Clozapine-induced hypersalivation: the association between quantification, perceived burden and treatment satisfaction reported by patients.
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ABSTRACT:
SUBMITTER: Man WH
PROVIDER: S-EPMC5593216 | biostudies-literature | 2017 Sep
REPOSITORIES: biostudies-literature
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Clozapine-induced hypersalivation: the association between quantification, perceived burden and treatment satisfaction reported by patients.
Man Wai Hong WH Colen-de Koning Jantine J Schulte Peter P Cahn Wiepke W van Haelst Ingrid I Heerdink Eibert E Wilting Ingeborg I
Therapeutic advances in psychopharmacology 20170501 8-9
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Project description:BackgroundClozapine-induced hypersalivation (CIH) is a common side effect of clozapine treatment and is disliked by clozapine patients, potentially threatening adherence to clozapine treatment. We proposed a trial of alternative medications, hyoscine and glycopyrrolate, for the treatment of CIH and the primary objective of the feasibility study was to assess the recruitment and retention of community clozapine patients as well as assess the metrics of the primary hypersalivation measure.MethodsThis 11-month trial took place in two NHS trusts in northwest UK. Participants were community-dwelling clozapine patients aged 18-65 years who were suffering from CIH, and were recruited from community mental health clinics. They were randomised using a telephone randomisation service to receive either hyoscine (1 week at 0.6 mg daily, 3 weeks at 0.9 mg daily), glycopyrrolate (1 week at 2 mg daily, 3 weeks at 3 mg daily) or placebo. Participants and investigators were blinded to which study arm the participants had been randomised to. We collected data on salivation levels and side effects on a weekly basis and also assessed cognition at the beginning and end of the trial. We also interviewed a sample of participants after the trial to gather information on their experience of having taken part.ResultsOne hundred and thirty-eight potential participants agreed to being contacted by researchers about participation in the trial and of these, 29 participants were randomised. Of these, four participants exited the trial before taking any trial medication, and two participants left the study owing to concerns of side effects. Data from four participants was missing, and complete data was available for 19 participants who completed the trial. The mean recruitment rate overall was 1.3 participants per site per month, and the overall retention rate was 76%. Interview data suggested that participants' experiences of trial participation were overwhelmingly positive.ConclusionsThe feasibility study demonstrated that a trial of alternative medications in the treatment of CIH is feasible; patients were willing to be randomised to the trial and retention rate was high.Trial registrationClinicalTrials.gov, NCT02613494, registered 24 November 2015.
| S-EPMC6580560 | biostudies-literature
Project description:BackgroundClozapine is the only medication licensed for the treatment of resistant schizophrenia in the UK. Although efficacious, a common and unpopular side effect of clozapine treatment is clozapine-induced hypersalivation (CIH), which can contribute to non-adherence. The standard treatment for CIH in the UK is hyoscine hydrobromide but this may aggravate cognitive deficits in patients with schizophrenia while glycopyrrolate may be an effective alternative with a more tolerable side effect profile. There is currently no convincing evidence for hyoscine, or any other medication, as an effective treatment for CIH.Methods/designThis is a multicentre randomised, double-blind, placebo-controlled feasibility study of glycopyrronium bromide (glycopyrrolate) and hyoscine hydrobromide (hyoscine) in patients with clozapine-induced hypersalivation. We aim to recruit 42 patients who have been prescribed clozapine and are experiencing hypersalivation, and randomise them to one of three study arms (either hyoscine, glycopyrrolate or placebo). The primary outcome measures will be the participant recruitment and attrition rates, and the secondary outcome will be the metrics of the daytime hypersalivation measure. After a 1-week washout period (discontinuing CIH medication, if any), there will be a 4-week treatment period where participants will be titrated up to the maximum tolerated dose of hyoscine, glycopyrrolate or placebo. Measurements of daytime salivation, nocturnal salivation, cognition and side effects will be taken during home visits in week 2 and week 5. Information on salivation and side effects will also be taken through telephone calls in week 3 and week 4. To gather information on the experience of study participants, exit interviews will also be requested with all participants who drop out of the study and a sample of participants who complete the study.DiscussionThere is currently no convincing evidence for hyoscine, or any other medication, as an effective treatment for CIH. There is promising evidence that glycopyrrolate may be more successful in the treatment of CIH causing fewer cognitive side effects. We propose to conduct a randomised placebo-controlled feasibility study of glycopyrrolate and hyoscine in the treatment of clozapine-induced hypersalivation to inform the design of a future efficacy trial.Trial registrationClinicaltrials.gov NCT02613494 , 23 November 2015.
