CT or Invasive Coronary Angiography in Stable Chest Pain.

BACKGROUND: In the diagnosis of obstructive coronary artery disease (CAD), computed tomography (CT) is an accurate, noninvasive alternative to invasive coronary angiography (ICA). However, the comparative effectiveness of CT and ICA in the management of CAD to reduce the frequency of major adverse cardiovascular events is uncertain. METHODS: We conducted a pragmatic, randomized trial comparing CT with ICA as initial diagnostic imaging strategies for guiding the treatment of patients with stable chest pain who had an intermediate pretest probability of obstructive CAD and were referred for ICA at one of 26 European centers. The primary outcome was major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) over 3.5 years. Key secondary outcomes were procedure-related complications and angina pectoris. RESULTS: Among 3561 patients (56.2% of whom were women), follow-up was complete for 3523 (98.9%). Major adverse cardiovascular events occurred in 38 of 1808 patients (2.1%) in the CT group and in 52 of 1753 (3.0%) in the ICA group (hazard ratio, 0.70; 95% confidence interval [CI], 0.46 to 1.07; P = 0.10). Major procedure-related complications occurred in 9 patients (0.5%) in the CT group and in 33 (1.9%) in the ICA group (hazard ratio, 0.26; 95% CI, 0.13 to 0.55). Angina during the final 4 weeks of follow-up was reported in 8.8% of the patients in the CT group and in 7.5% of those in the ICA group (odds ratio, 1.17; 95% CI, 0.92 to 1.48). CONCLUSIONS: Among patients referred for ICA because of stable chest pain and intermediate pretest probability of CAD, the risk of major adverse cardiovascular events was similar in the CT group and the ICA group. The frequency of major procedure-related complications was lower with an initial CT strategy. (Funded by the European Union Seventh Framework Program and others; DISCHARGE ClinicalTrials.gov number, NCT02400229.).

Coronary Artery Calcium Score Predicts Major Adverse Cardiovascular Events in Stable Chest Pain.

Background Coronary artery calcium (CAC) has prognostic value for major adverse cardiovascular events (MACE) in asymptomatic individuals, whereas its role in symptomatic patients is less clear. Purpose To assess the prognostic value of CAC scoring for MACE in participants with stable chest pain initially referred for invasive coronary angiography (ICA). Materials and Methods This prespecified subgroup analysis from the Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease (DISCHARGE) trial, conducted between October 2015 and April 2019 across 26 centers in 16 countries, focused on adult patients with stable chest pain referred for ICA. Participants were randomly assigned to undergo either ICA or coronary CT. CAC scores from noncontrast CT scans were categorized into low, intermediate, and high groups based on scores of 0, 1-399, and 400 or higher, respectively. The end point of the study was the occurrence of MACE (myocardial infarction, stroke, and cardiovascular death) over a median 3.5-year follow-up, analyzed using Cox proportional hazard regression tests. Results The study involved 1749 participants (mean age, 60 years ± 10 [SD]; 992 female). The prevalence of obstructive coronary artery disease (CAD) at CT angiography rose from 4.1% (95% CI: 2.8, 5.8) in the CAC score 0 group to 76.1% (95% CI: 70.3, 81.2) in the CAC score 400 or higher group. Revascularization rates increased from 1.7% to 46.2% across the same groups (P < .001). The CAC score 0 group had a lower MACE risk (0.5%; HR, 0.08 [95% CI: 0.02, 0.30]; P < .001), as did the 1-399 CAC score group (1.9%; HR, 0.27 [95% CI: 0.13, 0.59]; P = .001), compared with the 400 or higher CAC score group (6.8%). No significant difference in MACE between sexes was observed (P = .68). Conclusion In participants with stable chest pain initially referred for ICA, a CAC score of 0 showed very low risk of MACE, and higher CAC scores showed increasing risk of obstructive CAD, revascularization, and MACE at follow-up. Clinical trial registration no. NCT02400229 © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Hanneman and Gulsin in this issue.

Effect of Body Mass Index on Effectiveness of CT versus Invasive Coronary Angiography in Stable Chest Pain: The DISCHARGE Trial.

