Maren Dreier

Development of a comprehensive list of criteria for evaluating consumer education materials on colorectal cancer screening

BackgroundAppropriate patient information materials may support the consumer’s decision to attend or not to attend colorectal cancer (CRC) screening tests (fecal occult blood test and screening colonoscopy). The aim of this study was to develop a list of criteria to assess whether written health information materials on CRC screening provide balanced, unbiased, quantified, understandable, and evidence-based health information (EBHI) about CRC and CRC screening.MethodsThe list of criteria was developed based on recommendations and assessment tools for health information in the following steps: (1) Systematic literature search in 13 electronic databases (search period: 2000–2010) and completed by an Internet search (2) Extraction of identified criteria (3) Grouping of criteria into categories and domains (4) Compilation of a manual of adequate answers derived from systematic reviews and S3 guidelines (5) Review by external experts (6) Modification (7) Final discussion with external experts.ResultsThirty-one publications on health information tools and recommendations were identified. The final list of criteria includes a total of 230 single criteria in three generic domains (formal issues, presentation and understandability, and neutrality and balance) and one CRC-specific domain. A multi-dimensional rating approach was used whenever appropriate (e.g., rating for the presence, correctness, presentation and level of evidence of information). Free text input was allowed to ensure the transparency of assessment. The answer manual proved to be essential to the rating process. Quantitative analyses can be made depending on the level and dimensions of criteria.ConclusionsThis comprehensive list of criteria clearly has a wider range of evaluation than previous assessment tools. It is not intended as a final quality assessment tool, but as a first step toward thorough evaluation of specific information materials for their adherence to EBHI requirements. This criteria list may also be used to revise leaflets and to develop evidence-based health information on CRC screening. After adjustment for different procedure-specific criteria, the list of criteria can also be applied to other cancer screening procedures.

Comparison of tools for assessing the methodological quality of primary and secondary studies in health technology assessment reports in Germany.

Health care policy background Findings from scientific studies form the basis for evidence-based health policy decisions. Scientific background Quality assessments to evaluate the credibility of study results are an essential part of health technology assessment reports and systematic reviews. Quality assessment tools (QAT) for assessing the study quality examine to what extent study results are systematically distorted by confounding or bias (internal validity). The tools can be divided into checklists, scales and component ratings. Research questions What QAT are available to assess the quality of interventional studies or studies in the field of health economics, how do they differ from each other and what conclusions can be drawn from these results for quality assessments? Methods A systematic search of relevant databases from 1988 onwards is done, supplemented by screening of the references, of the HTA reports of the German Agency for Health Technology Assessment (DAHTA) and an internet search. The selection of relevant literature, the data extraction and the quality assessment are carried out by two independent reviewers. The substantive elements of the QAT are extracted using a modified criteria list consisting of items and domains specific to randomized trials, observational studies, diagnostic studies, systematic reviews and health economic studies. Based on the number of covered items and domains, more and less comprehensive QAT are distinguished. In order to exchange experiences regarding problems in the practical application of tools, a workshop is hosted. Results A total of eight systematic methodological reviews is identified as well as 147 QAT: 15 for systematic reviews, 80 for randomized trials, 30 for observational studies, 17 for diagnostic studies and 22 for health economic studies. The tools vary considerably with regard to the content, the performance and quality of operationalisation. Some tools do not only include the items of internal validity but also the items of quality of reporting and external validity. No tool covers all elements or domains. Design-specific generic tools are presented, which cover most of the content criteria. Discussion The evaluation of QAT by using content criteria is difficult, because there is no scientific consensus on the necessary elements of internal validity, and not all of the generally accepted elements are based on empirical evidence. Comparing QAT with regard to contents neglects the operationalisation of the respective parameters, for which the quality and precision are important for transparency, replicability, the correct assessment and interrater reliability. QAT, which mix items on the quality of reporting and internal validity, should be avoided. Conclusions There are different, design-specific tools available which can be preferred for quality assessment, because of its wider coverage of substantive elements of internal validity. To minimise the subjectivity of the assessment, tools with a detailed and precise operationalisation of the individual elements should be applied. For health economic studies, tools should be developed and complemented with instructions, which define the appropriateness of the criteria. Further research is needed to identify study characteristics that influence the internal validity of studies.

Communicating the Benefits and Harms of Colorectal Cancer Screening Needed for an Informed Choice: A Systematic Evaluation of Leaflets and Booklets

Objective Evidence-based health information (EBHI) can support informed choice regarding whether or not to attend colorectal cancer (CRC) screening. The present study aimed to assess if German leaflets and booklets appropriately inform consumers on the benefits and harms of CRC screening. Methods A systematic search for print media on CRC screening was performed via email enquiry and internet search. The identified documents were assessed for the presence and correctness of information on benefits and harms by two reviewers independently using a comprehensive list of criteria. Results Many of the 28 leaflets and 13 booklets identified presented unbalanced information on the benefits and harms of CRC screening: one-third did not provide any information on harms. Numeracy information was often lacking. Ten cross-language examples of common misinterpretations or basically false and misleading information were identified. Discussion Most of the CRC screening leaflets and booklets in Germany do not meet current EBHI standards. After the study, the publishers of the information materials were provided feedback, including a discussion of our findings. The results can be used to revise existing information materials or to develop new materials that provide correct, balanced, quantified, understandable and unbiased information on CRC screening.

