RESUMO
The PSY-HEART-I trial indicated that a brief expectation-focused intervention prior to heart surgery improves disability and quality of life 6 months after coronary artery bypass graft surgery (CABG). However, to investigate the clinical utility of such an intervention, a large multi-center trial is needed to generalize the results and their implications for the health care system. The PSY-HEART-II study aims to examine whether a preoperative psychological intervention targeting patients' expectations (EXPECT) can improve outcomes 6 months after CABG (with or without heart valve replacement). EXPECT will be compared to Standard of Care (SOC) and an intervention providing emotional support without targeting expectations (SUPPORT). In a 3-arm multi-center randomized, controlled, prospective trial (RCT), N = 567 patients scheduled for CABG surgery will be randomized to either SOC alone or SOC and EXPECT or SOC and SUPPORT. Patients will be randomized with a fixed unbalanced ratio of 3:3:1 (EXPECT: SUPPORT: SOC) to compare EXPECT to SOC and EXPECT to SUPPORT. Both psychological interventions consist of 2 in-person sessions (à 50 minute), 2 phone consultations (à 20 minute) during the week prior to surgery, and 1 booster phone consultation post-surgery 6 weeks later. Assessment will occur at baseline approx. 3-10 days before surgery, preoperatively the day before surgery, 4-6 days later, and 6 months after surgery. The study's primary end point will be patients' illness-related disability 6 months after surgery. Secondary outcomes will be patients' expectations, subjective illness beliefs, quality of life, length of hospital stay and blood sample parameters (eg, inflammatory parameters such as IL-6, IL-8, CRP). This large multi-center trial has the potential to corroborate and generalize the promising results of the PSY-HEART-I trial for routine care of cardiac surgery patients, and to stimulate revisions of treatment guidelines in heart surgery.
Assuntos
Procedimentos Cirúrgicos Cardíacos , Qualidade de Vida , Humanos , Estudos Prospectivos , Ponte de Artéria Coronária/métodos , Cuidados Pré-Operatórios/métodos , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como AssuntoRESUMO
OBJECTIVE: Psychological treatments for somatic symptom disorder and functional somatic syndromes (SSD/FSS) achieve moderate effects only, potentially because of the high chronicity in these patients. Therefore, we aimed to evaluate whether early treatment, that is, treatment in populations at risk or with recent onset, improves outcome. METHODS: We conducted a systematic review and meta-analysis of (cluster-)randomized controlled trials evaluating early psychological interventions in the prevention and treatment of SSD/FSS in adults compared with inactive control conditions, standard care, or placebo. Individuals at risk for SSD/FSS, suffering from subthreshold symptoms or new onsets of SSD/FSS, or presenting with SSD/FSS for the first time were included. RESULTS: We identified 30 eligible studies, mostly examining pain-related conditions. Interventions were diverse, ranging from bibliotherapy to cognitive-behavioral therapy. We found positive effects on depression post-treatment (Hedges' g = 0.12 [95% confidence interval = 0.03-0.2], k = 5) as well as on somatic symptom severity (g = 0.25 [0.096-0.41], k = 17) and health care utilization (g = 0.31 [0.18-0.44], k = 3) at follow-up. However, because of a high risk of bias, sensitivity to corrections for meta-bias, and missing outcome data, findings should be interpreted cautiously. CONCLUSIONS: Our review shows that targeting SSD/FSS at an early stage represents a conceptual and practical challenge. Readily accessible interventions addressing transsymptomatic processes of SSD/FSS development and consolidation are highly needed. Future studies are needed to evaluate individuals with diverse symptoms, examine symptom history thoroughly, use placebo controls, and report outcomes completely to determine the efficacy of early psychological interventions for SSD/FSS.PROSPERO Registration:CRD42020140122.
