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1.  Why not integrate ethics in HTA: identification and assessment of the reasons 
From the conception of HTA in the 1970s it has been argued that addressing ethical issues is an element of HTA, and many methods for integrating ethics in HTA have become available. However, despite almost 40 years with repeated intentions, only few HTA reports include ethical analysis. Why is this so? How come, ethics is a constituent part of HTA, there are many methods available, but ethics is rarely part of practical HTA work?
This is the key question of this article and several reasons why ethics is not a part of HTA are identified. A) Ethicists are professional strangers in HTA. B) A common agreed methodology for integrating ethics is lacking. Ethics methodology appears to be C) deficient, D) insufficient, or E) unsuitable. F) Integrating ethics in HTA is neither efficient nor needed for successful HTA. G) Most moral issues are general, and are not specific to a given technology. H) All relevant ethical issues can be handled within other frameworks, e.g., within economics. I) Ethics can undermine or burst the foundation of HTA.
Hence, there are many reasons why ethics is not an integrated part of HTA so many years after identifying ethics as constitutive to HTA. These reasons may all explain why it is so, but on closer scrutiny, they do not work as compelling arguments for not addressing ethical issues in HTA. Hence, the identified reasons may work well as explanations, but not as justifications.
In order to move on from a situation of failure we can:
Exclude ethics from definitions of HTA, and as a consequence, establish a separate kind of evaluation (Health Technology Evaluation – HTE). Take the existing definition seriously and actually integrate ethics in the performance of HTA practice. Amend, expand or change HTA so that ethics is more genuinely incorporated.
Which of these options to choose is open for discussion, but we need to move away from a situation where we have a definition of HTA which does not correspond with HTA practice.
doi:10.3205/hta000120
PMCID: PMC4260057  PMID: 25493101
ethics; methodology; HTE; evaluation; technology; moral philosophy
2.  Assessment vs. appraisal of ethical aspects of health technology assessment: can the distinction be upheld? 
An essential component of health technology assessment (HTA) is the assessment of ethical aspects. In some healthcare contexts, tasks are strictly relegated to different expert groups: the HTA-agencies are limited to assessment of the technology and other actors within the health care sector are responsible for appraisal and recommendations. Ethical aspects of health technologies are considered with reference to values or norms in such a way that may be prescriptive, or offer guidance as to how to act or relate to the issue in question. Given this internal prescriptivity, the distinction between assessment and appraisal seems difficult to uphold, unless the scrutiny stops short of a full ethical analysis of the technology. In the present article we analyse the distinction between assessment and appraisal, using as an example ethical aspects of implementation of GPS-bracelets for people with dementia.
It is concluded that for HTA-agencies with a strictly delineated assessment role, the question of how to deal with the internal prescriptivity of ethics may be confusing. A full ethical analysis might result in a definite conclusion as to whether the technology in question is ethically acceptable or not, thereby limiting choices for decision-makers, who are required to uphold certain ethical values and norms.
At the same time, depending on the exact nature of such a conclusion, different action strategies can be supported. A positive appraisal within HTA could result in a decision on mandatory implementation, or funding of the technology, thereby making it available to patients, or decisions to allow and even encourage the use of the technology (even if someone else will have to fund it). A neutral appraisal, giving no definite answer as to whether implementation is recommended or not, could result in a laissez-faire attitude towards the technology. A negative appraisal could result in a decision to discourage or even prohibit implementation. This paper presents an overview of the implications of different outcomes of the ethical analysis on appraisal of the technology. It is considered important to uphold the distinction between assessment and appraisal, primarily to avoid the influence of preconceived values and political interests on the assessment. Hence, as long as it is not based on the subjective value judgments of the HTA-agency (or its representative), such an appraising conclusion would not seem to conflict with the rationale for the separation of these tasks. Moreover, it should be noted that if HTA agencies abstain from including full ethical analyses because of the risk of issuing an appraisal, they may fail to provide the best possible basis for decision-makers. Hence, we argue that as long as the ethical analysis and its conclusions are presented transparently, disclosing how well-founded the conclusions are and/or whether there are alternative conclusions, the HTA-agencies should not avoid taking the ethical analysis as close as possible to a definite conclusion.
doi:10.3205/hta000121
PMCID: PMC4260058  PMID: 25493102
assessment; appraisal; ethical analysis; prescriptiveness; surveillance technology; persons with dementia
3.  Vaccination of children with a live-attenuated, intranasal influenza vaccine – analysis and evaluation through a Health Technology Assessment 
Background: Influenza is a worldwide prevalent infectious disease of the respiratory tract annually causing high morbidity and mortality in Germany. Influenza is preventable by vaccination and this vaccination is so far recommended by the The German Standing Committee on Vaccination (STIKO) as a standard vaccination for people from the age of 60 onwards. Up to date a parenterally administered trivalent inactivated vaccine (TIV) has been in use almost exclusively. Since 2011 however a live-attenuated vaccine (LAIV) has been approved additionally. Consecutively, since 2013 the STIKO recommends LAIV (besides TIV) for children from 2 to 17 years of age, within the scope of vaccination by specified indications. LAIV should be preferred administered in children from 2 to 6 of age. The objective of this Health Technology Assessment (HTA) is to address various research issues regarding the vaccination of children with LAIV. The analysis was performed from a medical, epidemiological and health economic perspective, as well as from an ethical, social and legal point of view.
Method: An extensive systematic database research was performed to obtain relevant information. In addition a supplementary research by hand was done. Identified literature was screened in two passes by two independent reviewers using predefined inclusion and exclusion criteria. Included literature was evaluated in full-text using acknowledged standards. Studies were graded with the highest level of evidence (1++), if they met the criteria of European Medicines Agency (EMA)-Guidance: Points to consider on applications with 1. meta-analyses; 2. one pivotal study.
Results: For the medical section, the age of the study participants ranges from 6 months to 17 years. Regarding study efficacy, in children aged 6 months to ≤7 years, LAIV is superior to placebo as well as to a vac-cination with TIV (Relative Risk Reduction – RRR – of laboratory confirmed influenza infection approx. 80% and 50%, respectively). In children aged >7 to 17 years (= 18th year of their lives), LAIV is superior to a vaccination with TIV (RRR 32%). For this age group, no studies that compared LAIV with placebo were identified. It can be concluded that there is high evidence for superior efficacy of LAIV (compared to placebo or TIV) among children aged 6 months to ≤7 years. For children from >7 to 17 years, there is moderate evidence for superiority of LAIV for children with asthma, while direct evidence for children from the general population is lacking for this age group. Due to the efficacy of LAIV in children aged 6 months to ≤7 years (high evidence) and the efficacy of LAIV in children with asthma aged >7 to 17 years (moderate evidence), LAIV is also very likely to be efficacious among children in the general population aged >7 to 17 years (indirect evidence). In the included studies with children aged 2 to 17 years, LAIV was safe and well-tolerated; while in younger children LAIV may increase the risk of obstruction of the airways (e.g. wheezing).
In the majority of the evaluated epidemiological studies, LAIV proved to be effective in the prevention of influenza among children aged 2–17 years under everyday conditions (effectiveness). The trend appears to indicate that LAIV is more effective than TIV, although this can only be based on limited evidence for methodological reasons (observational studies). In addition to a direct protective effect for vaccinated children themselves, indirect protective ("herd protection") effects were reported among non-vaccinated elderly population groups, even at relatively low vaccination coverage of children. With regard to safety, LAIV generally can be considered equivalent to TIV. This also applies to the use among children with mild chronically obstructive conditions, from whom LAIV therefore does not have to be withheld. In all included epidemiological studies, there was some risk of bias identified, e.g. due to residual confounding or other methodology-related sources of error.
