Bias in retrospective assessment of perceived dental treatment effects when using the Oral Health Impact Profile

Abstract Purpose Aim of this exploratory study was to investigate whether a retrospective assessment of oral health-related quality of life (OHRQoL) using the Oral Health Impact Profile (OHIP) is susceptible to bias such as implicit theory of change and cognitive dissonance. Methods In this prospective clinical study, a sample of 126 adult patients (age 17–83 years, 49% women) requiring prosthodontic treatment was consecutively recruited. The OHRQoL was assessed using the 49-item OHIP at baseline and at follow-up. Additionally, patients were asked at followup to retrospectively rate their oral health status at baseline (retrospective pretest or then-test) and the change in oral health status using a global transition question. Furthermore, patients’ ratings of overall oral health and general health were used as validity criteria for the OHRQoL assessments. Response shift was calculated as the difference between the initial and retrospective baseline assessments. Results Baseline and retrospective pretest did not differ substantially in terms of internal consistency and convergent validity. Response shift was more pronounced when patients perceived a large change in OHRQoL during treatment. Retrospective pretests were more highly correlated with the baseline than with the follow-up assessment. Conclusion Findings suggest that retrospective assessments of OHRQoL using the OHIP-49 are susceptible to bias. Cognitive dissonance is more likely to appear as a source of bias than implicit theory of change.:Inhaltsverzeichnis 1. Einführung in die Thematik…………………………………………………2 2. Formatierte Publikation……………………………………………………..11 3. Zusammenfassung…………………………………………………………. 19 4. Literaturverzeichnis……………………………………………………….... 24 5. Anlagen 5.1. Darstellung des eigenen Beitrags……………………………………. 27 5.2. Selbstständigkeitserklärung…………………………………………... 28 5.3. Lebenslauf……………………………………………………………… 29 5.4. Publikationen…………………………………………………………… 30 5.5. Danksagung……………………………………………………………. 3

How to improve drug dosing for patients with renal impairment in primary care - a cluster-randomized controlled trial

Background: Patients with chronic kidney disease (CKD) are at increased risk for inappropriate or potentially harmful prescribing. The aim of this study was to examine whether a multifaceted intervention including the use of a software programme for the estimation of creatinine clearance and recommendation of individual dosage requirements may improve correct dosage adjustment of relevant medications for patients with CKD in primary care. Methods: A cluster-randomized controlled trial was conducted between January and December 2007 in small primary care practices in Germany. Practices were randomly allocated to intervention or control groups. In each practice, we included patients with known CKD and elderly patients (>=70 years) suffering from hypertension. The practices in the intervention group received interactive training and were provided a software programme to assist with individual dose adjustment. The control group performed usual care. Data were collected at baseline and at 6 months. The outcome measures, analyzed across individual patients, included prescriptions exceeding recommended maximum daily doses, with the primary outcome being prescriptions exceeding recommended standard daily doses by 30% or more. Results: Data from 44 general practitioners and 404 patients are included. The intervention was effective in reducing prescriptions exceeding the maximum daily dose per patients, with a trend in reducing prescriptions exceeding the standard daily dose by more than 30%. Conclusions: A multifaceted intervention including the use of a software program effectively reduced inappropriately high doses of renally excreted medications in patients with CKD in the setting of small primary care practices

Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]

