Thomas Kötter

Methods for the guideline-based development of quality indicators--a systematic review

BackgroundQuality indicators (QIs) are used in many healthcare settings to measure, compare, and improve quality of care. For the efficient development of high-quality QIs, rigorous, approved, and evidence-based development methods are needed. Clinical practice guidelines are a suitable source to derive QIs from, but no gold standard for guideline-based QI development exists. This review aims to identify, describe, and compare methodological approaches to guideline-based QI development.MethodsWe systematically searched medical literature databases (Medline, EMBASE, and CINAHL) and grey literature. Two researchers selected publications reporting methodological approaches to guideline-based QI development. In order to describe and compare methodological approaches used in these publications, we extracted detailed information on common steps of guideline-based QI development (topic selection, guideline selection, extraction of recommendations, QI selection, practice test, and implementation) to predesigned extraction tables.ResultsFrom 8,697 hits in the database search and several grey literature documents, we selected 48 relevant references. The studies were of heterogeneous type and quality. We found no randomized controlled trial or other studies comparing the ability of different methodological approaches to guideline-based development to generate high-quality QIs. The relevant publications featured a wide variety of methodological approaches to guideline-based QI development, especially regarding guideline selection and extraction of recommendations. Only a few studies reported patient involvement.ConclusionsFurther research is needed to determine which elements of the methodological approaches identified, described, and compared in this review are best suited to constitute a gold standard for guideline-based QI development. For this research, we provide a comprehensive groundwork.

Metamizole-Associated Adverse Events: A Systematic Review and Meta-Analysis

Background Metamizole is used to treat pain in many parts of the world. Information on the safety profile of metamizole is scarce; no conclusive summary of the literature exists. Objective To determine whether metamizole is clinically safe compared to placebo and other analgesics. Methods We searched CENTRAL, MEDLINE, EMBASE, CINAHL, and several clinical trial registries. We screened the reference lists of included trials and previous systematic reviews. We included randomized controlled trials that compared the effects of metamizole, administered to adults in any form and for any indication, to other analgesics or to placebo. Two authors extracted data regarding trial design and size, indications for pain medication, patient characteristics, treatment regimens, and methodological characteristics. Adverse events (AEs), serious adverse events (SAEs), and dropouts were assessed. We conducted separate meta-analyses for each metamizole comparator, using standard inverse-variance random effects meta-analysis to pool the estimates across trials, reported as risk ratios (RRs). We calculated the DerSimonian and Laird variance estimate T2 to measure heterogeneity between trials. The pre-specified primary end point was any AE during the trial period. Results Of the 696 potentially eligible trials, 79 trials including almost 4000 patients with short-term metamizole use of less than two weeks met our inclusion criteria. Fewer AEs were reported for metamizole compared to opioids, RR = 0.79 (confidence interval 0.79 to 0.96). We found no differences between metamizole and placebo, paracetamol and NSAIDs. Only a few SAEs were reported, with no difference between metamizole and other analgesics. No agranulocytosis or deaths were reported. Our results were limited by the mediocre overall quality of the reports. Conclusion For short-term use in the hospital setting, metamizole seems to be a safe choice when compared to other widely used analgesics. High-quality, adequately sized trials assessing the intermediate- and long-term safety of metamizole are needed.

Involving patients in quality indicator development - a systematic review.

Background Quality indicators (QI) are used in many health care areas to measure, compare, and improve the quality of care. Ideas of quality differ between health care providers and patients, yet patients are not regularly involved in QI development nor does a methodological standard for patient involvement in QI development exist. In this study we systematically reviewed the medical journal articles and gray literature for published approaches for involving patients in QI development. Methods We searched medical literature databases (Medline, Excerpta Medica database, and Cumulative Index to Nursing and Allied Health Literature), screened websites, and contacted experts in the field of QI development for publications on approaches to patient involvement in QI development. Results Eleven relevant journal articles and four web-published documents were included. Four major approaches to patient involvement were extracted from the literature: (1) focus group interviews, (2) self-administered questionnaires, (3) individual interviews, and (4) participation in panels during systematic consensus processes. Patients’ views were collected by involving patients, patient representatives, or family members. Conclusion Although there is a large body of literature on QI, publications that describe approaches to patient involvement in QI development are scarce. In principle, indirect and direct methods of patient involvement can be distinguished, and it seems most promising to combine different approaches. However, the limited number of publications identified clearly shows that further research in this field is overdue and that the quality of reporting found in studies within this field needs to be improved.

