Validation of the Patient-Doctor-Relationship Questionnaire (PDRQ-9) in a representative cross-sectional German population survey

The patient-doctor relationship (PDR) as perceived by the patient is an important concept in primary care and psychotherapy. The PDR Questionnaire (PDRQ-9) provides a brief measure of the therapeutic aspects of the PDR in primary care. We assessed the internal and external validity of the German version of the PDRQ-9 in a representative cross-sectional German population survey that included 2,275 persons aged≥14 years who reported consulting with a primary care physician (PCP). The acceptance of the German version of this questionnaire was good. Confirmatory factor analysis demonstrated that the PRDQ-9 was unidimensional. The internal reliability (Cronbach's α) of the total score was .95. The corrected item-total correlations were≥.94. The mean satisfaction index of persons with a probable depressive disorder was lower than that of persons without a probable depressive disorder, indicating good discriminative concurrent criterion validity. The correlation coefficient between satisfaction with PDR and satisfaction with pain therapy was r = .51 in 489 persons who reported chronic pain, indicating good convergent validity. Despite the limitation of low variance in the PDRQ-9 total scores, the results indicate that the German version of the PDRQ-9 is a brief questionnaire with good psychometric properties to assess German patients' perceived therapeutic alliance with PCPs in public health research

Association of different restriction levels with COVID-19-related distress and mental health in somatic inpatients: a secondary analysis of swiss general hospital data

Background: The coronavirus disease 2019 (COVID-19) pandemic and related countermeasures hinder health care access and affect mental wellbeing of non-COVID-19 patients. There is lack of evidence on distress and mental health of patients hospitalized due to other reasons than COVID-19-a vulnerable population group in two ways: First, given their risk for physical diseases, they are at increased risk for severe courses and death related to COVID-19. Second, they may struggle particularly with COVID-19 restrictions due to their dependence on social support. Therefore, we investigated the association of intensity of COVID-19 restrictions with levels of COVID-19-related distress, mental health (depression, anxiety, somatic symptom disorder, and mental quality of life), and perceived social support among Swiss general hospital non-COVID-19 inpatients. Methods: We analyzed distress of 873 hospital inpatients not admitted for COVID-19, recruited from internal medicine, gynecology, rheumatology, rehabilitation, acute geriatrics, and geriatric rehabilitation wards of three hospitals. We assessed distress due to the COVID-19 pandemic, and four indicators of mental health: depressive and anxiety symptom severity, psychological distress associated with somatic symptoms, and the mental component of health-related quality of life; additionally, we assessed social support. The data collection period was divided into modest (June 9 to October 18, 2020) and strong (October 19, 2020, to April 17, 2021) COVID-19 restrictions, based on the Oxford Stringency Index for Switzerland. Results: An additional 13% (95%-Confidence Interval 4-21%) and 9% (1-16%) of hospital inpatients reported distress related to leisure time and loneliness, respectively, during strong COVID-19 restrictions compared to times of modest restrictions. There was no evidence for changes in mental health or social support. Conclusions: Focusing on the vulnerable population of general hospital inpatients not admitted for COVID-19, our results suggest that tightening of COVID-19 restrictions in October 2020 was associated with increased COVID-19-related distress regarding leisure time and loneliness, with no evidence for a related decrease in mental health. If this association was causal, safe measures to increase social interaction (e.g., virtual encounters and outdoor activities) are highly warranted. Trial registration: www.ClinicalTrials.gov, identifier: NCT04269005

How can the practice nurse be more involved in the care of the chronically ill? The perspectives of GPs, patients and practice nurses

