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Ethics approval and consent to participate | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The use of extracted teeth was approved by the Institutional Review Board and Ethics committee of The University of Yuzuncu Yil (2020/09–07) and informed consent was obtained from all subjects and/or their legal guardian(s). | PMC10386604 |
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Consent for publication | Not applicable. | PMC10386604 |
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Competing interests | The authors declare no competing interests. | PMC10386604 |
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References | PMC10386604 |
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ABSTRACT | PMC9839988 |
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Background | chronic kidney disease | The kidney has the highest level of selenium (Se) in the body, but the role of plasma Se in chronic kidney disease is uncertain. | PMC9839988 |
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Objective | hypertension | HYPERTENSION | We aimed to investigate the longitudinal association between baseline plasma Se and renal function decline in adults with hypertension and to explore possible effect modifiers. | PMC9839988 |
Methods | decline in renal function, hypertension, Stroke | HYPERTENSION, STROKE | This was a post hoc analysis of 935 men and women with hypertension aged 40 to 75 years from a folic-acid intervention trial (the China Stroke Primary Prevention Trial) in China. The baseline plasma Se was analyzed both as a continuous variable and as tertiles. The primary outcome was a rapid decline in renal function, defined as a mean decline in the estimated glomerular filtration rate of ≥ 5 mL/(min × 1.73 m | PMC9839988 |
Results | decline in renal function | The median follow-up duration from baseline to outcome was 4.4 years. After multivariate adjustment, there was an inverse association between plasma Se and a rapid decline in renal function (per 10-unit increment; OR: 0.85; 95% CI: 0.73, 0.99). When the baseline plasma Se was assessed as tertiles, compared to the lowest tertile (<74.5 μg/L), a lower trend of the primary outcome was found in the second tertile (74.5 to < 89.4 μg/L; OR: 0.60; 95% CI: 0.34, 1.07) and the highest tertile (89.4 to <150 μg/L; OR: 0.42; 95% CI: 0.22, 0.80; | PMC9839988 |
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Conclusions | Stroke | HYPERTENSION, STROKE | In this sample of Chinese adults with hypertension, baseline plasma Se concentrations were inversely associated with the risk of renal function decline. The China Stroke Primary Prevention Trial was registered at clinicaltrials.gov as NCT00794885. | PMC9839988 |
Introduction | CKD | HYPERTENSION, CHRONIC KIDNEY DISEASE (CKD) | Chronic kidney disease (CKD) is a major public health problem worldwide (Selenium (Se) is an essential trace element that is incorporated into selenoproteins. Selenocysteine is the key component of several selenoproteins, which have potent antioxidant, antiapoptotic, and anti-inflammatory effects (To address the above knowledge gaps, this current study aimed to examine the association of baseline plasma Se with the risk of renal function decline and to identify potential effect modifiers among adult patients with hypertension, a high-risk population for developing CKD ( | PMC9839988 |
Methods | PMC9839988 |
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Study participants and design | stroke, CKD, hypertensive, Stroke | STROKE, STROKE | This was a post hoc analysis of 935 hypertensive adults from the China Stroke Primary Prevention Trial (CSPPT), a folic acid intervention trial to prevent stroke. The study design and major results of the CSPPT (registered at clinicaltrials.gov as NCT00794885) (A total of 20,702 eligible participants were randomly assigned, in a 1:1 ratio, to 1 of 2 treatments: The renal substudy of the CSPPT suggested that folic acid treatment can significantly delay the progression of CKD by 55% among hypertensive patients with mild to moderate CKD (The parent study (CSPPT) was approved by the Ethics Committee of the Institute of Biomedicine, Anhui Medical University, Hefei, China (FWA assurance number: FWA00001263). All participants provided written, informed consent. | PMC9839988 |
Laboratory assays | BLOOD | Blood and spot-urine samples were collected from the participants at both the baseline and the exit visits. Methylenetetrahydrofolate reductase ( | PMC9839988 |
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Study outcomes | decline in renal function, CKD | SECONDARY | The primary outcome was a rapid decline in renal function, defined as a mean decline in eGFR of 5 mL/(min × 1.73 mThe secondary outcome was the development or progression of CKD, defined as any of the following: | PMC9839988 |
Other definitions | BMI was calculated as weight divided by height squared (kg/m | PMC9839988 |
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Statistical analyses | ±, decline in renal function, CKD, diabetes | REGRESSION, DIABETES | Of the 935 participants, there were missing data on serum folate (Participant characteristics were presented as means ± SDs for continuous variables and proportions for categorical variables, according to the tertiles of baseline plasma Se. Differences in baseline characteristics by tertiles of plasma Se were compared using ANOVA tests or chi-square tests, accordingly.ORs and 95% CIs of the study outcomes were estimated by modeling plasma Se both as a continuous variable and as tertiles using logistic regression models, without or with adjustment of covariables. Covariables were included in the models as continuous (per 1-unit increment) or categorical, as appropriate, including age (year), sex (male compared with female), eGFR [mL/(min × 1.73 mIn addition, possible modifications of the association between plasma Se (per 10-unit increment) and a rapid decline in renal function were also assessed for the following variables: age (≥60 compared with <60 years), sex, the presence of CKD (present compared with absent), the presence of diabetes (present compared with absent), treatment group (enalapril–folic acid compared with enalapril), serum folate (≥9.0 compared with <9.0 ng/mL), serum vitamin B12 (≥280 compared with <280 pmol/L), and serum tHcy (<10, 10 to <15, and ≥15 μmol/L), by including interaction terms (plasma Se, per 10-unit increment; × factor) into the multivariate-adjusted models.A 2-tailed | PMC9839988 |
Results | PMC9839988 |
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Characteristics of the study participants | ±, CKD, chronic kidney disease | As illustrated in Characteristics of participants by tertiles of plasma seleniumFor continuous variables, values are presented as means ± SDs. CKD, chronic kidney disease; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate; In addition, during the treatment period, the frequencies in use of concomitant calcium channel blockers, diuretics, antiplatelet drugs, and lipid-lowering drugs were similar across all plasma Se tertiles. However, participants with higher Se levels also had a higher frequency of glucose-lowering drug use ( | PMC9839988 |