Measurement of specific medical school stress: translation of the “Perceived Medical School Stress Instrument” to the German language

Objective: Medical students encounter specific stressors during their studies. As a result, they develop anxiety, depression and burnout symptoms more frequently than their similarly aged, but employed counterparts. In 1984, Vitaliano et al. published a 13-item instrument for the measurement of stress specific to medical school: the “Perceived Medical School Stress Instrument“ (PMSS). Since then, it has been widely applied and validated in English-speaking countries. No German version of the PMSS exists to date. Thus, our aim was to translate the instrument into the German language in order to be able to measure medical school stress in German-speaking countries. Method: The items of the PMSS were translated into German by three separate researchers. The resulting translations were compared and combined with each other to establish a first German version of each item in the PMSS. These items were then translated back into English by two native English speakers to validate the correct primary translation. Based on a revised German version, a cognitive debriefing with 19 German medical students and a theoretical testing on 169 German medical students, the final German translations for each of the 13 items were determined. Results: The PMSS was easily translated into German and there was a high congruency between the primary translations into German and the secondary translations back into English. Incongruities between the translations were solved quickly. The assessment of the German equivalent of the PMSS showed good results regarding its reliability (Cronbach’s Alpha 0.81). Conclusion: A German version of the PMSS is now available for measuring the medical school related stress in German-speaking countries.

Predictors of Participation of Sophomore Medical Students in a Health-Promoting Intervention: An Observational Study

Medical students and doctors have to be particularly stress-resilient, as both medical education and practice are considered very stressful. Specific stressors can lead to increased risks of developing, for example, depression, anxiety and burnout. Relaxation techniques have proven to be effective for the prevention of these outcomes in student populations. However, only a very few medical students practice relaxation techniques regularly early on in their studies. Furthermore, it is unclear which students make use of stress-management offers and hence whether vulnerable students are generally reachable. Therefore, the aim of our study was to explore predictors of participating in a voluntary stress management course for sophomore medical students. One cohort of freshmen at a German medical school was surveyed at the end of the freshman year [t1] and at the end of the sophomore year [t2]. In addition to sociodemographic information, we captured perceived study stress, self-rated general health and mental health and dimensions of study-related behaviour and experience as potential predictors of participation at t1. During the sophomore year, we offered the participants a progressive muscle relaxation (PMR) beginners’ course. At t2, we registered participation status. We used binary logistic regression analyses in order to assess correlations between potential predictors and participation. About one third of the whole class took part in the course. The main reason for non-participation was “no time”. Being female and higher levels of anxiety were the strongest predictors of course participation. Career ambition (the higher, the less likely to participate) and emotional distancing (the higher, the more likely to participate) were further significant predictors. Future interventions should be attractive to both male and female medical students. Ideally, for every hour of stress management teaching, the curriculum should be cut by at least the same amount of time.

Identifikation mit dem Studiengang

ZusammenfassungHintergrundEine hohe Identifikation mit einer Gruppe kann sich positiv auf das Wohlbefinden auswirken. In dieser Studie wurde getestet, inwiefern sich diese Ergebnisse auch auf den Kontext Universität und hierbei auf den Kontext Medizin übertragen lassen. Dabei wurde auch untersucht, inwiefern gerade in einem so leistungsorientierten Gruppenkontext wie dem Medizinstudium eine hohe Identifikation auch zu einem Risikofaktor für Selbstüberforderung werden kann.Material und MethodenDiese Studie ist Teil der LUST-Studie („Lübeck University Student Trial“), einer seit 2011 laufenden Längsschnittstudie zur Studierendengesundheit an der Universität zu Lübeck. Für diese Studie wurden 336 Medizinstudierenden im Juni 2015 zur ihrer Identifikation mit Medizinstudiengang, den studiumsbezogenen Verhaltens- und Erlebensmustern (AVEM) sowie zu ihrer allgemeinen und seelischen Gesundheit befragt.ErgebnisseIdentifikation hat insgesamt einen positiven Einfluss auf die Gesundheit der Medizinstudierenden. Die Betrachtung der AVEM-Muster zeigt aber auch, dass in diesem positiven Gesamteffekt zwei gegensätzliche indirekte Effekte der Identifikation liegen: ein positiver indirekter Effekt vermittelt über ein gesundes Muster und ein negativer indirekter Effekt vermittelt über ein Muster der Selbstüberforderung.DiskussionDiese Studie zeigt, dass sich eine hohe Identifikation auch im Kontext Universität grundlegend positiv auf die Gesundheit auswirkt. Sie zeigt aber auch, dass eine hohe Identifikation mit einem erhöhten Risiko zur Selbstüberforderung verbunden sein kann. Dies könnte gerade in sehr leistungsorientierten Gruppenkontexten wie dem Medizinstudium zu einem Risikofaktor werden – v. a. dann, wenn selbstgesetzte Leistungsziele von tatsächlichen Leistungen abweichen.AbstractBackgroundHigh group identification has a positive impact on wellbeing. In this study, we tested whether these results could be transferred to the university context and, more precisely, to the context of medical school. Regarding medical school as a high-achievement-oriented group context, we also investigated whether high identification could become a risk factor for obsessive demands on the self.Material and methodsThis research is part of the LUST Study (Lübeck University Student Trial), a longitudinal survey at Lübeck University investigating students’ health. For this study, we surveyed 336 students from medical school during June 2015 regarding their identification with the medical school, their study-related behaviour and experience patterns (AVEM) and their general physical and mental health.ResultsIdentification has a positive effect on medical students’ health. However, with regard to the AVEM pattern, our study demonstrates that within this total positive effect there are two opposing indirect effects of high identification: a positive indirect effect via a healthy pattern and a negative indirect effect via a pattern of over-commitment.DiscussionThis study highlights that, also in the university context, high identification has a positive impact on health. However, it also proves that high identification can become a risk factor for obsessive demands on the self. This negative impact is more likely to become a risk factor in high-achievement group contexts, such as medical school, and, more particularly, when self-defined performance goals do not correspond to real performance.