In the evaluated studies, both the vaccination of children with previous illnesses and the routine vaccination of (healthy) children frequently involve cost savings. This is especially the case if one includes indirect costs from a societal perspective. From a payer perspective, a routine vaccination of children is often regarded as a highly cost-effective intervention. However, not all of the studies arrive at consistent results. In isolated cases, relatively high levels of cost-effectiveness are reported that make it difficult to perform a conclusive assessment from an economic perspective. Based on the included studies, it is not possible to make a clear statement about the budget impact of using LAIV. None of the evaluated studies provides results for the context of the German healthcare setting.
The efficacy of the vaccine, physicians' recommendations, and a potential reduction in influenza symptoms appear to play a role in the vaccination decision taken by parents/custodians on behalf of their children. Major barriers to the utilization of influenza vaccination services are a low level of perception and an underestimation of the disease risk, reservations concerning the safety and efficacy of the vaccine, and potential side effects of the vaccine. For some of the parents surveyed, the question as to whether the vaccine is administered as an injection or nasal spray might also be important.
Conclusion: In children aged 2 to 17 years, the use of LAIV can lead to a reduction of the number of influenza cases and the associated burden of disease. In addition, indirect preventive effects may be expected, especially among elderly age groups. Currently there are no data available for the German healthcare setting. Long-term direct and indirect effectiveness and safety should be supported by surveillance programs with a broader use of LAIV.
Since there is no general model available for the German healthcare setting, statements concerning the cost-effectiveness can be made only with precaution. Beside this there is a need to conduct health eco-nomic studies to show the impact of influenza vaccination for children in Germany. Such studies should be based on a dynamic transmission model. Only these models are able to include the indirect protective effects of vaccination correctly.
With regard to ethical, social and legal aspects, physicians should discuss with parents the motivations for vaccinating their children and upcoming barriers in order to achieve broader vaccination coverage.
The present HTA provides an extensive basis for further scientific approaches and pending decisions relating to health policy.
doi:10.3205/hta000119
PMCID: PMC4219018  PMID: 25371764
Health Technology Assessment; HTA; LAIV; live attenuated vaccine; TIV; trivalent inactivated vaccine
4.  Effectiveness and efficacy of minimally invasive lung volume reduction surgery for emphysema 
Lung emphysema is a chronic, progressive and irreversible destruction of the lung tissue. Besides non-medical therapies and the well established medical treatment there are surgical and minimally invasive methods for lung volume reduction (LVR) to treat severe emphysema.
This report deals with the effectiveness and cost-effectiveness of minimally invasive methods compared to other treatments for LVR in patients with lung emphysema. Furthermore, legal and ethical aspects are discussed.
No clear benefit of minimally invasive methods compared to surgical methods can be demonstrated based on the identified and included evidence. In order to assess the different methods for LVR regarding their relative effectiveness and safety in patients with lung emphysema direct comparative studies are necessary.
doi:10.3205/hta000117
PMCID: PMC4185364  PMID: 25295123
bronchoscopy; obstructive lung diseases; lung volume reduction; lung volume reduction surgery; LVR; LVRS; pneumonectomy; chronic obstructive pulmonary disease; pulmonary emphysema
5.  Clinical effectiveness and cost-effectiveness of fissure sealants in children and adolescents with a high caries risk 
In Germany, the application of resin-based pits and fissures sealants on the occlusal surfaces of permanent molars is part of individual prophylaxis for children and adolescents between six and 18 years. The individual prophylaxis is covered by the Statutory Health Insurance since 1993.
The report addresses questions on medical effectiveness, cost-effectiveness, as well as ethical, social, and legal implications of pit and fissure sealants in preventing dental caries for children and adolescents at high caries risk.
The results of the studies indicate a protective effect of pit and fissure sealants, particularly for children and adolescents at high caries risk. Additionally, the economic evaluation suggests a tendency for cost savings in this group. Nevertheless, a general expansion of the intervention cannot be recommended. All studies show a risk of bias in favour of pit and fissure sealing and a limited transferability to the German health care system. Studies included in the economic evaluation revealed methodological flaws. Both the economic models and primary studies do not provide reliable results.
doi:10.3205/hta000118
PMCID: PMC4185365  PMID: 25295124
adolescent; carious; cement; child; decay; dental caries; dental sealants; DMFT; fissure sealants; glass ionomer cements; pit and fissure sealants; primary prevention
6.  Prevention of fetal alcohol syndrome 
The fetal alcohol syndrome (FAS) is the most avoidable handicap of newborns. It describes prenatal damages which result from the alcohol consumption of the mother. These can be: reduced body length and weight (pre- and postnatal), microcephaly, musculoskeletal, mental and statomotoric developmental retardations and impaired coordinative ability. There are preventive measures of which the efficiency is examined. Already, short counseling interviews, so-called short interventions, increase the abstinence of pregnant women.
doi:10.3205/hta000116
PMCID: PMC3761322  PMID: 24009646
alcohol-induced disorders; FAS; FASD; fetal alcohol syndrome; fetal diseases; infant, newborn; intervention; prevention; women
7.  The effectiveness of occupational therapy for persons with moderate and severe dementia 
An occupational therapy tailored for persons concerned with moderate to severe dementia is effective. Occupational therapy applies in a targeted manner activities as therapeutic measure. Aim is a high quality of life in everyday life – also without drugs. Mental capacity and independence in daily routine shall be maintained as long as possible. Occupational therapy can be more cost-effective than medical treatment because it reduces the nursing expenditures.
doi:10.3205/hta000115
PMCID: PMC3736276  PMID: 23935762
dementia; drugs; occupational therapy; quality of life; therapy
8.  Health Technology Assessment – science or art? 
The founding disciplines of HTA are clearly scientific, and have been firmly based among the natural sciences. However, common definitions of HTA indicate that HTA is something more than the “pure application of science”. This article investigates whether this “something” also makes HTA an art. The question of whether HTA is a science or an art is pursued in two specific and historically rich directions. The first is whether HTA is an art in the same way that medicine is described as an art. It has been argued extensively that medicine is based on two different and partly incompatible cultures, i.e., the natural sciences and humanities. Medicine is based on disciplines within the natural sciences, while its value judgments have been placed in the humanities camp. This dichotomy is present in HTA as well, and the first part of the investigation illustrates how HTA is an art in terms of its inherent and constitutive value-judgments. The second part of the science/art-scrutiny leads us to the ancient (Hippocratic) concept of art, téchne, where we find an etymological and a conceptual link between HTA and art. It demonstrates HTA is not an arbitrary process, even though it involves value judgments and relates complex decision making processes. As an art (téchne) HTA has a specific subject matter, requires inquiry and mastery of general rational principles, and is oriented to a specific end. In conclusion, the science-or-art-question makes sense in two specific perspectives, illustrating that HTA is a science based art. This has implications for the practice of HTA, for its education, and for the status of its results.
doi:10.3205/hta000114
PMCID: PMC3736275  PMID: 23935761
science; art; accountability; philosophy; téchne; phronesis
9.  Music therapy in palliative setting 
The expectations on the care of humans with an incurable disease are to console, to relieve pain and to take away somebody’s fears. Therefore, palliative care tries to support terminally ill persons during the last stage of life and to ameliorate the living conditions. The question is how far music therapy can increase the quality of life. Until now, there is only small evidence for that, because there are too few applicable studies.
doi:10.3205/hta000113
PMCID: PMC3728641  PMID: 23904890
end-of-life care; hospices; music; therapy; palliative care; terminal care
10.  Overweight and obesity: The efficacy of diets for weight maintenance after weight loss 
The report examines which diets are successful as therapy for overweight and obese persons. In general all considered diets are effective. Besides the food the patients have to change the kinesic behaviour and the lifestyle to achieve sustained success.