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Association between plasma Se and renal outcomes | decline in renal function, CKD, chronic kidney disease, hypertensive | During the median treatment duration of 4.4 years (IQR: 4.2–4.6 years), a rapid decline in renal function and the development or progression of CKD occurred in 72 (7.7%) and 33 (3.5%) participants, respectively.As shown in The frequency distribution of baseline plasma selenium in 935 participants by outcome status: (A) rapid decline in renal function and (B) development or progression of CKD. CKD, chronic kidney disease.Similar results were found for the association of plasma Se and the risk of the development or progression of CKD (The association between plasma selenium and renal outcomes in hypertensive adults from a folate supplementation trialCKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; Adjusted for age, sex, eGFR, treatment group, BMI, | PMC9839988 |
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Exploratory subgroup analyses | decline in renal function, hypertensive | Stratified analyses were performed to assess the association between plasma Se (per 10-unit increment) and the rapid decline in renal function in various subgroups (Forest plot of subgroup analyses on the association between plasma selenium (per 10-unit increment) and the risk of rapid decline in renal function in hypertensive adults from a folate supplementation trial. Adjusted, if not stratified, for age, sex, eGFR, treatment group, BMI, | PMC9839988 |
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Discussion | hypertensive | Our study demonstrated a significant, inverse association between plasma Se and the subsequent risk of renal function decline in hypertensive patients. Furthermore, folate was a significant modifier for the relation of plasma Se and renal function. The inverse association was more pronounced in participants receiving folic acid treatment or with higher baseline folate levels (i.e., ≥9.0 ng/mL). However, it should be noted that given the existing sample size, the positive findings of the interaction test could be due to chance. | PMC9839988 |
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Previous longitudinal studies on the association between Se and renal function | leukemias and lymphomas | SOLID TUMORS | The association between Se and renal function remains uncertain. Farhadnejad et al. (In support of our findings, a randomized, double-blind, placebo-controlled, phase-II, crossover study of 74 patients with leukemias and lymphomas (LL) and solid tumors (ST) reported that although there was no statistically significant difference in serum creatinine levels during either placebo or Se supplementation, 36.8% of LL patients ( | PMC9839988 |
The potential mechanisms on the association between Se and renal function | alleviating renal function, kidney injuries | Whilst the exact mechanisms underlying the inverse association of Se and renal function declines remains uncertain, it has been found that selenium exerts antioxidation, anti-inflammatory, and antiapoptotic functions, thus reducing kidney injuries and alleviating renal function declines, in animals ( | PMC9839988 |
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Strengths of our study | declines in renal functions, CKD | HYPERTENSION, ENDOTHELIAL DYSFUNCTION | Our study has made new contributions to the field. First, to our knowledge, this is the first study of its kind in Chinese adults with hypertension, a high-risk population for developing CKD. It showed an inverse association between plasma Se and the risk of declines in renal functions. If further confirmed, these findings could have important clinical and public health implications. Second, this study offers important new insights regarding the interplay of folate and Se on renal functions. We found that folate status was a significant modifier: a stronger inverse association between Se and renal function declines was found among participants receiving folic acid treatment or with baseline folate ≥ 9.0 ng/mL. This finding is biologically plausible. It has been reported that in addition to its effect on tHcy levels, folate has direct antithrombotic and antioxidant effects, and can ameliorate endothelial dysfunction and nitrate tolerance ( | PMC9839988 |
Limitations of our study | hypertensive | REGRESSION | Our study also has several limitations. First, as an observational study, although a number of covariates have been adjusted for in the regression models, we cannot exclude the possibility of residual confounding from other unmeasured or unknown factors, such as detailed information on antioxidant dietary intakes, dietary habits, and physical activity. Second, Se was only measured at a single time point. More frequent measurements of Se would have provided more information. Third, due to a lack of relatively high levels of Se in this study population, we were unable to further investigate the potentially U-shaped relationship of Se with renal function. Moreover, this sample size was not large enough to explore the 3-way interactions of selenium, folate, and tHcy on renal outcomes. Fourth, the study population consisted of hypertensive adults from China; the generalizability of the results to a general population or to other ethnicities remains to be verified. Owing to the study limitations, confirmation of our findings in an independent study is necessary. | PMC9839988 |
Conclusions | HYPERTENSION | Our study showed an inverse association of baseline plasma Se levels with the risk of renal function decline in adults with hypertension, especially among those receiving folic acid treatment or with higher baseline folate levels, suggesting a synergistic effect of Se and folate in preserving renal function. Our findings warrant additional investigation. | PMC9839988 |
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Supplementary Material | Click here for additional data file. | PMC9839988 |
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Acknowledgements | The authors’ responsibilities were as follows – YL, YS, LL, ZZ, ZW, XX, JL: conducted the research; YL, XW, JL: analyzed the data and wrote the manuscript; JL: had primary responsibility for the final content of the manuscript; and all authors: designed the research and read and approved the final manuscript. | PMC9839988 |
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Data Availability | Data described in the manuscript, code book, and analytic code will be made available from the corresponding author on request, after the request is submitted and formally reviewed and approved by the Ethics Committee of the Institute of Biomedicine, Anhui Medical University, and the Ethics Committee of Nanfang Hospital. | PMC9839988 |