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Terapia Cognitivo-Comportamental , Sintomas Inexplicáveis , Adulto , Humanos , Intervenção Psicossocial , Transtornos Somatoformes/psicologia , Transtornos Somatoformes/terapia , SíndromeRESUMO
BACKGROUND: In 2013, the diagnosis of somatic symptom disorder (SSD) was introduced into the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). This review aims to comprehensively synthesize contemporary evidence related to SSD. METHODS: A scoping review was conducted using PubMed, PsycINFO, and Cochrane Library. The main inclusion criteria were SSD and publication in the English language between 01/2009 and 05/2020. Systematic search terms also included subheadings for the DSM-5 text sections; i.e., diagnostic features, prevalence, development and course, risk and prognostic factors, culture, gender, suicide risk, functional consequences, differential diagnosis, and comorbidity. RESULTS: Eight hundred and eighty-two articles were identified, of which 59 full texts were included for analysis. Empirical evidence supports the reliability, validity, and clinical utility of SSD diagnostic criteria, but the further specification of the psychological SSD B-criteria criteria seems necessary. General population studies using self-report questionnaires reported mean frequencies for SSD of 12.9% [95% confidence interval (CI) 12.5-13.3%], while prevalence studies based on criterion standard interviews are lacking. SSD was associated with increased functional impairment, decreased quality of life, and high comorbidity with anxiety and depressive disorders. Relevant research gaps remain regarding developmental aspects, risk and prognostic factors, suicide risk as well as culture- and gender-associated issues. CONCLUSIONS: Strengths of the SSD diagnosis are its good reliability, validity, and clinical utility, which substantially improved on its predecessors. SSD characterizes a specific patient population that is significantly impaired both physically and psychologically. However, substantial research gaps exist, e.g., regarding SSD prevalence assessed with criterion standard diagnostic interviews.
Assuntos
Sintomas Inexplicáveis , Transtornos Somatoformes , Humanos , Transtornos Somatoformes/diagnóstico , Qualidade de Vida/psicologia , Reprodutibilidade dos Testes , Inquéritos e Questionários , Manual Diagnóstico e Estatístico de Transtornos MentaisRESUMO
This study examined whether baseline (3-14 days pre-surgery) levels of (i) depressive or (ii) anxiety symptoms and (iii) illness beliefs moderate the effects of additional preoperative interventions before coronary artery bypass graft surgery on (i) depressive or (ii) anxiety symptoms and (iii) illness beliefs 1 day before surgery, 1 week and 6 months after surgery. In the PSY-HEART trial, 115 patients were assessed. They were randomized into one of three groups: 1. receiving standard medical care only (SMC), additional psychological interventions: 2. aiming to optimize patients' expectations (EXPECT), or 3. focusing on emotional support. Patients with a higher baseline level of depressive symptoms receiving a preoperative psychological intervention indicated lower depressive symptoms 6 months after surgery compared to SMC. EXPECT increased personal control and concern levels in patients with low baseline personal control/concern 1 day before surgery. Brief preoperative psychological interventions can improve psychological outcomes in heart surgery patients. Baseline status may moderate these effects. The study has been approved by the medical ethics committee of the Philipps University of Marburg and has been pre-registered at www.clinicaltrials.gov (NCT01407055) on August 1, 2011.
Assuntos
Ponte de Artéria Coronária , Depressão , Ansiedade , Ponte de Artéria Coronária/psicologia , Humanos , Cuidados Pré-OperatóriosRESUMO
BACKGROUND: The stepped, coordinated, interdisciplinary Health Network for Somatoform and Functional Disorders (Sofu-Net) was developed to provide guideline-based care for patients with somatoform and functional disorders. This controlled cluster cohort study evaluated patients' mental and somatic health care use, clinical outcomes, and their predictors at 4-years follow-up. METHOD: 219 patients at risk for somatoform disorders from Sofu-Net practices (n=119) and control practices (n=100) were resurveyed after 4 years using structured interviews. Outcomes were mental and somatic health care use, somatic symptom burden and depressive symptoms. RESULTS: 127 patients (n=74 Sofu-Net, n=53 controls) were followed up. Compared with the control group, Sofu-Net patients were significantly more likely to be referred to psychotherapy (55.4 vs. 35.8%). Younger age and more frequent GP consultations on the occasion of psychosocial problems predicted mental health care use. No difference was found between the two groups in the severity of clinical symptoms or in the extent of somatic health care use. Significant predictors were the number of somatic diseases, increased fear of illness, female gender, increased depressive symptomatology, low physical and mental quality of life. DISCUSSION: In the long term, the coordinated and interdisciplinary network structure succeeded in more successfully referring high-risk patients to psychotherapy. The role of the primary care physician proved to be important. However, this was not accompanied by an improvement in the patients' clinical condition or a decrease in outpatient physician utilization.
