Clinical effectiveness of patient-targeted feedback following depression screening in general practice (GET.FEEDBACK.GP): an investigator-initiated, prospective, multicentre, three-arm, observer-blinded, randomised controlled trial in Germany.

BACKGROUND: Screening for depression in primary care alone is not sufficient to improve clinical outcomes. However, targeted feedback of the screening results to patients might result in beneficial effects. The GET.FEEDBACK.GP trial investigated whether targeted feedback of the depression screening result to patients, in addition to feedback to general practitioners (GPs), leads to greater reductions in depression severity than GP feedback alone or no feedback. METHODS: The GET.FEEDBACK.GP trial was an investigator-initiated, multicentre, three-arm, observer-blinded, randomised controlled trial. Depression screening was conducted electronically using the Patient Health Questionnaire-9 (PHQ-9) in 64 GP practices across five regions in Germany while patients were waiting to see their GP. Currently undiagnosed patients (aged ≥18 years) who screened positive for depression (PHQ-9 score ≥10), were proficient in the German language, and had a personal consultation with a GP were randomly assigned (1:1:1) into a group that received no feedback on their depression screening result, a group in which only the GP received feedback, or a group in which both GP and patient received feedback. Randomisation was stratified by treating GP and PHQ-9 depression severity. Trial staff were masked to patient enrolment and study group allocation and GPs were masked to the feedback recieved by the patient. Written feedback, including the screening result and information on depression, was provided to the relevant groups before the consultation. The primary outcome was PHQ-9-measured depression severity at 6 months after randomisation. An intention-to-treat analysis was conducted for patients who had at least one follow-up visit. This study is registered at ClinicalTrials.gov (NCT03988985) and is complete. FINDINGS: Between July 17, 2019, and Jan 31, 2022, 25 279 patients were approached for eligibility screening, 17 150 were excluded, and 8129 patients completed screening, of whom 1030 (12·7%) screened positive for depression. 344 patients were randomly assigned to receive no feedback, 344 were assigned to receive GP-targeted feedback, and 339 were assigned to receive GP-targeted plus patient-targeted feedback. 252 (73%) patients in the no feedback group, 252 (73%) in the GP-targeted feedback group, and 256 (76%) in the GP-targeted and patient-targeted feedback group were included in the analysis of the primary outcome at 6 months, which reflected a follow-up rate of 74%. Gender was reported as female by 637 (62·1%) of 1025 participants, male by 384 (37·5%), and diverse by four (0·4%). 169 (16%) of 1026 patients with available migration data had a migration background. Mean age was 39·5 years (SD 15·2). PHQ-9 scores improved for each group between baseline and 6 months by -4·15 (95% CI -4·99 to -3·30) in the no feedback group, -4·19 (-5·04 to -3·33) in the GP feedback group, and -4·91 (-5·76 to -4·07) in the GP plus patient feedback group, with no significant difference between the three groups (global p=0·13). The difference in PHQ-9 scores when comparing the GP plus patient feedback group with the no feedback group was -0·77 (-1·60 to 0·07, d=-0·16) and when comparing with the GP-only feedback group was -0·73 (-1·56 to 0·11, d=-0·15). No increase in suicidality was observed as an adverse event in either group. INTERPRETATION: Providing targeted feedback to patients and GPs after depression screening does not significantly reduce depression severity compared with GP feedback alone or no feedback. Further research is required to investigate the potential specific effectiveness of depression screening with systematic feedback for selected subgroups. FUNDING: German Innovation Fund. TRANSLATION: For the German translation of the abstract see Supplementary Materials section.

What motivates GPs to train medical students in their own practice? A questionnaire survey on the motivation of medical practices to train students as an approach to acquire training practices.