Background: Care management programmes are an effective approach to care for high risk patients with complex care needs resulting from multiple co-occurring medical and non-medical conditions. These patients are likely to be hospitalized for a potentially "avoidable" cause. Nurse-led care management programmes for high risk elderly patients showed promising results. Care management programmes based on health care assistants (HCAs) targeting adult patients with a high risk of hospitalisation may be an innovative approach to deliver cost-efficient intensified care to patients most in need. Methods: PraCMan is a cluster randomized controlled trial with primary care practices as unit of randomisation. The study evaluates a complex primary care practice-based care management of patients at high risk for future hospitalizations. Eligible patients either suffer from type 2 diabetes mellitus, chronic obstructive pulmonary disease, chronic heart failure or any combination. Patients with a high likelihood of hospitalization within the following 12 months (based on insurance data) will be included in the trial. During 12 months of intervention patients of the care management group receive comprehensive assessment of medical and non-medical needs and resources as well as regular structured monitoring of symptoms. Assessment and monitoring will be performed by trained HCAs from the participating practices. Additionally, patients will receive written information, symptom diaries, action plans and a medication plan to improve self-management capabilities. This intervention is addition to usual care. Patients from the control group receive usual care. Primary outcome is the number of all-cause hospitalizations at 12 months follow-up, assessed by insurance claims data. Secondary outcomes are health-related quality of life (SF12, EQ5D), quality of chronic illness care (PACIC), health care utilisation and costs, medication adherence (MARS), depression status and severity (PHQ-9), self-management capabilities and clinical parameters. Data collection will be performed at baseline, 12 and 24 months (12 months post-intervention). Discussion: Practice-based care management for high risk individuals involving trained HCAs appears to be a promising approach to face the needs of an aging population with increasing care demands. Trial registration: Current Controlled Trials ISRCTN5610450

Predictors of dropout in the German disease management program for type 2 diabetes

Background: To improve and assess the effectiveness of disease management programs (DMPs), it is critical to understand how many people drop out of disease management programs and why. Methods: We used routine data provided by a statutory health insurance fund from the regions North Rhine, North Wurttemberg and Hesse. As part of the German DMP for type 2 diabetes, the insurance fund received regular documentation of all members participating in the program. We followed 10,989 patients who enrolled in the DMP between July 2004 and December 2005 until the end of 2007 to study how many patients dropped out of the program. Dropout was defined based on the discontinuation of program documentation on a particular patient, excluding situations in which the patient died or left the insurance fund. Predictors of dropout, assessed at the time of program enrolment, were explored using logistic regression analysis. Results: 5.5% of the patients dropped out of the disease management program within the observation period. Predictors of dropout at the time of enrolment were: region; retirement status; the number of secondary diseases; presence of a disabling secondary disease; doctors recommendations to stop smoking or to seek nutritional counselling; and the completion and outcome of the routine foot and eye exams. Different trends of dropout were observed among retired and employed patients: retired patients of old age, who possibly drop out of the program due to other health care priorities and employed people of younger age who have not yet developed many secondary diseases, but were recommended to change their lifestyle. Conclusions: Overall, dropout rates for the German disease management programs for type 2 diabetes were low compared to other studies. Factors assessed at the time of program enrolment were predictive of later dropout and should be further studied to provide information for future program improvements

Reported barriers to evaluation in chronic care: experiences in six European countries.

INTRODUCTION: The growing movement of innovative approaches to chronic disease management in Europe has not been matched by a corresponding effort to evaluate them. This paper discusses challenges to evaluation of chronic disease management as reported by experts in six European countries. METHODS: We conducted 42 semi-structured interviews with key informants from Austria, Denmark, France, Germany, The Netherlands and Spain involved in decision-making and implementation of chronic disease management approaches. Interviews were complemented by a survey on approaches to chronic disease management in each country. Finally two project teams (France and the Netherlands) conducted in-depth case studies on various aspects of chronic care evaluation. RESULTS: We identified three common challenges to evaluation of chronic disease management approaches: (1) a lack of evaluation culture and related shortage of capacity; (2) reluctance of payers or providers to engage in evaluation and (3) practical challenges around data and the heterogeity of IT infrastructure. The ability to evaluate chronic disease management interventions is influenced by contextual and cultural factors. CONCLUSIONS: This study contributes to our understanding of some of the most common underlying barriers to chronic care evaluation by highlighting the views and experiences of stakeholders and experts in six European countries. Overcoming the cultural, political and structural barriers to evaluation should be driven by payers and providers, for example by building in incentives such as feedback on performance, aligning financial incentives with programme objectives, collectively participating in designing an appropriate framework for evaluation, and making data use and accessibility consistent with data protection policies