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Sintomas Inexplicáveis , Estudos de Coortes , Atenção à Saúde , Feminino , Seguimentos , Humanos , Atenção Primária à Saúde , Qualidade de Vida , Transtornos Somatoformes/psicologiaRESUMO
INTRODUCTION: Inflammation has been related to several somatic and psychological disorders and may moderate effects of psychological interventions. In the PSY-HEART trial patients benefitted from preoperative psychological interventions before undergoing coronary artery bypass graft surgery (CABG) and, if necessary, concomitant valvular surgery, compared to standard medical care. In this study we examined whether patients' baseline inflammatory status moderated the intervention effects. MATERIAL AND METHODS: In a prospective three-arm randomized clinical trial with 6-months follow-up, 124 patients scheduled for CABG surgery alone or concomitant with valvular surgery were randomized to (i) standard medical care only (SMC) or two preoperative psychological interventions: (ii) CBT-based optimizing expectations (EXPECT) and an (iii) an active control group focusing on emotional support (SUPPORT). Available baseline CRP- (n = 79), IL-6- (n = 78), IL-8- (n = 78) and TNF-alpha-(n = 80) parameters were considered as potential moderators (CRP as a categorical and continuous moderator). Linear mixed model analyses were calculated to test whether baseline inflammatory levels moderated intervention effects on disability, mental and physical quality of life at 6 months after surgery. RESULTS: IL-8 moderated intervention effects on patients' disability and categorical CRP moderated intervention effects on mental quality of life. Follow-up tests indicated that EXPECT (and in part SUPPORT) led to lower postoperative disability and higher mental quality of life compared to SMC in patients with low baseline inflammatory markers. EXPECT indicated higher mental quality of life compared to SUPPORT in the high CRP subgroup. Patients in the SMC group had higher mental quality of life in the high CRP subgroup compared to the low CRP subgroup. CONCLUSION: Especially for patients with a lower inflammatory baseline status preoperative psychological interventions might be helpful to optimize long-term CABG surgery outcomes.
Assuntos
Interleucina-8 , Qualidade de Vida , Ponte de Artéria Coronária , Humanos , Estudos Prospectivos , Intervenção PsicossocialRESUMO
Many primary care patients with high somatic symptom burden do not initiate mental health treatment. Using a cross-sectional design, this study aimed to identify predictors of psychotherapy seeking behavior for patients with high somatic symptom burden within the last 12 months. Data from 20 primary care practices were analyzed. Patients with high somatic symptom burden were identified using the Patient Health Questionnaire, structured interviews, and information from primary care physicians (PCPs). Within the final sample of 142 patients, 54 (38.03%) had been seeking psychotherapy. More severe somatic symptoms, taking psychopharmacological medication and frequently discussing psychosocial distress with PCPs, were associated with psychotherapy seeking behavior. Depressive and anxiety symptoms, and whether PCPs had diagnosed a somatoform disorder or recommended psychotherapy, were not. The results underline the importance of patient-related factors in psychotherapy seeking behavior.
Assuntos
Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Pacientes/psicologia , Psicoterapia/tendências , Adulto , Ansiedade , Transtornos de Ansiedade , Atitude , Estudos Transversais , Depressão , Transtorno Depressivo , Feminino , Previsões/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Relações Médico-Paciente , Atenção Primária à Saúde/tendências , Psicoterapia/métodos , Transtornos Somatoformes/psicologia , Inquéritos e QuestionáriosRESUMO
BACKGROUND: To investigate (a) the diagnostic agreement between diagnoses of somatoform disorders, depressive and anxiety disorders obtained from a structured clinical interview and diagnoses reported from primary care physicians (PCPs) and (b) to identify patient and PCP-related predictors for the diagnostic agreement regarding the presence of a somatoform disorder. METHODS: Data from a cross-sectional study comprising 112 primary care patients at high risk for somatoform disorders were analyzed. Diagnoses according to International Classification of Diseases, 10th revision (ICD-10) for somatoform, depressive and anxiety disorders were obtained from the Composite International Diagnostic Interview (CIDI) and compared with the diagnoses of the patients' PCPs documented in their medical records. Using multiple regression analyses, predictors for the PCPs' diagnosis of a somatoform disorder were analyzed. RESULTS: The agreement between PCP diagnoses and CIDI diagnoses was 32.3% for somatoform disorders, 48.0% for depressive disorders and 25.0% for anxiety disorders. Multiple regression analyses revealed the likelihood of being diagnosed with a somatoform disorder by PCP increased with somatic symptom severity (OR = 1.22, 95% CI 1.03-1.44). Regarding PCP-related characteristics, a specialization in internal medicine (OR = 5.95, 95% CI 1.70-20.80) and working in a solo practice (OR = 2.92, 95% CI 1.02-8.38) increased the likelihood that patients were diagnosed with a somatoform disorder. CONCLUSIONS: The present results indicate that the process of diagnosing somatoform disorders in primary care needs to be improved. Findings further underline the necessity to implement appropriate strategies to improve early detection of patients. TRIAL REGISTRATION: ISRCTN ISRCTN55870770 . Registered 22 October 2014. Retrospectively registered.