Background Recent trials support the role of cardiac CT in the evaluation of symptomatic patients suspected of having coronary artery disease (CAD); however, body mass index (BMI) has been reported to negatively impact CT image quality. Purpose To compare initial use of CT versus invasive coronary angiography (ICA) on clinical outcomes in patients with stable chest pain stratified by BMI category. Materials and Methods This prospective study represents a prespecified BMI subgroup analysis of the multicenter Diagnostic Imaging Strategies for Patients with Stable Chest Pain and Intermediate Risk of Coronary Artery Disease (DISCHARGE) trial conducted between October 2015 and April 2019. Adult patients with stable chest pain and a CAD pretest probability of 10%-60% were randomly assigned to undergo initial CT or ICA. The primary end point was major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, or stroke. The secondary end point was an expanded MACE composite, including transient ischemic attack, and major procedure-related complications. Competing risk analyses were performed using the Fine and Gray subdistribution Cox proportional hazard model to assess the impact of the relationship between BMI and initial management with CT or ICA on the study outcomes, whereas noncardiovascular death and unknown causes of death were considered competing risk events. Results Among the 3457 participants included, 831 (24.0%), 1358 (39.3%), and 1268 (36.7%) had a BMI of less than 25, between 25 and 30, and greater than 30 kg/m2, respectively. No interaction was found between CT or ICA and BMI for MACE (P = .29), the expanded MACE composite (P = .38), or major procedure-related complications (P = .49). Across all BMI subgroups, expanded MACE composite events (CT, 10 of 409 [2.4%] to 23 of 697 [3.3%]; ICA, 26 of 661 [3.9%] to 21 of 422 [5.1%]) and major procedure-related complications during initial management (CT, one of 638 [0.2%] to five of 697 [0.7%]; ICA, nine of 630 [1.4%] to 12 of 422 [2.9%]) were less frequent in the CT versus ICA group. Participants with a BMI exceeding 30 kg/m² exhibited a higher nondiagnostic CT rate (7.1%, P = .044) compared to participants with lower BMI. Conclusion There was no evidence of a difference in outcomes between CT and ICA across the three BMI subgroups. Clinical trial registration no. NCT02400229 © RSNA, 2024 Supplemental material is available for this article.

Impact of smoking in patients with suspected coronary artery disease in the randomised DISCHARGE trial.

OBJECTIVES: To investigate if the effect of cardiac computed tomography (CT) vs. invasive coronary angiography (ICA) on cardiovascular events differs based on smoking status. MATERIALS AND METHODS: This pre-specified subgroup analysis of the pragmatic, prospective, multicentre, randomised DISCHARGE trial (NCT02400229) involved 3561 patients with suspected coronary artery disease (CAD). The primary endpoint was major adverse cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, or stroke). Secondary endpoints included an expanded MACE composite (MACE, transient ischaemic attack, or major procedure-related complications). RESULTS: Of 3445 randomised patients with smoking data (mean age 59.1 years + / - 9.7, 1151 men), at 3.5-year follow-up, the effect of CT vs. ICA on MACE was consistent across smoking groups (p for interaction = 0.98). The percutaneous coronary intervention rate was significantly lower with a CT-first strategy in smokers and former smokers (p = 0.01 for both). A CT-first strategy reduced the hazard of major procedure-related complications (HR: 0.21, 95% CI: 0.03, 0.81; p = 0.045) across smoking groups. In current smokers, the expanded MACE composite was lower in the CT- compared to the ICA-first strategy (2.3% (8) vs 6.0% (18), HR: 0.38; 95% CI: 0.17, 0.88). The rate of non-obstructive CAD was significantly higher in all three smoking groups in the CT-first strategy. CONCLUSION: For patients with stable chest pain referred for ICA, the clinical outcomes of CT were consistent across smoking status. The CT-first approach led to a higher detection rate of non-obstructive CAD and fewer major procedure-related complications in smokers. CLINICAL RELEVANCE STATEMENT: This pre-specified sub-analysis of the DISCHARGE trial confirms that a CT-first strategy in patients with stable chest pain referred for invasive coronary angiography with an intermediate pre-test probability of coronary artery disease is as effective as and safer than invasive coronary angiography, irrespective of smoking status. TRIAL REGISTRATION: ClinicalTrials.gov NCT02400229. KEY POINTS: • No randomised studies have assessed smoking status on CT effectiveness in symptomatic patients referred for invasive coronary angiography. • A CT-first strategy results in comparable adverse events, fewer complications, and increased coronary artery disease detection, irrespective of smoking status. • A CT-first strategy is safe and effective for stable chest pain patients with intermediate pre-test probability for CAD, including never smokers.

