Study characteristics, listed by year of publication.
| 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.