doi:10.3205/hta000112
PMCID: PMC3728640  PMID: 23904889
body mass index; diet; meal replacement; obesity; overweight; weight loss
11.  Acute pain treatment on postoperative and medical non-surgical wards 
The effectiveness of acute pain treatment in hospitals is examined. An efficient therapy of acute pain is efficient and cost-effective. Although every patient is entitled for the relief of pain, many hospitals do not treat acute pain in an optimal manner.
doi:10.3205/hta000111
PMCID: PMC3728639  PMID: 23904888
acute pain; diagnosis-related groups; DRG; pain clinics; pain relief
12.  Medical specialist attendance in nursing homes 
The care in nursing homes was examined based on scientific studies. The analysis focuses on dementia and type II diabetes. There is evidence for deficits in the supply of medical specialist attendance to nursing home residents with these diseases in Germany. Compared with corresponding guidelines the medical care for nursing home residents may be too low or inadequate.
doi:10.3205/hta000108
PMCID: PMC3677380  PMID: 23755088
aged; delivery of health care, integrated; Germany; nursing homes; primary health care
13.  Efficacy and efficiency of psychological, psychiatric, sociomedical and complementary medical interventions for excessive crying in primary care services (“Schreiambulanzen”) 
There are different approaches to reduce excessive crying of babies. Studies prove positive effects of single measures, e. g. certain diets, acupuncture or psychological approaches improve the crying behaviour. No evaluation data support the effectiveness of the examined crying ambulances.
doi:10.3205/hta000109
PMCID: PMC3677381  PMID: 23755089
colic; crying baby; excessive crying; infantile regulatory problem; Wessel
14.  Diagnosing Alzheimer’s disease: are we any nearer to useful biomarker-based, non-invasive tests? 
Background: Alzheimer’s disease (AD) accounts for 60–80% of cases of dementia and causes significant morbidity in patients and carers, and expense for health and social services. There is a need for a validated, non-invasive and cheap test to diagnose early AD, as diagnosis may enable prompt treatment and service planning.
Aim: To identify emerging biomarker-based tests for the early diagnosis of AD which could be available for use in primary or generalist care in the near future.
Design: Horizon scanning review.
Methods: We searched online sources to identify emerging non-invasive, biomarker-based tests. Tests were included if they used blood, saliva or urine; and there was evidence of use in trials in patients with AD. For tests licensed for use in clinical or research settings we requested information from the developer on the intended place of use and plans for availability in Europe.
Results: We identified 6 biomarker-based tests of which 5 are available for research or clinical use. The closest to market were AclarusDX™ (ExonHit Therapeutics) a gene signature test, and INNO-BIA plasma Aβ forms assay (Innogenetics N.V.) which may be CE marked for clinical use in 2015. We found no evidence of clinical utility or cost.
Conclusion: Although biomarker-based tests are nearing clinical availability and may have a future role to help target AD-specific treatment and guide prognosis, they are not yet ready for trials of clinical utility in primary care.
doi:10.3205/hta000107
PMCID: PMC3677379  PMID: 23755087
Alzheimer's disease; diagnosis; biomarker; emerging health technology; primary health care; dementia
16.  Bone graft substitutes for the treatment of traumatic fractures of the extremities 
Health political and scientific background
Bone graft substitutes are increasingly being used as supplements to standard care or as alternative to bone grafts in the treatment of traumatic fractures.
Research questions
The efficacy and cost-effectiveness of bone graft substitutes for the treatment of traumatic fractures as well as the ethical, social and legal implications of their use are the main research questions addressed.
Methods
A systematic literature search was conducted in electronic medical databases (MEDLINE, EMBASE etc.) in December 2009. Randomised controlled trials (RCT), where applicable also containing relevant health economic evaluations and publications addressing the ethical, social and legal aspects of using bone graft substitutes for fracture treatment were included in the analysis. After assessment of study quality the information synthesis of the medical data was performed using metaanalysis, the synthesis of the health economic data was performed descriptively.
Results
14 RCT were included in the medical analysis, and two in the heath economic evaluation. No relevant publications on the ethical, social and legal implications of the bone graft substitute use were found.
In the RCT on fracture treatment with bone morphogenetic protein-2 (BMP-2) versus standard care without bone grafting (RCT with an elevated high risk of bias) there was a significant difference in favour of BMP-2 for several outcome measures. The RCT of calcium phosphate (CaP) cement and bone marrow-based composite materials versus autogenous bone grafts (RCT with a high risk of bias) revealed significant differences in favour of bone graft substitutes for some outcome measures. Regarding the other bone graft substitutes, almost all comparisons demonstrated no significant difference.
The use of BMP-2 in addition to standard care without bone grafting led in the study to increased treatment costs considering all patients with traumatic open fractures. However, cost savings through the additional use of BMP-2 were calculated in a patient subgroup with high-grade open fractures (Gustilo-Anderson grade IIIB). Cost-effectiveness for BMP-2 versus standard care with autologous bone grafts as well as for other bone graft substitutes in fracture treatment has not been determined yet.
Discussion
Although there were some significant differences in favour of BMP-2, due to the overall poor quality of the studies the evidence can only be interpreted as suggestive for efficacy. In the case of CaP cements and bone marrow-based bone substitute materials, the evidence is only weakly suggestive for efficacy. From an overall economic perspective, the transferability of the results of the health economic evaluations to the current situation in Germany is limited.
Conclusions
The current evidence is insufficient to evaluate entirely the use of different bone graft substitutes for fracture treatment. From a medical point of view, BMP-2 is a viable alternative for treatment of open fractures of the tibia, especially in cases where bone grafting is not possible. Autologous bone grafting is preferable comparing to the use of OP-1. Possible advantages of CaP cements and composites containing bone marrow over autogenous bone grafting should be taken into account in clinical decision making. The use of the hydroxyapatite material and allograft bone chips compared to autologous bone grafts cannot be recommended.
From a health economic perspective, the use of BMP-2 in addition to standard care without bone grafting is recommended as cost-saving in patients with high-grade open fractures (Gustilo-Anderson grade IIIB). Based on the current evidence no further recommendations can be made regarding the use of bone graft substitutes for the treatment of fractures. To avoid legal implications, use of bone graft substitutes outside their approved indications should be avoided.
doi:10.3205/hta000102
PMCID: PMC3434359  PMID: 22984371
academic review; accident; accuracy study; assessment; blinded; blinded study; blinded trial; blinding; bone and bones; bone fracture; bone graft; bone substitutes; bone substitutes/economics; bone substitutes/therapeutic use; bone transplantation; CCT; clinical study; clinical trial; clinical trials as topic; controlled clinical study; controlled clinical trial; controlled clinical trials as topic; cost analysis; cost control; cost effectiveness; cost minimisation; cost minimization; cost reduction; cost-benefit analysis; cost-cutting; cost-effectiveness; costs; costs and cost analysis; cross-over studies; CT; decision making; EBM; economic aspect; economic model; economics; economics, medical; effectiveness; efficiency; ethics; evaluation; evaluation studies as topic; evaluation study; evidence based medicine; evidence-based medicine; fracture; fractures, bone; health; health economic study; health economics; health funding; health policy; health technology assessment; HTA; HTA report; HTA-report; humans; judgment; medical assessment; medical costs; medical economics; medical efficacy; medical evaluation; medical laboratory science; medical technology; meta analysis; meta-analysis; meta-analysis as topic; models, economic; multicenter studies as topic; multicenter study; peer review; pharmacoeconomics; placebo; placebo effect; placebos; prospective studies; random; random allocation; randomisation; randomised clinical study; randomised clinical trial; randomised controlled trial; randomised study; randomised trial; randomization; randomized clinical study; randomized clinical trial; randomized controlled trial; randomized controlled trials as topic; randomized study; randomized trial; RCT; report; research article; research-article; review; review literature; review literature as topic; risk assessment; sensitivity; sensitivity and specificity; sickness costs; social economic factor; socioeconomic factor; socioeconomic factors; socioeconomics; specifity; systematic review; TA; technical report; technology; technology assessment; technology assessment, biomedical; technology evaluation; traumatology; validation studies as topic; validation study
17.  Therapy of the burnout syndrome 
Background
The prevalence, diagnostics and therapy of the burnout syndrome are increasingly discussed in the public. The unclear definition and diagnostics of the burnout syndrome are scientifically criticized. There are several therapies with unclear evidence for the treatment of burnout in existence.