Development of a patient-oriented navigation model for patients with lung cancer and stroke in Germany.

BACKGROUND: The concept of patient navigation was first established in the USA to support vulnerable patient groups in receiving timely and comprehensive access to cancer care. It has recently gained increasing interest in Germany to support patients with chronic diseases in a fragmented healthcare system. The aim of this paper is to present the development of such a model adapted to the German context based on the results of mixed-methods studies investigating the need for and barriers to patient-oriented care. METHODS: In a process adapted from Delphi rounds, we conducted regular structured workshops with investigators of the project to discuss results of their studies and identify content and structure of the model based on the data. Workshop discussions were structured along seven core components of a navigation model including target patient groups, navigator tasks, occupational background and education of navigators, and patient-navigator interaction mode. RESULTS: Using an approach based on empirical data of current care practices with special focus on patients' perspectives, we developed a patient-oriented navigation model for patients who have experienced stroke and lung cancer in the German healthcare context. Patients without personal social support were viewed as struggling most with the healthcare system, as well as multimorbid and elderly patients. Navigators should serve as a longer-term contact person with a flexible contact mode and timing based on the individual situation and preferences of patients. Navigator tasks include the provision of administrative and organizational support as well as referral and guidance to available resources and beneficial health programs with special forms of knowledge. Implementation of the navigator should be flexibly located to ensure a reliable outreach to vulnerable patients for first contact in settings like specialized in-patient and out-patient settings, while navigation itself focuses on care coordination in the out-patient setting. CONCLUSION: Flexibility of navigator tasks needed to be a core characteristic of a navigation model to be perceived as supportive from patients' perspectives. In a subsequent feasibility study, an intervention based on the model will be evaluated according to its acceptance, demand, and practicality.

[Structured Collection of Data on Support Offers for Lung Cancer and Stroke Patients in Berlin]. / Strukturierte Erfassung von Unterstützungsangeboten für Lungenkrebs- und Schlaganfallbetroffene in Berlin.

OBJECTIVES: The aim of this study was to investigate available offers of support for stroke and lung cancer patients and their caregivers in the Berlin region besides direct medical or therapeutic care and to identify barriers in the use of available support from the perspective of care experts. METHODS: A structured search of different sources, including an internet search, print information as well as interviews with experts and a group discussion, was conducted on support services available to lung cancer and stroke patients and their caregivers in Berlin for managing their altered health and life situation. Target groups of identified offers were verified and further information was gathered by a questionnaire. Further, barriers for utilization of support services were analyzed from conducted interviews and the group discussion with health care experts. RESULTS: A total of 150 support services were identified for lung cancer and stroke patients and their caregivers in Berlin. There were many different forms of such offers, including, but not limited to, providing information and counseling, helping with the organization and coordination of the new life situation as well as giving psychosocial support. Missing information or information that was not adjusted to the patients' education level about care entitlements, lack of knowledge about as well as spatial distance to facilities were stated as barriers for utilization. CONCLUSIONS: A variety of support services is available in Berlin for lung cancer and stroke patients and their caregivers regarding different needs that might arise from their altered health and living situation. Providing information on existing offers more broadly to the target group and improving local availability may optimize utilization of such services by patients.

Can routine register data be used to identify vulnerable lung cancer patients of suboptimal care in a German comprehensive cancer centre?

OBJECTIVES: Several patient factors have been described to influence access to optimal cancer care like socioeconomic factors or place of residence. In this study, we investigate whether data routinely collected in a clinical cancer registry can be used to identify populations of lung cancer patients with increased risk of not receiving optimal cancer care. METHODS: We analysed data of 837 lung cancer patients extracted from the clinical cancer registry of a German university hospital. We compared patient populations by two indicators of optimal care, namely implementation of tumour board meeting recommendations as well as the timeliness of care. RESULTS: There was a high rate of implementation of tumour board meeting recommendations of 94.4%. Reasons for non-implementation were mainly a patient's own wish or a worsening of the health situation. Of all patient parameters, only tumour stage was associated with the two optimal care indicators. CONCLUSION: Using routine data from a clinical cancer registry, we were not able to identify patient populations at risk of not getting optimal care and the implementation of guideline-conform care appeared to be very high in this setting. However, limitations were the ambiguity of optimal care indicators and availability of parameters predictive for patients' vulnerability.

