Study protocol: evaluation of the addictive potential of e-cigarettes (EVAPE): neurobiological, sociological, and epidemiological perspectives.

BACKGROUND: Tobacco use is the largest preventable cause of diseases and deaths; reducing tobacco intake is, therefore, an urgent public health goal. In recent years, e-cigarettes have been marketed as a 'healthier' alternative to tobacco smoking, whilst product features have evolved tremendously in the meantime. A lively scientific debate has developed regarding the potential benefits and risks of e-cigarettes although, surprisingly, there are few studies investigating the addictive potential of nicotine-containing e-cigarettes. The present work comprises three work packages investigating the addictive potential of e-cigarettes from different perspectives: (1) the neurobiological addictive potential of e-cigarettes; (2) the experience and perception of dependence symptoms among users of e-cigarettes in a social context; and (3) the epidemiological perspective regarding factors influencing the potential for dependence. METHODS: Work package I: the neurobiological study will investigate the key elements of addiction in e-cigarettes compared to tobacco cigarettes using neurobiological and neuropsychological correlates associated with craving, incentive motivation, cue reactivity and attentional bias. Work package II: the sociological study part examines self-reports on the experience and perception of dependence symptoms in a social context, using focus group interviews and the analysis of posts in online discussion forums on e-cigarettes. Work package III: the epidemiological study part focuses on tolerance development and the role of psychosocial and product factors by analyzing longitudinal data from the International Tobacco Control Policy Evaluation Project (ITC). DISCUSSION: The present study offers a chosen mix of three methodological approaches, thereby comprehensively examining core symptoms of positive and negative reinforcement in addiction. Whether e-cigarettes are as reinforcing and addictive as combustible tobacco cigarettes is an important public health issue with implications for prevention and treatment programs. TRIAL REGISTRATION: Work package I: Registered at clinicaltrials.gov/ct2/show/NCT04772014. Work package II: Registered at OSF Registries: https://osf.io/dxgya (2021, January 14).

[The practical training of medical students in General Medicine: Important characteristics of teaching practices]. / Die praktische Ausbildung des medizinischen Nachwuchses ­ Identifizierung von Lehrpraxen-Charakteristika in der Allgemeinmedizin.

BACKGROUND: Comprehensive general medical care is endangered by the socio-demographic development of the population as well as by recruitment problems in general medicine. Medical students' interest in general medicine increases if they experience their internships positively. However, the characteristics of teaching practice important to medical students have not been systematically investigated. METHODS: We conducted four focus groups with a total of 22 students. The group discussions were recorded, transcribed, and evaluated by means of qualitative content analysis. RESULTS: Students who rated their internship positively also expressed greater interest in becoming a family doctor. Variables that mattered to students were: Instruction and supervision by the owner's teaching practice and feedback behavior, being treated with respect, opportunity to work independently, the broad spectrum of diseases and the varied daily work when working as a family doctor, long-standing doctor-patient relationships, and good work-life balance. Variables that decreased students' interest in becoming a family doctor were the economic risk of starting a business, and being self-employed, referring patients to specialists for "interesting findings" and a poor work-life balance. CONCLUSION: The practical training of medical students in teaching practices has the potential to increase students' interest in working as a family doctor. This requires motivated teaching practice owners, who give students a positive insight into everyday practice.

Postoperative Pain Trajectories and Pain Chronification-an Empirical Typology of Pain Patients.

Background: High intensity of acute postsurgical pain is one of the strongest predictors of chronic postsurgical pain (CPSP). We investigated if different types of patients with distinct combinations of initial pain intensity and rate of pain resolution exhibit different risks for increased pain intensity six months after surgery. Methods: Data from 174 patients were examined using growth mixture analysis by means of structural equation modeling. Results: Three types of patients were distinguished on the basis of acute pain trajectories. The majority of patients (57%) showed an unproblematic pattern of little initial pain on the first postoperative day, combined with further pain resolution over the four subsequent days. There also was a substantial group of patients (30%) who started out with severe pain but exhibited a high rate of pain resolution. Finally, we found a problematic group of patients (13%) who reported high pain intensities throughout all five postoperative measurements, with no signs of pain resolution. Even after controlling for preoperative pain intensity, these patients exhibited significantly higher pain intensities six months after surgery than the remaining patient groups. Conclusions: In this study, we demonstrated that there is substantial variation in postsurgical pain trajectories, not only with regard to postsurgical initial pain intensity, but also with regard to individual rates of pain resolution. Successful pain resolution appeared to be a better predictor of absence of increased pain intensities six months after surgery than initial pain immediately after surgery. Hence, attention should be given to appropriate pain treatment in order to minimize the risk of CPSP.