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Notes | lymphomas, CKD, chronic kidney disease, Stroke | LEUKEMIAS, MYOCARDIAL INFARCTION, STROKE, SOLID TUMORS, LYMPHOMAS | This work was supported by the National Natural Science Foundation of China (82000691); the Science and Technology Planning Project of Guangzhou, China (202102021155); and the Outstanding Youths Development Scheme of Nanfang Hospital, Southern Medical University (2019J004).Author disclosures: Dr. Youbao Li reports grants from the National Natural Science Foundation of China, the Science and Technology Planning Project of Guangzhou, China, and the Outstanding Youths Development Scheme of Nanfang Hospital, Southern Medical University. All other authors report no conflicts of interest.The funders had no role in the design and conduct of the study (data collection, management, analysis, and interpretation), the preparation, review, approval of the manuscript, or the decision to submit the manuscript for publication. This work was supported by the National Natural Science Foundation of China [82000691]; the Science and Technology Planning Project of Guangzhou, China [202102021155]; and the Outstanding Youths Development Scheme of Nanfang Hospital, Southern Medical University [2019J004].Supplemental Figure 1 and Supplemental Tables 1 and 2 are available from the “Supplementary data” link in the online posting of the article and from the same link in the online table of contents at Abbreviations used: BP, blood pressure; CKD, chronic kidney disease; CSPPT, China Stroke Primary Prevention Trial; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate; ICP-MS, inductively coupled plasma mass spectrometry; LL, leukemias and lymphomas; MI, myocardial infarction; MTHFR, methylenetetrahydrofolate reductase; SBP, systolic blood pressure; Se, selenium; ST, solid tumors; TC, total cholesterol; tHcy, total homocysteine. | PMC9839988 |
References | PMC9839988 |
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Keywords | schizophrenia, schizophrenia-spectrum disorders | VIRUS | In the United States, the health and economic consequences of the COVID-19 pandemic have disproportionately affected the Latinx community. Within the Latinx community, people with schizophrenia-spectrum disorders are more susceptible to exposure to the virus. Given their increased risk of contracting and getting sick from the virus, efforts targeting the Latinx population should focus on increasing knowledge and safe practices associated with COVID-19. We developed a 10 min animated, Spanish-language audio-visual novela designed to improve knowledge, attitudes, and behaviors regarding COVID-19. Latinx adults with schizophrenia (N = 100) at a community mental health center in Los Angeles were randomly assigned to watch the novela or a non-COVID video (control group). Participants completed surveys immediately before and one month after viewing the material. One month after watching the audio-visual novela, subjects endorsed a greater likelihood of seeking a COVID-19 vaccine than control subjects. No other significant differences were observed between the two conditions. The findings of this study suggest that the presentation of health information in a relevant, engaging, and appealing manner may be useful way to improving salutary health behaviors of Latinx people with schizophrenia-spectrum disorders. | PMC9898851 |
Introduction | PMC9898851 |
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Background | cognitive impairment, schizophrenia, memory deficits, schizophrenia-spectrum disorders | VIRUS | The health and economic consequences of the COVID-19 pandemic have disproportionately affected the Latinx community. Across many states, their rates of contracting the virus are twice their population proportion [Within the Latinx community, those with schizophrenia-spectrum disorders may be more susceptible to virus exposure due to cognitive impairment [Given their increased risk of contracting and becoming ill from the virus, efforts targeted to the Latinx population should focus on increasing knowledge and safe practices associated with COVID-19. Moreover, this information must be presented in a format that can overcome the working memory deficits that are prominent in patients with schizophrenia [ | PMC9898851 |
Conceptual Framework | A commonly used form of visual narrative is the We developed a 12 min, Spanish-language, digitally animated audio-visual | PMC9898851 |
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Methods | PMC9898851 |
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Participants | schizophrenia-spectrum disorder, schizophrenia-spectrum disorders | The participants were 100 Spanish-speaking adults with schizophrenia-spectrum disorders receiving mental health services at the San Fernando Mental Health Center, a community mental health center operated by the Los Angeles County Department of Mental Health. The inclusion criteria were the participant self-identified as Latinx and spoke Spanish fluently; was between the ages 18 and 74; had a clinical diagnosis of a schizophrenia-spectrum disorder made by a licensed clinician; would be available for both the baseline and one-month follow up sessions; and had the ability and cognitive capacity to provide fully informed consent. There were no specific exclusion criteria for this study. | PMC9898851 |
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Data Collection | schizophrenia, schizoaffective disorder | Subjects with chart-diagnosed schizophrenia or schizoaffective disorder were recruited through advertisements posted at the community mental health center. Interested subjects contacted a Spanish-speaking research assistant, who obtained informed consent from the subject, administered the baseline measures (demographic information and the COVID-19 assessment battery), and randomized the subject to either the experimental or control condition using a computer-based system tailored for this project. All subjects randomized to the experimental condition were shown the COVID-19 audio-visual | PMC9898851 |
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Materials | The audio-visual novela, entitled “Examples of images from audio-visual novella. The development of the audio-visual novela was led by one of the co-authors (GM), whose team at the University of Southern California School of Pharmacy has produced numerous audio-visual novelas used throughout the world to improve health literacy among underserved populations [ | PMC9898851 |