[Support for General Practitioners in the Care of Patients with Complex Needs: A Questionnaire Survey of General Practitioners in Berlin]. / Unterstützungsbedarf und -möglichkeiten für Hausärzte in der Versorgung von Patienten mit komplexem Bedarf: Eine Fragebogenerhebung Berliner Hausärzte.

OBJECTIVES: Because of demographic changes, new models of care are important for supporting general practitioners in the care of patients with complex needs. This study addresses the question of the type of support that is requested by general practitioners working in Berlin. METHODS: All general practitioners working in Berlin (n=2354) were asked between August and September 2018 to return a questionnaire by post which has been developed for this study. Questions addressed support needs as well as support models within the practice (delegation, substitution) and outside the practice (social worker, navigator, community care points). Data were analysed descriptively and by exploratory multivariate analysis to show the influence of practice and doctor characteristics on the preference of support models (age, gender, location of the practice, type of practice, working hours). RESULTS: A total of 557 questionnaires (response rate 23.7%) were included in the analysis. Need for support was seen particularly for administrative, coordinative and organisational tasks and for advice on social issues. The majority of the study participants approved delegation and substitution. In their view, it was conceivable to get support from professionals or institutions outside their practice, such as mobile care services, community care points, social workers or navigators. Particularly younger and female doctors working in group practices were open for cooperative care models integrating other health professions. CONCLUSIONS: There is unused potential for delegation and cooperation within existing structures. Further research should investigate the acceptance and feasibility of different support models.

Brain-derived neurotrophic factor, depressive symptoms and somatic comorbidity in patients with coronary heart disease.

OBJECTIVE: Depression and coronary heart disease (CHD) are highly comorbid conditions. Brain-derived neurotrophic factor (BDNF) plays an important role in cardiovascular processes. Depressed patients typically show decreased BDNF concentrations. We analysed the relationship between BDNF and depression in a sample of patients with CHD and additionally distinguished between cognitive-affective and somatic depression symptoms. We also investigated whether BDNF was associated with somatic comorbidity burden, acute coronary syndrome (ACS) or congestive heart failure (CHF). METHODS: The following variables were assessed for 225 hospitalised patients with CHD: BDNF concentrations, depression [Patient Health Questionnaire-9 (PHQ-9)], somatic comorbidity (Charlson Comorbidity Index), CHF, ACS, platelet count, smoking status and antidepressant treatment. RESULTS: Regression models revealed that BDNF was not associated with severity of depression. Although depressed patients (PHQ-9 score >7) had significantly lower BDNF concentrations compared to non-depressed patients (p = 0.04), this was not statistically significant after controlling for confounders (p = 0.15). Cognitive-affective symptoms and somatic comorbidity burden each closely missed a statistically significant association with BDNF concentrations (p = 0.08, p = 0.06, respectively). BDNF was reduced in patients with CHF (p = 0.02). There was no covariate-adjusted, significant association between BDNF and ACS. CONCLUSION: Serum BDNF concentrations are associated with cardiovascular dysfunction. Somatic comorbidities should be considered when investigating the relationship between depression and BDNF.

Association of FKBP5 genotype with depressive symptoms in patients with coronary heart disease: a prospective study.

Depression and coronary heart disease (CHD) are prevalent and often co-occurring disorders. Both have been associated with a dysregulated stress system. As a central element of the stress system, the FKBP5 gene has been shown to be associated with depression. In a prospective design, this study aims to investigate the association of FKBP5 with depressive symptoms in CHD patients. N = 268 hospitalized CHD patients were included. Depressive symptoms were measured using the Hospital Anxiety and Depression Scale (HADS-D) at four time points (baseline, and after 1 month, 6 months, and 12 months). The functional FKBP5 single-nucleotide polymorphism (SNP) rs1360780 was selected for genotyping. Linear regression models showed that a higher number of FKBP5 C alleles was associated with more depressive symptoms in CHD patients both at baseline (p = 0.015) and at 12-months follow-up (p = 0.025) after adjustment for confounders. Further analyses revealed that this effect was driven by an interaction of FKBP5 genotype with patients' prior CHD course. Specifically, only in patients with a prior myocardial infarction or coronary revascularization, more depressive symptoms were associated with a higher number of C alleles (baseline: p = 0.046; 1-month: p = 0.026; 6-months: p = 0.028). Moreover, a higher number of C alleles was significantly related to a greater risk for dyslipidemia (p = .016). Our results point to a relevance of FKBP5 in the association of the two stress-related diseases depression and CHD.