Diagnostic barriers for somatic symptom disorders in primary care: study protocol for a mixed methods study in Germany.

INTRODUCTION: Somatoform or somatic symptom disorders ((S)SD) are common and have a negative impact on the patients' health-related quality of life, healthcare use and costs. In primary care, which is central to the management of (S)SD, diagnosis and treatment tend to be delayed. There is a significant lack of evidence regarding the barriers in the diagnostic process of (S)SD in primary care and how interventions should be tailored to address them. The aim of this study is to analyse the diagnostic process in primary care that results in the diagnosis or non-diagnosis of a (S)SD. METHODS AND ANALYSIS: This mixed methods study will investigate the topic with qualitative methods, subsequently proceeding to a quantitative phase where the initial results will be validated and/or generalised. First, focus groups will explore meanings and patterns, inconsistencies and conflicts in general practitioners' (GPs) thoughts and behaviours when diagnosing (S)SD. Second, the results of these focus groups will be used to develop interview guidelines for subsequent face-to-face interviews. Patients and their treating GPs will be interviewed separately on how they experience the history of illness, the diagnostic process and treatment. Third, based on the results of the first two study parts, a questionnaire will be derived and a nationwide survey among German GPs will be conducted, quantifying the barriers and difficulties identified before. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ethics Committee of the Hamburg Medical Association, Germany (approval number PV4763). The results of this study will be disseminated through conference presentation and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: The study is registered in the German Clinical Trial Register (DRKS), DRKS-ID DRKS00009736.

Impact of intercostal paravertebral neurectomy on post thoracotomy pain syndrome after thoracotomy in lung cancer patients: a randomized controlled trial.

BACKGROUND: Thoracotomy leads to chronic neuropathic pain in up to 50% of patients and is responsible for an impaired quality of life. Intercostal nerve injury has been suggested to be responsible for this pain. In the present study the impact of paravertebral intercostal neurectomy on post thoracotomy pain was assessed. METHODS: In this single center parallel-group randomized controlled trial patients underwent muscle sparing anterolateral thoracotomy and anatomical lung resection for lung cancer. A subcostal approach was used for thoracotomy with single paravertebral neurectomy being performed at the beginning of the procedure at the level of the retracted intercostal space. For documentation of neuropathic pain the Leeds Assessment Score for Neuropathic Symptoms and Signs (LANSS) was used postoperatively. The primary endpoint was defined as LANSS ≥12 points on day 120. In addition, the numeric pain rating scale (NRS) was used to score pain intensity. RESULTS: Out of 172 patients initially randomized 161 patients were investigated following intraoperative and postoperative drop-out criteria. All patients required anatomical lung resection via thoracotomy. Five patients were lost for follow up. For the remaining 156 patients there was no difference between the two groups with regard to LANSS ≥12: 26.6% in patients with neurectomy and 28.8% in control-subjects (P=0.78). In addition, the NSR score at day 120 did not differ significantly at rest and during activity between the two groups (at rest: 21.7% vs. 15.8% P=0.439; activity: 24.5% vs. 21.9% P=0.735). CONCLUSIONS: Neurectomy was not shown to reduce the post thoracotomy pain syndrome in patients with anatomical lung resection following anterolateral muscle sparing thoracotomy.

The challenge of diagnosing non-specific, functional, and somatoform disorders: A systematic review of barriers to diagnosis in primary care.