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Measures | fatigue, fever, pain, infection, dry cough | VIRUS, INFECTION, EVENTS | All data was generated from interviews conducted by a Spanish-speaking research assistant. Demographic variables including age, gender, marital status, educational level, and working status were ascertained. Acculturation level was measured using the 23-item Cuellar acculturation scale [The assessment of COVID-19 Knowledge, Attitudes, and Behaviors were derived from Spanish-language measures available through the NIH COVID-19 Survey repository at: COVID-19 Knowledge was queried through a 12-item questionnaire that included Yes–No questions such as: “The principal symptoms of COVID-19 are fever, fatigue, dry cough and body pain” and “People with COVID-19 are not contagious if they don’t have a fever.” Correct answers received 1 point and incorrect answers received 0 points. Knowledge was calculated as the total number of correct answers on the 12-item questionnaire. Higher scores indicate greater knowledge about COVID-19. The internal consistency for this scale was 0.70 and 0.71 for the baseline and month 1 assessments.COVID-19 Attitudes were assessed through seven questions using a 5-point Likert style rating (impossible-possible-probable-very probable-definitely). One three-item subscale measured attitudes about infection: “How likely do you think it is that the following events will happen in light of the current COVID-19 pandemic (you will be infected, someone in your family will be infected, you will be quarantined).” Cronbach alphas were 0.67 for baseline and 0.76 for month 1 assessments. The other three-item subscale assessed attitudes toward safety behaviors: “How effective are the following actions for keeping you safe from COVID-19 (wearing a face mask, washing your hands, and maintaining physical distance).” Cronbach alphas were 0.90 and 0.89 for the two assessment periods. The final item concerned attitudes toward vaccination: “How likely are you to become vaccinated when a vaccine becomes available?” Higher scores for all attitudinal items suggest more realistic attitudes towards the effects of the COVID-19 virus and what can be done to mitigate these effects.COVID-19 Behaviors were evaluated with five items in which a 5-point Likert style rating (not at all-somewhat-half the time-mostly-always) was applied. Respondents were asked, “Over the past week, how often have you engaged in the following behaviors: (1) worn a mask, (2) maintained six feet of physical space from others when out of your house, (3) avoided contact with people who could be high risk, (4) talked to a key relative about safe practices, and (5) washed your hands with soap and water after being in a public area.” Higher scores represent increased use of safe behaviors to prevent contracting the COVID-19 virus. The Cronbach alpha for the behavior measure was 0.87 for both baseline and month 1 assessments. | PMC9898851 |
Data Analysis | infection | REGRESSION, INFECTION | SPSS Version 27 was used to carry out the data analysis. We carried out independent t-tests and Pearson Chi-square analyses to assess whether there were significant differences in the background of the participants in the two conditions. The study hypotheses were that subjects exposed to the COVID-19 material would have: (1) greater knowledge, (2) more realistic attitudes and (3) safer behaviors than control subjects. To test these hypotheses, data were collected at baseline and 1 month later. A 2 × 2 mixed design analysis of variance was carried out in which the between-subjects factor was the intervention (audio-visual novela, La CLAve) and the within-subjects factor was time (Baseline, Month 1). We conducted these analyses separately for knowledge of COVID, beliefs about infection, beliefs about safety behavior, engagement in safety behaviors, and the likelihood of obtaining vaccination when available. Finally, we carried out exploratory regression analyses to further understand the key finding.There were five participants who did not return for the month 1 follow-up, three in the audio-visual novela condition and two in the La CLAve condition. Those five participants were dropped from the main analyses.This study was reviewed and approved by the UCLA Institutional Review Board and the Human Subjects Research Committee of the Los Angeles County Department of Mental Health. | PMC9898851 |
Results | PMC9898851 |
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Sample | schizophrenia-spectrum disorder | Of the 137 people screened for eligibility, 23 did not meet inclusion criteria (insufficient Spanish language proficiency = 9; did not meet criteria for a schizophrenia-spectrum disorder = 8, lacked capacity to provide informed consent = 6). Of the 114 people invited to participate, 14 refused because they would not be available for the follow-up visit (e.g., travel plans). A total of 100 participants were consented and enrolled in the study (see Consort Diagram in Fig. CONSORT diagramThe baseline characteristics of the participants are depicted in Table Sample characteristics at baseline (n = 100) | PMC9898851 |
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Participants’ Background by Condition | There were no differences in the two conditions regarding age (p = 0.53), years of schooling (p = 0.37), gender (p = 0.67), employment status (not employed, employed, p = 0.36), marital status (never married, married at some time, p = 0.19) and language preference (Spanish or bilingual, p = 0.51). | PMC9898851 |
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Discussion | infection, schizophrenia-spectrum disorders | INFECTION | The purpose of this study was to test the hypotheses that Spanish-speaking individuals with schizophrenia-spectrum disorders would demonstrate increased knowledge, more realistic attitudes, and engage in safer behaviors after watching a digitally animated audio-visual novela focused on COVID-19. We found partial support for our hypotheses. Although no statistically significant differences were observed between the subjects exposed to the audio-visual novela and La CLave videos on COVID knowledge, beliefs about infection, beliefs about safety behavior, and engagement in safety behaviors, subjects who watched the audio-visual novela did report a greater likelihood of seeking a vaccine at their post-intervention assessment. This finding is consistent with several studies of Contrary to our expectation that watching the audio-visual novela would increase COVID knowledge, which in turn would increase the likelihood of obtaining a vaccine, we found that subjects who reported an increased likelihood of becoming vaccinated after watching the audio-visual novela were those who were less knowledgeable about COVID. Combined with our finding that participants in both conditions demonstrated greater knowledge about COVID over time, this result suggests that the audio-visual novela delivered in a video format may be effective in positively changing attitudes towards vaccination without necessarily increasing knowledge about the illness in question. One possibility is that watching the audio-visual novela may have prompted participants to discuss the experience with a family member, sparking a dialogue that encouraged the participant to get vaccinated. We have shown that such social influences improve treatment adherence in this population [ | PMC9898851 |
Limitations | schizophrenia-spectrum disorders, cognitive deficits | These findings are subject to several limitations. The intervention itself was very brief and delivered only once. Given the cognitive deficits often found in people with schizophrenia-spectrum disorders [ | PMC9898851 |
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Acknowledgements | The funding for this research was provided by the UCLA David Geffen School of Medicine COVID-19 Research Award Program. This study was reviewed and approved by the UCLA Institutional Review Board and the Human Subjects Research Committee of the Los Angeles County Department of Mental Health. The authors thank the members of the production team responsible for the creation of the “Cara, Manos, y Pies” audio-visual | PMC9898851 |