Are the results of questionnaires measuring non-cognitive characteristics during the selection procedure for medical school application biased by social desirability?

Introduction: A stronger consideration of non-cognitive characteristics in Medical School application procedures is desirable. Psychometric tests could be used as an economic supplement to face-to-face interviews which are frequently conducted during university internal procedures for Medical School applications (AdH, Auswahlverfahren der Hochschulen). This study investigates whether the results of psychometric questionnaires measuring non-cognitive characteristics such as personality traits, empathy, and resilience towards stress are vulnerable to distortions of social desirability when used in the context of selection procedures at Medical Schools. Methods: This study took place during the AdH of Lübeck University in August 2015. The following questionnaires have been included: NEO-FFI, SPF, and AVEM. In a 2x1 between-subject experiment we compared the answers from an alleged application condition and a control condition. In the alleged application condition we told applicants that these questionnaires were part of the application procedure. In the control condition applicants were informed about the study prior to completing the questionnaires. Results: All included questionnaires showed differences which can be regarded as social-desirability effects. These differences did not affect the entire scales but, rather, single subscales. Conclusion: These results challenge the informative value of these questionnaires when used for Medical School application procedures. Future studies may investigate the extent to which the differences influence the actual selection of applicants and what implications can be drawn from them for the use of psychometric questionnaires as part of study-place allocation procedures at Medical Schools.

IM BLICKPUNKTVersorgung der chronischen Herzinsuffizienz – eine systematische Leitliniensynopse im Rahmen der geplanten DMP-AktualisierungManagement of chronic heart failure – a systematic review of guidelines in the context of the DMP revision

BACKGROUND Disease Management Programmes (DMPs) are structured treatment programmes for chronic diseases. The DMP requirements are primarily derived from evidence-based guidelines. DMPs are regularly revised to ensure that they reflect current best practice and medical knowledge. The aim of this study was to assess the need for updating the German DMP module on heart failure by comparing it to relevant guidelines and identifying recommendations that should be revised. METHODS We systematically searched for clinical guidelines on heart failure published in German, English or French, and extracted relevant guideline recommendations. All included guidelines were assessed for methodological quality. To identify revision needs in the DMP, we performed a synoptic analysis of the extracted guideline recommendations and DMP requirements. RESULTS 27 guidelines were included. The extracted recommendations covered all aspects of the management of heart failure. The comparison of guideline recommendations with DMP requirements showed that, overall, guideline recommendations were more detailed than DMP requirements, and that the guidelines covered topics not included in the DMP module. CONCLUSIONS The DMP module is largely consistent with current guidelines on heart failure. We did not identify any need for significant revision of the DMP requirements. However, some specific recommendations of the DMP module could benefit from revision.

Versorgung der chronischen Herzinsuffizienz – eine systematische Leitliniensynopse im Rahmen der geplanten DMP-Aktualisierung

BACKGROUND Disease Management Programmes (DMPs) are structured treatment programmes for chronic diseases. The DMP requirements are primarily derived from evidence-based guidelines. DMPs are regularly revised to ensure that they reflect current best practice and medical knowledge. The aim of this study was to assess the need for updating the German DMP module on heart failure by comparing it to relevant guidelines and identifying recommendations that should be revised. METHODS We systematically searched for clinical guidelines on heart failure published in German, English or French, and extracted relevant guideline recommendations. All included guidelines were assessed for methodological quality. To identify revision needs in the DMP, we performed a synoptic analysis of the extracted guideline recommendations and DMP requirements. RESULTS 27 guidelines were included. The extracted recommendations covered all aspects of the management of heart failure. The comparison of guideline recommendations with DMP requirements showed that, overall, guideline recommendations were more detailed than DMP requirements, and that the guidelines covered topics not included in the DMP module. CONCLUSIONS The DMP module is largely consistent with current guidelines on heart failure. We did not identify any need for significant revision of the DMP requirements. However, some specific recommendations of the DMP module could benefit from revision.