Objectives
The health technology assessment (HTA) report deals with the question of usage and efficacy of different burnout therapies.
Methods
For the years 2006 to 2011, a systematic literature research was done in 31 electronic databases (e.g. EMBASE, MEDLINE, PsycINFO). Important inclusion criteria are burnout, therapeutic intervention and treatment outcome.
Results
17 studies meet the inclusion criteria and are regarded for the HTA report. The studies are very heterogeneous (sample size, type of intervention, measuring method, level of evidence). Due to their study design (e.g. four reviews, eight randomized controlled trials) the studies have a comparable high evidence: three times 1A, five times 1B, one time 2A, two times 2B and six times 4. 13 of the 17 studies are dealing with the efficacy of psychotherapy and psychosocial interventions for the reduction of burnout (partly in combination with other techniques). Cognitive behaviour therapy leads to the improvement of emotional exhaustion in the majority of the studies. The evidence is inconsistent for the efficacy of stress management and music therapy. Two studies regarding the efficacy of Qigong therapy do not deliver a distinct result. One study proves the efficacy of roots of Rhodiola rosea (evidence level 1B). Physical therapy is only in one study separately examined and does not show a better result than standard therapy.
Discussion
Despite the number of studies with high evidence the results for the efficacy of burnout therapies are preliminary and do have only limited reach. The authors of the studies complain about the low number of skilled studies for the therapy of burnout. Furthermore, they point to the insufficient evaluation of the therapy studies and the need for further research. Some authors report the effects of considerable natural recovering.
Numerous limitations affect the quality of the results. Intervention contents and duration, study design and study size are very diverse and do not permit direct comparison. Most of the samples are small by size with low statistical power, long-term follow-ups are missing. Comorbidities and parallel utilized therapies are insufficient documented or controlled. Most of the studies use the Maslach Burnout Inventory (MBI) as diagnostic or outcome-tool, but with different cut-off-points. It should be noticed that the validity of the MBI as diagnostic tool is not proved. Ethical, juridical and social determining factors are not covered or discussed in the studies.
Conclusion
The efficacy of therapies for the treatment of the burnout syndrome is insufficient investigated. Only for cognitive behavioural therapy (CBT) exists an adequate number of studies which prove its efficacy. Big long-term experimental studies are missing which compare the efficacy of the single therapies and evaluate their evidence. The natural recovering without any therapy needs further research. Additionally, it has to be examined to what extent therapies and their possible effects are thwarted by the conditions of the working place and the working conditions.
doi:10.3205/hta000103
PMCID: PMC3434360  PMID: 22984372
burnout; burnout intervention study; burnout, professional; CBT; cognitive behavior therapy; cognitive behavior treatment; cognitive behaviour therapy; cognitive behaviour treatment; cognitive therapy; cognitive-behavioral therapy; cognitive-behavioral treatment; cognitive-behavioural therapy; cognitive-behavioural treatment; depression; depressive disorder; EBM; evidence based medicine; evidence-based medicine; health technology assessment; HTA; HTA report; HTA-report; humans; individual-focused intervention; mind-body therapies; mind-body therapy; music therapy; person-directed intervention; phytotherapy; prognostic instrument; psychotherapy; qigong; relaxation; review; review literature; review literature as topic; rhodiola; rhodiola rosea; stress management training; systematic review; TA; technology assessment; technology assessment, biomedical; therapeutics; therapy; treatment; treatment outcome
18.  Alternative methods for the treatment of post-menopausal troubles 
Background
Menopause is described as the transition from the reproductive phase of a women to the non reproductive. Changes in hormone levels might lead to complaints and health consequences especially during peri- and postmenopause. Hormone therapy has a potential damaging health risk profile and is recommended for temporal limited therapy for acute vasomotor symptoms only.
Objective
The present HTA-report aims to assess the effectiveness and the cost-effectiveness of alternative treatment methods for women with postmenopausal symptoms in Germany regarding patient relevant endpoints (reduction of symptoms and frequency of adverse events and improvement of quality of life).
Methods
A systematic literature search was carried out in 33 relevant databases in September 2010. Citations were selected according to pre-defined criteria and were extracted and evaluated.
Results
In the systematic research 22 studies are identified for the effectiveness evaluation, 22 primary studies and one review.
High doses of isolated genistein reduce the frequency/intensity of hot flashes while low doses of genistein show no significant effect. Intake of isoflavone extract such as genistein, daidzein, glycitein in various combinations does not have an effect on improvement of cognitive function or vaginal dryness. The effect of black cohosh and hop extract for menopausal complaints cannot be determined since results are heterogenous. The combination of isoflavone, black cohosh, monk’s pepper, valerian and vitamin E has a positive effect on menopause symptoms. Ginkgo biloba shows no significant effect on menopause symptoms and cognitive improvement beside mental flexibility. Acupuncture has a significant influence on hot flashes especially in severe cases.
Discussion/Conclusion
No final statement can be drawn regarding the effectiveness of alternative treatment methods due to qualitative shortcomings of included studies and a general limited availability of studies in this field. Furthermore, the generalization of the present HTA is limited due to the inclusion of only postmenopausal women.
doi:10.3205/hta000101
PMCID: PMC3356850  PMID: 22690252
acupuncture; alternative treatment method; change of life; climacteric disorders; climacteric/*; complementary therapies/*; complementary therapies/*adverse effects; complementary therapies/*economics; complementary therapies/*standards; complemtary medicine; cost effectiveness; cost-effectiveness; cure; diagnosis; EBM; effectiveness; efficacy; evidence-based medicine; female; Health Technology Assessment; hormone level; hormone preparation; hormone replacement therapy; hormones; hormonotherapy; hot flashes; HTA; HTA report; HTA-report; humans; influence; life quality; medical treatment; menopause; method of treatment; peer review; phytotherapy; plant extracts; postmenopausal woman; postmenopause/*; quality of life; randomised controlled study; randomised controlled trial; randomized controlled study; randomized controlled trial; randomized controlled trials as topic; RCT; relaxation technique; relaxation therapy; review; review literature; review literature as topic; symptom; systematic review; TA; technology assessment; technology assessment, biomedical; therapeutics; therapy; treatment; treatment method; treatment outcome; vasomotor symptom; women's health
19.  CT coronary angiography vs. invasive coronary angiography in CHD 
Scientific background
Various diagnostic tests including conventional invasive coronary angiography and non-invasive computed tomography (CT) coronary angiography are used in the diagnosis of coronary heart disease (CHD).
Research questions
The present report aims to evaluate the clinical efficacy, diagnostic accuracy, prognostic value cost-effectiveness as well as the ethical, social and legal implications of CT coronary angiography versus invasive coronary angiography in the diagnosis of CHD.
Methods
A systematic literature search was conducted in electronic data bases (MEDLINE, EMBASE etc.) in October 2010 and was completed with a manual search. The literature search was restricted to articles published from 2006 in German or English. Two independent reviewers were involved in the selection of the relevant publications.