Assuntos
Transtornos de Ansiedade/diagnóstico , Transtorno Depressivo/diagnóstico , Erros de Diagnóstico/estatística & dados numéricos , Atenção Primária à Saúde/métodos , Transtornos Somatoformes/diagnóstico , Estudos Transversais , Feminino , Humanos , Classificação Internacional de Doenças , Masculino , Pessoa de Meia-Idade , Questionário de Saúde do Paciente/estatística & dados numéricos , Médicos de Atenção Primária/estatística & dados numéricos , Esquizofrenia/diagnósticoRESUMO
BACKGROUND: Somatoform disorders are highly prevalent mental disorders causing impairment and large economic burden. In order to improve the diagnosis and management of affected patients, a health care network for somatoform disorders (Sofu-Net) was implemented in primary care. AIMS OF THE STUDY: The aim of the study was to determine the cost-effectiveness of a stepped, collaborative and coordinated health care network for somatoform and functional disorders (Sofu-Net) compared with regular primary care physician (PCP) practices in German primary care from a societal perspective. METHODS: This study was part of a 6-month controlled, prospective, non-randomized, observer-blinded cluster cohort trial. Participants were recruited from 33 PCP practices in Hamburg, Germany. The health care network was a collaboration of PCPs, psychotherapists, inpatient clinics and a specialized outpatient clinic. Participants in the control group received usual care. A cost-effectiveness analysis, using treatment response as measure of effectiveness, was performed. Uncertainty in cost-effectiveness was analyzed using cost-effectiveness acceptability curves. RESULTS: In total, n=218 patients (n=119 patients in the intervention group and n=99 patients in the control group) were included in the study. At 6 months, patients within the Sofu-Net group did not differ significantly from the control group with regard to costs (533; standard error 941) and treatment response (--10.3%). For Sofu-Net, the probability of being cost-effective at a willingness-to-pay (WTP) of 10,000 per additional response to treatment was only 31%. DISCUSSION: Sofu-Net is unlikely to be cost-effective. Even for high WTP, the probability of cost-effectiveness was low. The results were robust to variation of costs included in the analysis as well as when only complete cases were included in the analysis. The most important limitations of the study were that randomization could not be established at patient level and at practice level and that the study design did not allow measurement of costs at baseline. CONCLUSION: Patients with severe somatic symptoms did not benefit from the health care network. Sofu-Net might have reduced costs in patients with moderate somatic symptoms. IMPLICATIONS FOR FURTHER RESEARCH: Owing to the limitations and due to a short follow-up of this study, further cost-effectiveness analyses with high methodological quality and a follow-up of at least one year are needed in order to produce results that are more reliable.
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Redes Comunitárias/economia , Análise Custo-Benefício/economia , Comunicação Interdisciplinar , Colaboração Intersetorial , Transtornos Somatoformes/economia , Transtornos Somatoformes/terapia , Adulto , Idoso , Estudos de Coortes , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Questionário de Saúde do Paciente , Atenção Primária à Saúde/economia , Estudos Prospectivos , Melhoria de Qualidade/economia , Método Simples-Cego , Transtornos Somatoformes/diagnósticoRESUMO
BACKGROUND: Placebo effects contribute substantially to outcome in most fields of medicine. While clinical trials typically try to control or minimize these effects, the potential of placebo mechanisms to improve outcome is rarely used. Patient expectations about treatment efficacy and outcome are major mechanisms that contribute to these placebo effects. We aimed to optimize these expectations to improve outcome in patients undergoing coronary artery bypass graft (CABG) surgery. METHODS: In a prospective three-arm randomized clinical trial with a 6 month follow-up, 124 patients scheduled for CABG surgery were randomized to either a brief psychological pre-surgery intervention to optimize outcome expectations (EXPECT); or a psychological control intervention focusing on emotional support and general advice, but not on expectations (SUPPORT); or to standard medical care (SMC). Interventions were kept brief to be feasible with a heart surgery environment; "dose" of therapy was identical for both pre-surgery interventions. Primary outcome was disability 6 months after surgery. Secondary outcomes comprised further clinical and immunological variables. RESULTS: Patients in the EXPECT group showed significantly larger improvements in disability (-12.6; -17.6 to -7.5) than the SMC group (-1.9; -6.6 to +2.7); patients in the SUPPORT group (-6.7; -11.8 to 1.7) did not differ from the SMC group. Comparing follow-up scores and controlling for baseline scores of EXPECT versus SUPPORT on the variable disability only revealed a trend in favor of the EXPECT group (P = 0.09). Specific advantages for EXPECT compared to SUPPORT were found for mental quality of life and fitness for work (hours per week). Both psychological pre-surgery interventions induced less pronounced increases in pro-inflammatory cytokine concentrations reflected by decreased interleukin-8 levels post-surgery compared to changes in SMC patients and lower interleukin-6 levels in patients of the EXPECT group at follow-up. Both pre-surgery interventions were characterized by great patient acceptability and no adverse effects were attributed to them. Considering the innovative nature of this approach, replication in larger, multicenter trials is needed. CONCLUSIONS: Optimizing patients' expectations pre-surgery helps to improve outcome 6 months after treatment. This implies that making use of placebo mechanisms has the potential to improve long-term outcome of highly invasive medical interventions. Further studies are warranted to generalize this approach to other fields of medicine. TRIAL REGISTRATION: Ethical approval for the study was obtained from the IRB of the Medical School, University of Marburg, and the trial was registered at ( NCT01407055 ) on July 25, 2011.