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References | PMC9898851 |
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Background | Joint first authors.One size does not fit all in assessment and intervention for people with convictions for sexual offences. Crime scene indicators and risk-related variables have been used to identify distinct clusters of people with convictions for sexual offences, but there is a need for more robust typologies that identify clusters based on psychologically meaningful risk factors that can be targeted in treatment. | PMC10727912 |
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Aims | To use robust modelling techniques to identify latent profiles of people with convictions for sexual offences based on indicators of dynamic risk. | PMC10727912 |
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Method | Adult male participants, who had been convicted for sexual offences and assessed for eligibility for the prison-based Core Sex Offender Treatment Programme delivered by His Majesty's Prison and Probation Service (UK), were randomly allocated to a test ( | PMC10727912 |
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Results | low psychological impairment | Five latent profiles were identified in the test and validation data-sets. These were labelled low psychological impairment, impulsive, distorted thinker, rape preoccupied and child fantasist. Profiles varied in individual characteristics, offence histories, victim preferences and level of risk. | PMC10727912 |
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Conclusions | Our findings should be used to guide assessment and intervention practices that are tailored to distinct psychological profiles consistent with principles of risk, need and responsivity. | PMC10727912 |
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Keywords: | familiality | Sexual violence is an international public health concern that entails a substantial cost to society.Given this heterogeneity, it is unsurprising that attempts have been made to categorise people into more homogeneous groups on the basis of offence type (e.g. contact versus online offending), victim age (e.g. prepubescent versus pubescent) or victim familiality.In this exploratory study, we used latent profile analysis (LPA) to identify distinct subtypes of people convicted of sexual offences based on indicators of dynamic risk from psychological test data. We aimed to build on earlier work, which identified dynamic risk clusters that largely resembled a continuum of severity, | PMC10727912 |
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Method | PMC10727912 |
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Sample | MAY | Participants were part of a data-set of 2394 UK adult males convicted of sexual offences. All participants were assessed between 2003 and 2014 (with 65% of assessments occurring between 2007 and 2011, inclusive) for eligibility for the prison-based version of HMPPS Core Sex Offender Treatment Programme (SOTP). Approximately 97% of the sample was serving a sentence for a conviction between 1996 and 2012, with 77% convicted between 2003 and 2009. Ages ranged between 21 and 84 years (mean 41.8, s.d. = 12.7, median 42 years). Most of the sample was recorded as being in aggregate White ethnic categories (89.8%), with 5.9% classified in aggregate Black ethnic categories, 2.7% in aggregate Asian ethnic categories, 1.3% in aggregate ‘mixed-race’ ethnic categories, 0.2% in aggregate ‘other’ ethnic categories, with a further 0.1% not specified and 4.4% of the data missing. Most of the full sample (After removing duplicates and individuals for whom more than 10% of data were missing, a final data-set of 2245 participants remained for analysis. Participants were randomly allocated to a test (Ethics approval was not received for this human study because we used existing data collected by HMPPS for the purposes of service evaluation. All adult participants provided written informed consent for their data to be used in research. The project was approved by the Ministry of Justice National Research Committee (granted 5 May 2021). | PMC10727912 |
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Measure selection | The clinical data-set contained pre- and post-programme test scores on 92 scales from 17 psychological measures (see Supplementary Material A for descriptions), along with demographic, intervention and offence characteristics. Only pre-programme test scores were considered for inclusion. One scale was removed because of missing data (30% missing) and two further scales were removed because of perfect or near-perfect positive correlations with other study measures (Supplementary Material A). Any scales that were positively oriented were reverse scored so that higher scores were indicative of greater risk/impairment. Forty scales were removed because of a lack of theoretical support as psychologically meaningful risk factors.Exploratory factor analysis (EFA) was employed to reduce the number of variables, with the aim of selecting one variable per theoretically plausible risk domain for use in the LPA. Three metrics were used to judge how many factors could plausibly be extracted from the data: (a) parallel analysis; (b) Velicer's minimal average partial (MAP) criterion; and (c) the very simple structure (VSS) criterion.The EFA resulted in four classes of scales, approximating three of the four SARN domains of risk:A total of six subscales were selected for inclusion in the LPA: one from the socio-affective and emotional management factor (Impulsive carelessness: | PMC10727912 |
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Socially desirable responding | Given concerns about the tendency towards socially desirable responding, we used the Balanced Inventory of Desirable Responding (BIDR) | PMC10727912 |
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Latent profile analysis | Model-based clustering is based on the theory that data are derived from a mixture of underlying probability distributions.It is recommended that a range of criteria are used for identifying the correct number of profiles. | PMC10727912 |
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Validity of latent profiles | REGRESSION | The replicability of the final profile solution was validated using the validation data-set (30% of the total sample). To establish criterion-related evidence, a series of linear regression models and tests of association were used to examine whether profile allocation was associated with theoretically plausible criminological outcomes, including intelligence, assessed using various versions of the Wechsler Adult Intelligence Scale or Wechsler Abbreviated Scale of Intelligence, | PMC10727912 |
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Results | PMC10727912 |
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Socially desirable responding | Scores on the BIDR subscales in the test sample (Self-Deceptive Enhancement: mean 5.9, s.d. = 3.4; Impression Management: mean 6.3, s.d. = 4.0) showed that the extent of socially desirable responding was small and within the range of normative values reported in the BIDR manual (Self-Deceptive Enhancement: mean 7.5, s.d. = 3.2; Impression Management: mean 4.3, s.d. = 3.1). | PMC10727912 |
