Barbara Buchberger

Symptoms of depression and anxiety in youth with type 1 diabetes: A systematic review and meta-analysis

INTRODUCTION The interaction between psychosocial factors and type 1 diabetes is complex and screening for psychosocial risk factors from diagnosis of type 1 diabetes has been recommended. This is a systematic review and meta-analysis to address the following questions: (1) How prevalent are symptoms of depression and anxiety in children and adolescents with type 1 diabetes? (2) Is there an association of symptoms of depression and anxiety with diabetes management and glycemic control? MATERIAL AND METHODS We searched EMBASE, MEDLINE, The Cochrane Library, and PsycINFO in April 2014 with an update in May 2015. When possible, data were pooled to estimate summary effects. RESULTS 14 studies investigated symptoms of depression and anxiety in children and adolescents with type 1 diabetes. The pooled prevalence of depressive symptoms was 30.04%, 95% CI [16.33; 43.74]. There were correlations between symptom levels and glycemic control as well as three-way interactions between HbA1c, blood glucose monitoring frequency or diabetes-specific stress and depression. Symptoms of anxiety were reported for up to 32% of patients. A negative impact on glycemic control was demonstrated. CONCLUSIONS Our analyses confirmed a high prevalence of symptoms of depression and anxiety in youth with type 1 diabetes that potentially compromise diabetes management and glycemic control. In our opinion these findings support recommendations for early screening for psychological comorbidity and regular psychosocial assessment from diagnosis. Future prospective studies are warranted to further explore the interaction of symptoms of depression and anxiety with type 1 diabetes and develop evidence-based treatment models.

Systematic review of surgical treatments for benign prostatic hyperplasia and presentation of an approach to investigate therapeutic equivalence (non‐inferiority)

Study Type – Therapy (systematic review)

The evidence for the use of growth factors and active skin substitutes for the treatment of non-infected diabetic foot ulcers (DFU): a health technology assessment (HTA).

AIMS Assessment of the safety, efficacy and effectiveness of growth factors alone or in combination with other technologies in the treatment of DFU including medical, economical, social, ethical and juridical aspects. METHODS We systematically searched relevant data bases limited to English and German language and publications since 1990. Review and assessment of the quality of publications followed methods conforming to widely accepted standards for evidence-based medicine and health economics. RESULTS We identified 25 studies comparing becaplermin, rhEGF, bFGF and the metabolically active skin grafts Dermagraft and Apligraf with standard wound care (SWC) alone or extracellular wound matrix. Study duration ranged from 12 to 20 weeks and the study population comprised between 17 and 382 patients. Treatment with becaplermin, rhEGF, Dermagraft and Apligraf resulted in a higher incidence of complete wound closure and shorter time to complete wound healing with statistically significant differences. Regarding the proportion of adverse events there was no difference between treatment groups. The methodological quality of the studies was affected by significant deficiencies. Economic evaluations showed becaplermin being cost-effective. CONCLUSIONS Add-on therapy with growth factors and active skin substitutes for treating uncomplicated DFU could be an alternative to SWC alone. For explicit recommendations further studies with stronger evidence are necessary.

Quality assurance for care of melanoma patients based on guideline‐derived quality indicators and certification

In 2013 the first German S‐3 guidelines on the diagnosis, treatment, and follow‐up of melanoma were published in the framework of the German Guideline Program on Oncology. Quality indicators were developed at the same time as the guideline development process in order to implement the guideline recommendations.

The importance of growth factors for the treatment of chronic wounds in the case of diabetic foot ulcers.