Health-related qualify of life, angina type and coronary artery disease in patients with stable chest pain.

BACKGROUND: Health-related quality of life (HRQoL) is impaired in patients with stable angina but patients often present with other forms of chest pain. The aim of this study was to compare the pre-diagnostic HRQoL in patients with suspected coronary artery disease (CAD) according to angina type, gender, and presence of obstructive CAD. METHODS: From the pilot study for the European DISCHARGE trial, we analysed data from 24 sites including 1263 patients (45.9% women, 61.1 ± 11.3 years) who were clinically referred for invasive coronary angiography (ICA; 617 patients) or coronary computed tomography angiography (CTA; 646 patients). Prior to the procedures, patients completed HRQoL questionnaires: the Short Form (SF)-12v2, the EuroQoL (EQ-5D-3 L) and the Hospital Anxiety and Depression Scale. RESULTS: Fifty-five percent of ICA and 35% of CTA patients had typical angina, 23 and 33% had atypical angina, 18 and 28% had non-anginal chest discomfort and 5 and 5% had other chest discomfort, respectively. Patients with typical angina had the poorest physical functioning compared to the other angina groups (SF-12 physical component score; 41.2 ± 8.8, 43.3 ± 9.1, 46.2 ± 9.0, 46.4 ± 11.4, respectively, all age and gender-adjusted p < 0.01), and highest anxiety levels (8.3 ± 4.1, 7.5 ± 4.1, 6.5 ± 4.0, 4.7 ± 4.5, respectively, all adjusted p < 0.01). On all other measures, patients with typical or atypical angina had lower HRQoL compared to the two other groups (all adjusted p < 0.05). HRQoL did not differ between patients with and without obstructive CAD while women had worse HRQoL compared with men, irrespective of age and angina type. CONCLUSIONS: Prior to a diagnostic procedure for stable chest pain, HRQoL is associated with chest pain characteristics, but not with obstructive CAD, and is significantly lower in women. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02400229.

Correction to: Health-related qualify of life, angina type and coronary artery disease in patients with stable chest pain.

An amendment to this paper has been published and can be accessed via the original article.

Prevalence, 12-Month Prognosis, and Clinical Management Need of Depression in Coronary Heart Disease Patients: A Prospective Cohort Study.

BACKGROUND: Screening for depression in patients with coronary heart disease (CHD) remains controversial. There is limited data on the actual depression management need in routine care. The aim of this study was to examine the prevalence, treatment rates, prognosis, and management need of clinical and subclinical depression in CHD patients according to the American Heart Association recommendations and the National Institute for Health and Care Excellence (NICE) guideline "Depression in Adults with a Chronic Physical Health Problem". METHODS: Patients were recruited at 2 German university clinics between 2012 and 2014. Depressive disorders were assessed according to the DSM-IV and depressive symptom severity at baseline and during follow-up was evaluated with the Patient Health Questionnaire (PHQ-9). Depression management need was determined by the severity and longitudinal course of depression symptoms. RESULTS: Of 1,024 patients (19% women), 12% had clinical depression (depressive disorder) and 45% had subclinical depression (PHQ-9 score ≥5) at baseline. Among those with clinical depression, 46% were in treatment at least once during 12 months; 26% were continuously in treatment during follow-up. Depressive disorder and depressive symptoms were significant risk factor-adjusted predictors of the 12-months mortality (adjusted HR = 3.19; 95% CI 1.32-7.69, and adjusted HR = 1.09; 95% CI 1.02-1.16, respectively). Depressive symptoms persisted in 85% of the clinically depressed and in 47% of the subclinically depressed patients. According to current recommendations, 29% of all CHD patients would require depression management within 1 year. CONCLUSIONS: There is a need for enhanced recognition, referral, and continuous and improved clinical management of depression in CHD patients.

Psychometric properties of the Perceived Stress Scale in a sample of German dementia patients and their caregivers.