Background: With the new licensing regulations for doctors coming into force, medical faculties are faced with the task of recruiting and qualifying more GP colleagues to train students in their practices. Objective: The aim of the study was to determine the motivation of GPs to train students in their own medical practices. Method: A cross-sectional survey of Thuringian GPs was conducted from April to May 2020. 21 items on motivation, incentives and barriers were recorded and examined using univariate and multivariate analyses. Results: The response rate was 35.8% (538/1,513). The GPs surveyed considered themselves motivated to train students in their medical practices. The motives can be described as predominantly intrinsic: the mutual exchange of knowledge, desire to share knowledge and to promote future doctors. Incentives included the opportunity to keep up to date with the latest knowledge, further training and contacts with colleagues. Barriers to teaching in the own medical practice were concerns about not being able to treat the same number of patients, a possible disruption of practice operations and lack of space. An analysis of the subgroups of GPs who were not yet teaching physicians indicated similar motives and barriers regarding training students in their practices, with a slightly lower overall motivation. Conclusion: The results describe the facets of the motivation of Thuringian GPs to train students and can be helpful for the expansion of a sustainable network of training GP practices. It is essential to address motives, to counter difficulties with individual solutions and to create targeted incentives.

Outpatient teaching in specialist practices - a qualitative study with doctors about attitudes, influencing factors and specialist features.

Aim: The aim is to record existing attitudes, influencing factors and specialised requirements with regard to the training of medical students in specialist outpatient care with doctors working in outpatient care. Method: Between September 2020 and May 2021, individual interviews with 15 specialists employed in outpatient care were held as part of this qualitative study. The recorded interviews were evaluated structurally in accordance with the Kuchartz method. Results: Enhanced outpatient training for medical students in specialist teaching practices was considered as important by all participants. Among other things, motivational factors were pleasure in teaching, a feeling of duty, the desire to pass something on, the need to convey one's own ideas and to generate future talent for the field. A lack of time, greater organisational effort and legal concerns were stated as hurdles. Reducing organisational effort for teaching practices, appreciation of their teaching activity and financial considerations were in particular given as significant incentives for participating. The attitude of participants towards financial remuneration was heterogeneous. Different specialist features and requirements for student training were mapped out. Conclusion: This study provides, for the first time, findings about teaching in specialist outpatient establishments. They point to a great degree of willingness of specialist doctors to undertake teaching and provide starting points for creating concepts about producing teaching practices in specialist fields. Further quantitative investigation is required to substantiate the findings before us.

Illness behaviour and influencing aspects of general practitioners in Germany and their use of the health care system: a qualitative study.

OBJECTIVES: The aim of this study was to explore aspects that play a role when general practitioners (GPs) become ill and thus gain a more comprehensive understanding of the overall illness behaviour of GPs and their use of the healthcare system. SETTING: Primary care practices in Thuringia, Germany. PARTICIPANTS: Convenience sample of 16 GPs. DESIGN: Qualitative study design with semistructured interviews and content analysis. RESULTS: Using our approach of having participants report their own episodes of illness, we found that self-treatment was practised and accepted by all 16 participants. The widespread use of naturopathy and complementary methods seems to be a special feature of German GPs. Formal use of the healthcare system mainly took place through direct consultation with specialists.Our study revealed various aspects influencing the illness behaviour of the GPs and their use of the healthcare system. Some aspects also apply to lay patients, but it became clear how strongly illness behaviour is influenced by participants' activities as physicians. Noteworthy and less described aspects are especially the influence of patients and practice staff, the influence of biographical and professional imprint and the attitudes and values of the physicians.Complex inter-relationships were found between illness behaviour and influencing aspects; these are subjected to a dynamic and recursive process. CONCLUSIONS: The illness behaviour of German GPs seems to be comprehensively influenced by their activities as responsible healthcare providers. The ability to perceive and reflect in this regards should already be actively promoted in studies and further education. Further research is needed for a better understanding of the inter-relationships.

[Participation rate of diabetes patients in structured education programs and reasons for non-participation: A cross-sectional survey among patients with diabetes mellitus in Thuringia]. / Teilnahmerate von Diabetespatient*innen an einer strukturierten Schulung und Gründe für eine Nicht-Teilnahme: eine querschnittliche Befragung von Patient*innen mit Diabetes mellitus in Thüringen.