Development of a primary care-based complex care management intervention for chronically ill patients at high risk for hospitalization: a study protocol

Background: Complex care management is seen as an approach to face the challenges of an ageing society with increasing numbers of patients with complex care needs. The Medical Research Council in the United Kingdom has proposed a framework for the development and evaluation of complex interventions that will be used to develop and evaluate a primary care-based complex care management program for chronically ill patients at high risk for future hospitalization in Germany. Methods and design: We present a multi-method procedure to develop a complex care management program to implement interventions aimed at reducing potentially avoidable hospitalizations for primary care patients with type 2 diabetes mellitus, chronic obstructive pulmonary disease, or chronic heart failure and a high likelihood of hospitalization. The procedure will start with reflection about underlying precipitating factors of hospitalizations and how they may be targeted by the planned intervention (pre-clinical phase). An intervention model will then be developed (phase I) based on theory, literature, and exploratory studies (phase II). Exploratory studies are planned that entail the recruitment of 200 patients from 10 general practices. Eligible patients will be identified using two ways of 'case finding': software based predictive modelling and physicians' proposal of patients based on clinical experience. The resulting subpopulations will be compared regarding healthcare utilization, care needs and resources using insurance claims data, a patient survey, and chart review. Qualitative studies with healthcare professionals and patients will be undertaken to identify potential barriers and enablers for optimal performance of the complex care management program. Discussion: This multi-method procedure will support the development of a primary care-based care management program enabling the implementation of interventions that will potentially reduce avoidable hospitalizations

MALDI-TOF : A powerful technique for environmental risk assessment studies of potential pathogenic vibrios

Establishment of mass spectrometric profiling in Vibrio Population analyses Coastal areas of the North and Baltic Sea are threatened by potential pathogenic Vibrio species. So far, outbreaks were generally reported to occur in regions with elevated water temperature. But due to Global Warming, an infiltration of Northern European temperate waters by perilous vibrios can be assumed. Major human pathogenic species are V. cholerae, V. vulnificus and V. parahaemolyticus. These bacteria can be transmitted by contaminated water or seafood. Infections lead to fatal diarrheas, septicemias or gastroenteritides, and cases of death caused by V. vulnificus strains have recently been reported from Baltic Sea countries. This implies the significance and urgency of Vibrio population analyses. In this study, we aim to establish a mass spectrometric method to distinguish Vibrio strains on the species level. In contrast to DNA-based methods, species identification by this matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) method can be performed cost and time effective. First of all, identification results have to be confirmed by ribosomal protein fingerprinting. Additionally, MALDI-TOF cluster analyses allow the detection of possible interspecific groups with pathogenic properties. Another aim is to get information on the geographical distribution of specific Vibrio populations. For this reason potentially pathogenic vibrios are mapped according to their sampling site and environmental conditions like salinity or temperature at the sampling time. The outcome will be a detailed report about the composition of Vibrio populations in the North and Baltic Sea. Hence, it will be possible to answer the question whether pathogenic vibrios are to be perceived as a serious threat for German coasts. So far, over 600 potential pathogenic Vibrio isolates were collected from environmental samples of the North and Baltic Sea. Sampling took place all along the German Coast, from the Dutch border to the isle of Usedom near Poland. Reference mass spectra are acquired from all these strains. Hence, the MALDI-TOF database will be expanded by environmental vibrios, which in turn leads to more specific classification results of further Vibrio strains. In order to detect interspecific cluster, comparative analyses of MALDI-TOF and ribosomal protein fingerprinting are performed. Such a comparison has been already accomplished with V. alginolyticus strains isolated from the German Bight and it has been proven that MALDI-TOF can distinguish two interspecific V. alginolyticus groups which were identified by RNA polymerase beta unit sequence analyses. In context with this result, similar cluster should be expected in the case of potential pathogenic Vibrio species. Hence, mass spectrometric profiling by MALDI-TOF can be a huge improvement in Vibrio population analyses