The medical evaluation was based on systematic reviews of diagnostic studies with invasive coronary angiography as the reference standard and on diagnostic studies with intracoronary pressure measurement as the reference standard. Study results were combined in a meta-analysis with 95 % confidence intervals (CI). Additionally, data on radiation doses from current non-systematic reviews were taken into account.
A health economic evaluation was performed by modelling from the social perspective with clinical assumptions derived from the meta-analysis and economic assumptions derived from contemporary German sources.
Data on special indications (bypass or in-stent-restenosis) were not included in the evaluation. Only data obtained using CT scanners with at least 64 slices were considered.
Results
No studies were found regarding the clinical efficacy or prognostic value of CT coronary angiography versus conventional invasive coronary angiography in the diagnosis of CHD.
Overall, 15 systematic reviews with data from 44 diagnostic studies using invasive coronary angiography as the reference standard (identification of obstructive stenoses) and two diagnostic studies using intracoronary pressure measurement as the reference standard (identification of functionally relevant stenoses) were included in the medical evaluation.
Meta-analysis of the nine studies of higher methodological quality showed that, CT coronary angiography with invasive coronary angiography as the reference standard, had a sensitivity of 96 % (95 % CI: 93 % to 98 %), specificity of 86 % (95 % CI: 83 % to 89 %), positive likelihood ratio of 6.38 (95 % CI: 5.18 to 7.87) and negative likelihood ratio of 0.06 (95 % CI: 0.03 to 0.10). However, due to non-diagnostic CT images approximately 3.6 % of the examined patients required a subsequent invasive coronary angiography.
Using intracoronary pressure measurement as the reference standard, CT coronary angiography compared to invasive coronary angiography had a sensitivity of 80 % (95 % CI: 61 % to 92 %) versus 67 % (95 % CI: 51 % to 78 %), a specificity of 67 % (95 % CI: 47 % to 83 %) versus 75 % (95 % CI: 60 % to 86 %), an average positive likelihood ratio of 2.3 versus 2.6, and an average negative likelihood ratio 0.3 versus 0.4, respectively.
Compared to invasive coronary angiography, the average effective radiation dose of CT coronary angiography was higher with retrospective electrocardiogram (ECG) gating and relatively similar with prospective ECG gating.
The health economic model using invasive coronary angiography as the reference standard showed that at a pretest probability of CHD of 50 % or lower, CT coronary angiography resulted in lower cost per patient with true positive diagnosis. At a pretest probability of CHD of 70 % or higher, invasive coronary angiography was associated with lower cost per patient with true positive diagnosis. Using intracoronary pressure measurement as the reference standard, both types of coronary angiographies resulted in substantially higher cost per patient with true positive diagnosis.
Two publications dealing explicitly with ethical aspects were identified. The first addressed ethical aspects regarding the principles of beneficence, autonomy and justice, and the second addressed those regarding radiation exposition, especially when used within studies.
Discussion
The discriminatory power of CT coronary angiography to identify patients with obstructive (above 50 %) coronary stenoses should be regarded as “high diagnostic evidence”, to identify patients without coronary stenoses as “persuasive diagnostic evidence”. The discriminatory power of both types of coronary angiography to identify patients with or without functionally relevant coronary stenoses should be regarded as “weak diagnostic evidence”.
It can be assumed that patients with a high pretest probability of CHD will need invasive coronary angiography and patients with a low pretest probability of CHD will not need subsequent revascularisation. Therefore, CT coronary angiography may be used before performing invasive coronary angiography in patients with an intermediate pretest probability of CHD.
For identifying or excluding of obstructive coronary stenosis, CT coronary angiography was shown to be more cost-saving at a pretest probability of CHD of 50 % or lower, and invasive coronary angiography at a pretest probability of CHD of 70 % or higher. The use of both types of coronary angiography to identify or to exclude functionally relevant coronary stenoses should be regarded as highly cost-consuming.
With regard to ethical, social or legal aspects, the following possible implications were identified: under-provision or over-provision of health care, unnecessary complications, anxiety, social stigmatisation, restriction of self-determination, unequal access to health care, unfair resource distribution and legal disputes.
Conclusion
From a medical point of view, CT coronary angiography using scanners with at least 64 slices should be recommended as a test to rule out obstructive coronary stenoses in order to avoid inappropriate invasive coronary angiography in patients with an intermediate pretest probability of CHD. From a health economic point of view, this recommendation should be limited to patients with a pretest probability of CHD of 50 % or lower.
From a medical and health economic point of view, neither CT coronary angiography using scanners with at least 64 slices nor invasive coronary angiography may be recommended as a single diagnostic test for identifying or ruling out functionally relevant coronary stenoses.
To minimise any potential negative ethical, social and legal implications, the general ethical and moral principles of benefit, autonomy and justice should be considered.
doi:10.3205/hta000100
PMCID: PMC3334923  PMID: 22536300
CHD; coronary angiography; coronary disease; coronary heart disease; cost-benefit-analysis; diagnosis; EBM; evidence based medicine; evidence-based medicine; health technology assessment; health-economic analysis; HTA; humans; meta-analysis; meta-analysis as topic; review literature as topic; stenosis; systematic review
20.  Falls prevention for the elderly 
Background
An ageing population, a growing prevalence of chronic diseases and limited financial resources for health care underpin the importance of prevention of disabling health disorders and care dependency in the elderly. A wide variety of measures is generally available for the prevention of falls and fall-related injuries. The spectrum ranges from diagnostic procedures for identifying individuals at risk of falling to complex interventions for the removal or reduction of identified risk factors. However, the clinical and economic effectiveness of the majority of recommended strategies for fall prevention is unclear. Against this background, the literature analyses in this HTA report aim to support decision-making for effective and efficient fall prevention.
Research questions
The pivotal research question addresses the effectiveness of single interventions and complex programmes for the prevention of falls and fall-related injuries. The target population are the elderly (> 60 years), living in their own housing or in long term care facilities. Further research questions refer to the cost-effectiveness of fall prevention measures, and their ethical, social and legal implications.
Methods
Systematic literature searches were performed in 31 databases covering the publication period from January 2003 to January 2010. While the effectiveness of interventions is solely assessed on the basis of randomised controlled trials (RCT), the assessment of the effectiveness of diagnostic procedures also considers prospective accuracy studies. In order to clarify social, ethical and legal aspects all studies deemed relevant with regard to content were taken into consideration, irrespective of their study design. Study selection and critical appraisal were conducted by two independent assessors. Due to clinical heterogeneity of the studies no meta-analyses were performed.
Results
Out of 12,000 references retrieved by literature searches, 184 meet the inclusion criteria. However, to a variable degree the validity of their results must be rated as compromised due to different biasing factors. In summary, it appears that the performance of tests or the application of parameters to identify individuals at risk of falling yields little or no clinically relevant information. Positive effects of exercise interventions may be expected in relatively young and healthy seniors, while studies indicate opposite effects in the fragile elderly. For this specific vulnerable population the modification of the housing environment shows protective effects. A low number of studies, low quality of studies or inconsistent results lead to the conclusion that the effectiveness of the following interventions has to be rated unclear yet: correction of vision disorders, modification of psychotropic medication, vitamin D supplementation, nutritional supplements, psychological interventions, education of nursing personnel, multiple and multifactorial programs as well as the application of hip protectors.
For the context of the German health care system the economic evaluations of fall prevention retrieved by the literature searches yield very few useful results. Cost-effectiveness calculations of fall prevention are mostly based on weak effectiveness data as well as on epidemiological and cost data from foreign health care systems.