BACKGROUND: The aim of the present study was to investigate the psychometric characteristics of the Perceived Stress Scale (PSS) in a sample of dementia patients and their spousal caregivers. METHODS: We investigated the reliability and validity of the 14-item PSS in a sample of 80 couples, each including one spouse who had been diagnosed with mild to moderate dementia (mean age 75.55, SD = 5.85, 38.7% female) and one spousal caregiver (mean age 73.06, SD = 6.75, 61.3% female). We also examined the factor structure and sensitivity of the scale with regard to gender differences. RESULTS: Exploratory factor analysis of the PSS revealed a two-factor solution for the scale; the first factor reflected general stress while the second factor consisted of items reflecting the perceived ability to cope with stressors. A confirmatory factor analysis verified that the data were a better fit for the two-factor model than a one-factor model. The two factors of the PSS showed good reliability for patients as well as for caregivers ranging between α = 0.73 and α = 0.82. Perceived stress was significantly positively correlated with depressive symptomatology in both caregivers and patients. Mean PSS scores did not significantly differ between male and female patients nor did they differ between male and female caregivers. CONCLUSION: The present data indicate that the PSS provides a reliable and valid measure of perceived stress in dementia patients and their caregivers.

Implications of standardization of serum 25-hydroxyvitamin D data for the evaluation of vitamin D status in Germany, including a temporal analysis.

BACKGROUND: Comparability of 25-hydroxyvitamin D (25(OH)D) measurements is hampered by method-related differences in measurement values. International standardization of laboratory assays has been suggested to solve this problem. METHODS: As part of the European Commission-funded project 'Food-based solutions for optimal vitamin D nutrition and health through the life cycle' (ODIN), original measurements of serum 25(OH)D of three German national health surveys conducted between 1998 and 2011 have been standardized retrospectively. In these representative population-based samples including persons aged between 1 and 79 years, the original 25(OH)D values were compared with those after standardization. Mean values and prevalences of vitamin D deficiency, insufficiency, and sufficiency (25(OH)D levels < 30, 30- < 50, and > =50 nmol/l, respectively) were calculated by sex and age groups based on original and standardized 25(OH)D data. RESULTS: In comparison to the original 25(OH)D levels, the standardized levels showed higher means overall and in age- and sex-specific analyses. After standardization, the prevalence of vitamin D deficiency was lower in all surveys while the prevalence of vitamin D sufficiency was higher. Nevertheless, even after standardization ~ 15% of adults and 12.5% of children had serum 25(OH)D levels < 30 nmol/l. Thus, the proportion of deficient vitamin D levels in the German population is still considerable. CONCLUSIONS: The use of standardization of 25(OH)D levels has a substantial impact on estimates of the vitamin D status in Germany. Since clinical diagnostic, therapeutic and public health decision-making require valid and comparable data, standardization and calibration of commercial, clinical and research laboratory assays for 25(OH)D measurement should become common practice. Until then, researchers, health practitioners and policy makers should be aware of the peculiarities of the measurement methods when comparing and interpreting 25(OH)D levels.

Effect of a Website That Presents Patients' Experiences on Self-Efficacy and Patient Competence of Colorectal Cancer Patients: Web-Based Randomized Controlled Trial.

BACKGROUND: Patients often seek other patients' experiences with the disease. The Internet provides a wide range of opportunities to share and learn about other people's health and illness experiences via blogs or patient-initiated online discussion groups. There also exists a range of medical information devices that include experiential patient information. However, there are serious concerns about the use of such experiential information because narratives of others may be powerful and pervasive tools that may hinder informed decision making. The international research network DIPEx (Database of Individual Patients' Experiences) aims to provide scientifically based online information on people's experiences with health and illness to fulfill patients' needs for experiential information, while ensuring that the presented information includes a wide variety of possible experiences. OBJECTIVE: The aim is to evaluate the colorectal cancer module of the German DIPEx website krankheitserfahrungen.de with regard to self-efficacy for coping with cancer and patient competence. METHODS: In 2015, a Web-based randomized controlled trial was conducted using a two-group between-subjects design and repeated measures. The study sample consisted of individuals who had been diagnosed with colorectal cancer within the past 3 years or who had metastasis or recurrent disease. Outcome measures included self-efficacy for coping with cancer and patient competence. Participants were randomly assigned to either an intervention group that had immediate access to the colorectal cancer module for 2 weeks or to a waiting list control group. Outcome criteria were measured at baseline before randomization and at 2 weeks and 6 weeks. RESULTS: The study randomized 212 persons. On average, participants were 54 (SD 11.1) years old, 58.8% (124/211) were female, and 73.6% (156/212) had read or heard stories of other patients online before entering the study, thus excluding any influence of the colorectal cancer module on krankheitserfahrungen.de. No intervention effects were found at 2 and 6 weeks after baseline. CONCLUSIONS: The results of this study do not support the hypothesis that the website studied may increase self-efficacy for coping with cancer or patient competencies such as self-regulation or managing emotional distress. Possible explanations may involve characteristics of the website itself, its use by participants, or methodological reasons. Future studies aimed at evaluating potential effects of websites providing patient experiences on the basis of methodological principles such as those of DIPEx might profit from extending the range of outcome measures, from including additional measures of website usage behavior and users' motivation, and from expanding concepts, such as patient competency to include items that more directly reflect patients' perceived effects of using such a website. TRIAL REGISTRATION: Clinicaltrials.gov NCT02157454; https://clinicaltrials.gov/ct2/show/NCT02157454 (Archived by WebCite at http://www.webcitation.org/6syrvwXxi).