BACKGROUND: A well established "midlevel" of patient care, such as nurse practitioners and/or physician assistants, exits in many countries like the US, Canada, and Australia. In Germany, however there is only one kind of profession assisting the physician in practices, the practice nurse. Little is known about the present involvement of practice nurses in patients' care in Germany and about the attitudes of GPs, assistants and patients concerning an increased involvement. The aim of our study was to get qualitative information on the extent to which practice nurses are currently involved in the treatment of patients and about possibilities of increased involvement as well as on barriers of increased involvement. METHODS: We performed qualitative, semi-structured interviews with 20 GPs, 20 practice nurses and 20 patients in the Heidelberg area. The interviews were digitally recorded, transcribed and content-analysed with ATLAS.ti. RESULTS: Practice nurses are only marginally involved in the treatment of patients. GPs as well as patients were very sceptical about increased involvement in care. Patients were sceptical about nurses' professional background and feared a worsening of the patient doctor relationship. GPs also complained about the nurses' deficient education concerning medical knowledge. They feared a lack of time as well as a missing reimbursement for the efforts of an increased involvement. Practice nurses were mostly willing to be more involved, regarding it as an appreciation of their role. Important barriers were lack of time, overload with administrative work, and a lack of professional knowledge. CONCLUSION: Practice nurses were only little involved in patient care. GPs were more sceptical than patients regarding an increased involvement. One possible area, accepted by all interviewed groups, was patient education as for instance dietary counselling. New treatment approaches as the chronic care model will require a team approach which currently only marginally exists in the German health care system. Better medical education of practice nurses is indispensable, but GPs also have to accept that they cannot fulfil the requirement of future care alone

A European Research Agenda for Somatic Symptom Disorders, Bodily Distress Disorders, and Functional Disorders : Results of an Estimate-Talk-Estimate Delphi Expert Study

Background: Somatic Symptom Disorders (SSD), Bodily Distress Disorders (BDD) and functional disorders (FD) are associated with high medical and societal costs and pose a substantial challenge to the population and health policy of Europe. To meet this challenge, a specific research agenda is needed as one of the cornerstones of sustainable mental health research and health policy for SSD, BDD, and FD in Europe. Aim: To identify the main challenges and research priorities concerning SSD, BDD, and FD from a European perspective. Methods: Delphi study conducted from July 2016 until October 2017 in 3 rounds with 3 workshop meetings and 3 online surveys, involving 75 experts and 21 European countries. EURONET-SOMA and the European Association of Psychosomatic Medicine (EAPM) hosted the meetings. Results: Eight research priorities were identified: (1) Assessment of diagnostic profiles relevant to course and treatment outcome. (2) Development and evaluation of new, effective interventions. (3) Validation studies on questionnaires or semi-structured interviews that assess chronic medical conditions in this context. (4) Research into patients preferences for diagnosis and treatment. (5) Development of new methodologic designs to identify and explore mediators and moderators of clinical course and treatment outcomes (6). Translational research exploring how psychological and somatic symptoms develop from somatic conditions and biological and behavioral pathogenic factors. (7) Development of new, effective interventions to personalize treatment. (8) Implementation studies of treatment interventions in different settings, such as primary care, occupational care, general hospital and specialty mental health settings. The general public and policymakers will benefit from the development of new, effective, personalized interventions for SSD, BDD, and FD, that will be enhanced by translational research, as well as from the outcomes of research into patient involvement, GP-patient communication, consultation-liaison models and implementation. Conclusion: Funding for this research agenda, targeting these challenges in coordinated research networks such as EURONET-SOMA and EAPM, and systematically allocating resources by policymakers to this critical area in mental and physical well-being is urgently needed to improve efficacy and impact for diagnosis and treatment of SSD, BDD, and FD across Europe

Management of patients with persistent medically unexplained symptoms: a descriptive study