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Latent profile analysis | Seventy-two cases were removed owing to missingness, and 1505 cases were included in the LPA. BIC and SABIC indicated that Model 3 generated a better relative fit than Model 1 and showed a plateau at five latent profiles (Supplementary Fig. 2, Supplementary Material A). For Model 3, ICL and BLRT were also highest at five latent profiles, and both entropy and minimum probability steeply dropped at five latent profiles. Consequently, a five-profile solution was employed with fixed variances and equal covariances (Model 3: BIC = 21 167.07, ICL = −21 973.86, entropy 0.84).The proportion of the overall sample allocated to each profile and aggregate probability values are shown in Proportion of test cases (Five-profile solutions with fixed variances and fixed covariances for the test and validation data-sets.PREICA, pre-treatment impulsive carelessness; PRECMF, pre-treatment child molest: fantasy; PRERAF¸ pre-treatment rape: fantasy; PRESO, pre-treatment sexual obsession; PRERAPE, pre-treatment rape myth acceptance; PRESWCH, pre-treatment sex with children. Top row: 1, Low psychological impairment; 2, Impulsive; 3, Distorted thinker; 4, Rape preoccupied; 5, Child fantasist. Bottom row: 1, Low psychological impairment; 2, Child fantasist; 3, Distorted thinker; 4, Rape precoccupied; 5, Impulsive. | PMC10727912 |
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Solution validation | Our validation data-set generated a very similar five-profile solution. Nineteen cases were removed owing to missingness, and 649 cases were included in the validation LPA. For Model 3, BIC and SABIC plateaued at five profiles, ICL and BLRT were also high at five profiles, and both entropy and minimum probability steeply dropped at five profiles. The Model 3 five-profile solution generated similar profile characteristics and similar group proportions compared to the test sample ( | PMC10727912 |
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Exploratory analyses | In a | PMC10727912 |
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Discussion | heightened impulsive, antisocial, high-functioning | In a pre-treatment sample of people convicted for sexual offences in the UK, we used psychological test measures, indexing three of the four SARN domains of dynamic risk,The second profile was termed impulsive and accounted for approximately 8.4% of the test sample. These individuals were characterised by heightened impulsive carelessness, had relatively low IQ and a relatively high number of overall convictions. People allocated to this profile appear to conform to a more ‘generalist’ antisocial pattern of offendingApproximately 12.4% of the test sample were allocated to a distorted thinker profile and were characterised by relatively high scores for rape myth acceptance and distorted thinking about children and sex. Distorted thinkers tended to be older, had fewer overall convictions, with a relatively high frequency of index offences that were child specific, female specific or related to IIOC, consistent with a preference for younger victims despite elevated scores for rape myth acceptance.The final two profiles were termed rape preoccupied and child fantasist and accounted for 8.1 and 19.8% of the test sample respectively. People with these profiles showed more specific areas of risk and need related to deviant sexual preferences and preoccupations with sex. The rape preoccupied group accounted for the smallest proportion of the test sample and included individuals who showed particularly elevated scores for rape fantasies and non-child-specific obsessive thinking about sex. People allocated to a rape preoccupied profile had a relatively high number of previous sexual offences, with a relatively high frequency of very high-risk individuals but fewer medium-risk, and relatively few people with child-specific and female-specific index offences. People in this profile appear to show a preference for adult victims but offended less preferentially against female victims.Child fantasists showed a specific elevation for child and sex fantasies, and tended to be older and to have higher IQs relative to the LPI profile. This profile included a disproportionately high frequency of child-specific and IIOC index offences and a much less extensive overall criminal history. People with this profile may conform to a more high-functioning, preferentially paedophilic pattern of offending, | PMC10727912 |
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Clinical implications | Our findings have clear implications for assessment and treatment, and can be considered in the context of SARN domains of dynamic risk, and principles of risk, need and responsivity. | PMC10727912 |
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Strengths and limitations | Our work has several strengths, including a large, heterogeneous sample, data on intelligence, the number and type of previous convictions, and information about level of risk and index offence codes. However, our results are nonetheless subject to some limitations. First, factor analyses revealed that the psychological test data indexed three of the four domains of risk identified by Thornton, | PMC10727912 |
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Future research | Future work should aim to authenticate the five identified latent profiles within and outside the UK and examine differences between profiles in responsivity to different interventions (including pharmacological interventions where indicated). | PMC10727912 |
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Supporting information | PMC10727912 |
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Gillespie and Elliott supplementary material 1 | Gillespie and Elliott supplementary material | PMC10727912 |
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Gillespie and Elliott supplementary material 2 | Gillespie and Elliott supplementary material | PMC10727912 |
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Supplementary material | Supplementary material is available online at | PMC10727912 |
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Data availability | The data that support the findings of this study are available from Ministry of Justice, UK. Restrictions apply to the availability of these data, which were used under licence for this study. | PMC10727912 |
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Author contributions | S.M.G. formulated the research question. S.M.G. and I.A.E. designed the study and wrote the article. I.A.E. analysed the data. | PMC10727912 |
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Funding | This research was funded in whole, or in part, by a grant from the Economic and Social Research Council (ES/T002824/1), awarded to S.M.G. | PMC10727912 |
