The present study was approved by the Meijo University Research Ethics Board to ensure privacy, confidentiality, and anonymity (H30-3). It was conducted according to the principles expressed in the Declaration of Helsinki.
Development of a scale to assess the stigma of schizophrenia among community pharmacists
To develop a scale to assess the stigma of schizophrenia among community pharmacists, items related to the constructs of stigma as a barrier for pharmacists to provide professional support for patients with schizophrenia were extracted from existing scales [5, 15-18]. A pool of items was created with these items and those newly developed upon deliberations among 3 pharmacists (1 university professor conducting research on psychiatry, 1 communication specialist, and 1 researcher). There were 67 items, representing 3 constructs; 1) recognition of patients with schizophrenia, 2) social distance, and 3) self-disclosure/help-seeking behavior. The appropriateness of the 67 items in terms of content and expression was then examined with 12 pharmacists, including 2 of the above-mentioned pharmacists and 3 pharmacists specializing in psychiatry, and a 33-item scale was created.
The assessment tool was distributed with a survey on personal background information to 1,500 pharmacies in Aichi Prefecture between December 1, 2018, and January 31, 2019. These pharmacies were randomly selected. A 5-point scale was used in the assessment tool as follows: 1: strongly agree, 2: agree, 3: neither agree nor disagree, 2: disagree, 1: strongly disagree. Negative responses were given 5 points, and positive responses 1 point. Correlations between each item and the total score (item total correlation) were confirmed from the scale proposals collected. Based on the answers provided, an exploratory factor analysis was performed using the principal axis factoring method with a promax rotation to further examine the factors constituting the assessment tool. The 33-item scale created by 12 pharmacists described above was extracted into a 27-item scale by the factor analysis.
Cronbach’s α confidence coefficient was calculated for each item and factor of the assessment tool to assess the level of internal consistency. The correlation between the total score and social desirability scale [19, 20] was confirmed from the 27-item scale. The test-retest reliability of the 27-item scale was verified by conducting a retest for those who consented among the sub-sample of community pharmacists eight to twelve weeks after the completion of the survey, and the intra-class correlation comparing the total scores at the 2 points they completed was calculated.
Furthermore, to confirm criterion-related validity, the correlation between the total 27-item scale score and total score from the following 2 conventional scales was used to assess the stigma of mental disorders: the Whatley Social Distance Scale (WSDS) [17] and Index of Attitudes toward the Mentally Ill (IATM) [15]. WSDS examines attitudes that prevent social participation by patients with mental disorders (social distance), and IATM measures the levels of negative recognition of these disorders. We used the 2 scales in our previous studies, involving pharmacy students [13], and an internet survey [10], conducted by physicians, nurses, pharmacists, and general citizens. The scale developed through these processes was named the Stigma Scale towards Schizophrenia for Community Pharmacists (SSCP), and was used in subsequent studies.
Randomized controlled trial
A randomized controlled trial was conducted to clarify the effects of reducing the stigma of schizophrenia using an educational program for community pharmacists with a focus on communication with patients with schizophrenia.
Participants and study design
An outline of the study design is shown in Figure 1. Community pharmacies in Aichi Prefecture in Japan were randomly selected to receive a document to recruit participants by e-mail or post, and consent was obtained from 120 pharmacists belonging to these pharmacies. They participated in the educational program twice, on July 28 and November 10, 2019, and were divided into 2 groups of 60, adopting the stratified block randomization method using a computer-generated randomization list with a block size of four: a lecture group (only attending a lecture on schizophrenia) and communication group (communicating with patients with schizophrenia and attending the lecture). Randomization was stratified by (1) sex (female versus male), (2) age (<30 years versus >30 years), (3) experience of communicating with patients with mental disorders (whether participants have or do not have this experience). Following the exclusion of 4 participants in the lecture group and 1 in the communication group, who withdrew, the final numbers in each group were 56 and 59, respectively (a total of 115 participants). Approximately 50% of each group participated in each session. After the lecture, the group to which each participant belonged was disclosed.
Outline of the educational program
All 115 participants attended a 60-minute lecture on schizophrenia given by a psychiatrist. The contents of the lecture were the epidemiology, symptoms, diagnosis, treatment methods based on the latest evidence, treatment effects, main side effects, and prognosis of schizophrenia.
After the lecture, 59 communication members formed groups of 4 or 5 to perform the following activities in a single room: a lecture staff introduction and breaking the ice (self-introduction in each group); a lecture on mental disorders and the associated stigma (prejudice and discrimination); group work 1: holding a group discussion on the management of patients with schizophrenia, and making a presentation with 1 member of each group (a total of 5 groups) as the presenter; group work 2: holding a group discussion and offering opinions on the points of an interview with patients with schizophrenia to clarify their experience; an interview with a patient with schizophrenia, who was allocated to the table of each group (a total of 6 patients), and introduced him/herself for 20 minutes using a self-introduction sheet previously filled out; interviews with 2 other patients (a total of 3 rotations); group work 3: holding a group discussion on points of learning by pharmacists from patient experiences, making a presentation with 1 member of each group (a total of 5 groups) as the presenter, followed by a lecture to summarize the opinions offered at the group presentations.
The 6 (4 males and 2 females) patients with schizophrenia who shared their experiences belonged to a patient group in Nagoya city. They had taken antipsychotics for 5 years or longer and were visiting psychiatric hospitals as outpatients. Their signed consent was previously obtained using a written document specifying the study objective.
After the consent process, they entered: 1) medical history, 2) difficulties associated with pharmacotherapy, 3) issues they may or may not consult about with community pharmacists, 4) cases in which they had perceived stigmatizing behaviors/attitudes (prejudice and discrimination), and 5) demands to be fulfilled by community pharmacists, in a self-introduction sheet, and rehearsed self-introductions using this sheet.
Stigma assessment
The stigma of schizophrenia among community pharmacists was assessed using SSCP at 3 points: before the lecture (both groups: T1), immediately after the lecture (lecture group: T2), and immediately after communicating with patients (communication group: T3). SSCP consists of 27 statements to be evaluated on a 5-point scale: <Strongly agree>, <Agree>, <Neutral>, <Disagree>, and <Strongly disagree>, which were scored as 1-5, respectively. Five items among 27 statements were reverse scored (i.e., #11, 20, 24, 25, and 26). The total score ranged between 27 and 135. Scores that were higher than or equal to a median of 81 represented more favorable attitudes.
Statistical analysis
Statistical analyses were performed using IBM SPSS statistics ver. 22. The attributes of the 2 groups were compared using the Mann-Whitney U test and chi-squared test. The Wilcoxon signed-rank test was used to compare between before and after the educational program. The effect size r was calculated using the standardized test statistic (Z) and sample size (N) (r=Z/√N). An effect size of 0.1 was considered to be small, 0.3 medium, and 0.5 or more a large effect. The significance of differences was set at two-tailed p<0.05 unless otherwise specified.
To identify fundamental factors from the 33-item scale, an exploratory factor analysis was performed using the principal axis factoring method with a promax rotation. The choice of the number of factors was based on the scree plot. Items with factor loadings lower than 0.4 were deemed meaningful and assigned to the given factor, with only the highest factor loading for each item being considered. Even if an item had a factor load of lower than 0.4, the item was adopted if researchers found it necessary to explain the construct to which the item belongs. We labeled each factor based on what best characterized the group of items that loaded on a particular factor. The internal consistency of the SSCP and subscales was evaluated using Cronbach’s α coefficient and construct validity for SSCP was examined using Spearman’s correlation (rs).