Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.
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SUBMITTER: Sugawara N
PROVIDER: S-EPMC4658191 | biostudies-other | 2015
REPOSITORIES: biostudies-other
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Project description:BackgroundMetabolic syndrome is a growing concern among patients with schizophrenia because metabolic abnormalities are widely regarded as a major risk factor for cardiovascular disease and premature death. The current study assessed attitudes toward metabolic adverse events among patients with schizophrenia.MethodsA brief questionnaire was constructed to investigate patient recognition of the following broad areas: dietary habits, lifestyle, self-monitoring, knowledge, and medical practice. Between January 2012 and June 2013, questionnaires were sent to patients associated with 520 outpatient facilities and 247 inpatient facilities belonging to the Japan Psychiatric Hospital Association. All of the participants (n=22,072; inpatients =15,170, outpatients =6,902) were diagnosed with schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, or the International Classification of Diseases, tenth revision.ResultsApproximately 55.0% (8,069/14,669) of inpatients and 44.8% of outpatients (2,978/6,649) reported that they did not exercise at all. Although 60.9% (4,116/6,760) of outpatients reported that they felt obese, only 35.6% (5,261/14,794) of inpatients felt obese. More than half of the inpatients (51.2%; 7,514/14,690) and outpatients (60.8%; 4,086/6,721) hoped to receive regular blood tests to prevent weight gain and diseases such as diabetes.ConclusionAlthough more than half of patients hoped to prevent weight gain and diabetes, only a minority of patients were mindful of eating balanced meals and having physical exercise. Educational efforts and the promotion of the best pharmacotherapy and monitoring practices are needed for patients with schizophrenia.
| S-EPMC4771408 | biostudies-literature
Project description:Two previous randomized controlled trials (RCTs) suggested that adjunctive aspirin is efficacious in treating schizophrenia. We conducted two 16-week double-blind randomized placebo-controlled RCTs of adjunctive 1000 mg aspirin vs placebo in schizophrenia. Study 1 included 200 patients, with Positive and Negative Syndrome Scale (PANSS) total score as the primary outcome. Study 2 included 160 patients with C-reactive protein (CRP) >1 mg/L at baseline; the primary outcome was PANSS-positive score. Dropout rates for aspirin/placebo were 12% in study 1 and 20% in study 2. Differences in outcome between aspirin and placebo were calculated with linear regression, adjusting for the baseline value of the outcome. No statistically significant between-group differences were found in primary or secondary outcomes in either study. Study 1: mean difference in PANSS at 16 weeks was -3.9 (95% CI: -8.4 to 0.5, P = .10, effect size (ES) = -0.25) and at 8 weeks was -3.5 (95% CI: -7.5 to 0.5, P = .11, ES = -0.22). Study 2: mean difference in PANSS at 16 weeks was 0.3 (95% CI: -4.1 to 4.7, P = .90, ES = 0.02) and in positive PANSS was 0.5 (95% CI: -1.0 to 2.1, P = .50, ES = 0.11). A meta-analysis of these data with the existing studies, excluding one with large baseline differences in total PANSS, found that the overall estimate of the effect of adjunctive aspirin on the PANSS total score comparing group means at the end of the study was -2.9 (95% CI: -6.6 to 0.7; P = .21), favoring aspirin. Our studies and meta-analysis failed to find a statistically significant improvement in the symptoms of schizophrenia from adjunctive aspirin therapy in comparison to placebo in schizophrenia. Trial registration: study 1: Clinicaltrials.gov: NCT01320982; study 2 (high CRP): EudraCT Number: 2014-000757-36.