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Declaration of interest | S.M.G. has provided paid consultancy for Ministry of Justice, UK. I.A.E. is an employee of Ministry of Justice, UK. | PMC10727912 |
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References | PMC10727912 |
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Background | Overtreatment poses a challenge to healthcare systems due to harmful consequences of avoidable side-effects and costs. This study presents the first account for examining the feasibility of placebo use for reducing overtreatment in primary care, including whether public attitudes support the use of different placebo types in place of inappropriate prescriptions of antibiotics, antidepressants, or analgesics. | PMC10510165 |
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Methods | We used a multi-study, mixed-methods design, including patient and public (PPI) consultations, focus groups (Study 1) and two pre-registered online experiments (Studies 2 and 3). | PMC10510165 |
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Results | Study 1 ( | PMC10510165 |
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Conclusions | Findings from PPI and three studies indicate general support for combatting overprescribing in primary care through clinical placebo use. This is an indicator for wider UK public support for a novel, behavioural strategy to target a long-standing healthcare challenge. General acceptability appears to be highest for the use of open-label + impure placebos in the context of antibiotic overprescribing. | PMC10510165 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12916-023-03074-4. | PMC10510165 |
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Keywords | PMC10510165 |
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Background | This article presents the first comprehensive evidence around public acceptability of clinical placebo use as a behavioural strategy to reduce overtreatment in “primary care”, defined by the World Health Organisation as “a model of care that supports first-contact, accessible, continuous, comprehensive and coordinated person-focused care” [While reasons for medicine overuse vary, key factors include diagnostic uncertainty and defensive medicine, aimed to reduce chances of patient litigation [A theory-based, behavioural solution to action bias is substitution [ | PMC10510165 |
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Placebo use in primary care | Placebos are “inert” substances that have no therapeutic effects but can alleviate symptoms through patients’ participation in the therapeutic encounter and the associated, measurable effects on neurobiological mechanisms [Placebo types can be categorised based on the amount of information provided upon administration. Most historical placebo use has included some level of deception, meaning that patients were misled into believing that the prescribed placebo substances constituted a type of medical treatment [An additional distinction of placebos categories is made based on the type of substance administered [Informal, clinical use of placebos is prevalent across different global healthcare contexts, but quantification of use is complicated due to varying definitions of impure placebos [ | PMC10510165 |
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Public acceptability of placebo use | ’ | DISEASE | The present research aims to test clinical placebo use as a substitution strategy to reduce the overuse of unnecessary medicines in UK primary care. Based on decision theory and empirical results pertaining to placebo effectiveness, we predict the benefits of placebos to be twofold. Firstly, they offer a behavioural solution to action bias that may satisfy both doctors’ and patients’ desires for an active treatment solution while reducing the use of potentially harmful medicines. Secondly, they are likely to provide significant symptom relief without reliance on actual medical treatment.Given the evidence for existing non-systematic placebo use in UK primary care, there is a strong rationale for formalising placebo use by investigating conditions for successful clinical use across specific disease contexts. However, a key factor influencing the feasibility of any wider placebo roll-out is public acceptance of different placebo types as well as related beliefs about their efficacy.Studies of placebo health literacy show that most members of the general public have a satisfactory but narrow working definition of placebos as “sham treatments” [Previous research shares a number of key limitations, meaning that there is no reliable evidence on public acceptability of clinical placebo use for tackling overtreatment. Firstly, many studies relied on small sample sizes and/or samples from specific cultural contexts [In addition to these general limitations, there are a number of factors that have received comparatively little attention despite their theoretical relevance to the topic; these include the potential importance of language and framing and the influence of individual difference variables on placebo acceptability. | PMC10510165 |
Framing effects | Evidence from the decision sciences shows that the specific way information is worded or “framed” can influence the way information is processed, perceived and subsequently acted upon. For example, a classic study suggested that framing the same treatment outcomes either in terms of losses (number of patients lost) or gains (number of patients saved) affected people’s acceptance of the treatment programme in question [ | PMC10510165 |
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Individual differences | anxiety | A 2020 systematic review suggests that personality variables may affect the strength of patients’ placebo responses, with optimism leading to higher effectiveness of placebos and health anxiety leading patients to experience more negative side effects (“nocebo effects”) when taking placebos [ | PMC10510165 |
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Study 1: focus groups | RESPIRATORY INFECTIONS | The first study consisted of an in-depth qualitative exploration of public attitudes around placebos. Focus groups were employed to generate discussion between different participants. At the same time, this initial qualitative study served to test the wording and general appropriateness of the patient scenario for later use in our follow-up experiments. Study 1 focused on exploring potential placebo use in the context of respiratory infections, where overprescribing of antibiotics is a very common problem [ | PMC10510165 |
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Methods | PMC10510165 |
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Participants | Using advertisements on social media (Twitter, Facebook), we recruited an opportunity sample of 16 adult members of the general public living in the UK. The sample included 9 males and 7 females with a mean age of 26.56 ( | PMC10510165 |
