Article Figures & Data
Figures
- Figure 1.
PRISMA flow diagram of studies considered for the scoping review. PRISMA: Preferred Reporting Items for Systematic Reviews.
Tables
Author (Framework) Yr Instrument Population Patient Input Aim Safety Aspect (Definition/content) Fries, et al14 1990 STI Rheumatic Yes This report describes the development of a morbidity toxicity index and a mortality toxicity index for comparing the overall toxicity of different drugs. Toxicity (frequency, severity, laboratory features, importance to clinician) Welch, et al15 2001 rSTI Rheumatic Not reported (1) Propose revisions to the STI to satisfy attributes of OMERACT Drug Safety Working Party for patient-based safety assessment, and (2) propose methods for validation of rSTI as an outcome for clinical trials according to the OMERACT filter. Toxicity (frequency, severity, importance to the clinician, importance to patient, effect on economic resources, integration of adverse effects with benefit; overall satisfaction) Woodworth, et al16 2001 RCTC Rheumatic (clinical trials) No To develop an adverse event assessment tool to enable the use of common terminology to improve the consistency of reporting severity of side effects. Toxicity (allergic/immunologic, general, skin/integument, ophthalmologic, ENT, gastrointestinal, cardiac, pulmonary, musculoskeletal, neuropsychiatric, hematology, chemistry, urinalysis, autoimmune syndromes, if not part of basic disease) Lassere, et al17 2005 Patient and investigator adverse event instruments Rheumatic Yes To find the optimal tradeoff between comprehensiveness and ease of administration, enabling reports of adverse effects from the patient perspective, as well as that of the investigator. Event importance (severity, frequency and duration, physical, psychological, dissatisfaction, general, head/eyes/ears/nose/mouth/throat, chest/lungs/heart, musculoskeletal, gastrointestinal tract, neurological and psychological, skin) Woodworth, et al18 2007 RCTC 2.0 Rheumatic (clinical trials) No To revise and to stimulate the implementation of the RCTC. Toxicity (allergic/immunologic, cardiac, general, dermatologic, ENT, eye/ophthalmologic, gastrointestinal, musculoskeletal, neuropsychiatric, pulmonary, hematology, chemistry, urinalysis) Boers, et al19 2010 OMERACT 3 × 3 Rheumatic No To develop a simple system to assess benefit and harm of treatment on a single scale. Benefit (any occurrence or change that results in a patient being in a better state than before treatment). Harm (any occurrence or change such that a patient is in a worse state than before treatment). Gossec, et al20 2013 BioSecure questionnaire Patients treated with biologic therapies Yes To elaborate a questionnaire to measure patient knowledge and skills regarding management of safety issues, for clinicians and patients during treatment with biologics. Self-care safety skills (general knowledge; communication: who to contact; dealing with injuries, preventing infectious complications, vaccinations; planning child conception; dealing with infectious symptoms and fever; dealing with other infectious symptoms; planning surgery, information to share with the surgeon/anaesthesiologist; subcutaneous treatments: cold chain/cold storage, subcutaneous injection techniques; dental hygiene, preventing infectious complications, information to share with the dentist) Thanou, et al21 2014 cSFI Systemic lupus erythematosus No To examine the effect of modifications to the cSFI. Flare (mild, moderate, or severe) Miloslavsky, et al22 2016 GTI Patients treated with GC No To develop a GTI useful across medical disciplines to assess the effect of GC-associated morbidity. GC toxicity (composite GTI: toxicity likely to change during a clinical trial, and occurs commonly, varies with GC exposure). GC toxicity not included in the composite GTI (rare but important events) RCTC: Rheumatology Common Toxicity Criteria; STI: Stanford Toxicity Index; rSTI: revised STI; OMERACT: Outcome Measures in Rheumatology; cSFI: classic Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index flare index; GC: glucocorticoid; GTI: Glucocorticoid Toxicity Index.
- Table 2.
Type of information retrieved by the instruments, with number of items for each type, an example of an item, and the instrument from which the example was taken.
Type Items Example Instrument Symptoms 125 Arthralgia, leg cramps, myalgia, flare, fatigue RCTC 2.018 Laboratory results 53 Creatinine (mg/dl), neutrophil count (cells/mm3), hemoglobin (g/dl) RCTC16,18 Drug-specific 34 5. Who do I need to tell about my biologic treatment? BioSecure questionnaire20 Descriptive 3 4. Did you discontinue the drug as a result? STI14 Severity 3 3. Were the side effects mild, moderate or severe? STI14, RCTC18 Importance 3 Considering the frequency, severity, and impact on activities, how important was this side effect to you? rSTI15 Resource use 1 Data on endoscopy, outpatient procedures, hospitalization, emergency visits, and surgery. No data on extra physician visits due to drug-associated side effects. rSTI15 Benefit 1 Benefit (any occurrence or change that results in a patient being in a better state than before treatment) OMERACT 3 × 319 Harm 1 Harm (any occurrence or change such that a patient is in a worse state than before treatment) OMERACT 3 × 319 Disease-specific 1 Hospitalization for SLE activity cSFI21 RCTC: Rheumatology Common Toxicity Criteria; STI: Stanford Toxicity Index; rSTI: revised STI; OMERACT: Outcome Measures in Rheumatology; SLE: systemic lupus erythematosus; cSFI: classic Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index flare index.