| S-EPMC8266648 | biostudies-literature
Project description:BackgroundThere is growing concern about the metabolic abnormalities in patients with schizophrenia.AimsThe aim of this study was to assess the attitudes of psychiatrists toward metabolic adverse events in patients with schizophrenia.MethodA BRIEF QUESTIONNAIRE WAS CONSTRUCTED TO COVER THE FOLLOWING BROAD AREAS: the psychiatrists' recognition of the metabolic risk of antipsychotic therapy, pattern of monitoring patients for physical risks, practice pattern for physical risks, and knowledge of metabolic disturbance. In March 2012, the questionnaire was mailed to 8,482 psychiatrists who were working at hospitals belonging to the Japan Psychiatric Hospitals Association.ResultsThe overall response rate was 2,583/8,482 (30.5%). Of the respondents, 85.2% (2,200/2,581) reported that they were concerned about prescribing antipsychotics that have a risk of elevating blood sugar; 47.6% (1,201/2,524) stated that their frequency of monitoring patients under antipsychotic treatment was based on their own experiences; and only 20.6% (5,22/2,534) of respondents answered that the frequency with which they monitored their patients was sufficient to reduce the metabolic risks.ConclusionsPsychiatrists practicing in Japan were generally aware and concerned about the metabolic risks for patients being treated with antipsychotics. Although psychiatrists should monitor their patients for metabolic abnormalities to balance these risks, a limited number of psychiatrists answered that the frequency with which they monitored patients to reduce the metabolic risks was sufficient. Promotion of the best practices of pharmacotherapy and monitoring is needed for psychiatrists treating patients with schizophrenia.
| S-EPMC3900677 | biostudies-literature
Project description:IntroductionPsychotherapy is considered part of the standard treatment of cancer in Western countries. However, there is no literature on the attitudes of Chinese cancer patients toward psychotherapy.MethodsIn a multicenter, cross-sectional study in China, a homemade questionnaire was delivered to cancer patients. The targeted population was Chinese hospitalized cancer patients who were informed of their state of illness.ResultsFive hundred and fifty cancer patients received our questionnaire, and 83.3% completed the questionnaire. Among the 458 patients, 43.2% indicated that they had never heard of psychotherapy before the survey. However, after a brief introduction of psychotherapy, most (92.1%) cancer patients indicated that psychotherapy is essential for cancer patients, and over half of patients (57.4%) were willing to take psychotherapy on the advice of the oncologist in charge. Participants aged 45 years or younger, had a family income > 10000 yuan per month, and had an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 2-4 were more willing to receive psychotherapy. Of all patients, 59.2% and 57.6% were willing to participate in individual and group psychotherapy clinical trials, respectively. Participants who had a bachelor's degree or higher (odds ratio, OR = 2.09) and were aged 45 years or younger (OR = 1.67) were more willing to participate in individual and group psychotherapy clinical trials, respectively.ConclusionThe unmet psychological needs of cancer patients in China remain high, and doctors' advice is likely to positively impact the patients' acceptance of psychotherapy. Psychological education for Chinese cancer patients should be strengthened. More high-quality clinical trials of psychotherapy should be conducted in China to achieve greater benefits for cancer patients and their families.
| S-EPMC9260575 | biostudies-literature
Project description:Genomic tumor profiling tests (GTPTs) to find molecular targeted drugs for patients with advanced cancer are being introduced into clinical settings, which may result in secondary germline findings. Although small-scale qualitative studies have revealed patients' attitudes toward GTPTs and preferences on receiving germline findings, no large-scale quantitative research exists that includes family members. We conducted anonymous surveys with 757 cancer patients (CPs), 763 family members (FMs), and 3697 general adults (GAs) in Japan. Awareness of GTPTs was low in all groups, however, both CPs and FMs showed a higher degree of recognition in the benefits of GTPTs. FMs wanted information on germline findings to be shared more than the CPs. Since advanced CPs may have psychological burdens that make it difficult to express their opinions on their therapeutic options and sharing germline findings, GTPTs should be offered with advanced care planning for patients.