OBJECTIVE: Despite their prevalence and impact on patients and the health care system, non-specific, functional, and somatoform disorders are underdiagnosed. This problem is especially problematic in primary care if we are moving towards an integrated care model. The objective of the current study was to identify and aggregate potential barriers to the diagnosis in primary care settings. METHODS: Our systematic review methodology followed a pre-published protocol and was registered in PROSPERO (CRD42013002540). We combined qualitative and quantitative data from studies identified in online databases and by hand searching of reference lists. Data were synthesized in a data-driven way using a grounded-theory approach. The level of evidence and assessment of bias for the final included studies was independently conducted. RESULTS: Data from n=177 full text publications were independently extracted and combined in a custom database. The final list of included studies was n=42. From these, a total of n=379 barriers were identified comprising 77 barrier-level codes, 16 thematic categories and five over-arching themes, i.e., patient-related, primary-care-practitioner related, doctor-patient interactional, situational, and conceptual and operational barriers. CONCLUSION: Given the thematic range of the identified barriers, the diagnostic process of non-specific, functional, and somatoform disorders in primary care is highly complex. Individual or practice-level interventions, as well as public awareness initiatives are needed to help address the diagnostic challenges. A multi-factorial understanding of symptoms with a biopsychosocial parallel diagnostic approach should be encouraged. More direct empirical investigations are also needed.

Is there a difference in postdural puncture headache after continuous spinal anesthesia with 28G microcatheters compared with punctures with 22G Quincke or Sprotte spinal needles?

In this retrospective study, the question was raised and answered whether the rate of postdural puncture headache (PDPH) after continuous spinal anesthesia with a 28G microcatheter varies using a Quincke or a Sprotte needle. The medical records of all patients with allogenic joint replacement of the knee or hip or arthroscopic surgery of the knee joint undergoing continuous spinal anesthesia with a 22G Quincke (n=1,212) or 22G Sprotte needle (n=377) and a 28G microcatheter during the past 6 years were reviewed. We obtained the approval of the ethical committee. The rates of PDPH were statistically not different between both groups: 1.5% of patients developed PDPH after dura puncture with a Quincke needle and 2.1% with a Sprotte needle in women and men.

Incidence of chronic postsurgical pain (CPSP) after general surgery.

OBJECTIVE: This study investigated the incidence and determinants of chronic postsurgical pain (CPSP) in a general surgical patient population. DESIGN: This is a prospective cross-sectional study at a university-affiliated clinic/level 1 trauma center. Patients were followed at least 1 year postoperatively. By surgical discipline, procedures were 50% orthopedic/trauma, 33% general (abdominal/visceral), and 17% vascular. SETTING: All patients admitted during one year (N = 3020) were eligible. Exclusion criteria were cognitive impairment, communication/language barrier, nonoperative treatment, and refusal to participate. A CPSP questionnaire was completed. Step-by-step analysis followed with a 2(nd) questionnaire to detect CPSP with numeric rating scale (NRS) pain intensity ≥3. Finally, individual follow-up examinations were performed. RESULTS: 911 patients responded (30.2%). 522 complained of pain intensity ≥3 on NRS (scale 0-10). The second step identified 214 patients with chronic pain (NRS ≥3, mean 29 months postoperatively). On final examination, 83 CPSP patients (14.8%) were identified. By surgical discipline, 28% were general, 15% vascular, and 57% trauma/orthopedic surgery. Most oftenly cited pain sites were joint (49.4%), incisional/scar (37.7%), and nerve pain (33.7%). By procedure, patients underwent pelvic surgery, colon surgery, laparoscopies, inguinal herniorrhaphies, arthroscopies, and hardware extractions. All patients in the "laborer" and "unemployed" categories reported chronic pain. CONCLUSION: Bias due to study design and/or heterogeneity of patients is possible, but there was a high CPSP rate after 2 years both generally and particularly in orthopedic/trauma (57%) patients. Both "major" and "minor" surgical procedures led to CPSP.

Barriers to the diagnosis of somatoform disorders in primary care: protocol for a systematic review of the current status.