BACKGROUND AND AIM: Structured education programs for patients with diabetes mellitus are an important and effective component of therapy. The aim of this survey is to assess the rate of participation in education programs in selected practices in Thuringia. Furthermore, we intend to identify factors that influence participation in order to derive strategies to increase participation. METHODS: Survey of patients with diabetes in Thuringian general practices and a diabetology practice using a newly developed questionnaire regarding "patient characteristics", "diabetes characteristics", "DMP and education programs" as well as reasons for non-participation in education programs and the wishes of non-educated patients. Data were analyzed using binary logistic regression analysis and other descriptive statistics in SPSS (IBM). RESULTS: Of the 1,254 questionnaires sent out, 637 (51%) were returned. Participation rate in education programs was 68% (n=405). HbA1c > 7.5%, diabetes sequelae, DMP participation and the awareness of education programs were significantly associated with participation in education programs. Recommendation/invitation to education programs, complex treatment regimes, long diabetes duration and urban practice led to a significant increase in the odds of attending an education program. Non-educated patients subjectively mentioned lack of need for training, lack of information, logistical reasons, and lack of time as reasons for non-participation. They expressed the wish for more information and recommendations from their general practitioner, shorter duration of education programs and online offerings. DISCUSSION: The participation rate in education programs was in the range of the evaluation reports on DMP programs for diabetes. Lower participation rates in rural areas may be explained by the lower physician density and especially education program offers as well as the more difficult accessibility. The factors and reasons for non-participation underline the need for comprehensive care and the general practitioner's key role in motivating, coordinating and educating patients. CONCLUSION: General practitioners play a central role in the care of patients with diabetes, and there is a need for comprehensive care and education programs. Telemedicine and digital applications can complement DMP and education programs.

Trajectories of depression in sepsis survivors: an observational cohort study.

BACKGROUND: Advances in critical care medicine have led to a growing number of critical illness survivors. A considerable part of them suffers from long-term sequelae, also known as post-intensive care syndrome. Among these, depressive symptoms are frequently observed. Depressive symptom trajectories and associated factors of critical illness survivors have rarely been investigated. Study objective was to explore and compare different trajectories of depressive symptoms in sepsis survivors over 1 year after discharge from ICU. METHODS: Data of a randomized controlled trial on long-term post-sepsis care were analyzed post hoc. Depressive symptoms were collected at 1, 6 and 12 months post-ICU discharge using the Major Depression Inventory (MDI), among others. Statistical analyses comprised descriptive analysis, univariate and multivariate, linear and logistic regression models and Growth Mixture Modeling. RESULTS: A total of 224 patients were included into this analysis. We identified three latent classes of depressive symptom trajectories: Over the course of 1 year, 152 patients recovered from mild symptoms, 27 patients showed severe persistent symptoms, and 45 patients recovered from severe symptoms. MDI sum scores significantly differed between the three classes of depressive symptom trajectories at 1 and 6 months after ICU discharge (p < 0.024 and p < 0.001, respectively). Compared with other classes, patients with the mild recovered trajectory showed lower levels of chronic pain (median sum score of 43.3 vs. 60.0/53.3 on the Graded Chronic Pain Scale, p < 0.010) and posttraumatic stress (4.6% with a sum score of ≥ 35 on the Posttraumatic Stress Scale 10 vs. 48.1%/33.3%, p < 0.003); and higher levels of health-related quality of life (HRQOL) using the Short Form-36 scale within 1 month after ICU discharge (p < 0.035). CONCLUSIONS: In the first year after discharge from ICU, sepsis survivors showed three different trajectories of depressive symptoms. Course and severity of depressive symptoms were associated with chronic pain, posttraumatic stress and reduced HRQOL at discharge from ICU. Regular screening of sepsis survivors on symptoms of depression, chronic pain and posttraumatic stress within 1 year after ICU may be considered. Trial registration ISRCTN, ISRCTN 61744782. Registered April 19, 2011-Retrospectively registered, http://www.isrctn.com/ISRCTN61744782 .

Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial.