Introduction Ulcers as a result of diabetes mellitus are a serious problem with an enormous impact on the overall global disease burden due to the increasing prevalence of diabetes. Because of long hospital stays, rehabilitation, often required home care and the use of social services diabetic foot complications are costly. Therapy with growth factors could be an effective and innovative add-on to standard wound care. Research questions What is the benefit of therapies with growth factors alone or in combination with other technologies in the treatment of diabetic foot ulcer assessed regarding medical, economical, social, ethical and juridical aspects? Methods We systematically searched relevant databases limited to English and German language and publications since 1990. Cost values were adjusted to the price level of 2008 and converted into Euro. A review and an assessment of the quality of publications were conducted following approved methodical standards conforming to evidence-based medicine and health economics. Results We identified 25 studies (14 randomized controlled trials (RCT), nine cost-effectiveness analyses, two meta-analyses). The RCT compared an add-on therapy to standard wound care with standard wound care/placebo alone or extracellular wound matrix: in six studies becaplermin, in two rhEGF, in one bFGF, and in five studies the metabolically active skin grafts Dermagraft and Apligraf. The study duration ranged from twelve to 20 weeks and the study population included between 17 to 382 patients, average 130 patients. The treatment with becaplermin, rhEGF and skin implants Dermagraft and Apligraf showed in eight out of 13 studies an advantage concerning complete wound closure and the time to complete wound healing. Evidence for a benefit of treatment with bFGF could not be found. In four out of 14 studies the proportion of adverse events was 30% per study group with no difference between the treatment groups. The methodological quality of the studies was affected by significant deficiencies. The results showed becaplermin being cost-effective whereas no obvious statement can be made regarding Dermagraft and Apligraf because of diverging cost bases and incremental cost-effectiveness ratios. Discussion Differences in standard wound care are complicating the comparison of study results. Taking into consideration the small to very small sample sizes and other methodological flaws with high potential of bias, the validity of the results with regard to effectiveness and cost-effectiveness has to be considered limited. The duration of treatment and follow-up examinations is not long enough to assess the sustainability of the intervention and the surveillance of ulcer recurrences or treatment related adverse events like the development of malignancy. Conclusions There are indications of an advantage for the add-on therapy with growth factors in diabetic foot ulcers concerning complete wound closure and the time to complete wound healing. Further more studies of high methodological quality with adequate sample sizes and sufficient follow-up periods are necessary also investigating patient-relevant parameters like the health-related quality of life, the acceptance and tolerance of the intervention in addition to clinical outcomes.

The effectiveness of interventions in workplace health promotion as to maintain the working capacity of health care personal.

Background The increasing proportion of elderly people with respective care requirements and within the total population stands against aging personnel and staff reduction in the field of health care where employees are exposed to high load factors. Health promotion interventions may be a possibility to improve work situations and behavior. Methods A systematic literature search is conducted in 32 databases limited to English and German publications since 1990. Moreover, internet-searches are performed and the reference lists of identified articles are scanned. The selection of literature was done by two reviewers independently according to inclusion and exclusion criteria. Data extraction and tables of evidence are verified by a second expert just like the assessment of risk of bias by means of the Cochrane Collaboration’s tool. Results We identified eleven intervention studies and two systematic reviews. There were three randomized controlled trials (RCT) and one controlled trial without randomization (CCT) on the improvement of physical health, four RCT and two CCT on the improvement of psychological health and one RCT on both. Study duration ranged from four weeks to two years and the number of participants included from 20 to 345, with a median of 56. Interventions and populations were predominantly heterogeneous. In three studies intervention for the improvement of physical health resulted in less complaints and increased strength and flexibility with statistically significant differences between groups. Regarding psychological health interventions lead to significantly decreased intake of analgesics, better stress management, coping with workload, communication skills and advanced training. Discussion Taking into consideration the small to very small sample sizes, other methodological flaws like a high potential of bias and poor quality of reporting the validity of the results has to be considered as limited. Due to the heterogeneity of health interventions, study populations with differing job specializations and different lengths of study durations and follow-up periods, the comparison of results would not make sense. Conclusions Further research is necessary with larger sample sizes, with a sufficient study duration and follow-up, with a lower risk of bias, by considering of relevant quality criteria and with better reporting in publications.

[Health economics of chronic infectious diseases: the example of hepatitis C].

Based on the German Hepatitis C Model (GEHMO) we developed a Hepatitis C Policy Model and applied it to the heterogeneous German hepatitis C population within the German health care context. We used Markov cohort simulation to predict absolute clinical and economic outcomes for a 20-year time horizon. For the cost-effectiveness analysis, a lifelong time horizon was used. Four different strategies were compared: (1) no antiviral treatment, (2) interferon monotherapy, (3) combination therapy with interferon plus ribavirin, and (4) combination therapy with pegylated interferon plus ribavirin. Based on our model, antiviral therapy with pegylated interferon and ribavirin could prevent about 17,000 cases of cirrhosis, 580 liver transplants, and 7,600 HCV-related deaths and is expected to save about 53,000 life years at total costs of 1.3 billion Euros within the next 20 years. Pegylated interferon plus ribavirin was the most effective treatment with an incremental cost-utility ratio of 23,000 Euros per quality-adjusted life year saved.