Background: In 2013 the Dutch guideline for management of medically unexplained symptoms (MUS) was published. The aim of this study is to assess medical care for patients with persistent MUS as recorded in their electronic medical records, to investigate if this is in line with the national guideline for persistent MUS and whether there are changes in care over time. Methods: We conducted an observational study of adult primary care patients with MUS. Routinely recorded health care data were extracted from electronic medical records of patients participating in an ongoing randomised controlled trial in 30 general practices in the Netherlands. Data on general practitioners’ (GPs’) management strategies during MUS consultations were collected in a 5-year period for each patient prior. Management strategies were categorised according to the options offered in the Dutch guideline. Changes in management over time were analysed. Results: Data were collected from 1035 MUS consultations (77 patients). Beside history-taking, the most frequently used diagnostic strategies were physical examination (24.5%) and additional investigations by the GP (11.1%). Frequently used therapeutic strategies were prescribing medication (24.6%) and providing explanations (11.2%). As MUS symptoms persisted, GPs adjusted medication, discussed progress and scheduled follow-up appointments more frequently. The least frequently used strategies were exploration of all complaint dimensions (i.e. somatic, cognitive, emotional, behavioural and social) (3.5%) and referral to a psychologist (0.5%) or psychiatrist (0.1%). Conclusions: Management of Dutch GPs is partly in line with the Dutch guideline. Medication was possibly prescribed more frequently than recommended, whereas exploration of all complaint dimensions, shared problem definition and referral to mental health care were used less

The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial

Background: Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychological interventions can reduce symptoms associated with USD and improve functioning. Previous research has either been conducted in secondary care or interventions have been provided by general practitioners (GPs) or psychologists in primary care. As efficiency and cost-effectiveness are imperative in primary care, it is important to investigate whether nurse-led interventions are effective as well. The aim of this study is to examine the effectiveness and cost-effectiveness of a short cognitive behavioural therapy (CBT)-based treatment for patients with USD provided by mental health nurse practitioners (MHNPs), compared to usual care. Methods: In a cluster randomised controlled trial, 212 adult patients with USD will be assigned to the intervention or care as usual. The intervention group will be offered a short, individual CBT-based treatment by the MHNP in addition to usual GP care. The main goal of the intervention is that patients become less impaired by their physical symptoms and cope with symptoms in a more effective way. In six sessions patients will receive problem-solving treatment. The primary outcome is improvement in physical functioning, measured by the physical component summary score of the RAND-36. Secondary outcomes include health-related quality of life measured by the separate subscales of the RAND-36, somatization (PHQ-15) and symptoms of depression and anxiety (HADS). Problem-solving skills, health anxiety, illness perceptions, coping, mastery and working alliance will be assessed as potential mediators. Assessments will be done at 0, 2, 4, 8 and 12 months. An economic evaluation will be conducted from a societal perspective with quality of life as the primary outcome measure assessed by the EQ-5D-5L. Health care, patient and lost productivity costs will be assessed with the Tic-P. Discussion: We expect that the intervention will improve physical functioning and is cost-effective compared to usual care. If so, more patients might successfully be treated in general practice, decreasing the number of referrals to specialist care. Trial registration: Dutch Trial Registry, identifier: NTR4686, Registered on 14 July 2014. © 2017 The Author(s)

A European research agenda for somatic symptom disorders, bodily distress disorders, and functional disorders: Results of an estimate-talk-estimate delphi expert study

Background: Somatic Symptom Disorders (SSD), Bodily Distress Disorders (BDD) and functional disorders (FD) are associated with high medical and societal costs and pose a substantial challenge to the population and health policy of Europe. To meet this challenge, a specific research agenda is needed as one of the cornerstones of sustainable mental health research and health policy for SSD, BDD, and FD in Europe. Aim: To identify the main challenges and research priorities concerning SSD, BDD, and FD from a European perspective. Methods: Delphi study conducted from July 2016 until October 2017 in 3 rounds with 3 workshop meetings and 3 online surveys, involving 75 experts and 21 European countries. EURONET-SOMA and the European Association of Psychosomatic Medicine (EAPM) hosted the meetings. Results: Eight research priorities were identified: (1) Assessment of diagnostic profiles relevant to course and treatment outcome. (2) Development and evaluation of new, effective interventions. (3) Validation studies on questionnaires or semi-structured interviews that assess chronic medical conditions in this context. (4) Research into patients preferences for diagnosis and treatment. (5) Development of new methodologic designs to identify and explore mediators and moderators of clinical course and treatment outcomes (6). Translational research exploring how psychological and somatic symptoms develop from somatic conditions and biological and behavioral pathogenic factors. (7) Development of new, effective interventions to personalize treatment. (8) Implementation studies of treatment interventions in different settings, such as primary care, occupational care, general hospital and specialty mental health settings. The general public and policymakers will benefit from the development of new, effective, personalized interventions for SSD, BDD, and FD, that will be enhanced by translational research, as well as from the outcomes of research into patient involvement, GP-patient communication, consultation-liaison models and implementation. Conclusion: Funding for this research agenda, targeting these challenges in coordinated research networks such as EURONET-SOMA and EAPM, and systematically allocating resources by policymakers to this critical area in mental and physical well-being is urgently needed to improve efficacy and impact for diagnosis and treatment of SSD, BDD, and FD across Europe