Ethical analysis demonstrates ambivalent views of the target population concerning fall risk and the necessity of fall prevention. The willingness to take up preventive measures depends on a variety of personal factors, the quality of information, guidance and decision-making, the prevention program itself and social support.
The analysis of papers regarding legal issues shows three main challenges: the uncertainty of which standard of care has to be expected with regard to fall prevention, the necessity to consider the specific conditions of every single case when measures for fall prevention are applied, and the difficulty to balance the rights to autonomous decision making and physical integrity.
Discussion and conclusions
The assessment of clinical effectiveness of interventions for fall prevention is complicated by inherent methodological problems (esp. absence of blinding) and meaningful clinical heterogeneity of available studies. Therefore meta-analyses are not appropriate, and single study results are difficult to interpret. Both problems also impair the informative value of economic analyses. With this background it has to be stated that current recommendations regarding fall prevention in the elderly are not fully supported by scientific evidence. In particular, for the generation of new recommendations the dependency of probable effects on specific characteristics of the target populations or care settings should be taken into consideration. This also applies to the variable factors influencing the willingness of the target population to take up and pursue preventive measures.
In the planning of future studies equal weight should be placed on methodological rigour (freedom from biases) and transferability of results into routine care. Economic analyses require input of German data, either in form of a “piggy back study“ or in form of a modelling study that reflects the structures of the German health care system and is based on German epidemiological and cost data.
doi:10.3205/hta000099
PMCID: PMC3334922  PMID: 22536299
accidental falls; accidents, home/*; activities of daily living; aged/*; aged/*psychology; adjustment of the living environment; cataract surgery; correction of the visual acuity; customisation of the living environment; diagnosis; dietary supplements; dose-response relationship, drug; EBM; economic evaluation; elderly; environment design; evidence-based medicine; exercise program; exercise/physiology; eye test; eyesight; eyesight test; fall; fall prevention; fall prophylaxis; fall risk; fall risk factors; falling consequences; falling danger; fall-related injuries; fracture; freedom/*; freedom-depriving measures; geriatric nursing home; health technology assessment; hip fracture; hip fractures; hip protectors; homes for the aged; HTA; humans; interventions; medical adjustment; meta-analysis as topic; motor activity; motor activity/drug effects; motor skills; motor function; multi-factorial programs; multimodal programs; nursing homes; peer review; power of movement; prevention; primary prevention; private domesticity; prophylaxis; randomized controlled trial; randomized controlled trials as topic; RCT; review literature as topic; risk assessment; risk factors; risk reduction behavior; seniors; sight; stabilized; systematic review; technology assessment, biomedical; training program; visual acuity; Vitamin D/administration & dosage
21.  Percutaneous coronary intervention with optimal medical therapy vs. optimal medical therapy alone for patients with stable angina pectoris 
Scientific background
Stable Angina Pectoris (AP) is a main syndrome of chronic coronary artery disease (CAD), a disease with enormous epidemiological and health economic relevance. Medical therapy and percutaneous coronary interventions (PCI) are the most important methods used in the treatment of chronic CAD.
Research questions
The evaluation addresses questions on medical efficacy, incremental cost-effectiveness as well as ethic, social and legal aspects in the use of PCI in CAD patients in comparison to optimal medical therapy alone.
Methods
A systematic literature search was conducted in June 2010 in the electronic databases (MEDLINE, EMBASE etc.) and was completed by a hand search.
The medical analysis was initially based on systematic reviews of randomized controlled trials (RCT) and was followed by the evaluation of RCT with use of current optimal medical therapy. The results of the RCT were combined using meta-analysis. The strength and the applicability of the determined evidence were appraised.
The health economic analysis was initially focused on the published studies. Additionally, a health economic modelling was performed with clinical assumptions derived from the conducted meta-analysis and economic assumptions derived from the German Diagnosis Related Groups 2011.
Results
Seven systematic reviews (applicability of the evidence low) and three RCT with use of optimal medical therapy (applicability of the evidence for the endpoints AP and revascularisations moderate, for further endpoints high) were included in the medical analysis. The results from RCT are used as a base of the evaluation. The routine use of the PCI reduces the proportion of patients with AP attacks in the follow-up after one and after three years in comparison with optimal medical therapy alone (evidence strength moderate); however, this effect was not demonstrated in the follow-up after five years (evidence strength low). The difference in effect in the follow-up after four to five years was not found for the further investigated clinical endpoints: death, cardiac death, myocardial infarction and stroke (evidence strength high) as well as for severe heart failure (evidence strength moderate).
Two studies were included in the health economic analysis. The costs estimations from these studies are not directly transferable to the corresponding costs in Germany. The average difference in the total costs for PCI in comparison with optimal medical therapy alone, which was calculated in the modelling, was found to be 4,217 Euro per patient. The incremental cost-effectiveness ratio per life-year of a patient with avoided AP attacks was estimated to be 24,805 Euro (evidence strength moderate).
No publication was identified concerning ethical, social or legal aspects.
Discussion
Important methodical problems of the studies are a lack of blinding of the patients and incomplete data for several endpoints in the follow-up. The determined incremental cost-effectiveness ratio per life-year of a patient with avoided AP attacks was appraised not to be cost-effective.
Conclusions
From a medical point of view the routine use of PCI in addition to the optimal medicinal therapy in patients with stable AP can be recommended for the reduction of the proportion of patients with AP attacks after one year and after three years (recommendation degree weak). Otherwise, PCI is to be performed in patients with refractory or progressing AP despite of optimal medical therapy use; in this case PCI is expected to be applied in 27% to 30% of patients in five years.
From the health economic view the routine use of PCI in addition to an optimal medical therapy in patients with stable AP cannot be recommended.
No special considerations can be made concerning special ethical, social or legal aspects in the routine use of PCI in addition to optimal medical therapy in patients with stable AP.
doi:10.3205/hta000098
PMCID: PMC3244729  PMID: 22205918
acute coronary syndrom/therapy; angina pectoris/*; angioplasty; balloon-dilation/therapy; blood flow; blood supply; CAD; cardiac muscle; circulatory disorder; coronary heart disease; cost-benefit analysis; drug therapy/*; drug therapy/*economics; drug-eluting stents; drug-eluting stents/adverse effects; drug-eluting stents/economics; drug-eluting stents/utilization; Germany; health economic analysis; heart diseases/*; humans; ischemia; medicamental therapy; meta analysis; meta analysis as topic; myocardial insufficiency; myocardial ischemia; myocardium; PCI; percutaneous coronary intervention; perfusion; prevention; primary prevention; prophylaxis; randomized controlled trial; randomized controlled trial as topic; RCT; review literature; stable angina pectoris; stenting; systematic review; therapeutics; treatment
22.  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.
doi:10.3205/hta000097
PMCID: PMC3198117  PMID: 22031811
ability to work; absenteeism; academic review; accident; aged; behaviour-oriented; biomedical technology assessment; blinded; blinding; care; CCT; CT; clinical trial; condition-oriented; controlled clinical trials as topic; cost analysis; cost control; cost-effectiveness; cost reduction; cost-benefit analysis; cost-cutting; costs; costs and cost analysis; decision making; demographic development; demography; diagnosis; EBM; economic aspect; economics; economics, medical; effectiveness; efficacy; efficiency; ethics; evidence-based medicine; fitness for employment; fitness for work; Germany; health economic studies; health economics; health education; health policy; health promotion/*; Health Technology Assessment; HTA; HTA report; HTA-report; humans; judgment; juricical; medical assessment; medical costs; medical evaluation; mental health; meta analysis; meta analysis as topic; meta-analysis; methods; models, economic; nursing; nursing staff/*; nursing staff/psychology; nursing staff/standards; occupational health services; occupational health/*; orderlies; pathogenesis; peer review; pharmaeconomics; physical health; placebo; placebo effect; placebos; population development; prevention; primary prevention; random; random allocation; randomisation; randomised clinical study; randomised clinical trial; randomised controlled study; randomised controlled trial; randomised study; randomised trial; randomization; randomized clinical study; randomized clinical trial; randomized controlled study; randomized controlled trials as topic; randomized study; randomized trial; RCT; rehabilitation; report; research article; review; review literature; review literature as topic; rigths; risk assessment; risk of bias tool; salutogenesis; sensitivity; sickness costs; social economic factors; socioeconomic factors; socioeconomics; specifity; systematic review; technical report; technology; technology assessment; technology assessment, biomedical; technology evaluation; technology, medical; terms and condition of employment; therapy; treatment; Work Schedule Tolerance; workableness; working conditions; workload; workplace health promotion
23.  Individual health services 
Background
The German statutory health insurance (GKV) reimburses all health care services that are deemed sufficient, appropriate, and efficient. According to the German Medical Association (BÄK), individual health services (IGeL) are services that are not under liability of the GKV, medically necessary or recommendable or at least justifiable. They have to be explicitly requested by the patient and have to be paid out of pocket.
