, etc)
4 / Cancer Intervention / List modality (Radiotherapy , Chemotherapy, Surgery, BMT, combinations) as well as details (RT type & fractionation, chemo regimen, BMT type and conditioning regimen, surgery type, etc)
5 / [Excluding RCT] What percentage (%) of individuals or clusters refused to participate? / ---
6 / What percentage (%) of individuals or clusters was lost to follow-up? / ---
7 / Are study participants representative of cancer population in general? / 1=Yes 2= No 3 =Don’t know
(e.g. If only stage 4 cancers or stage 1 cancers are evaluated, then this would NOT be representative of the cancer population in general)
8 / Sampling frame / Multi-institution=2; single institution=1; convenience sample=0
(i.e. was data collected from one site or multiple. A convenience sample is when patients are enrolled with limited attempt to insure that the sample is an accurate representation of some larger group or population)
9 / Sampling accrual / Consecutive patients = 1; non-consecutive patients=0
(Consecutive accrual with enrollment of all potential patients available within the study time frame)
10 / Control group / Was the information from the control group collected concurrently with the study group?
1=Yes 2=No 3= No Control
4= Don’t know
11 / What is the study type? / 1 = Randomized Controlled Trials (RCT)
2 = Non-Randomized Control Trials (N-RCS)
3 = Cohorts (4 = Before and After Studies (BAS) with/without controls (
5 = Case Control Studies (C-CS) define whether population or hospital based case control study.
12 / What oral complications are reported? / List complications
13 / Oral Complication Intervention / List intervention if a clinical trial to assess a treatment strategy for an oral complications (e.g. pilocarpine to treat xerostomia or zinc lozenge to treat dysgeusia)
14 / [only RCT and N-RCS] Are individuals within groups/clusters blind to which intervention group they belong AND are those delivering the intervention (health professionals) blind to the intervention group? / 1 = Double blinded
2 = Only participants blinded
3 = Only investigators blinded
4 = No blinding
5 = Don’t know
15 / [only C-CS] Is exposure to interventions measured in a standard, valid and reliable way (avoidance of recall bias)? / 1=Yes 2= No 3 =Don’t know
(e.g. if use previously published scales or consistent study specific scale)
16 / [only C-CS] Is exposure to interventions measured in the same way for both case
and control groups? (NB: Objective measures would meet this criteria). / 1=Yes 2= No 3 =Don’t know
17 / List measurement scales used by name
18 / Oral complication ascertainment: frequency / Weekly or more frequent assessment=2;
> 1 assessment per cycle=1;
1 assessment per cycle=0
19 / Oral complication ascertainment: timing / Prospective assessment (patient or professional) = 1; Retrospective (patient recall) = 0
20 / Oral complication ascertainment: Examiner / Blinded= 1; Unblinded=0
21 / How are oral complications measured? / Standard validated scale=2;
Well defined, study-specific scale=1;
Not defined or stated =0
22 / Are factors other than the intervention e.g. confounding factors, comparable between intervention and control groups and if not comparable, are they adjusted for in the analysis? / 1 = Yes
2 = Not comparable, were adjusted
3 = Not comparable, were not adjusted
4 = Don’t know
23 / What factors other than the intervention could affect the outcome? / Include potential confounding factors, differences in baseline characteristics between intervention and control groups.
24 / Are outcomes measured in the same way for both intervention and control groups? (NB: Blinding or objective measures would meet / 1=Yes 2= No 3 =Don’t know
25 / How many groups/sites in the study? / ---
26 / [only Multicenter studies] Are results homogeneous between sites? / 1=Yes 2= No 3 =Don’t know
27 / Sample size / List total evaluable sample size for each regimen separately
(If an interventional study, list intervention and control separately)
28 / Provide estimate of incidence or proportion affected for each oral complication reported, along with SD and/or CI of intervention and control group / This is referring only to % affected by the oral complication
29 / Provide mean and/or median, and SD and/or CI of intervention and control group / This is referring to continuous outcomes of the oral complication (e.g. VAS, salivary flow, Likert scales)
30 / What QOL measures are reported? / e.g. QOL domains: physical function, role function, social function, emotional function, cognitive function, and global overall health status. Others: oral pain; nutrition: the ability to eat solids, liquids or nothing; denture use (if dentures present); speech; appearance; fatigue; nausea; weight loss; and analgesic use due to oral pain.
31 / How is QOL measured? / Standard validated scale=2;
Well defined, study-specific scale=1;
Not defined or stated =0
32 / List QOL scales used by name
33 / Provide estimate of incidence or proportion affected for each QOL measure reported along with SD and/or CI of intervention and control group / This is referring only to % affected by the oral complication
34 / Provide mean and/or median, and SD and/or CI of intervention and control group / This is referring to continuous outcomes of QOL (e.g. VAS, salivary flow, Likert scales)
35 / Are inpatient or outpatient charges reported? / 1=Yes 2= No 3 =Don’t know
(Referring to the economic impact, thus if additional charges related to the presence and/or severity of an oral complication)
36 / If Yes, list charges by intervention and control group
37 / Are resource utilization variables reported? / 1=Yes 2= No 3 =Don’t know
(See next row for examples)
38 / If Yes, list resource utilization by intervention and control group / Mean visits, hospital days or treatment days, extra clinic visits, days of total parenteral nutrition (TPN), days of antibiotic use, and opiate use will be aggregated.
39 / What is the conclusion of the study? / Long-term opioids dId not affect neuropsychologic tests;
Pain negatively impacts performance more than opioids
40 / Other comments (areas for further research, etc.)