Independent Pre-Transplant Recipient Cancer Risk Factors after Kidney Transplantation and the Utility of G-Chart Analysis for Clinical Process Control.

Background The aim of this study is to identify independent pre-transplant cancer risk factors after kidney transplantation and to assess the utility of G-chart analysis for clinical process control. This may contribute to the improvement of cancer surveillance processes in individual transplant centers. Patients and Methods 1655 patients after kidney transplantation at our institution with a total of 9,425 person-years of follow-up were compared retrospectively to the general German population using site-specific standardized-incidence-ratios (SIRs) of observed malignancies. Risk-adjusted multivariable Cox regression was used to identify independent pre-transplant cancer risk factors. G-chart analysis was applied to determine relevant differences in the frequency of cancer occurrences. Results Cancer incidence rates were almost three times higher as compared to the matched general population (SIR = 2.75; 95%-CI: 2.33–3.21). Significantly increased SIRs were observed for renal cell carcinoma (SIR = 22.46), post-transplant lymphoproliferative disorder (SIR = 8.36), prostate cancer (SIR = 2.22), bladder cancer (SIR = 3.24), thyroid cancer (SIR = 10.13) and melanoma (SIR = 3.08). Independent pre-transplant risk factors for cancer-free survival were age <52.3 years (p = 0.007, Hazard ratio (HR): 0.82), age >62.6 years (p = 0.001, HR: 1.29), polycystic kidney disease other than autosomal dominant polycystic kidney disease (ADPKD) (p = 0.001, HR: 0.68), high body mass index in kg/m2 (p<0.001, HR: 1.04), ADPKD (p = 0.008, HR: 1.26) and diabetic nephropathy (p = 0.004, HR = 1.51). G-chart analysis identified relevant changes in the detection rates of cancer during aftercare with no significant relation to identified risk factors for cancer-free survival (p<0.05). Conclusions Risk-adapted cancer surveillance combined with prospective G-chart analysis likely improves cancer surveillance schemes by adapting processes to identified risk factors and by using G-chart alarm signals to trigger Kaizen events and audits for root-cause analysis of relevant detection rate changes. Further, comparative G-chart analysis would enable benchmarking of cancer surveillance processes between centers.

Sind Informationsmaterialien zur Darmkrebsfrüherkennung in Deutschland verständlich oder verfehlen sie ihre Wirkung

Evidence-based patient information is an essential part of decision making in health issues. A qualitative study was conducted to examine whether consumers consider the health information on colorectal cancer screening in Germany helpful in supporting their decision making. In this study, eight texts from different German authors about colorectal cancer screening were evaluated with a criteria-based selection. The texts were tested for understandability, structure, design, and effect on readers. Thirteen semi-structured focus groups were formed including 59 higher-educated and 15 lower-educated testers, 46 % of them being male with a mean age of 62.9 years. The transcripts were analyzed by content-analytic assessment. The testers provided detailed comments on the content and design of the texts. They revealed inaccuracies and suggested improvements of the texts. The testers differed from each other in terms of the intensity of their participation in the discussions and comprehension of the material. The reception of the flyers and brochures varied according to the educational level of the testers. Lower-educated testers often skipped passages of texts about risks as well as passages containing numbers and graphics. The texts had different effects on the testers, regardless of the level of education. If adverse effects were presented, some testers became scared while others were reassured because they felt informed. Most of the testers appreciated a call for participation as a central message of the text. Sometimes, if there was no clear appeal to attend the screening, the testers even asked for it. The recently introduced political strategy of promoting an informed choice is applied to an unprepared population who was used to getting a clear yes-or-no recommendation. Thus, at first, the population has to learn how to make an informed choice. This topic must be addressed and taken into account in the process of developing health information. Since this is not always the case, we conclude that current materials are limited in their contribution toward the decision of attending CRC screening.

Quality Assessment in Meta-analysis

Quality assessment of primary studies to evaluate the reliability of study results is an essential and mandatory part of meta-analyses. It refers to the internal validity of a study and is described more precisely as assessing the risk of bias. Potential biases derive from selection of participants, data collection, analysis and selective reporting of study results. Quality assessment tools systematically collect information about study characteristics that may lead to bias in order to estimate the overall risk of bias. There are numerous tools available; they can be classified into checklists, scales and component ratings. Focusing on tools for assessing randomized controlled studies, an overview of covered elements of six selected generic tools is given. The Cochrane Collaboration’s tool is described in more detail because it incorporates some important features. Practical aspects of conducting quality assessments are discussed including the meaning and importance of detailed and precise guidance.

Report bias favours screening.