Gesundheitsökonomische Aspekte chronischer Infektionskrankheiten am Beispiel der chronischen Hepatitis C

Based on the German Hepatitis C Model (GEHMO) we developed a Hepatitis C Policy Model and applied it to the heterogeneous German hepatitis C population within the German health care context. We used Markov cohort simulation to predict absolute clinical and economic outcomes for a 20-year time horizon. For the cost-effectiveness analysis, a lifelong time horizon was used. Four different strategies were compared: (1) no antiviral treatment, (2) interferon monotherapy, (3) combination therapy with interferon plus ribavirin, and (4) combination therapy with pegylated interferon plus ribavirin. Based on our model, antiviral therapy with pegylated interferon and ribavirin could prevent about 17,000 cases of cirrhosis, 580 liver transplants, and 7,600 HCV-related deaths and is expected to save about 53,000 life years at total costs of 1.3 billion Euros within the next 20 years. Pegylated interferon plus ribavirin was the most effective treatment with an incremental cost-utility ratio of 23,000 Euros per quality-adjusted life year saved.

Ultrasound in the Diagnostics of Metaphyseal Forearm Fractures in Children: A Systematic Review and Cost Calculation.

Objectives Metaphyseal forearm fractures are a common occurrence in childhood accounting up to 20% of all pediatric fractures. The standard diagnostic procedure is an x-ray scan. Sonographic examinations could be an alternative that avoids exposition to ionizing radiation and possibly reduces pain, time, and costs. This is a systematic review of clinical studies evaluating ultrasound as a possible alternative to radiographs in diagnosing metaphyseal forearm fractures in children. Methods A systematic literature research for diagnostic studies and reviews was conducted in EMBASE, MEDLINE, and the Cochrane Library in May 2013 and updated in May 2014. In addition, reference lists of publications included were scanned. Outcome parameters were diagnostic accuracy, costs, examination time, and the assessment of pain. The study population is defined as children, because forearm fractures are very common in this age group and the impact of radiation on younger patients is greater than that on adults. Methodological quality of the studies has been assessed with Quality Assessment of Diagnostic Accuracy Studies-2. In addition, we carried out a cost center accounting. Results Eight diagnostic studies and 2 reviews were included in the analysis. The risk of bias of 4 studies was low; and of the other 4 ones, it was moderate. Critical aspects were missing or inaccurate blinding and insufficient descriptions of the study protocol, especially the order of examinations. Twenty-six to 115 patients within the age of 0 to 21 years were included in the studies. Sensitivity ranged from 64% to 100% and specificity did between 73% and 100%. Sensitivity was in six studies and specificity was in seven studies higher than 90%. Chaar-Alvarez et al reported an average time reduction of 25 minutes by using sonography instead of x-ray and a reduction of pain from 1.7 to 1.2 points on a visual analog scale (0-5 points). In 2 other studies, all patients reported pain-free sonographic examinations. The results of the cost center accounting, not being representative, were costs of &OV0556;20.54 per examination with ultrasound and &OV0556;26.60 per radiography-based one, which is a potential saving of 22.79% by replacing radiographic examinations by ultrasound. Conclusions Sensitivity and specificity of ultrasound examinations are high. Single study results show that sonographic examinations can be faster and less painful. In addition, the calculation model shows a tendency towards less-expensive ultrasound examinations. Further studies are needed with an adequate sample size calculation for assessing equivalence or non-inferiority of ultrasound and x-ray and to collect data on pain, examination time, and costs. The age of the older participants may be problematic because of the fact that epiphyseal plates close within the age from 15 to 22 years, which may influence the diagnostic accuracy of sonographic examinations. Therefore, future studies should contain age-stratified analyses. In addition, the calculation model for costs should be tested on a wider data base.

Bewertung des Risikos für Bias in kontrollierten Studien

BACKGROUND Practicing physicians are faced with many medical decisions daily. These are mainly influenced by personal experience but should also consider patient preferences and the scientific evidence reflected by a constantly increasing number of medical publications and guidelines. With the objective of optimal medical treatment, the concept of evidence-based medicine is founded on these three aspects. It should be considered that there is a high risk of misinterpreting evidence, leading to medical errors and adverse effects without knowledge of the methodological background. OBJECTIVES This article explains the concept of systematic error (bias) and its importance. Causes and effects as well as methods to minimize bias are discussed. This information should impart a deeper understanding, leading to a better assessment of studies and implementation of its recommendations in daily medical practice. CONCLUSION Developed by the Cochrane Collaboration, the risk of bias (RoB) tool is an assessment instrument for the potential of bias in controlled trials. Good handling, short processing time, high transparency of judgements and a graphical presentation of findings that is easily comprehensible are among its strengths. Attached to this article the German translation of the RoB tool is published. This should facilitate the applicability for non-experts and moreover, support evidence-based medical decision-making.