Research questions
The following questions regarding IGeL in the outpatient health care of GKV insurants are addressed in the present report:
What is the empirical evidence regarding offers, utilization, practice, acceptance, and the relation between physician and patient, as well as the economic relevance of IGeL?What ethical, social, and legal aspects are related to IGeL?
For two of the most common IGeL, the screening for glaucoma and the screening for ovarian and endometrial cancer by vaginal ultrasound (VUS), the following questions are addressed:
What is the evidence for the clinical effectiveness?Are there sub-populations for whom screening might be beneficial?
Methods
The evaluation is divided into two parts. For the first part a systematic literature review of primary studies and publications concerning ethical, social and legal aspects is performed.
In the second part, rapid assessments of the clinical effectiveness for the two examples, glaucoma and VUS screening, are prepared. Therefore, in a first step, HTA-reports and systematic reviews are searched, followed by a search for original studies published after the end of the research period of the most recent HTA-report included.
Results
29 studies were included for the first question. Between 19 and 53% of GKV members receive IGeL offers, of which three-quarters are realised. 16 to 19% of the insurants ask actively for IGeL. Intraocular tension measurement is the most common single IGeL service, accounting for up to 40% of the offers. It is followed by ultrasound assessments with up to 25% of the offers. Cancer screening and blood or laboratory services are also frequent and represent a major proportion of the demand.
The ethical, social, and legal aspects discussed in the context of IGeL concern eight subject areas:
autonomous patient decisions versus obtrusion,commercialization of medicine, duty of patient information, benefit, evidence, and (quality) control, role and relation of physicians and patients,relation to the GKV, social inequality,formally correct performance.
For glaucoma screening, no randomized controlled trial (RCT) is identified that shows a patient relevant benefit. For VUS three RCT are included. However, they do not yet present mortality data concerning screened and non-screened persons. VUS screening shows a high degree of over-diagnosis in turn leading to invasive interventions. To diagnose one invasive carcinoma, 30 to 35 surgical procedures are necessary.
Conclusion
IGeL are a relevant factor in the German statutory health care system. To provide more transparency, the requests for evidence-based and independent patient information should be considered. Whether official positive and negative-lists could be an appropriate instrument to give guidance to patients and physicians, should be examined. Generally, IGeL must be seen in the broader context of the discussions about the future design and development of the German health care system.
doi:10.3205/hta000096
PMCID: PMC3182028  PMID: 21966301
accident; additional benefit; add-on benefit; appropriateness; benefit package; biomedical technology assessment; care; catalogue of benefits; catalogue of services; clinical freedom; clinical trials as topic; commercialisation; commercialization; controlled clinical trials as topic; co-payment; cost analysis; cost control; cost effectiveness; cost reduction; cost repayment; cost-benefit analyses; cost-benefit analyses; cost-cutting; cost-effectiveness; costs; costs and cost analysis; decision making; demand; diagnosis; Doctor's duty to give patients information; EBM; economic aspect; economics; economics, medical; effectiveness; efficacy; efficiency; endometrial neoplasms; endometrial neoplasms/economics; ethics; evaluation studies as topic; evidence based medicine; Federal Joint Commitee; fee schedule; freedom of therapy; glaucoma; glaucoma/economics; health care costs/*; health care costs/*ethics; health care costs/*standards; health economic studies; health economics; health insurance fund; health technology assessment; HTA; HTA report; HTA-report; humans; individual health services; insurance benefits; insurance, health, reimbursement/*; interview; interviews as topic; juricical; mass screening; medical assessment; medical costs; medical evaluation; meta analysis as topic; methods; obligation to pay; obligation to render services; obligation to supply services; offer; Peer review; physician-patient relations/*ethics; poll; prevention; preventive benefits; preventive services; private health insurance; private service; random; random allocation; randomisation; randomization; randomized controlled trials as topic; range of benefits; reimbursement of costs; report; return of costs; review; review literature; review literature as topic; risk assessment; screening; screening for glaucoma; self retention; sensitivity; social economic factors; socioeconomic factors; socioeconomics; specifity; statutory health insurance; supplementary benefit; survey; systematic review; technical report; technology; technology assessment; technology assessment, biomedical; technology evaluation; technology, medical; therapy; treatment; vaginal ultrasound; VUS
24.  Prevention of alcohol misuse among children, youths and young adults 
Background
Despite many activities to prevent risky alcohol consumption among adolescents and young adults there is an increase of alcohol intoxications in the group of ten to twenty year old juveniles.
Objectives
This report gives an overview about the recent literature as well as the German federal prevention system regarding activities concerning behavioral and policy prevention of risky alcohol consumption among children, adolescents and young adults. Furthermore, effective components of prevention activities are identified and the efficiency and efficacy of ongoing prevention programs is evaluated.
Methods
A systematic literature review is done in 34 databases using Bool’sche combinations of the key words alcohol, prevention, treatment, children, adolescents and young adults.
Results
401 studies were found and 59 studies were selected for the health technology assessment (HTA). Most of the studies are done in USA, nine in Germany. A family strengthening program, personalized computer based intervention at schools, colleges and universities, brief motivational interventions and policy elements like increase of prices and taxes proved effective.
Discussion
Among the 59 studies there are three meta-analyses, 15 reviews, 17 randomized controlled trials (RCT) and 18 cohort studies. Despite the overall high quality of the study design, many of them have methodological weaknesses (missing randomization, missing or too short follow-ups, not clearly defined measurement parameters). The transferability of US-results to the German context is problematic. Only a few prevention activities reach a sustainable reduction of frequency and/or amount of alcohol consumption.