Assuntos
Ponte de Artéria Coronária/métodos , Cuidados Pré-Operatórios/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida , Resultado do TratamentoRESUMO
OBJECTIVE: Stepped, collaborative, and coordinated approaches have been proposed as the optimal treatment strategy for somatic symptom and related disorders, but evidence supporting this strategy is lacking. The aim of this study was to assess the effectiveness of a guideline-based health care network for patients who are at high risk of somatoform disorder (Sofu-Net). METHODS: In a controlled, prospective, observer-blinded cluster cohort study, patients who were at high risk of somatoform disorder were recruited at 18 primary care practices in the Sofu-Net and at 15 primary care practices that provided care as usual (CAU). The primary outcome at 6-month follow-up was the rate at which the patients received mental health treatment since the establishment of Sofu-Net. The secondary outcomes included the patients' clinical symptom severity. RESULTS: A total of 119 patients in the Sofu-Net intervention group and 100 patients in the CAU control group who were at high risk of somatoform disorder were followed for 6 months. A significantly greater proportion of Sofu-Net patients than CAU patients received mental health treatment (47.9% versus 31.0%; odds ratio = 1.96; 95% confidence interval, 1.07-3.58). However, the Sofu-Net group did not show greater reductions in clinical symptom burden compared with the CAU group. CONCLUSIONS: The treatment of somatoform disorders within a guideline-based health care network resulted in increased rates of mental health treatment but failed to improve patient clinical outcomes. Future investigations are needed to investigate the combined value of health care networks with specialized psychotherapy interventions in patients at high risk of somatic symptom and related disorders. TRIAL REGISTRATION: ISRCTN55870770.
Assuntos
Colaboração Intersetorial , Serviços de Saúde Mental/estatística & dados numéricos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Atenção Primária à Saúde/estatística & dados numéricos , Transtornos Somatoformes/terapia , Adulto , Idoso , Feminino , Seguimentos , Coalizão em Cuidados de Saúde/organização & administração , Coalizão em Cuidados de Saúde/estatística & dados numéricos , Humanos , Masculino , Serviços de Saúde Mental/organização & administração , Pessoa de Meia-Idade , Atenção Primária à Saúde/organização & administração , Risco , Método Simples-CegoRESUMO
OBJECTIVE: The aim of the study was to examine whether preoperative psychological interventions targeting patients' expectations are capable of influencing the biological stress response after coronary artery bypass graft (CABG) surgery and could thus improve recovery after heart surgery. METHODS: Randomized controlled trial with assessments 10 days before surgery, after psychological intervention (day of hospital admission, but before surgery), postoperative (6-8 days later), and at follow-up (6 months after surgery). Eligible patients (N = 124) scheduled for elective on-pump CABG or CABG with valve replacement surgery were approached before hospital admission. Standard medical care (SMC) was compared with two additional preoperative psychological interventions: (a) an expectation manipulation intervention to optimize patients' expectations about course and outcomes or (b) supportive therapy, containing the same amount of therapeutic attention, but without specifically focusing on expectations. Postoperative plasma adrenaline, noradrenaline, and cortisol levels were a secondary outcome of our study (primary outcome patients' disability 6 months after surgery and other secondary patient-reported or clinical outcomes were reported elsewhere). RESULTS: Expectation manipulation intervention (3.68 ln pg/mL, 95% confidence interval = 3.38-3.98, p = .015) and supportive therapy (3.70 ln pg/mL, 95% confidence interval = 3.38-4.01, p = .026) led to significantly lower postoperative adrenaline levels compared with SMC (4.26 ln pg/mL, 95% confidence interval = 3.99-4.53) only. There were no treatment effects of the preoperative intervention for noradrenaline (p = .90) or cortisol (p = .30). Higher postoperative adrenaline levels predicted disability 6 months after surgery (r = .258, p = .018). CONCLUSIONS: In addition to SMC, preoperative psychological interventions seem to buffer psychobiological stress responses and could thus facilitate recovery from CABG surgery. Patients' postoperative stress responses could be an important factor for explaining trajectories of long-term outcomes. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov(NCT01407055).