Garbage in Garbage out? Morbidity oriented budgets for GPs and validity of coded diagnoses from GP claims records

Titelblatt und Inhaltsverzeichnis Einleitung Hintergrund und Stand der Forschung Fragestellung und Hypothesen Methoden Ergebnisse Diskussion Zusammenfassung LiteraturverzeichnisIn Zukunft soll die Vergütung von Vertragsärzten auch im ambulanten Bereich morbiditätsorientiert erfolgen. In diesem Rahmen soll ein Risikoadjustierungssystem eingeführt werden, das nach ICD-10 codierte Abrechnungsdiagnosen eines Jahres, Alter und Geschlecht für eine Morbiditätsklassifikation von Patienten verwendet. Insbesondere im hausärztlichen Bereich stellt sich die Frage, inwieweit Abrechnungsdiagnosen die tatsächlichen Behandlungsanlässe eines Jahres abbilden, welche Auswirkungen eine mangelnde Diagnosenvalidität auf die Klassifizierung von Patienten in einem Risikoadjustierungssystem haben würde, und welche Einflussfaktoren auf die Diagnosenvalidität in diesem Zusammenhang eine Rolle spielen könnten. Methode: In einer retrospektiven Querschnittsstudie wurde für eine Zufallsstichprobe von 250 Patienten aus zehn hausärztlichen Praxen untersucht, inwieweit anhand der Patientenakten identifizierte Behandlungsanlässe eines Jahres mit den von den Ärzten im gleichen Zeitraum angegebenen Abrechnungsdiagnosen übereinstimmten. Anhand von Abrechnungsdiagnosen und Behandlungsanlässen wurde die Morbiditätsklassifikation und die Schätzung des Ressourcenverbrauchs der Patienten im Risikoadjustierungssystem ACG verglichen. Zusätzlich wurden die Qualität der Dokumentation und Codierung, sowie die Eignung des Codierungssystem ICD-10 für die Verschlüsselung hausärztlicher Behandlungsanlässe analysiert und geprüft, ob die Verwendung von Diagnosenzusätzen die Validität von Abrechnungsdiagnosen erhöhen könnte. Ergebnisse: Trotz der hohen Zahl von durchschnittlich 6,1 Abrechnungsdiagnosen pro Patient lag in Bezug auf die im Untersuchungszeitraum behandelten Erkrankungen in 30% der Fälle ein Underreporting vor, das insbesondere akute Diagnosen mit geringem Schweregrad, nicht medikamentös behandelte chronische Erkrankungen, Vorsorgeuntersuchungen und Impfungen betraf. Ein Overreporting von im Untersuchungszeitraum nicht behandelten Dauerdiagnosen , wurde in 19% der Fälle vor allem bei chronischen Erkrankungen beobachtet. Für sechs in deutschen Hausarztpraxen häufige Erkrankungen (Hypertonie, Diabetes mellitus, Hyperlipoproteinämie, KHK, Rückenschmerzen und akute Atemwegserkrankungen) lag die Korrektheit von Abrechnungsdiagnosen zwischen 71% und 93%, die Vollständigkeit zwischen 56% und 86%. Die Kombination aus der fehlenden Angabe akuter Erkrankungen und Maßnahmen und der zusätzlichen Angabe inaktiver chronischer Erkrankungen führte bei einer Risikoadjustierung mittels des Patientenklassifikationssystems ACG insgesamt zu einer Überschätzung der Morbidität und des Ressourcenverbrauchs der Studienpatienten anhand ihrer Abrechnungsdiagnosen. Mittels einer Kennzeichnung als Verdacht , Ausschluss , gesichert und Zustand nach konnte die Übereinstimmung von Abrechnungsdiagnosen und Behandlungsanlässen in der vorliegenden Untersuchung um 1%, durch eine Klassifizierung als aktive (im Untersuchungszeitraum behandelte) und inaktive (im Untersuchungszeitraum nicht behandelte) Diagnosen dagegen um 9% erhöht werden.In future, German GPs will receive remuneration according to the morbidity of their patients. For this purpose, a risk adjustment system will be introduced, which requires ICD-10 diagnosis codes, age and sex as risk factors to estimate morbidity and resource use of patients. Especially in GP practice it is not clear whether diagnosis codes, which are documented by GPs for remuneration purposes and are subsequently billed, accurately describe health problems for which the patient has actually been treated. The consequences of an incongruence in documented and treated health problems for the correct estimation of resource use by a risk adjustment system are also unknown, as well as factors which might influence the validity of coded diagnoses. Method: In a retrospective cross-sectional study a random sample of 250 patients in 10 GP practices was examined. For each patient, billed ICD-10 diagnosis codes for the year 2003 were compared with the health problems treated in the same year as documented in the patient s medical records. Patients allocation to morbidity groups and estimation of resource consumption on the basis of billed diagnoses and health problems in the medical record was compared by means of the risk adjustment system ACG. In addition, the quality of the GP´s documentation and coding of diagnoses was analyzed, as well as the suitability of ICD-10 to describe and code health problems in primary care. Results: Despite the large number of billed diagnoses per patient (on average 6.1), health problems which had been treated during the year 2003 according to the medical record were underreported in 30% of cases. This was especially the case for acute minor diseases, chronic diseases for which a prescription had not been issued, screening tests and vaccinations. Billed diagnoses which had not been treated in 2003 (=overreporting) were found in 19% of cases and concerned mainly inactive chronic diseases. Billing diagnoses for six diseases with high prevalence in primary care in Germany (hypertension, diabetes, lipid disorder, coronary heart disease, back pain and acute respiratory disease) were correct in 71% to 93% of cases und complete in 56% to 86% of cases. The combination of an underreporting of acute minor diseases and an overreporting of inactive chronic diseases led to an overestimation of morbidity and resource consumption in the risk adjustment system ACG for the study population. When health problems are labelled as active or inactive , the agreement between billed and treated diagnoses can be improved by 9%

