[The informed decision as an aim of evidence-based health information: the example of cancer screening]. / Die informierte Entscheidung als Ziel von evidenzbasierten Gesundheitsinformationen: Das Beispiel Krebsfrüherkennung.

In order to enable people to make an informed decision about participating in cancer screening, disadvantages like medical risks have be communicated in addition to advantages. The information in the decision aids should be evidence-based, neutral, balanced, understandable, and adequate in scope. The Institute for Quality and Efficiency in Health Care (IQWiG) was commissioned by the Federal Joint Committee (G-BA) in 2014 and 2015 to develop decision aids in the form of brochures on participation in mammography, colorectal cancer, and cervical cancer screening, which are now in use.This article describes the development of the decision aids, with a focus on the results of user tests, which were executed by an external provider. Of the testers, 10 to 20% changed their attitude toward taking part in the screening test within the three categories "willing to take part," "undecided," and "not willing to take part" after reading the brochures. This indicates that an informed decision is supported by the materials. The user tests helped to better adapt the decision aids to the information needs of target groups.

[Development of Decision Aids for Organized Cervical Carcinoma Screening in Germany]. / Entwicklung von Entscheidungshilfen für das organisierte Zervixkarzinom-Screening in Deutschland.

AIM OF THE STUDY: The Federal Joint Committee has decided to introduce organized cervical carcinoma screening in 2020. The present work describes the development of decision aids that will be sent to women in this program. METHODS: A systematic search for qualitative studies and surveys was conducted to gather information on experiences, attitudes and information needs. Furthermore, we searched for systematic reviews on advantages and disadvantages of screening. An existing decision analysis for cervical carcinoma screening in Germany was used. The designs were subjected to a qualitative test (focus groups with 26 women and 8 expert interviews), to a quantitative user test (online survey n=2,014 women) and to a public hearing. RESULTS: Most women found the decision aids informative and helpful. The majority would recommend the use of these materials to others. For many women, part of the information was new, although they had been involved in cervical cancer screening for some time. The presentation of the advantages and disadvantages was judged to be balanced. However, 10% changed their attitude towards participation and 70% of women would attend screening. CONCLUSION: The decision aids found a high acceptance among the users. They can help to reduce knowledge deficits on cervical carcinoma screening and support a informed decision making.

The role of PET and PET-CT scanning in assessing response to neoadjuvant therapy in esophageal carcinoma.

BACKGROUND: The response to neoadjuvant (radio-)chemotherapy for esophageal carcinoma is often assessed with the aid of positron-emission tomography (PET), either alone or in combination with computed tomography (PET-CT). In this review, we discuss the diagnostic validity and clinical benefit of these imaging techniques. METHODS: We systematically searched the Medline, Embase, and Cochrane Library databases for randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing PET-CT with conventional techniques such as endosonography and CT. We then determined the diagnostic validity of these methods on the basis of information from published systematic reviews, updated with further information from more recent primary studies. RESULTS: We did not find any RCTs that addressed the question of the patient-relevant benefit of PET-CT. We found 20 studies of diagnostic methods, carried out on a total of 854 patients, of whom 82.2% were male. These studies had a high potential for bias. In two of them, PET-CT was directly compared with endosonography or CT. Estimates of sensitivity and specificity varied widely across studies. 54% of all patients (median value across studies) had no histopathological response to therapy at the end of treatment. Taking a reduction of the standard uptake value (SUV) by at least 35% as a threshold criterion, we found that the median negative predictive value of PET across all studies was 86.5. CONCLUSION: There is no robust evidence for a patient-relevant benefit of PET and PET-CT in patients with esophageal carcinoma. PET could potentially be used to distinguish treatment responders from non-responders after the first cycle of treatment. RCTs with patient-relevant endpoints will be needed in order to determine whether this is useful.

A descriptive review on methods to prioritize outcomes in a health care context.

BACKGROUND: Evidence synthesis has seen major methodological advances in reducing uncertainty and estimating the sizes of the effects. Much less is known about how to assess the relative value of different outcomes. OBJECTIVE: To identify studies that assessed preferences for outcomes in health conditions. SEARCH STRATEGY: we searched MEDLINE, EMBASE, PsycINFO and the Cochrane Library in February 2014. INCLUSION CRITERIA: eligible studies investigated preferences of patients, family members, the general population or healthcare professionals for health outcomes. The intention of this review was to include studies which focus on theoretical alternatives; studies which assessed preferences for distinct treatments were excluded. DATA EXTRACTION: study characteristics as study objective, health condition, participants, elicitation method, and outcomes assessed in the study were extracted. MAIN RESULTS: One hundred and twenty-four studies were identified and categorized into four groups: (1) multi criteria decision analysis (MCDA) (n = 71), (2) rating or ranking (n = 25), (3) utility eliciting (n = 5) and (4) studies comparing different methods (n = 23). The number of outcomes assessed by method group varied. The comparison of different methods or subgroups within one study often resulted in different hierarchies of outcomes. CONCLUSIONS: A dominant method most suitable for application in evidence syntheses was not identified. As preferences of patients differ from those of other stakeholders (especially medical professionals), the choice of the group to be questioned is consequential. Further research needs to focus on validity and applicability of the identified methods.

F-18-fluoro-2-deoxyglucose positron emission tomography (PET) and PET/computed tomography imaging in primary staging of patients with malignant melanoma: a systematic review.