INTRODUCTION: Approximately one out of six patients in primary care suffers from depression, which often remains undetected. Evidence regarding the efficacy of depression screening in primary care, however, is inconsistent. A previous single-centre randomised controlled trial (RCT) in cardiac patients, the DEPSCREEN-INFO trial, provided the first evidence that written feedback to patients following a positive depression screening reduces depression severity and leads to more comprehensive patient engagement in mental healthcare. To amplify these effects, the feedback should be tailored according to patients' needs and preferences. The GET.FEEDBACK.GP RCT will test the efficacy of this patient-targeted feedback intervention in primary care. METHODS AND ANALYSIS: The multicentre three-arm GET.FEEDBACK.GP RCT aims to recruit a total of 1074 primary care patients from North, East and South Germany. Patients will be screened for depression using the Patient Health Questionnaire-9 (PHQ-9). In the case of a positive depression screening result (PHQ-9 score ≥10), the participant will be randomised into one of three groups to either receive (a) patient-targeted and general practitioner (GP)-targeted feedback regarding the depression screening results, (b) only GP-targeted feedback or (c) no feedback. Patients will be followed over a period of 12 months. The primary outcome is depression severity (PHQ-9) 6 months after screening. Secondary outcomes include patient engagement in mental healthcare, professional depression care and cost-effectiveness. According to a statistical analysis plan, the primary endpoint of all randomised patients will be analysed regarding the intention-to-treat principle. ETHICS AND DISSEMINATION: The Ethics Committee of the Hamburg Medical Association approved the study. A clinical trial company will ensure data safety, monitoring and supervision. The multicentre GET.FEEDBACK.GP RCT is the first trial in primary care that tests the efficacy of a patient-targeted feedback intervention as an adjunct to depression screening. Its results have the potential to influence future depression guidelines and will be disseminated in scientific as well as patient-friendly language. TRIAL REGISTRATION NUMBER: NCT03988985.

Psychological interventions for posttraumatic stress disorder involving primary care physicians: systematic review and Meta-analysis of randomized controlled trials.

BACKGROUND: Evidence-based psychological interventions for posttraumatic stress disorder (PTSD) are available in specialized settings, but adequate care in primary care is often lacking. The aim of this systematic review was to determine the effectiveness of psychological interventions for PTSD involving primary care physicians (PCPs) and to characterize these interventions as well as their providers. METHOD: A systematic review and meta-analyses of randomized controlled trials (RCTs). Primary outcome were symptoms of PTSD. RESULTS: Four RCTs with a total of 774 patients suffering from PTSD symptoms were included, all applying cognitive behavioural based interventions. Three studies with psychological interventions being conducted by case managers were pooled in a meta-analysis. Interventions were not effective in the short term (0-6 months; SMD, - 0.1; 95% CI, - 0.24-0.04; I2 = 0%). Only two studies contributed to the meta-analysis for long term (12-18 months) outcomes yielding a small effect (SMD, - 0.23; 95% CI, - 0.38- -0.08; I2 = 0%). CONCLUSIONS: Psychological interventions for PTSD in primary care settings may be effective in the long term but number and quality of included studies was limited so the results should be interpreted with caution.

[Panic disorder and agoraphobia in general practice: Advantages and pitfalls of a practice team-supported exposure training from the general practitioner's perspective - a qualitative study]. / Panikstörung und Agoraphobie hausärztlich behandelt: Vorzüge und Fallstricke eines Praxisteam-unterstützten Expositionstrainings aus Sicht von Hausärztinnen und Hausärzten ­ eine qualitative Studie.

INTRODUCTION: For the treatment of anxiety disorders behavior therapy-oriented methods are recommended for primary care as well. Within the trial "Jena-PARADISE" a primary care practice team-supported exposure training for patients with panic disorder with or without agoraphobia was developed and evaluated. The present paper gives an overview of general practitioners' subjective views on the practicability, feasibility and effectiveness of this new intervention for both patients and GP teams. METHODS: Questions were operationalized based on Bellg's intervention fidelity framework. Fourteen GPs of the intervention group were sampled purposefully and interviewed in a semi-structured way. Generated data were analyzed following Mayring's content analysis approach. RESULTS: The treatment program was positively assessed among the GPs and seen as a useful therapeutic option for inadequately treated patients. The therapy elements 'psycho-education' and 'interoceptive exposure exercises' were described as feasible, while situational exercises and relapse prevention got a less positive rating. The active participation of the nurse in the treatment program was seen as supportive. CONCLUSION: From the GP perspective, the treatment program for patients with panic disorder and/or agoraphobia seems to be a viable therapeutic option in primary care.