Acceptance and efficacy of interventions for family caregivers of elderly persons with a mental disorder: a meta-analysis.

BACKGROUND: The aim of the present study was to conduct an extended meta-analysis of the efficacy and acceptance of supportive interventions for alleviating depressive symptoms in family caregivers of elderly relatives with a mental disorder, including dementia. The second aim was to analyze intervention characteristics as potential moderators of the efficacy and acceptance of these interventions. METHODS: We searched electronic databases for randomized controlled trials (RCTs) published between 2005 and 2014. Thirty-three studies were included in the meta-analysis with a total of 5,980 participants. RESULTS: No RCTs that tested interventions for caregivers of elderly patients with mental disorders other than dementia were found. The weighted pooled effect size of the interventions for caregivers of dementia patients was positive but small (standardized mean difference = 0.13; CI0.95 [0.03; 0.23], p = 0.01). Meta-regression analysis revealed higher effect sizes for interventions that were individually customized. Intervention discontinuation rates were low (mean 11%, SD = 6.3) and independent of most intervention characteristics. If the intervention was delivered via telecommunication intervention discontinuation rates tended to be higher (r = -0.39, p = 0.07). CONCLUSIONS: Comparative research for caregivers of elderly patients with mental disorders other than dementia is lacking. RCTs of interventions for family caregivers of dementia patients of the last decade show good acceptance among intervention participants, but there is still a need to improve the efficacy of these interventions. Individual customization of intervention components might enhance efficacy. More research is needed on the acceptance of telecommunication interventions for family caregivers.

Drug and Exercise Treatment of Alzheimer Disease and Mild Cognitive Impairment: A Systematic Review and Meta-Analysis of Effects on Cognition in Randomized Controlled Trials.

OBJECTIVE: Demographic changes are increasing the pressure to improve therapeutic strategies against cognitive decline in Alzheimer disease (AD) and mild cognitive impairment (MCI). Besides drug treatment, physical activity seems to be a promising intervention target as epidemiological and clinical studies suggest beneficial effects of exercise training on cognition. Using comparable inclusion and exclusion criteria, we analyzed the efficacy of drug therapy (cholinesterase inhibitors, memantine, and Ginkgo biloba) and exercise interventions for improving cognition in AD and MCI populations. METHODS: We searched The Cochrane Library, EBSCO, OVID, Web of Science, and U.S Food and Drug Administration data from inception through October 30, 2013. Randomized controlled trials in which at least one treatment arm consisted of an exercise or a pharmacological intervention for AD or MCI patients, and which had either a non-exposed control condition or a control condition that received another intervention. Treatment discontinuation rates and Standardized Mean Change score using Raw score standardization (SMCR) of cognitive performance were calculated. RESULTS: Discontinuation rates varied substantially and ranged between 0% and 49% with a median of 18%. Significantly increased discontinuation rates were found for galantamine and rivastigmine as compared to placebo in AD studies. Drug treatments resulted in a small pooled effect on cognition (SMCR: 0.23, 95% CI: 0.20 to 0.25) in AD studies (N = 45, 18,434 patients) and no effect in any of the MCI studies (N = 5, 3,693 patients; SMCR: 0.03, 95% CI: 0.00 to 0.005). Exercise interventions had a moderate to strong pooled effect size (SMCR: 0.83, 95% CI: 0.59 to 1.07) in AD studies (N = 4, 119 patients), and a small effect size (SMCR: 0.20, 95% CI: 0.11 to 0.28) in MCI (N = 6, 443 patients). CONCLUSIONS: Drug treatments have a small but significant impact on cognitive functioning in AD and exercise has the potential to improve cognition in AD and MCI. Head-to-head trials with sufficient statistical power are necessary to directly compare efficacy, safety, and acceptability. Combining these two approaches might further increase the efficacy of each individual intervention. IDENTIFIER: PROSPERO (2013:CRD42013003910).