Assuntos
Ponte de Artéria Coronária/psicologia , Epinefrina/sangue , Hidrocortisona/sangue , Norepinefrina/sangue , Avaliação de Processos e Resultados em Cuidados de Saúde , Cuidados Pré-Operatórios/métodos , Psicoterapia/métodos , Estresse Psicológico/sangue , Estresse Psicológico/prevenção & controle , Idoso , Ponte de Artéria Coronária/efeitos adversos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Período Pós-Operatório , Estresse Psicológico/etiologiaRESUMO
OBJECTIVE: The harmonization of core outcome domains in clinical trials facilitates comparison and pooling of data, and simplifies the preparation and review of research projects and comparison of risks and benefits of treatments. Therefore, we provide recommendations for the core outcome domains that should be considered in clinical trials on the efficacy and effectiveness of interventions for somatic symptom disorder, bodily distress disorder, and functional somatic syndromes. METHODS: The European Network on Somatic Symptom Disorders group of more than 20 experts in the field met twice in Hamburg to discuss issues of assessment and intervention research in somatic symptom disorder, bodily distress disorder, and functional somatic syndromes. The consensus meetings identified core outcome domains that should be considered in clinical trials evaluating treatments for somatic symptom disorder and associated functional somatic syndromes. RESULTS: The following core domains should be considered when defining ascertainment methods in clinical trials: a) classification of somatic symptom disorder/bodily distress disorder, associated functional somatic syndromes, and comorbid mental disorders (using structured clinical interviews), duration of symptoms, medical morbidity, and prior treatments; b) location, intensity, and interference of somatic symptoms; c) associated psychobehavioral features and biological markers; d) illness consequences (quality of life, disability, health care utilization, health care costs; e) global improvement and treatment satisfaction; and f) unwanted negative effects. CONCLUSIONS: The proposed criteria are intended to improve synergies of clinical trials and to facilitate decision making when comparing different treatment approaches. These recommendations should not result in inflexible guidelines, but increase consistency across investigations in this field.
Assuntos
Ensaios Clínicos como Assunto/normas , Sintomas Inexplicáveis , Avaliação de Resultados em Cuidados de Saúde/normas , Transtornos Psicofisiológicos , Sociedades Médicas/normas , Transtornos Somatoformes , Europa (Continente) , Humanos , Transtornos Psicofisiológicos/classificação , Transtornos Psicofisiológicos/diagnóstico , Transtornos Psicofisiológicos/terapia , Transtornos Somatoformes/classificação , Transtornos Somatoformes/diagnóstico , Transtornos Somatoformes/terapiaRESUMO
OBJECTIVES: Patients' negative treatment expectations can lead to nocebo-related side effects and non-initiation of treatment. This study aims to identify correlates of treatment expectations in patients with breast cancer before the start of endocrine therapy. METHODS: Expectations were assessed in a cross-sectional sample of 166 patients with breast cancer after receiving treatment information. Side effect expectations (one item) and treatment necessity-concern balance (Beliefs about Medicines Questionnaire) were assessed. Correlates were analyzed using regression analyses. The structure of treatment expectations was investigated using a network analysis. RESULTS: About 25% of patients expressed negative expectations. Higher side effect expectations were associated with lower treatment efficacy expectations (ß = -0.20, p = 0.01), higher medication overuse beliefs (ß = 0.17, p = 0.01), and a negative treatment appraisal before study treatment information (ß = -0.17, p = 0.02). A negative necessity-concern balance was associated with lower treatment efficacy expectations (ß = 0.36, p < 0.001), lower adherence intention (ß = 0.21, p < 0.001), and no knowledge of tumor's receptor status (ß = 0.21, p < 0.001); furthermore, it was associated with higher medication harmfulness beliefs (ß = -0.16, p = 0.02), negative treatment pre-appraisal (ß = 0.15, p = 0.01), higher somatosensory amplification (ß = -0.14, p = 0.02), and higher education (ß = -0.12, p = 0.02). The most important network node was the concern that endocrine therapy disrupts life. CONCLUSION: Negative treatment expectations before treatment start are mainly associated with psychological variables. These results are relevant for patient education in clinical settings. To improve expectations, clinicians might emphasize treatment efficacy and discuss general and specific medication concerns. Improving treatment knowledge could also be beneficial. Copyright © 2016 John Wiley & Sons, Ltd.