| S-EPMC5117505 | biostudies-literature
Project description:BACKGROUND:Approximately 50% of patients are nonadherent to prescribed medications. Patient perception regarding medication effectiveness has been linked to improved adherence. However, how patients perceive effectiveness is poorly understood. OBJECTIVE:The aim of this study was to elucidate factors associated with perceived treatment satisfaction and effectiveness among patients with chronic health conditions. METHODS:We conducted a descriptive study using a cross-sectional survey design. We administered a Web-based survey to participants with migraine, multiple sclerosis (MS), or rheumatoid arthritis (RA). Patients were recruited from established online communities of Health Union. Descriptive statistics, correlations, and comparison tests were used to examine outcomes. RESULTS:Data were collected from 1820 patients: 567 with migraine, 717 with MS, and 536 with RA. The majority of participants were female (1644/1820, 90.33%), >40 years old (1462/1820, 80.33%), and diagnosed >5 years ago (1189/1820, 65.33%). Treatment satisfaction and perceived medication effectiveness were highly correlated (r=0.90, P<.01). Overall, three temporal factors were positively correlated with satisfaction or perceived effectiveness: time on current medication (satisfaction rs=0.22, P<.01; effectiveness rs=0.25, P<.01), time since diagnosis (satisfaction rs=0.07, P<.01; effectiveness rs=0.09, P<.01), and time on treatment (effectiveness rs=0.08, P<.01). CONCLUSIONS:Findings validated the strong relationship between treatment satisfaction and perceived effectiveness. Understanding the (1) positive relationship between time and treatment satisfaction and effectiveness and (2) factors associated with determining medication effectiveness can help clinicians better understand the mindset of patients regarding treatment. Clinicians may be better prepared to elicit patient beliefs, which influence medication adherence, for people diagnosed with chronic health conditions.
| S-EPMC7084280 | biostudies-literature
Project description:BackgroundTreatment for tuberculosis lasts for a minimum of 6 months. The treatment burden experienced by patients in a low-incidence setting where directly observed therapy is the standard of care is not well-known.MethodsPatients receiving tuberculosis treatment through the chest clinic at a tertiary hospital in Sydney, Australia, participated in a semi-structured interview. The interviews explored the treatment burden experienced by patients and possible solutions to ameliorate this burden. Interviews were conducted until data saturation was achieved. They were recorded, transcribed and analysed using NVivo 12 software.ResultsTwenty participants (80% male, mean age 40 years) with pulmonary (n = 13) and extra-pulmonary (n = 7) tuberculosis were interviewed. Participants experienced healthcare, financial, social and medication burdens along with lifestyle changes due to treatment. Medication intake was challenging due to the high number of pills, and 55% (n = 11) of patients experienced fatigue amongst other side effects. Patients found clinic-based directly observed therapy inconvenient, especially those working and/or studying. Suggestions to lessen treatment burden included reducing medication burden and better access to health services.ConclusionTuberculosis treatment is associated with substantial treatment burden for patients. Measures to reduce treatment burden including alternative treatment delivery methods which are more accommodating to patients than clinic-based directly observed therapy, such as video directly observed therapy or partially self -administered treatment, should be considered on a case-by-case basis.