German general practitioners' self-reported management of patients with chronic depression.

BACKGROUND: Patients with chronic depression (persisting symptoms for ≥2 years) are a clinically relevant group with extensive (co)morbidity, high functional impairment and associated costs in primary care. The General Practitioner (GP) is the main health professional attending to these patients. The aim of this study was to examine the GPs' perception on managing patients with chronic depression. METHODS: We performed an explorative cross-sectional study with a systematic sample of GPs in central Germany. Source of data was a written questionnaire (46 items). Descriptive analysis was carried out. RESULTS: Two hundred twenty (out of 1000; 22%) GPs participated. 93% of the GPs distinguish between care for patients with chronic depression and acute depressive episode. 92% would recommend psychotherapeutic co-treatment to the chronically depressed patient. 52% of GPs would favour a general restraint on antidepressants (ADs) in older chronically depressed patients (≥ 75 years) whereas 40% suggest long-term pharmacotherapy. If severe physical comorbidity is present GPs would be restrictive in prescribing ADs (65%) or would urgently refer to specialist psychiatric services (40%). In case of a comorbid anxiety disorder 66% of the GPs would suggest a combined psycho- und pharmacotherapy. If a substance use disorder coexists 84% would prefer urgent referrals to specialist services. CONCLUSIONS: Participating GPs report awareness towards chronic depression in their patients. Physical and mental comorbidity seem to play an important role in GPs' treatment decisions.

Depression management within GP-centered health care - A case-control study based on claims data.

OBJECTIVE: For most patients with depression, GPs are the first and long-term medical providers. GP-centered health care (GPc-HC) programs target patients with chronic diseases. What are the effects of GPc-HC on primary care depression management? METHOD: An observational retrospective case-control study was conducted using health insurance claims data of patients with depressive disorder from July 2011 to December 2012. RESULTS: From 40,298 patients insured with the largest health plan in Central Germany participating in the GPc-HC program (intervention group, IG), we observed 4645 patients with depression over 18months: 72.2% women; 66.6years (mean); multiple conditions (morbidity-weight 2.50 (mean), 86%>1.0). We compared them with 4013 patients who did not participate (control group). In participants we found lower number of incomplete/non-specified depression diagnoses (4.46vs.4.82;MD-0.36; p<0.01); lower rate of patients consulting more than one GP-practice (49.1%vs.58.0%;PP-8.9;p<0.01); more GP-contacts (18.19vs.15.59;MD+2.60;p<0.01); more GP-initiated referrals to specialists (82.9%vs.79.3%;PP+3.6;p<0.05), more antidepressant pharmacotherapy prescribed by a GP (37.9%vs.35.4%;PP+2.5;p<0.05), more frequent guideline-concordant therapy duration (19.2%vs.13.1%;PP+6.1;p<0.01) and more patients receiving "GP-psychosomatic basic care" (38.2%vs.30.2%;PP+8.0;p<0.01). CONCLUSION: Depressive patients participating in a GPc-HC program may be more often diagnosed by a GP, receive symptom-monitoring and appropriate depression treatment.

The Impact of GP-Centered Healthcare.