Conclusion
The HTA-report shows the need to develop specific and target group focused prevention activities for the German situation. Essential for that is the definition of target goals (reduction of consumption, change of behaviour) as well as the definition and empirical validation of risky alcohol consumption. The efficacy of prevention activities should be proven before they are launched. At present activities for the reduction or prevention of risky alcohol consumption are not sufficiently evaluated in Germany concerning their sustainable efficacy.
doi:10.3205/hta000095
PMCID: PMC3145353  PMID: 21808659
abstinence from alcohol; academic review; accident; adolescent; aggressiveness; alcohol abuse; alcohol addiction; alcohol consumption; alcohol dependence; alcohol dependency; alcohol drinking; alcohol intervention; alcohol misuse; alcohol policy; alcohol prevention programs; alcohol taxation; alcohol use; alcohol use disorder; alcoholic intoxication; alcoholism; alcohol-related disorders; alcohol-related problems; at-risk college drinkers; at-risk drinking; behavior therapy; behavioral measures; behaviour therapy; benefit; binge drinking; binge-drinking; biomedical technology assessment; blinded; blinded study; blinded trial; blinding; blood alcohol; blood alcohol concentration; blood alcohol level; boy; brief motivational intervention; care; child; clinical study; clinical trial; clinical trials as topic; cognitive behavior therapy; cognitive behavioural therapy; community; community-based prevention; controlled clinical study; controlled clinical trial; controlled clinical trials as topic; cost; cost analysis; cost control; cost effectiveness; cost reduction; cost-benefit analyses; cost-cutting; cost-effectiveness; costs; costs and cost analysis; crossover; cross-over; cross-over studies; cross-over trials; decision making; diagnosis; drinking; drinking behavior; drinking behaviour; early adulthood; EBM; economic aspect; economic evaluation; economics; economics, medical; effectiveness; efficacy; efficiency; ethical aspects; ethics; evaluation studies as topic; evidence based medicine; evidence-based medicine; extraordinary tax; family; family therapy; hazardous drinking; health; health economic studies; health economics; health policy; health problem; health technology assessment; high school; HTA; HTA report; HTA-report; humans; indicative prevention; inebriation; infant; intoxication; intoxication, alcoholic; judgment; juridical; kids; law; media campaign; medical assessment; medical costs; medical evaluation; meta analysis; meta analysis as topic; meta-analysis; methods; models, economic; motivation programme; mulitcentre; multicenter; multicenter studies as topic; multicenter trial; parents; peer review; pharmaeconomics; placebo; placebo effect; placebos; potential of aggressiveness; pre-teen; prevention; prevention campaign; primary prevention; program evaluation; prohibition; prophylaxis; prospective studies; protection; psychologic disorder; psychotherapy; random; random allocation; randomisation; randomised clinical study; randomised clinical trial; randomised controlled study; randomised controlled trial; randomised study; randomised trial; randomization; randomized clinical study; randomized clinical trial; randomized controlled study; randomized controlled trial; randomized controlled trials as topic; randomized study; randomized trial; RCT; rehabilitation; report; research article; research-article; review; review literature; review literature as topic; rights; risk assessment; school; school culture; school-based prevention; schools; sector-based prevention; selective prevention; sensitivity; sickness costs; social aspects; social care; social economic factors; social skills; social therapy; socioeconomic factors; socioeconomics; specifity; students; systematic review; tax increase; tax on alcohol; technical report; technology; technology assessment; technology assessment, biomedical; technology evaluation; technology, medical; teenager; therapy; treatment; trial, crossover; trial, cross-over; underage; undergraduates; universal prevention; universities; validation studies; validation studies as topic; young adult; youth; youth alcoholism
25.  Over-, under- and misuse of pain treatment in Germany 
Background
The HTA-report (Health Technology Assessment) deals with over- and undertreatment of pain therapy. Especially in Germany chronic pain is a common reason for the loss of working hours and early retirement. In addition to a reduction in quality of life for the affected persons, chronic pain is therefore also an enormous economic burden for society.
Objectives
Which diseases are in particular relevant regarding pain therapy?What is the social-medical care situation regarding pain facilities in Germany?What is the social-medical care situation in pain therapy when comparing on international level?Which effects, costs or cost-effects can be seen on the micro-, meso- and macro level with regard to pain therapy?Among which social-medical services in pain therapy is there is an over- or undertreatment with regard to the micro-, meso- and macro level?Which medical and organisational aspects that have an effect on the costs and/or cost-effectiveness have to be particularly taken into account with regard to pain treatment/chronic pain?What is the influence of the individual patient's needs (micro level) in different situations of pain (e. g. palliative situation) on the meso- and macro level?Which social-medical and ethical aspects for an adequate treatment of chronic pain on each level have to be specially taken into account?Is the consideration of these aspects appropriate to avoid over- or undertreatment?Are juridical questions included in every day care of chronic pain patients, mainly in palliative care?On which level can appropriate interventions prevent over- or undertreatment?
Methods
A systematic literature research is done in 35 databases. In the HTA, reviews, epidemiological and clinical studies and economic evaluations are included which report about pain therapy and in particular palliative care in the years 2005 till 2010.
Results
47 studies meet the inclusion criteria. An undertreatment of acupuncture, over- and misuse with regard to opiate prescription and an overuse regarding unspecific chest pain and chronic low back pain (LBP) can be observed. The results show the benefit and the cost-effectiveness of interdisciplinary as well as multi-professional approaches, multimodal pain therapy and cross-sectoral integrated medical care. Only rough values can be determined about the care situation regarding the supply of pain therapeutic and palliative medical facilities as the data are completely insufficient.
Discussion
Due to the broad research question the HTA-report contains inevitably different outcomes and study designs which partially differ qualitatively very strong from each other. In the field of palliative care hospices for in-patients and palliative wards as well as hospices for out-patients are becoming more and more important. Palliative care is a basic right of all terminally ill persons.
Conclusion
Despite the relatively high number of studies in Germany the HTA-report shows a massive lack in health care research. Based on the studies a further expansion of out-patient pain and palliative care is recommended. Further training for all involved professional groups must be improved. An independent empirical analysis is necessary to determine over or undertreatment in pain care.
doi:10.3205/hta000094
PMCID: PMC3080661  PMID: 21522485
accident; analgesia; back pain; biomedical technology assessment; blinded; blinding; care; chronic; chronic pain; clinical study; clinical trial; controlled clinical study; controlled clinical trial; controlled clinical trials as topic; cost analysis; cost control; cost effectiveness; cost reduction; cost-benefit analyses; cost-benefit analysis; cost-cutting; cost-effectiveness; costs; costs and cost analysis; cross over; crossover; cross-over; cross-over studies; cross-over trials; decision making; delivery of health care; diagnosis; doctor's note; double blind; doubleblind; double-blind; double-blind method; early retirement; EBM; economic aspect; economics; economics, medical; effectiveness; efficacy; efficiency; ethics; evaluation studies as topic; evidence based medicine; evidence-based medicine; headache; health; health care; health care costs; health economic studies; health economics; health policy; health technology assessment; healthcare needs; hospice; HTA; HTA report; HTA-report; humans; integrated care; ischialgia; judgment; juricical; lack of work; life qualities; low back pain; lumbar pain; medical assessment; medical care; medical costs; medical evaluation; meta analysis; meta-analysis; methods; migraine; misuse; models, economic; multicenter; multicenter trial; multicentre; multimodal supply; neck pain; overuse; pain; pain care; pain clinic; pain clinics; pain disorder; pain management; pain measurement; pain patient; pain reduction; pain situation; pain therapy; palliative; palliative care; palliative medicine; palliative therapy; palliative treatment; palliative treatments; peer review; pharmaeconomics; placebo; placebo effect; placebos; prevention; program effectiveness; prospective studies; psychotherapy; quality of life; random; random allocation; randomisation; randomised clinical study; randomised clinical trial; randomised controlled study; randomised controlled trial; randomised study; randomised trial; randomization; randomized clinical study; randomized clinical trial; randomized controlled study; randomized controlled trial; randomized study; randomized trial; RCT; rehabilitation; report; research article; research-article; review; review literature; rights; risk assessment; sensitivity; shoulder pain; sick certificate; sick note; sickness costs; single blind; single blind method; singleblind; single-blind; social economic factors; socioeconomic factors; socioeconomics; somatoform disorders; specifity; spinal column; spondylosis; stoppage; supply shortage; systematic review; technical report; technology; technology assessment; technology assessment, biomedical; technology evaluation; technology, medical; therapy; thoracic spine; thoracic vertebral column; treatment; trial, crossover; trial, cross-over; triple blind; tripleblind; triple-blind; underuse; validation studies; vertebral column

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