| S-EPMC8075943 | biostudies-literature
Project description:OBJECTIVES:Clinical trials (CTs) are considered an important method for developing new treatments and providing access to potentially effective drugs that are still under investigation. Measuring the public's knowledge of and attitudes toward CTs is important for assessing their readiness for and acceptance of human drug testing, which has previously not been assessed in the Kingdom of Saudi Arabia (KSA). The objective of this study is to explore the Saudi public's knowledge of and attitudes toward CTs as well as participation in trials to test new or approved drugs. DESIGN:Cross-sectional. SETTING:The 2016 Al Jenadriyah cultural/heritage festival in Riyadh, KSA. PARTICIPANTS:Participating booths and exhibition halls, as well as festival visitors, were approached to participate in the study. PRIMARY AND SECONDARY OUTCOME MEASURES:Knowledge of and attitudes toward CTs. RESULTS:The final number of participants was 938. The responses were converted to a percentage mean score (out of 100) for each knowledge-related response and attitude. The total mean knowledge score was 56.8±24.8 and the attitude-related score was 61.5±28.0. Although most of the participants supported testing approved or off-label and new drugs on adult and paediatric patients, only a third (30.5%) agreed that new drugs could be tested on healthy volunteers. The results indicated that gender, educational level, income, medical background, age and health insurance were independently associated with the level of knowledge of CTs. In terms of attitudes toward CTs, the factors that were independently associated were gender, educational level and medical background. CONCLUSIONS:The Saudi public has a low level of knowledge and a moderately positive attitude toward CTs. There is a moderate positive correlation between the two factors such that as knowledge of CTs increases, the Saudi public will hold more positive attitudes toward CTs.
| S-EPMC6830621 | biostudies-literature
Project description:Few studies have been conducted on the attitudes of patients seeking fecal microbiota transplantation (FMT). This study aimed to investigate the reasons for patients with Crohn's disease (CD) seeking FMT and their attitude changes after FMT.In this prospective study, all included patients were diagnosed with CD for at least 6 months and intended to receive FMT. A questionnaire was designed to investigate the history of medical visits and patients' attitudes toward FMT. Only refractory patients who failed to clinically respond to previous treatment were selected for undergoing FMT. Three months after the first FMT, patients were required to complete the second questionnaire on attitudes toward the first FMT.A total of 207 patients with CD were included for questionnaire survey. In 118 refractory patients, 94.07% sought FMT because they had no other choice. In 89 nonrefractory patients, 78.65% sought FMT for the reason that they wanted to achieve better clinical results or even a cure, although the current treatment was effective for them. In all, 118 refractory patients received FMT. Three months after the first FMT, 88.98% (105/118) patients completed the questionnaire on patients' attitudes toward FMT. Of these 105 patients, 56.19% reported to have satisfactory clinical efficacy and 74.29% were willing to receive the second FMT. Moreover, 89.52% (94/105) showed their willingness to recommend FMT to other patients.In conclusion, this study at least first time demonstrated that patients with CD were willing to accept FMT due to its efficacy.
| S-EPMC5265816 | biostudies-literature
Project description:ObjectivesExisting treatments for schizophrenia can improve positive symptoms, but it is unclear if they have any impact on negative symptoms. This meta-analysis was conducted to assess the efficacy of available treatments for negative symptoms in schizophrenia.MethodsAll randomized-controlled trials of interventions for negative symptoms in schizophrenia until December 2013 were retrieved; 168 unique and independent placebo-controlled trials were used. Negative symptom scores at baseline and follow-up, duration of illness, doses of medication, type of interventions, and sample demographics were extracted. Heterogeneity was addressed with the I (2) and Q statistic. Standardized mean difference in values of the Negative Symptom Rating Scale used in each study was calculated as the main outcome measure.Results6503 patients in the treatment arm and 5815 patients in the placebo arm were included. No evidence of publication biases found. Most treatments reduced negative symptoms at follow-up relative to placebo: second-generation antipsychotics: -0.579 (-0.755 to -0.404); antidepressants: -0.349 (-0.551 to -0.146); combinations of pharmacological agents: -0.518 (-0.757 to -0.279); glutamatergic medications: -0.289 (-0.478 to -0.1); psychological interventions: -0.396 (-0.563 to -0.229). No significant effect was found for first-generation antipsychotics: -0.531 (-1.104 to 0.041) and brain stimulation: -0.228 (-0.775 to 0.319). Effects of most treatments were not clinically meaningful as measured on Clinical Global Impression Severity Scale.Conclusions and relevanceAlthough some statistically significant effects on negative symptoms were evident, none reached the threshold for clinically significant improvement.