BACKGROUND: In Germany, enhanced primary care ('GP-centered health care') is being promoted in order to strengthen the role of GPs and improve the quality of primary care. The aim of this study was to evaluate the impact of a GPcentered healthcare program, established in 2011 in the German federal state of Thuringia, on healthcare costs, care coordination, and pharmacotherapy. METHODS: We conducted a retrospective case-control study based on insurance claims data. Participants were followed from 18 months before the start of the program to 18 months after its introduction. The intervention and control groups were matched via propensity scores. RESULTS: 40 298 participants enrolled in the program for a minimum of 18 months (between July 2011 and December 2012) were included in the intervention arm of the study. The mean age was 64.8 years. There was no significant difference in total direct costs (primary outcome) between cases and controls. Turning to secondary outcomes, the number of GP consultations rose sharply (+47%; p<0.001), there were less patients who consulted more than one GP (-41.4%; p<0.001), and less specialist consultations without referral (-5.8%; p<0.001) among patients in the intervention group. The number of patients who participated in Disease Management Programs (DMPs) increased (+17.7%; p<0.001), as did the number of GP home visits (+5.0%; p<0.001), specialist consultations (+4.1%; p<0.01), and the number of hospitalizations (+4.3%; p=0.006). The costs for pharmaceuticals were lowered by 3.9% (p<0.001). CONCLUSION: The study indicates that the GP-centered healthcare program does not lead to lower direct health care costs. However, it may lead to more intense and better coordinated healthcare in older, chronically ill patients with multiple conditions. Further studies are needed on long-term effects and clinical endpoints.

Self-efficacy in multimorbid elderly patients with osteoarthritis in primary care--influence on pain-related disability.

The impact of self-efficacy on pain-related disability in multimorbid elderly patients in primary care is not known. The aim of our study was to analyze the influence of self-efficacy on the relation between pain intensity and pain-related disability, controlled for age and disease count, in aged multimorbid primary care patients with osteoarthritis and chronic pain. Patients were recruited in the German MultiCare study (trial registration: ISRCTN89818205). Pain was assessed using the Graded Chronic Pain Scale, and self-efficacy using the General Self-Efficacy Scale. We employed SPSS for statistical analysis. One thousand eighteen primary care patients were included in the study. Correlation analyses showed significant correlations between pain intensity and pain-related disability (r = 0.591, p < 0.001), pain intensity and general self-efficacy (r = 0.078, p < 0.05), and between general self-efficacy and pain-related disability (r = 0.153, p < 0.001). Multiple mediator analysis gives indications that self-efficacy partially mediates the relation between pain intensity and pain-related disability. In our results, we found little evidence that self-efficacy partially mediates the relation between pain intensity and pain-related disability in aged multimorbid primary care patients with osteoarthritis and chronic pain. Further research is necessary to prove the effect.

Analysis of the effects of androgens and training on myostatin propeptide and follistatin concentrations in blood and skeletal muscle using highly sensitive immuno PCR.

Myostatin propeptide (MYOPRO) and follistatin (FOLLI) are potent myostatin inhibitors. In this study we analysed effects of training and androgens on MYOPRO and FOLLI concentrations in blood and skeletal muscle using Immuno PCR. Young healthy males performed either a 3-month endurance training or a strength training. Blood and biopsy samples were analysed. Training did not significantly affect MYOPRO and FOLLI concentrations in serum and muscle. To investigate whether total skeletal muscle mass may affect circulating MYOPRO and FOLLI levels, blood samples of tetraplegic patients, untrained volunteers and bodybuilders were analysed. MYOPRO was significantly increased exclusively in the bodybuilder group. In orchiectomised rats MYOPRO increased in blood and muscle after treatment with testosterone. In summary our data demonstrate that moderate training does not affect the concentrations of MYOPRO to FOLLI. In contrast androgen treatment results in a significant increase of MYOPRO in skeletal muscle and serum.

The German MultiCare-study: Patterns of multimorbidity in primary health care - protocol of a prospective cohort study.