BACKGROUND: Somatoform-type disorders and functional medically unexplained symptoms are extremely common in primary care settings. These disorders, however, are consistently underdiagnosed and under-recognised which precludes effective treatment. Given that somatoform symptoms are associated with high impairment, healthcare costs and both physician and patient frustration, it is critical to improve early detection. The first step in improving patient care is to identify the current barriers which obstruct successful diagnosis to enable the design of targeted interventions. We aim to conduct a systematic review to identify the possible physician-, patient- and society-related factors and other practical constraints which may impede successful diagnosis. In the process, we will also be able to recognise the differences in methodological techniques, recommend potential avenues for future research and comment on the literature in this field as a whole. METHODS/DESIGN: We aim to conduct a systematic review of the relevant peer-reviewed literature published in English or German in the past 10 years in MEDLINE, EMBASE, PsycINFO and the Cochrane Database of Systematic Reviews. Additional studies may be identified from the reference lists of included studies. Title and abstract screening and data extraction from full text manuscripts will be conducted by two independent reviewers. Because we are including a combination of qualitative and quantitative studies, the review will provide a broad understanding of the current situation. Wherever possible, the method and reporting of the review will adhere to the guidelines outlined in the PRISMA statement and bias will be assessed using the Cochrane collaboration's recommendations. We envisage that data will be synthesised using a multilevel (qualitative and quantitative) approach which combines textual narrative and thematic analysis. Barriers will be categorised as modifiable or non-modifiable according to a conceptual framework. The review has been registered in an international registry of systematic reviews PROSPERO (CRD42013002540). DISCUSSION: We hope that this study will provide an insight into the barriers to diagnosis of somatoform-type disorders and the results can be used to target appropriate interventions to improve care for these patients.

Early short-term inpatient psychotherapeutic treatment versus continued outpatient psychotherapy on psychosocial outcome: a randomized controlled trial in trauma patients.

BACKGROUND: Inpatient psychotherapeutic support has been shown to reduce mental health problems in severely injured patients. However, this effect mostly disappears after discharge. The aim of this study was to compare short-term inpatient versus continued long-term outpatient psychotherapeutic support. METHODS: Patients with at least two injuries of a combined Abbreviated Injury Scale Severity Score Index≥5 were included in the study. Of 862 screened patients, 113 met all inclusion criteria. They were randomly assigned to a short-term group (n=59), where only inpatient support was given, and a long-term group (n=54), with additional outpatient sessions. The cognitive behavioral treatment was standardized by a manual. Psychological assessment for depression, anxiety, and posttraumatic stress disorder (PTSD) was performed in written form at the time of inclusion, discharge, and 6 months, 12 months, and 18 months after trauma. RESULTS: Forty-one percent (n=46) of all patients completed follow-up visits. The results show that symptoms of depression, anxiety, and PTSD disappeared more often in the long-term group than in the short-term group 1 year after trauma. Differences nearly reach significance for anxiety (p=0.051) and PTSD (p=0.059). Twenty-one percent of the short-term group patients showed at least one mental health disorder compared with no patients in the long-term group 1 year after trauma (p=0.035). CONCLUSION: Psychotherapeutic support of severely injured patients seems to be more effective in reducing depression, anxiety, and PTSD if extended further into outpatient care. This conclusion should be considered preliminary because of the small number of study patients.

Psychiatric symptoms in Parkinson's disease.

Parkinson's disease (PD) is a neurodegenerative disorder which is often reduced to a mere dysfunction of motor performance. Non-motor symptoms, however, are frequent impairments in PD and result in a major impact on the patients and their caregivers. The major neuropsychiatric comorbidities depression, anxiety, and psychotic symptoms are briefly discussed. Additionally, a brief outlook on deep brain stimulation and its effect on psychiatric symptoms is provided. Several studies did show that neuropsychiatric symptoms are underdiagnosed and consecutively treated inadequately. All in all more attention should be directed to the detection and treatment of psychiatric symptoms in PD patients in routine clinical settings.

Frequency and treatment of depressive symptoms in a Parkinson's disease registry.