While aiming to assess prostate cancer specific mortality, Sandblom and colleagues indicate a “prostate cancer specific mortality” in the screening group of 35% and in the control group of 45%, which actually is the case fatality rate.1 The true prostate cancer specific mortality was 2% (30/1494) in the screening group and 1.7% (130/7532) in …

Migration background and childhood overweight in the Hannover Region in 2010–2014: a population-based secondary data analysis of school entry examinations

Overweight and obesity constitute a global epidemic with rates that are increasing rapidly in children. The aim of the present study was to examine ethnic differences in the prevalence of overweight in pre-school children in a multicultural context. Data were collected from a compulsory school entry examination in the Hannover Region, Germany (n = 50,716) from 2010 to 2014. The prevalence of overweight (including pre-obesity and obesity status) and obesity was estimated using a German national reference. The migration status of the children was based on the parent’s migration history. Multivariable logistic and hierarchical multinomial regression analyses were performed to identify factors associated with the overweight, pre-obesity, and obesity status. The prevalence of overweight was significantly higher among migrant children (12.7%) than among the non-migrant children (6.9%). After adjusting for socioeconomic and child development variables, migration background was strongly associated with weight status. The Turkish migrant children showed the highest odds of being pre-obesity (OR 2.05, 95%CI 1.7–2.56) and obesity (OR 2.09, 95%CI 1.67–2.77) compared to non-migrant children.Conclusion: Ethnic and social inequalities exist in childhood overweight among pre-school children in the Hannover Region. Thus, appropriate interventions targeting high-risk migrant groups are needed.What is Known:• The current trend of prevalence rates in Germany for overweight and obesity of pre-school children is becoming stable.• Prevalence of overweight and obesity is clearly higher among migrant children than among non-migrant children.What is New:• This article reveals ethnic variance among different migrant groups.• Turkish migrant children have a higher rate of prevalence even compared to other migrant groups.• Length of child day care attendance fails to exert a strong influence on overweight after adjusting for socio-economic and child development variables

Patient-rated importance of key information on screening colonoscopy in Germany: a survey of statutory health insurance members

Background Primary colonoscopic screening is considered to be of great benefit but also has the potential to cause severe harm. Thus, eligible subjects should be supported in making an informed choice whether to participate. Objectives To identify information on screening colonoscopy that colonoscopy-naïve subjects rate as particularly important for decision making. Design Survey of German statutory health insurance members using a written questionnaire in November 2015. Study population Colonoscopy-naïve individuals aged 50 to 65 years. Main outcome measures Importance of key information about screening colonoscopy, including potential risks and benefits, baseline risk of colorectal cancer/polyps and practical aspects of the procedure, as well as associations between participants’ characteristics and their judgement of information as to being ‘very important’. Results Of 1871 respondents (overall response rate: 31%), a subgroup of 370 colonoscopy-naïve subjects was eligible for inclusion (average age: 55 years, 47% male). Information on the risks was rated as very important by most respondents, unimportant by 6%. Information on the benefits was considered unimportant by 26%. Regression analysis showed that less educated persons regarded most items to be more often relevant than highly educated subjects. A greater proportion of women than men rated details regarding pain and practical aspects as very important. Subjects with a low educational level living alone were identified as the group with the least interest in information on risks. Conclusion Cultivating awareness around the central meaning of the (quantitative) benefits of screening in informed decision making should be focused on more in future information materials. The high requirement of less educated people to become more informed provides a strong motivation for further efforts to develop evidence-based information that adequately informs this group. Tailoring information according to gender-specific needs may be warranted in light of the observed differences in information preferences between women and men.

Printmedien- und Internetangebote mit Informationen zur Darmkrebsfrüherkennung und ihre kriteriengestützte Bewertung aus Expertensicht@@@Leaflets and websites on colorectal cancer screening and their quality assessment from experts’ views

In Germany, individuals who have statutory health insurance have free access to colorectal cancer (CRC) screening tests, and can choose between a fecal occult blood test and a screening colonoscopy. Evidence-based health information may support informed choices regarding whether or not to undergo CRC screening. The aim of this study was to assess whether the available German information materials on CRC screening meet evidence-based health information standards. A systematic search was made for print media and websites on CRC screening addressed to German people with average CRC risk (search period for print media August 2010, for websites January-March 2012). The identified information was assessed with a newly developed comprehensive list of criteria. In all, 41 print media, including 28 flyers and 13 brochures, and 36 websites were identified and assessed. These materials reported more often the benefits than the risks of CRC screening, and quantified presentations of benefits and risks were less frequently given. Most of the materials called for participation and did not indicate the option to decide whether or not to attend CRC screening. This bias in favor of screening was increased by fear-provoking or downplayed wording. Most materials included false and misleading information. The requirements for evidence-based patient information were currently not met by most of the leaflets and websites in Germany. Feedback was given to the producers of the leaflets including a discussion of the findings. The results may be used to revise existing leaflets or to develop new health information on CRC screening.