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Table 1 Summary of studies included in the meta-analysis

From: Testing decision-making competency of schizophrenia participants in clinical trials. A meta-analysis and meta-regression

Study

Total No Subjects

Schiz. Subjects

Control group

Mean age (St dev)a

Men%a

Description

Qualityc

2008, Candillis [18]

109

52

57

37.79(11.67), 41.04(13.16)

76.9, 57.9

Subjects: 45 stable patients from a state hospital, seven outpatients. Controls: patients from a diabetes clinic Answers were given regarding the participation to a potential drug trial; payment of 10$ per participation

5

2000, Carpenter [19]

54

30

24

40.2(8.8), 39.7(10.2)

56.7, 78.2

Subjects: inpatients and outpatients (20 and 10 respectively). 28 schizophrenia patients, 2 patients with schizoaffective disorder. Controls: recruited from community centres and a free medical clinic. Answers regarding the participation to a randomised, double-blind trial for a novel anti-psychotic medication

5

2004, Cohen [34]

26

6

20

40.0 (7.8), 41.1 (10.3)

33.3, 60

Subjects: 6 inpatients. Controls: community volunteers Answers: regarding two studies – a drug study, and a ketamine study. We averaged the values of the two studies for each MacCAT CR subscale

5

2012, Harmell [20]

17

9

8

57(10), 52.2(12.1)

89, 50

Subjects: outpatients, recruited through a registry; randomly assigned for receiving either a normal or a web-media enhanced consent procedure. Controls: non-psychiatry patients, recruited through a registry Answers: regarding a hypothetical clinical trial for an experimental cognition enhancing medication

6.5

2012, Harmell [20]

18

10

8

57.9(8.9), 48.6(15.9)

40, 62.5

  

2009, Jeste [21]

95

66

29

51.2(6.5), 54.2(9.3)

64, 52

Subjects: community-dwelling outpatients aged >40 years, with schizophrenia. Subjects were randomly assigned to either a standard or a multimedia consent procedure. Controls: recruited through newspaper advertisements, flyers, or word of mouth Answers: regarding a 14-week double-blind, placebo-controlled RCT to determine the effectiveness of a cognition-enhancing drug for cognitive deficits associated with schizophrenia or with normal ageing

5

2009, Jeste [21]

93

62

31

52.4(8), 54.7(7.3)

65, 45

  

2007, Kim [22]

131

91

40

42.2(10.2), 39.9(10.9)

 

Subjects: with severe mental illness consisted of two subgroups: 55 participants from a schizophrenia study from six different sites across the US; 36 people from two outpatient clinics serving individuals with severe and persistent mental illnesses, and from inpatient units. Controls: recruited through advertisements from the community, in support staff work areas of a general hospital and at an out-patient substance misuse recovery program Answers: regarding participation in the CATIE study

6

2003, Kovnick [15]

51

27

24

39.1(7.1), 39.7(10.2)

78, 79

Cases: 27 psychiatric inpatients, non-acutely ill. Controls: individuals from the community, without known psychiatric pathologies Answers regarding a hypothetical randomized, double blind trial for a new schizophrenia drug

5

2016, López-Jaramillo [35]

120

80

40

34.9(10.5), 37(14.3)

73,47

Cases: 80 individuals with schizophrenia. Controls: healthy volunteers Answers regarding the participation to a clinical trial

6

2006, Moser [36]

60

30

30

34.1(10.65), 30(11.46)

73, 87

Cases: 30 individuals with schizophrenia (6 outpatients, 24 inpatients). Controls: healthy individuals, without significant psychiatric or medical pathologies Answers regarding a possible double-blind, placebo-controlled trial of a cognitive-enhancing agent called Synaptoclear

4.5

2006, Moser [36]

60

30

30

34.1(10.65), 30(11.46)

73, 87

  

2002, Moser [13]

50

25

25

31.56(9.77), 37.4(7.76)

84, 76

Cases: 25 individuals with schizophrenia, 21 outpatients, and four inpatients, 18 of which received antipsychotic medication. Controls: 25 infected individuals, 24 outpatients, one inpatient, 15 under psychotropic medication (primarily for depression); none was under antipsychotic medication Answers regarding a hypothetical 6-week, randomised, double-blind, placebo-con- trolled study of a cognition-enhancing agent called Synaptoclear

5.5

2005, Palmer [33]

71

35

36

65.7(5.2), 70.9(6.2)

57.1, 97.2

Cases: 35 clinically stable outpatients with diagnoses of schizophrenia (30) or schizoaffective disorder (5). Controls: 36 outpatients with diabetes mellitus, recruited through clinical research programs Answers regarding participation in a randomised controlled trial for an experimental compound (“plakmin”), tested for cognitive-enhancing effects, which was modelled after a local study that tested the cognitive benefits of a cholinomimetic agent

5

2007, Palmer [37]

59

31

28

52.4(7), 56.6(11.1)

48.4,46.4

Cases: 31 outpatients with schizophrenia. Controls: recruited from the community (28) Answers regarding a longitudinal study of side effects, including tardive dyskinesia, of FDA–approved second-generation antipsychotic medications among middle-aged and older patients

5.5

2015, Wang [38]

128

100

28

35.85(11.21), 45.68(11.54)

56, 53

Cases: both inpatients and outpatients. Controls: community volunteers Answers regarding the participation to a hypothetical clinical trial

4.5

  1. astatistics for both schizophrenia patients and controls, separated by a comma
  2. bitalic lines – decision-making capacity after using enhancement techniques
  3. cNewcastle-Ottawa Scale for case-control studies