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Inibidores da Aromatase/efeitos adversos , Inibidores da Aromatase/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/psicologia , Cultura , Neoplasias Hormônio-Dependentes/tratamento farmacológico , Neoplasias Hormônio-Dependentes/psicologia , Satisfação do Paciente , Tamoxifeno/efeitos adversos , Tamoxifeno/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Feminino , Humanos , Pessoa de Meia-Idade , Efeito Nocebo , Educação de Pacientes como Assunto , Estatística como Assunto , Inquéritos e Questionários , Resultado do Tratamento , Adulto JovemRESUMO
Patients' expectations have shown to be a major psychological predictor of health outcome in cardiac surgery patients. However, it is unclear whether patients' expectations can be optimized prior to surgery. This study evaluates the development of a brief psychological intervention focusing on the optimization of expectations and its effect on change in patients' expectations prior to cardiac surgery. Ninety patients scheduled for coronary artery bypass graft were randomly assigned to (1) standard medical care, (2) additional expectation manipulation intervention (EMI), and (3) additional attention control group. Therapists' fidelity to intervention manuals and patients satisfaction with the intervention were assessed for both active intervention conditions. Patients' expectations about post-surgical disability, treatment control, personal control, and disease duration were assessed before and after the psychological intervention. Demographical, medical, and psychosocial characteristics and disability were assessed at baseline. Treatment fidelity and patient satisfaction was very high in both intervention conditions. Only patients receiving EMI developed higher personal control expectations and longer (more realistic) expectations of disease duration. The effect of intervention group on patients' disability expectations and patients' personal control expectations was moderated by patient's level of disability. EMI patients with low to moderate disability developed positive expectations whereas patients with high disability did not. This study shows the successful development of a short psychological intervention that was able to modify patients' expectations, especially in those with low to moderate disability. Given the robust association of expectations and surgery outcome, such an intervention might offer the opportunity to enhance patients' health following cardiac surgery.
Assuntos
Ponte de Artéria Coronária/psicologia , Pessoas com Deficiência/psicologia , Cuidados Pré-Operatórios , Psicoterapia Breve , Idoso , Pessoas com Deficiência/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente/estatística & dados numéricos , Resultado do TratamentoRESUMO
Emotions have a considerable impact on eating behaviour; however, research addressing emotion regulation in obesity is rare. The present study is the first to investigate the association between emotional suppression and overeating in individuals with overweight. In total, 314 participants including 190 individuals with obesity filled in a cross-sectional online survey, which assessed emotional suppression, eating behaviour and psychopathology. A hierarchical linear regression analysis was conducted to identify factors associated with overeating. Individuals with obesity reported more frequent overeating compared with individuals without obesity. The habitual use of emotional suppression was associated with more overeating; however, this link was moderated by increased body mass index (BMI). The results suggest that suppression of emotional expression contributes to overeating and is maladaptive especially in individuals with obesity. Further research should longitudinally investigate the predictive value of emotional suppression on overweight, as the training of emotion regulation could contribute to treating obesity. Copyright © 2016 John Wiley & Sons, Ltd and Eating Disorders Association.
Assuntos
Emoções , Transtornos da Alimentação e da Ingestão de Alimentos/psicologia , Hiperfagia/psicologia , Obesidade/psicologia , Sobrepeso/psicologia , Adulto , Estudos Transversais , Ingestão de Alimentos/psicologia , Transtornos da Alimentação e da Ingestão de Alimentos/complicações , Transtornos da Alimentação e da Ingestão de Alimentos/diagnóstico , Feminino , Humanos , Hiperfagia/diagnóstico , Obesidade/diagnóstico , Psicopatologia , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: Adherence to adjuvant endocrine therapy in women with breast cancer is low, and patients are not informed sufficiently. This study analyzes the effects of a structured treatment information on patients' satisfaction, knowledge, and adherence. METHODS: An interventional single cohort study of postoperative women with estrogen-receptor-positive breast cancer was conducted to study the effects of enhanced information about endocrine therapy given additionally to clinical routine information. Knowledge and satisfaction with additional information given 1-3 weeks after surgery were assessed before and after informing patients; adherence and knowledge were measured 3 months after start of treatment. RESULTS: A total of 137 patients were analyzed before and after provision of enhanced treatment information as well as 3 months after start of endocrine therapy. Enhanced information increased satisfaction with information and knowledge. The percentage of patients who knew their estrogen receptor status increased from 50% to 93%. At 3 months follow-up, 60% still had correct knowledge. Patients who learned their receptor status were older, and those who forgot had lower cognitive abilities and lower educational level. Patients with higher satisfaction, better learning, and comprehension directly after enhanced information showed better adherence at 3 months follow-up. CONCLUSION: Patients, especially older ones, can benefit from enhanced treatment information given additionally to routine care. Enhanced information about mode of action and potential side effects of endocrine therapy when included into clinical routine might foster patient autonomy and prevent early disruptions in adherence.