Purpose of this cross-sectional study was to estimate the occurrence of depressive symptoms, as related to other clinical data, in a sample of Parkinson's disease (PD) patients (n=226). Furthermore, we examined the medical care of depressive symptoms in this sample. H&Y stages, cognitive status, sleeping disorders, and dysphagia resulted as significant predictors for depression. Prevalence of depressive symptoms was 35.4%. Only 25.0% of patients suffering from moderate to severe depressive symptoms were prescribed antidepressants. This study supports the view that depression may be underrecognized and undertreated in PD patients. A significant proportion of patients continues to experience depressive symptoms despite antidepressive medication. Recognition and treatment of depression remains a challenge for management of PD. Possible coexisting depressive symptoms should be revealed and assessed by standardized interviews in everyday clinical routine. Large scale randomized controlled trials examining efficacy and safety of antidepressants in PD patients are urgently required.

Health-related quality of life in patients with narcolepsy.

BACKGROUND: To evaluate the health-related quality of life (HRQoL) in patients suffering from narcolepsy. METHODS: Subjects included 75 narcoleptic patients diagnosed at the Hephata Klinik, Germany, who met the International Classification of Sleep Disorders (ICSD) criteria for narcolepsy. A standardized telephone interview was used to inquire about the disease and its burdens to the patients. HRQoL was recorded using the 36-item short-form Medical Outcomes Study (SF-36) as well as the Euroqol (EQ-5D). Frequency and factors of influence on decreased HRQoL were evaluated by using bivariate and multivariate analyses. RESULTS: Patients with narcolepsy had considerably lower scores on all eight domains of the SF-36 compared to the general German population. In particular, scores were poor for the dimensions "physical role", "vitality", and "general health perception". Forty-eight percent of the patients reported problems in at least one of the EQ-5D items; most frequent were problems in the dimension "usual activity" (63.8%), "pain/discomfort" (61.7%) and "anxiety/depression" (41.1%). Difficulty maintaining "self-care" was documented only by 6.8%. The mean VAS score was 60.7%. Interestingly, signs and symptoms of narcolepsy, except for irresistible sleep episodes (p<0.03), had only a minor impact on HRQoL. Multivariate analyses confirmed a strong influence of employment status, living with a partner, excessive daytime sleepiness (EDS) and professional advancement. CONCLUSIONS: HRQoL is considerably reduced in patients, with narcolepsy affecting the different dimensions to various degrees. Factors other than clinical signs and symptoms are associated also with poor HRQoL. Measures should be taken to integrate those factors into healthcare guidelines in order to improve the quality of life in patients with narcolepsy.

Long-term outcome after stroke: evaluating health-related quality of life using utility measurements.

BACKGROUND AND PURPOSE: As stroke mortality rates decline, individuals are increasingly likely to live with their residual impairments and disabilities. Therefore, the quality of poststroke life is 1 of the pivotal topics that have to be considered beneath the functional outcome. However, data on health-related quality of life (HRQoL) have been infrequently used in stroke trials. The purpose of this study was to examine the long-term outcome (4 years after stroke) of HRQoL and to identify the determinants of HRQoL in stroke survivors. METHODS: Seventy-seven patients were included who were admitted to the Department of Neurology, Philipps-University Marburg, after experiencing an ischemic stroke, a transient ischemic attack, or a hemorrhagic stroke. All patients were examined by a physician, and assessment was performed using a standardized questionnaire. HRQoL was assessed using the German version of the EuroQoL Index (EQ-5D) and the Health Utility Index 2 and 3 (HUI2/3). RESULTS: Four years after stroke, besides physical functioning, neuropsychological sequelae such as depression and cognitive impairment contributed to a reduced HRQoL. In addition, the incidence of incontinence proved to be an important factor for HRQoL. Explained variances in regression analysis models were high (R2=0.802 for HUI and 0.633 for EQ-5D--visual analogue scale) and were based on a few important determinants, including physical state, depression, cognitive impairment, and incontinence. CONCLUSIONS: Our results underscore the importance of nonmotor symptoms on HRQoL in patients with stroke.