BACKGROUND: Multimorbidity is a highly frequent condition in older people, but well designed longitudinal studies on the impact of multimorbidity on patients and the health care system have been remarkably scarce in numbers until today. Little is known about the long term impact of multimorbidity on the patients' life expectancy, functional status and quality of life as well as health care utilization over time. As a consequence, there is little help for GPs in adjusting care for these patients, even though studies suggest that adhering to present clinical practice guidelines in the care of patients with multimorbidity may have adverse effects. METHODS/DESIGN: The study is designed as a multicentre prospective, observational cohort study of 3.050 patients aged 65 to 85 at baseline with at least three different diagnoses out of a list of 29 illnesses and syndromes. The patients will be recruited in approx. 120 to 150 GP surgeries in 8 study centres distributed across Germany. Information about the patients' morbidity will be collected mainly in GP interviews and from chart reviews. Functional status, resources/risk factors, health care utilization and additional morbidity data will be assessed in patient interviews, in which a multitude of well established standardized questionnaires and tests will be performed. DISCUSSION: The main aim of the cohort study is to monitor the course of the illness process and to analyse for which reasons medical conditions are stable, deteriorating or only temporarily present. First, clusters of combinations of diseases/disorders (multimorbidity patterns) with a comparable impact (e.g. on quality of life and/or functional status) will be identified. Then the development of these clusters over time will be analysed, especially with regard to prognostic variables and the somatic, psychological and social consequences as well as the utilization of health care resources. The results will allow the development of an instrument for prediction of the deterioration of the illness process and point at possibilities of prevention. The practical consequences of the study results for primary care will be analysed in expert focus groups in order to develop strategies for the inclusion of the aspects of multimorbidity in primary care guidelines.

Detection of Rotavirus from stool samples using a standardized immuno-PCR ("Imperacer") method with end-point and real-time detection.

Immuno-PCR (IPCR) has been studied to increase the detection sensitivity of current enzyme-linked immuno-sorbent assays (ELISA) as a novel approach for the early detection of Rotavirus infection, a major source for serious diarrhoea for susceptible risk groups. IPCR utilizes specific antibody-DNA conjugates with subsequent amplification of the marker-DNA. An antibody-DNA conjugate specific for Rotavirus antigen VP6 was synthesized and used in combination with a commercially available Rotavirus-ELISA kit. IPCR was carried out using reagents and protocols of the standardized Imperacer system. Real-time PCR monitoring of the marker-DNA amplification was compared to endpoint quantification of amplified haptene-labeled PCR products, using a microtiterplate-based PCR-ELISA. In spiked calibration samples, as few as 100 virus particles/ml could be clearly detected using the IPCR method and either real-time or end-point quantification compared to about 100,000 virus particles/ml in ELISA. Rotavirus positive and negative stool samples were correctly identified by IPCR with a clear separation even of a 10,000-fold dilution of the positive stool samples from the negative control.

The impact of fetal renal pelvic diameter on postnatal outcome.

OBJECTIVES: To determine thresholds for the fetal renal pelvic anterior-posterior diameter (APD) predicting postnatal clinically relevant pelvicaliceal dilatation. METHODS: One hundred and forty-eight infants whose prenatal sonography had identified an isolated uni- or bilateral fetal APD of > or = 4 mm before 33 and/or > or = 7 mm after 33 weeks' gestational age were investigated postnatally. On the basis of postnatal ultrasound examination, these infants were grouped according to the Society for Fetal Urology Grading System: no pelvic dilatation (n = 38); only pelvic dilatation (n = 59); pelvicaliceal dilatation (n = 33); pelvicaliceal and ureter dilatation (n = 18). RESULTS: Fetal pyelectasis of 7 mm was 89.3% sensitive and 78.9% specific < 33 weeks, and > or = 33 weeks pyelectasis of 10 mm was 88.4% and 78.6% in predicting subsequent postnatal pelvicaliectasis, respectively. Using a threshold of 4 mm < 33 weeks and 7 mm > or = 33 weeks yielded a sensitivity of 100% and a specificity of 18.7% and 47.8%, respectively. The median APD (range) at > or = 33 weeks was 19 mm (9-36 mm) in patients requiring surgery and 13 mm (7-21 mm) in conservatively treated patients (p = 0.001). Thirteen of fourteen patients with APD > or = 19 mm underwent surgery. CONCLUSION: Women with ultrasonographically detected prenatal fetal pelvic dilatation of > or = 4 mm before 33 weeks and of > or = 7 mm from 33 weeks onwards of gestation should have repeated prenatal ultrasound scans and a detailed postnatal evaluation. The dilatations of an APD > 4 mm before 33 weeks, which have disappeared at the post-33-week scan need no further investigation in the postnatal period.