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Materials and procedure | The project idea and research plans including draft focus group materials were presented at two separate PPI (Patient and Public Involvement) group meetings of the “Leicester, Leicestershire and Rutland Ageing Patient and Public Involvement Forum” and the “Ethnic Minority Research Inclusion (EMRI) Hub (South Yorkshire)” prior to data collection. Overall, PPI group members were supportive of the research ideas, but highlighted a number of potential limitations and practical barriers to clinical placebo use, which were considered by the research team and implemented in the study materials. One PPI group suggestion included asking focus groups about the acceptability of charging patients for placebo prescriptions. A separate question on this topic was included in the topic guide.Four virtual focus groups were conducted 2–4 November 2022 and lasted 30–70 min. Group sizes depended on participant availability and turn-up rates. Groups 1–4 comprised four, three, two and seven participants, respectively. All participants were recruited through an advertisement on social media. Prior to participation, they completed a consent form and a pre-study questionnaire including demographic items and basic questions about existing knowledge or previous experiences with placebos. According to this questionnaire, all participants had a personal working definition of placebos, but no participant was an expert in the topic (e.g. a medical prescriber or researcher in the field). All focus groups were conducted by the same researcher (EMK), following the same semi-structured topic guide (see Additional File | PMC10510165 |
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Data analysis | Focus group recordings were transcribed verbatim and imported into NVivo 12 for coding. In accordance with a Grounded Theory approach [ | PMC10510165 |
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Results | The responses from the focus groups fell into three primary categories: ethical considerations around placebo usage, perceptual and conceptual understandings of placebos by the respondents, and practicalities of using placebos within healthcare provision. A detailed overview of individual codes as well as exemplary participant quotations is provided in Table Axial codes, individual codes and example quotations for the qualitative focus group results | PMC10510165 |
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Theme 1: ethical considerations | pain | MINOR, BLIND | Trust within the patient-clinician relationship was viewed as foundational to the use of placebos in appropriate conditions and contexts. Primarily, trusting that a clinician would be using the placebo for an appropriate condition—i.e. one that would not be worsened by substituting a placebo—and in a context that was beneficial for the patient. Participants suggested increasing levels of societal enculturation to build trust, via public health campaigns and clinician-based education during consultations. However, some participants expressed concern that the offer of a placebo could undermine the seriousness a patient had attached to their complaint, and erode the relationship and trust between the patient and clinician, especially in vulnerable communities with low health adherence. Participants also considered the ethical concerns of deontological and utilitarian aspects of placebo use. They generally preferred open-label placebos to the inherently deceptive use of blind placebos, which they perceived as violating the professional duties of care by not keeping the patient fully informed—regardless of being potentially more efficacious. Participants identified specific circumstances where placebo use could be ethically acceptable, such as mental health contexts, while pain alleviation was viewed as an unsuitable application. The expected temporality of the illness played a role in how ethically suitable placebo use was perceived, with short-term applications for minor acute illnesses viewed as relatively low risk, while long-term use of placebos was seen as high risk for a patient. | PMC10510165 |
Theme 2: perceptions and conceptions of placebos | The discussions also revealed how participants perceived placebos as a “non-real” form of treatment, with descriptors such as “pseudo-medication”, “does nothing”, and “not a real treatment” being used. Nevertheless, the placebo effect itself was largely accepted and spoken about as a real phenomenon. Participants suggested that the terminology around how placebos functioned should be clear to patients, indicating that placebos “help” or provide temporary “relief” rather than “work”. The labels “pure” and “impure” were also viewed as holding inherent connotations that could potentially affect a patient’s attitude towards placebo use. Some participants likened their perception of placebos to foods in which an active ingredient has been removed (e.g. decaffeinated coffee) or to lifestyle cosmetics that have unproven health benefits but create a “feel good” mindset through the action of attending to health.Participants noted that a patient's initial mindset or expectations prior to receiving a placebo could expedite their efficacy. Initial positive expectations were linked to a more widespread enculturation around the use of placebos as a legitimate form of treatment, and the role of clinicians in engendering a positive view of placebo use for their patients. A patient’s religious or socio-cultural background was viewed as potentially influencing their perceptions towards placebos and their predisposition towards their use; alongside previous poor experiences with healthcare services. | PMC10510165 |
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Theme 3: practicalities of placebo usage in healthcare | infection | INFECTION | Participants debated whether placebos should be priced as regular medication, with most believing that as a tangible good or service received from a healthcare provider, a placebo should be treated monetarily similar to any other medication. However, others viewed charging for placebos as either unethical or unfair to patients. Some suggested alternative funding routes for placebos through charities or subsidisation. Individual physiological differences between patients and the degree to which this affected receptiveness were raised as a potential practical barrier to the widespread use of placebos as substitutes. Participants also considered wider ramifications, such as the potential reinforcement of a transactional, medicalized response to ailments, increased traffic towards primary care services, and the potential spread of infection within primary care sites. | PMC10510165 |
Brief discussion | CHRONIC PAIN | Our study aligns with previous research indicating trust in doctor-patient relationships as crucial for placebo utilisation [The participants’ identification of mental health contexts as suitable for placebo use suggests a promising avenue for further research; especially when this is contrasted with their view of placebo use as unsuitable for tangible conditions like chronic pain and considered alongside the generally held view of placebos as a “non-real” medication. Based on these findings, we decided to include scenarios involving mental health problems and chronic pain in Study 3. | PMC10510165 |
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