Long-term effect of a low-intensity smoking intervention embedded in an adherence program for patients with hypercholesterolemia: Randomized controlled trial.

OBJECTIVE: We evaluated the long-term effect of a smoking intervention embedded in an adherence program in patients with an increased risk for cardiovascular disease. METHOD: Secondary analysis of a randomized controlled trial: In 2002-2004, 8108 patients with hypercholesterolemia were enrolled from general practices in Germany. Patients received a 12-month adherence program and statin medication (intervention) or statin medication only (control). The program aimed to improve adherence to medication and lifestyle by educational material, mailings, and phone calls. Smoking was self-reported at baseline and every 6months during the 3-year follow-up. RESULTS: In total, 7640 patients were analyzed. At baseline, smoking prevalence was 21.7% in the intervention and 21.5% in the control group. Prevalence decreased in both groups to 16.6% vs. 19.5%, 15.3% vs. 16.8%, and 14.2% vs. 15.6% at the 12-, 24-, and 36-month follow-up. The intervention had a beneficial effect on smoking differing over time (group×time: P=0.005). The effect was largest after 6 and 12months [odds ratios (95% confidence intervals): 0.67 (0.54-0.82) and 0.63 (0.51-0.78)]. The effect decreased until the 18-month follow-up [0.72 (0.58-0.90)] and was not significant after 24months. CONCLUSION: A low-intensity smoking intervention embedded in an adherence program can contribute to smoking cessation although the intervention effect diminished over time. TRIAL REGISTRATION: ClinicalTrials.gov (www.clinicaltrials.gov): NCT00379249.

Vitamin D status among adults in Germany--results from the German Health Interview and Examination Survey for Adults (DEGS1).

BACKGROUND: In 1998, more than half of the adult population in Germany had serum 25-hydroxy-vitamin-D [25(OH)D] levels below the common threshold of 50 nmol/l. Since then, there has been a lot of attention for vitamin D in the scientific community, the media and the general population and serum 25(OH)D levels may have increased as a consequence. With data from the 'German Health Interview and Examination Survey for Adults' (DEGS1) the current situation of vitamin D status can be analysed. METHODS: DEGS1, a national health survey among adults in Germany conducted by the Robert Koch Institute between 2008 and 2011, included 6,995 persons with available serum 25(OH)D levels. We calculated the proportion of participants with serum 25(OH)D levels <30 nmol/l, 30- < 50 nmol/l and > =50 nmol/l overall and according to age, season and latitude of residence as well as percentiles of serum 25(OH)D according to month of examination. Determinants of vitamin D status were analysed with multiple linear regression models. RESULTS: Mean serum 25(OH)D level was 45.6 nmol/l with no significant sex differences (p = 0.47). 61.6% of the participants had serum 25(OH)D levels <50 nmol/l, 30.2% had levels <30 nmol/l. During summer, half of the participants had levels > =50 nmol/l, during winter time, 25% of the participants had levels <30 nmol/l. A significant latitudinal gradient was observed in autumn for men and in winter for women. In multiple linear regression analyses, examination during winter time, residing in northern latitude, non-use of vitamin D supplements, low sport activity, high Body Mass Index (BMI) and high media consumption were independently and significantly associated with lower serum 25(OH)D levels in both sexes. In addition, among women, significant associations with lower 25(OH)D levels were observed for older age and lower socio-economic status, among men, for low vitamin D intake and more residential traffic. CONCLUSIONS: Serum 25(OH)D levels below the threshold of 50 nmol/l are still common among adults in Germany, especially during winter and spring and in higher latitudes. Potentially modifiable factors of poorer vitamin D status are higher BMI, lack of sport activity and high media use.