| S-EPMC7580887 | biostudies-literature
Project description:Biological agents are widely used for the management of systemic rheumatic diseases (SRDs) and their therapeutic implications have been expanded beyond inflammatory arthropathies to more complicated autoimmune disorders, such as systemic lupus erythematosus, vasculitis, and systemic sclerosis. The aim of this study was to investigate treatment satisfaction and overall experience of SRDs' patients receiving biologics as well as to explore patient's perspectives on the quality of services provided by rheumatology departments and to determine factors related to the level of satisfaction. We performed a synchronous correlation study. Patients with SRDs answered an anonymous questionnaire assessing their satisfaction and how treatment with biologics has affected their quality of life and functionality. Sample consisted by 244 patients (65.2% women), with mean age of 50.4 years, and the most common diagnosis was rheumatoid arthritis (37.3%). Sixty one percent of patients received intravenous therapy and 39% subcutaneously. Overall, 80.5% of the patients reported a positive/very positive effect of their treatment on their life. The average total patient satisfaction from the unit was 79.8%. The presence of mental disease was significantly associated with less positive impact of the treatment on patients' life, worse quality of life, and greater pain. In conclusion, patients with a broad spectrum of SRDs were generally satisfied and treatment with biologic regimens appeared to have a positive impact on several aspects of their life. The majority of patients were at least satisfied with all the characteristics of the unit staff and better quality of life was associated with greater satisfaction about the Unit and more positive affect of the treatment in patients' life.
| S-EPMC9925926 | biostudies-literature
Project description:BackgroundHealth care-related costs and satisfaction are compelling targets for quality improvement in cancer care delivery; however, little is known about how financial burden affects patient satisfaction.MethodsThis was an observational, cross-sectional, survey-based study assessing patient-reported financial burden (FB). Eligible patients were ≥ 21 years with solid tumor malignancy and were receiving chemotherapy or hormonal therapy for ≥ 1 month. The Patient Satisfaction Questionnaire Short-Form assessed patient satisfaction with health care. Subjective FB related to cancer treatment was measured on a 5-point Likert scale.ResultsOf 174 participants (32% response rate), 47% reported significant/catastrophic FB. Participants reported highest satisfaction with interpersonal manner and lowest satisfaction with financial aspects of care. In adjusted analysis, high FB was negatively associated with general satisfaction (coefficient: -.29), satisfaction with technical quality (coefficient: -.26), and satisfaction with financial aspects of care (coefficient: -.62). Older age was associated with higher scores in all satisfaction subscales except patient-physician communication and financial aspects. Annual household income of <$20,000 was associated with lower satisfaction scores in all subscales except time spent with doctor. High FB was not associated with patient satisfaction scores for accessibility and convenience, communication, interpersonal manner, or time spent with doctor.ConclusionFB is a potentially modifiable correlate of poor satisfaction with cancer care including general satisfaction and satisfaction with the technical quality of care. Addressing cancer-associated FB may lead to improved satisfaction, which in turn can influence adherence, outcomes, and quality of life.
| S-EPMC3983822 | biostudies-literature
Project description:Clozapine is highly effective for treatment-resistant schizophrenia but is underutilized due to patient and clinician-related concerns. Little is known about the general level of patient satisfaction with clozapine and determinants thereof. We therefore explored determinants of patient satisfaction with clozapine in individuals diagnosed with schizophrenia spectrum disorders (SSDs). Cross-sectional data from 480 clozapine users were used to examine demographic and clinical factors, including symptom severity, treatment response, and adverse drug reactions (ADRs). Patient satisfaction was self-rated on a scale of 1 to 10. Results showed a mean satisfaction score of 7.4 (SD = 1.9), with significant associations between satisfaction and treatment response (B = 0.42, R² = 0.19, p = 3.9 × 10⁻¹⁸), symptom severity (B = 0.10, R² = 0.05, p = 2.06 × 10-9), occurrence of ADRs (B = -0.16, R² = 0.06, p = 3.2 × 10-5), and recreational drug use (B = -1.32, R² = 0.05, p = 2.09 × 10-4). Hypersalivation and prolonged sleep duration were the only ADRs linked to lower satisfaction (B = -0.72, R² = 0.06, p = 3.5 × 10-5 and B = -0.57, R² = 0.04, p = 1.4 × 10-3, respectively). Despite concerns about ADRs, treatment effectiveness showed a stronger association with patient satisfaction among clozapine users than the occurrence of ADRs. In conclusion, our findings suggest that strategies aimed at bolstering clozapine's effectiveness may help counter worldwide underprescription rates of clozapine in patients with SSDs.
