TABLE 3.
Schizophrenia-specific ClinROs/ObsROs
| CLINICAL OUTCOME ASSESSMENT | CLINICAL OUTCOME ASSESSMENT REFERENCES | DOMAIN | INTERPRETATION | LANGUAGES | RELIABILITY | VALIDITY | ORIGINAL VALIDATION |
|---|---|---|---|---|---|---|---|
| Positive and Negative Syndrome Scale (PANSS)a | Baandrup et al (2017),26 Birur et al (2016),32 Domenech et al (2019),48 Durgam et al (2015),49 Fe Bravo-Ortiz et al (2011)54 Gattaz et al (2014),63 Itokawa et al (2018),79 Jakubovski et al (2015),80 Lee et al (2014),90 Lin et al (2018),93 Lin et al (2018),94 Lloyd et al (2010),96 Niitsu et al (2012),112 Pagsberg et al (2014),116 Suzuki et al (2017),134 Thwin et al (2013)138 | Symptomatic | 30 items; total score (sum of positive, negative, and general psychopathology subscale scores) range: 30–210; higher score=more severe | Multiple | +++ Cronbach’s α ≥0.8 | +++ on a number of COAs | Kay et al (1987)171 |
| Scale for Positive Symptoms (SAPS) and Scale for Negative Symptoms (SANS) | Niolu et al (2015),113 Secher et al (2015)128 | Symptomatic | SANS: 25 negative symptoms rated on 6-point scale; SAPS: 34 positive symptoms rated on 6-point scale; higher scores=greater severity | English | +++ ICC=0.97 (SAPS) ICC=0.96 (SANS) | ++ on GAF | Startup et al (2002)175 |
| Brief Assessment of Cognition in Schizophrenia (BACS) | Baandrup et al (2017),26 Ogino et al (2011),115 Takahashi et al (2017)136 | Cognition | Composite score calculated as a mean z-score of the components of the score | English, Japanese | ++ ICC ≥0.79 | ++ on GAF | Keefe et al (2004)172 |
| Functional Recovery Scale in Schizophrenia (FROGS) | Capar and Kavak (2019)37 | Symptomatic | 19 items rated on 5-point Likert scale | English | +++ Cronbach’s α=0.909 | N/A | Llorca et al (2009)233 |
| Calgary Depression Scale for Schizophrenia (CDSS) | Addington et al (1990),169 Amri et al (2014),24 Farreny et al (2018),53 Hayhurst et al (2014),73 Maurino et al (2011),104 Yee et al (2017)144 | Symptomatic | 8 questions; score range: 0–3; higher score=more severe depression | English, Spanish, Korean, Thai | +++ Cronbach’s α ≥0.84 | N/A | Addington et al (1990)169 |
| Schedule for Deficit Syndrome (SDS) | Ahmed et al (2015)21 | Symptomatic | Individuals meet criteria for the deficit syndrome if they have ≥2 negative symptoms that are clinically significant, and those symptoms are considered primary and stable | English | ++ ICC=0.73 | N/A | Kirkpatrick et al (1989)161 |
| 4-Item Negative Symptom Assessment (NSA-4) | Alphs et al (2011),23 Garcia-Portilla et al (2015)62 | Symptomatic | Each of the 4 items and the overall global negative symptoms are rated on a 1- to 6-point scale, with higher scores indicating higher degree of impairment | English | ++ Cronbach’s α=0.64 ICC=0.82 | +++ on PANSS ++ QLESQ | Alphs et al (2011)23 |
| Negative Symptom Assessment (NSA-16) | Alphs et al (2011)23 | Symptomatic | Higher score=more severe | Multiple | +++ Cronbach’s α=0.92 | +++ on PANSS | Axelrod et al (1993),170 Garcia-Portilla et al (2015),62 Kumari et al (2017)173 |
| Psychosocial Remission in Schizophrenia Scale (PSRS) | Barak et al (2010)27 | Symptomatic | Items scored from 1 (poor) to 4 (excellent); higher score=more severe psychosocial impairment | English | N/A | N/A | Barak et al (2010)27 |
| Clinical Assessment Interview for Negative Symptoms (CAINS) | Blanchard et al (2017),33 Horan et al (2011)76 | Symptomatic | 2 scales (9-item Motivation and Pleasure scale, 4-item Expression scale), scored separately; higher score=greater severity | English | ++ ICC ≥70 ++ Cronbach’s α=84 | + on CDSS | Horan et al (2011)76 |
| Epidemiological Study of Cognitive Impairment in Schizophrenia (EPICOG-SCH) | Zaragoza Domingo et al (2017),145 Zaragoza Domingo et al (2015)146 | Symptomatic | 4 domains; impairment prevalence is percent of patients with scores <1.5 the standard deviation (or 10th centile) from the mean of standardized scores | English | ++ Cronbach’s α=0.78 | ++ on WHO-DAS and CGI-S (≥0.4) | Zaragoza Domingo et al (2015),146 Zaragoza Domingo et al (2017)145 |
| Virtual Reality Functional Capacity Assessment Tool (VRFCAT) | Keefe et al (2016)86 | Cognition | 4 scenarios simulating everyday activity; 12 objectives rated 1/0 for completion; 3 domains (errors, progression time, and completion time) | English | ++ ICC (time)=0.81, ICC (errors)=0.65, ICC (progression)=0.61 | +++ on Matrics/MCCB | Keefe et al (2016)86 |
| The Measurement and Treatment Research to Improve Cognition in Schizophrenia (Matrics/MCCB) | Green et al (2011),67 Lystad et al (2014),97 Velligan et al (2014)140 | Cognition | Score range: 1–100; higher score=better cognition | English, Norwegian | ++ ICC ≥0.7 | + on CGI-S ++ on other COAs | Green et al (2011)67 |
| Personal and Social Performance Scale (PSP) | Fleischhacker et al (2013),58 Gattaz et al (2014),63 Jelastopulu et al (2014),81 Lee et al (2016),91 Patrick et al (2009)174 | Emotional/psychological wellbeing | 4 subdomains rated 1–6; total score range: 1–100; higher score=better functioning | English | +++ ICC ≥ 0.87 | ++ on PANSS ++ on CGI-S | Patrick et al (2009)175 |
| Clear Thinking Scale (CTS) | Bridges et al (2010)36 | Emotional/psychological wellbeing | Complete scoring details unavailable at time of publication | English | N/A | N/A | Bridges et al (2010)36 |
aPANSS was used in more than 50 of the included studies.
CDSS: Calgary Depression Scale for Schizophrenia; CGI-S: Clinical Global Impressions Scale-Severity; ClinRO: clinician-reported outcome; COA: clinical outcome assessment; ICC: intraclass correlation coefficient; GAF: Global Assessment of Functioning; MCCB: MATRICS Consensus Cognitive Battery; N/A: not available; ObsRO: observer-reported outcome; PANSS: Positive and Negative Syndrome Scale; QLESQ: Quality of Life Enjoyment and Satisfaction Questionnaire; WHO-DAS: World Health Organization Disability Schedule