Assuntos
Antineoplásicos Hormonais/uso terapêutico , Inibidores da Aromatase/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Conhecimentos, Atitudes e Prática em Saúde , Adesão à Medicação , Educação de Pacientes como Assunto/métodos , Tamoxifeno/uso terapêutico , Adulto , Fatores Etários , Idoso , Neoplasias da Mama/metabolismo , Quimioterapia Adjuvante , Cognição , Estudos de Coortes , Escolaridade , Feminino , Humanos , Mastectomia , Mastectomia Segmentar , Pessoa de Meia-Idade , Satisfação do Paciente , Receptores de Estrogênio/metabolismoRESUMO
BACKGROUND: Heart surgery patients' expectations have been shown to be related to surgery outcome, independent of medical status. However, it is unclear which factors determine patients' expectations about disability following heart surgery. PURPOSE: Investigating the associations of patients' disability expectations with demographic, medical, and psychosocial factors as well as other aspects of patients' expectations might help to tailor psychological interventions more specifically to optimize patient's expectations. METHODS: Eighty-three patients were invited to a psycho-educational intervention to optimize expectations prior to elective coronary artery bypass graft (CABG). Before the psychological intervention and before surgery, disability expectations, demographical, medical, psychosocial variables as well as patient and treatment related expectations were collected via questionnaires and patients' files. Associations with disability expectations were assessed using hierarchical linear multiple regression analysis. RESULTS: Patients self-rated disability (ß = 0.50; p < 0.001) and beliefs about treatment efficacy (ß = -0.42; p < 0.001) was independently associated with disability expectations. Expectations about the efficacy of patients' own health behavior as well as demographical variables, psychological distress, perceived social support, and measures of medical morbidity did not explain any additional variance in patients' disability expectations. CONCLUSION: CABG patients seem to form their disability expectations upon their perceptions about their current disability and their expectations about the efficacy of treatment. Patients' disability expectations appear to be independent from scientifically established risk factors and other psychosocial patient characteristics in heart surgery. Future research is necessary to further determine what factors psychological interventions should focus on to modify patients' disability expectations.
Assuntos
Ponte de Artéria Coronária/psicologia , Doença das Coronárias/psicologia , Avaliação da Deficiência , Idoso , Doença das Coronárias/cirurgia , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Percepção , Fatores de Risco , Inquéritos e Questionários , Resultado do TratamentoRESUMO
OBJECTIVE: Treatment expectations alter the probability of experiencing unpleasant side effects from an intervention, including vaccinations. To date, expectations have mostly been assessed explicitly bearing the risk of bias. This study aims to compare implicit expectations of side effects from COVID-19 and flu vaccinations and to examine their relationships with vaccine attitudes and intentions. METHODS: N = 248 participants took part in a cross-sectional online survey assessing explicit and implicit expectations, as well as vaccine-related attitudes and personal characteristics. A Single Category Implicit Association Test (SC-IAT) was developed to assess implicit side effect expectations. Explicit side effect expectations were measured with the Treatment Expectation Questionnaire (TEX-Q). RESULTS: Whereas explicit and implicit expectations regarding COVID-19 vaccine were significantly correlated (r = -0.325, p < .001), those correlations could not be found regarding flu vaccine (r = -0.072, p = .32). Explicit measures (COVID-19: ß = -0.576, p < .001; flu: ß = -0.301, p < .001) predicted the intention to receive further vaccinations more than implicit measures (COVID-19: ß = -0.005, p = .93; flu: ß = 0.004, p = .96). Explicit measures (COVID-19: OR = 0.360, p < .001; flu: OR = 0.819, p = .03) predicted vaccination status, while implicit measures did not (COVID- 19: OR = 2.643, p = .35; flu: OR = 0.829, p = .61). CONCLUSION: Expectations to experience side effects from vaccinations can be measured implicitly, in addition to explicit measures. Further investigation needs to determine the relative contribution and additive value of using implicit measures to assess treatment expectations.