| S-EPMC11847932 | biostudies-literature
Project description:INTRODUCTION: The aim of this study is to explore the association between mu suppression and self-reported empathy in nurses with patients' satisfaction. METHODS: For this correlational study, 30 male nurses, as well as 30 patients took care by these nurses during the week before data gathering, were selected via accessible and random sampling method, respectively. The tools included Jefferson's Scale of Empathy-health professionals, and patient's satisfaction scale of La Monica-Oberst. Activation of Mirror Neurons System (MNS) was investigated by mu suppression. For this purpose, electroencephalography (EEG) was recorded in three phases: 1) Watching the video of a non-moving hand, 2) Watching the video of a hand being open and closed, and 3) Opening and closing one-self's hand. EEG recordings were analyzed using Matlab R 2014a software. Data were analyzed by Pearson's correlation coefficients and multiple regression analyses. RESULTS: There was no significant correlation between mu suppression in nurses with nurses' self-reported empathy and patients' satisfaction, however, a significant correlation was found between nurses' self-reported empathy and patients' satisfaction. Regression analysis outcomes showed that nurses' self-reported empathy could predict 18.5% (nearly one fifth) of patients' satisfaction variance while mu suppression did not forecast patients' satisfaction significantly. CONCLUSION: These findings suggested that mu rhythm was a good biomarker neither for nurses' self-reported empathy nor for patients' satisfaction. In addition, it was manifested that patients' satisfaction, at least partly, depended on skills that nurses could learn, since showing empathy is highly learnable.
| S-EPMC4591612 | biostudies-other
Project description:ObjectiveAlthough patient satisfaction is increasingly used to rate hospitals, it is unclear how patient satisfaction is associated with health outcomes. We sought to define the relationship of self-reported patient satisfaction and health outcomes.DesignRetrospective cross-sectional analysis using regression analyses and generalized linear modeling.SettingUtilizing the Medical Expenditure Panel Survey Database (2010-2014), patients who had responses to survey questions related to satisfaction were identified.ParticipantsAmong the 9166 patients, representing 106 million patients, satisfaction was rated as optimal (28.2%), average (61.1%), and poor (10.7%). Main Outcome Measures: We sought to define the relationship of self-reported patient satisfaction and health outcomes.ResultsPatients who were younger, male, black/African American, with Medicaid insurance, as well as patients with lower socioeconomic status were more likely to report poor satisfaction (all P < .001). In the adjusted model, physical health score was not associated with an increased odds of poor satisfaction (1.42 95% confidence interval [CI]: 0.88-2.28); however, patients with a poor mental health score or ≥2 emergency department visits were more likely to report poor overall satisfaction (3.91, 95% CI: 2.34-6.5; 2.24, 95% CI: 1.48-3.38, respectively).ConclusionPoor satisfaction was associated with certain unmodifiable patient-level characteristics, as well as mental health scores. These data suggest that patient satisfaction is a complex metric that can be affected by more than provider performance.
| S-EPMC6739681 | biostudies-literature
Project description:BackgroundHigher physician self-reported empathy has been associated with higher overall patient satisfaction. However, more evidence-based research is needed to determine such association in an emergent care setting.ObjectiveTo evaluate the association between physician self-reported empathy and after-care instant patient-to-provider satisfaction among Emergency Department (ED) healthcare providers with varying years of medical practice experience.Research designA prospective observational study conducted in a tertiary care hospital ED.MethodsForty-one providers interacted with 1,308 patients across 1,572 encounters from July 1 through October 31, 2016. The Jefferson Scale of Empathy (JSE) was used to assess provider empathy. An after-care instant patient satisfaction survey, with questionnaires regarding patient-to-provider satisfaction specifically, was conducted prior to the patient moving out of the ED. The relation between physician empathy and patient satisfaction was estimated using risk ratios (RR) and their corresponding 95% confidence limits (CL) from log-binomial regression models.ResultsEmergency Medicine (EM) residents had the lowest JSE scores (median 111; interquartile range [IQR]: 107-122) and senior physicians had the highest scores (median 119.5; IQR: 111-129). Similarly, EM residents had the lowest percentage of "very satisfied" responses (65%) and senior physicians had the highest reported percentage of "very satisfied" responses (69%). There was a modest positive association between JSE and satisfaction (RR = 1.04; 95% CL: 1.00, 1.07).ConclusionThis study provides evidence of a positive association between ED provider self-reported empathy and after-care instant patient-to-provider satisfaction. Overall higher empathy scores were associated with higher patient satisfaction, though minor heterogeneity occurred between different provider characteristics.
| S-EPMC6136813 | biostudies-literature