Application of MALDI-TOF MS for environmental Vibrio surveillance programs

Application of MALDI-TOF MS for environmental Vibrio surveillance programs G. Gerdts1, R. Erler1, and A. Wichels1 1. Alfred Wegener Institute for Polar and Marine Research, Shelf Sea System Ecology, Kurpromenade 201, 27498 Helgoland, Germany Three mesophilic Vibrio species pose a serious threat for humans: V. cholerae, V. parahaemolyticus and V. vulnificus. Due to Global Warming an increase of Vibrio infections is expected in Northern Europe. Hence a fast and cost-effective approach for the identification of those potentially pathogenic strains is needed to evaluate this risk. Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) fulfills these requirements and is therefore a promising analytical tool for environmental surveillance programs. Creation of a MALDI-TOF MS database filled with 1000 Vibrio reference spectra was crutial for this application. These isolates were characterized simultaneously with approved rpoB sequence data analysis. A comparative examination is getting performed to check the validity of MALDI-TOF identifications and the distinctness for closely related Vibrio species. First results reveal that species-specific groups found by the rpoB sequence analysis are equal to MALDI-TOF MS cluster. Congeneric species like V. vulnificus/V. navarrensis and V. cholerae/V. mimicus respectively can clearly be distinguished from each other. And in case of V. alginolyticus and V. vulnificus it was even possible to divide them into intraspecific groups. The first environmental application took place on a research cruise in July 2012. Agar plates were incubated with environmental samples like water or plankton. About 2100 single colonies were processed to obtain MALDI-TOF MS samples. Using the constructed reference database allows the species identification of these colonies which gives rise to conclusions about the species composition of Vibrio populations in the North and Baltic Sea. First results show high abundances of zoonotic vibrios like V. fluvialis, V. anguillarum and V. diazotrophicus. In contrast, putative human pathogenic vibrios were found rarely. However, MALDI-TOF MS identified the species of over 90 per cent of these environmental colonies. Hence, this technique can be a valuable tool in future surveillance programs