PURPOSE: The aim of this systematic review was to systematically assess the potential patient-relevant benefit (primary aim) and diagnostic and prognostic accuracy (secondary aim) of positron emission tomography (PET) and PET/computed tomography (CT) in primary staging of malignant melanoma. This systematic review updates the previous evidence for PET(/CT) in malignant melanoma. MATERIALS AND METHODS: For the first aim, randomized controlled trials (RCTs) investigating patient-relevant outcomes and comparing PET and PET(/CT) with each other or with conventional imaging were considered. For the secondary aim, a review of reviews was conducted, which was amended by an update search for primary studies. MEDLINE, EMBASE and four databases of the Cochrane Library were searched. The risk of bias was assessed using a modified QUADAS tool. RESULTS: No RCTs investigating the patient-relevant benefit of PET(/CT) and no prognostic accuracy studies were found. Seventeen diagnostic accuracy studies of varying quality were identified. For patients with American Joint Committee on Cancer (AJCC) stages I and II, sensitivity mostly ranged from 0 to 67%. Specificity ranged from 77 to 100%. For AJCC stages III and IV, sensitivity ranged from 68 to 87% and specificity from 92 to 98%. CONCLUSION: There is currently no evidence of a patient-relevant benefit of PET(/CT) in the primary staging of malignant melanoma. RCTs investigating patient-relevant outcomes are therefore required. The diagnostic accuracy of PET(/CT) appears to increase with higher AJCC stages.

Randomized controlled trials on PET: a systematic review of topics, design, and quality.

UNLABELLED: Randomized controlled trials (RCTs) add important information to diagnostic accuracy studies in the evaluation of PET and PET/CT. We evaluated how many RCTs on PET existed, which clinical topics they addressed, and what their design and quality were. METHODS: We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (Clinical Trials) up to August 2010. We also searched in ClinicalTrials.gov and the International Clinical Trials Registry Platform for ongoing RCTs up to March 2011. Titles and abstracts and full texts were screened independently by 2 reviewers. Study characteristics were extracted with standard extraction sheets for ongoing and published RCTs, and risk of bias was assessed for published ones. RESULTS: We identified 54 RCTs, 12 of which were published. The main topics in published studies were non-small cell lung cancer and colorectal cancer; only 3 were conducted in nononcologic fields (this trend was similar in ongoing studies, in which the most common topic was Hodgkin disease). The main indications in the oncologic PET studies were staging in published studies and restaging (mostly including an early assessment of treatment response) in ongoing ones. All except 1 of the published studies applied a marker-based strategy design, whereas about 43% (18/42) of ongoing studies use a more efficient design (Enrichment Design or Marker by Treatment Interaction Design). CONCLUSION: A relatively high number of ongoing RCTs of PET in several oncologic fields are expected to produce robust results over the next few years. For nononcologic topics, further high-quality studies are still needed to ascertain the benefit of this technique for patients. As funding is usually difficult in nondrug topics, alternative concepts of funding, which should also involve the manufacturers of diagnostic devices, but also more efficient study designs, should be applied to bridge the evidence gap on PET in the near future.

[Does the lack of evidence of effectiveness among international studies on interventions in prevention and health promotion have an impact on a German Act of Prevention?]. / Evidenz der Wirksamkeit internationaler Präventionsmassnahmen und Auswirkungen auf ein deutsches Präventionsgesetz.

BACKGROUND AND PURPOSE: Efforts have been undertaken to devise and pass an Act of Prevention in Germany. To date, no consensus could be reached with changing political majorities in parliament. Hence, the authors ask the question whether the lack of evidence in prevention and health promotion could also be contributing to this delay. METHODS: After a systematic search of the literature on prevention and health promotion in nutrition, exercise, depression, and smoking, all retrieved studies were evaluated in terms of their effect as well as the quality of study design like prior power calculation and intervention like documentation of process or participation of intended group. For inclusion, studies had to be undertaken in one of 13 countries that have a socioeconomic standard of living comparable to Germany. The authors of this article exemplarily included studies from the following focus areas into the systematic review: prevention of depression among children and adolescents, exercise in the work environment, nutrition for children and adolescents, and smoking cessation programs among pregnant women, all from 1990 to 2006. RESULTS: The authors retrieved 18 studies on prevention of depression among children and adolescents, 26 on exercise in the work environment, 23 on nutrition for children and adolescents, and 34 on smoking cessation programs among pregnant women. Six out of 26 on exercise had a positive effect (23.1%), one out of 18 on depression (5.6%), seven out of 23 in the field of nutrition (30.4%), and nine out of 34 smoking cessation programs (26.5%). If one takes into account the quality of study design and intervention as a marker for the reliability and validity of results, one intervention on exercise, two on nutrition, three on smoking and none on depression would remain with a positive effect. CONCLUSION: In four exemplarily selected fields only six out of a total of 101 international studies (5.9%) had an effect, if one also ties in quality of study design and intervention. With regard to this result, allocation of resources for prevention and health promotion would be highly ambiguous without sufficient evidence. This condition might contribute to the deferment of an Act of Prevention in the German legislation. For the future, the authors strongly urge that the Act of Prevention takes into account the evaluation both of effects and quality of any intervention in order to prevent false allocation of resources.