The alternative serotonin transporter promoter P2 impacts gene function in females with irritable bowel syndrome

Irritable bowel syndrome (IBS) is a gut-brain disorder in which symptoms are shaped by serotonin acting centrally and peripherally. The serotonin transporter gene SLC6A4 has been implicated in IBS pathophysiology, but the underlying genetic mechanisms remain unclear. We sequenced the alternative P2 promoter driving intestinal SLC6A4 expression and identified single nucleotide polymorphisms (SNPs) that were associated with IBS in a discovery sample. Identified SNPs built different haplotypes, and the tagging SNP rs2020938 seems to associate with constipation-predominant IBS (IBS-C) in females. rs2020938 validation was performed in 1978 additional IBS patients and 6,038 controls from eight countries. Meta-analysis on data from 2,175 IBS patients and 6,128 controls confirmed the association with female IBS-C. Expression analyses revealed that the P2 promoter drives SLC6A4 expression primarily in the small intestine. Gene reporter assays showed a functional impact of SNPs in the P2 region. In silico analysis of the polymorphic promoter indicated differential expression regulation. Further follow-up revealed that the major allele of the tagging SNP rs2020938 correlates with differential SLC6A4 expression in the jejunum and with stool consistency, indicating functional relevance. Our data consolidate rs2020938 as a functional SNP associated with IBS-C risk in females, underlining the relevance of SLC6A4 in IBS pathogenesis

The serotonin receptor 3E variant is a risk factor for female IBS-D

Irritable bowel syndrome (IBS) is a gut-brain disorder of multifactorial origin. Evidence of disturbed serotonergic function in IBS accumulated for the 5-HT3 receptor family. 5-HT3Rs are encoded by HTR3 genes and control GI function, and peristalsis and secretion, in particular. Moreover, 5-HT3R antagonists are beneficial in the treatment of diarrhea predominant IBS (IBS-D). We previously reported on functionally relevant SNPs in HTR3A c.-42C > T (rs1062613), HTR3C p.N163K (rs6766410), and HTR3E c.*76G > A (rs56109847 = rs62625044) being associated with IBS-D, and the HTR3B variant p.Y129S (rs1176744) was also described within the context of IBS. We performed a multi-center study to validate previous results and provide further evidence for the relevance of HTR3 genes in IBS pathogenesis. Therefore, genotype data of 2682 IBS patients and 9650 controls from 14 cohorts (Chile, Germany (2), Greece, Ireland, Spain, Sweden (2), the UK (3), and the USA (3)) were taken into account. Subsequent meta-analysis confirmed HTR3E c.*76G > A (rs56109847 = rs62625044) to be associated with female IBS-D (OR = 1.58; 95% CI (1.18, 2.12)). Complementary expression studies of four GI regions (jejunum, ileum, colon, sigmoid colon) of 66 IBS patients and 42 controls revealed only HTR3E to be robustly expressed. On top, HTR3E transcript levels were significantly reduced in the sigma of IBS patients (p = 0.0187); more specifically, in those diagnosed with IBS-D (p = 0.0145). In conclusion, meta-analysis confirmed rs56109847 = rs62625044 as a risk factor for female IBS-D. Expression analysis revealed reduced HTR3E levels in the sigmoid colon of IBS-D patients, which underlines the relevance of HTR3E in the pathogenesis of IBS-D