| S-EPMC4466178 | biostudies-literature
Project description:To understand factors affecting nurses' attitudes toward the Therapeutic Hypothermia After Pediatric Cardiac Arrest trials and association with approach/consent rates.Cross-sectional survey of pediatric/cardiac intensive care nurses' perceptions of the trials.Study was conducted at 16 of 38 self-selected study sites.Pediatric and cardiac intensive care nurses.The primary outcome was the proportion of nurses with positive perceptions, as defined by agree or strongly agree with the statement "I am happy to take care of a Therapeutic Hypothermia after Pediatric Cardiac Arrest patient". Associations between perceptions and study approach/consent rates were also explored. Of 2,241 nurses invited, 1,387 (62%) completed the survey and 77% reported positive perceptions of the trials. Nurses, who felt positively about the scientific question, the study team, and training received, were more likely to have positive perceptions of the trials (p < 0.001). Nurses who had previously cared for a research patient had significantly more positive perceptions of Therapeutic Hypothermia After Pediatric Cardiac Arrest compared with those who had not (79% vs 54%; p < 0.001). Of the 754 nurses who cared for a Therapeutic Hypothermia After Pediatric Cardiac Arrest patient, 82% had positive perceptions, despite 86% reporting it required more work. Sixty-nine percent believed that hypothermia reduces brain injury and mortality; sites had lower consent rates when their nurses believed that hypothermia was beneficial. Institution-specific approach rates were positively correlated with nurses' perceptions of institutional support for the trial (r = 0.54; p = 0.04), ICU support (r = 0.61; p = 0.02), and the importance of conducting the trial in children (r = 0.61; p = 0.01).The majority of nurses had positive perceptions of the Therapeutic Hypothermia After Pediatric Cardiac Arrest trials. Institutional, colleague, and study team support and training were contributing factors. Despite increased work, nurses remained enthusiastic demonstrating that studies with intensive bedside nursing procedures are feasible. Institutions whose nurses believed hypothermia was beneficial had lower consent rates, suggesting that educating nurses on study rationale and equipoise may enhance study participation.
| S-EPMC4779735 | biostudies-literature
Project description:Treatment guidelines for patients with schizophrenia recommend evaluating their risk of physical comorbidities, especially since these patients are known to have decreased life expectancy due to comorbidities. Therefore, to the authors' knowledge, this is the first national survey conducted to investigate how Italian psychiatrists deal with the risk of physical comorbidities and sexual dysfunction in patients with schizophrenia. A sample of 750 psychiatrists completed an ad hoc online survey investigating their decision making about performing blood tests, clinical and instrumental examinations, and scheduling follow-up appointments in relation to the different phases of the illness and possible pharmacological side effects. Compared to patients in therapeutic continuation, those diagnosed for the first time and those who received a therapeutic change were visited more frequently (every 15 to 17 days vs. every 40 days, respectively), and were more regularly prescribed blood tests and instrumental examinations (every 4.2 to 4.4 months vs. every 9 months, respectively). There was a high interest in the surveillance of cardiometabolic risk. In 54% of patients, prolactin testing was not requested before starting an antipsychotic. In terms of specialist referrals, only 5% of surveyed psychiatrists "never" sought for additional counseling. There was little attention given to sexual functioning assessment based on the survey results about patients' daily life and with regard to deciding to prescribe additional examinations. In fact, only up to 3% of psychiatrists reported assessing sexual functioning using specific psychometric tests. In summary, Italian psychiatrists describes themselves as careful healthcare providers for the physical illnesses of patients with schizophrenia but with several shortcomings. For instance, clinical attention toward patients' sexual and reproductive healthcare needs remains a challenge. Psychiatrists should take the lead for the integrated education, assessment, and care of medical needs of their patients with mental illness. Based on the results of this survey, the authors also believe that a future challenge for the management of patients with mental illness will be the classification of patients based on their risk of comorbidities, to help ensure optimal healthcare provision for those at greater risk of other illnesses.
| S-EPMC6879649 | biostudies-literature