Self-reported medication intake vs information from other data sources such as pharmacy records or medical records: Identification and description of existing publications, and comparison of agreement results for publications focusing on patients with cancer - a systematic review.

PURPOSE: To identify and describe publications addressing the agreement between self-reported medication and other data sources among adults and, in a subgroup of studies dealing with cancer patients, seek to identify parameters which are associated with agreement. METHODS: A systematic review including a systematic search within five biomedical databases up to February 28, 2019 was conducted as per the PRISMA Statement. Studies and agreement results were described. For a subgroup of studies dealing with cancer, we searched for associations between agreement and patients' characteristics, study design, comparison data source, and self-report modality. RESULTS: The literature search retrieved 3392 publications. Included articles (n = 120) show heterogeneous agreement. Eighteen publications focused on cancer populations, with relatively good agreement identified in those which analyzed hormone therapy, estrogen, and chemotherapy (n = 11). Agreement was especially good for chemotherapy (proportion correct ≥93.6%, kappa ≥0.88). No distinct associations between agreement and age, education or marital status were identified in the results. There was little evaluation of associations between agreement and study design, self-report modality and comparison data source, thus not allowing for any conclusions to be drawn. CONCLUSION: An overview of the evidence available from validation studies with a description of several characteristics is provided. Studies with experimental design which evaluate factors that might affect agreement between self-report and other data sources are lacking.

Correction to: Information needs in people with diabetes mellitus: a systematic review.

Following publication of the original article [1], the authors opted to revise Table 1. Below is the updated version of the table.

Information needs in people with diabetes mellitus: a systematic review.

BACKGROUND: The purpose of this study was to identify and analyse currently available knowledge on information needs of people with diabetes mellitus, also considering possible differences between subgroups and associated factors. METHODS: Twelve databases including MEDLINE, EMBASE and the Cochrane Library were searched up until June 2015. Publications that addressed self-reported information needs of people with diabetes mellitus were included. Each study was assessed by using critical appraisal tools, e.g. from the UK National Institute for Health and Care Excellence. Extraction and content analysis were performed systematically. RESULTS: In total, 1993 publications were identified and 26 were finally included. Nine main categories of information needs were identified, including 'treatment-process', 'course of disease', 'abnormalities of glucose metabolism' and 'diabetes through the life cycle'. Differences between patient subgroups, such as type of diabetes or age, were sparsely analysed. Some studies analysed associations between information needs and factors such as participation preferences or information seeking. They found, for example, that information needs on social support or life tasks were associated with information seeking in Internet forums. CONCLUSION: Information needs in people with diabetes mellitus, appear to be high, yet poorly investigated. Research is needed regarding differences between diverse diabetes populations, including gender aspects or changes in information needs during the disease course. SYSTEMATIC REVIEW REGISTRATION: The review protocol has been registered at Prospero ( CRD42015029610 ).

Correction to: Diabetes-related information-seeking behaviour: a systematic review.

CORRECTION: During the production process for this article [1] some errors were introduced into Table 2. The correct version of Table 2 can be found below; the original article [1] has also been updated with the correct version of Table 2. BMC apologises to the authors and to readers for this error.

Diabetes-related information-seeking behaviour: a systematic review.

BACKGROUND: Information-seeking behaviour is necessary to improve knowledge on diabetes therapy and complications. Combined with other self-management skills and autonomous handling of the disease, it is essential for achieving treatment targets. However, a systematic review addressing this topic is lacking. The aims of this systematic review were to identify and analyse existing knowledge of information-seeking behaviour: (1) types information-seeking behaviour, (2) information sources, (3) the content of searched information, and (4) associated variables that may affect information-seeking behaviour. METHODS: The systematic review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) requirements. MEDLINE, CINAHL, EMBASE, ScienceDirect, PsycInfo, Cochrane Library, Web of Science, CCMed, ERIC, Journals@OVID, Deutsches Ärzteblatt and Karlsruher virtueller Katalog (KvK) databases were searched. Publications dealing with information-seeking behaviour of people with diabetes mellitus published up to June 2015 were included. A forward citation tracking was performed in September 2016 and June 2017. Additionally, an update of the two main databases (MEDLINE, CINAHL) was conducted, considering studies published up to July 2017. Studies published in languages other than English or German were excluded, as well as letters, short reports, editorials, comments and discussion papers. A study selection and the critical appraisal of the selected studies were performed independently by two reviewers. A third reviewer was consulted if any disagreement was found. Data extraction and content analysis were performed using selected dimensions of Wilson's 'model of information behaviour'. RESULTS: Twenty-six studies were included. Five 'types of information-seeking behaviour' were identified, e.g. passive and active search. The 'Internet' and 'healthcare professionals' were the most frequently reported sources. 'Diet', 'complications', 'exercise' and 'medications and pharmacological interactions' were the most frequently identified content of information. Seven main categories including associated variables were identified, e.g. 'socioeconomic', 'duration of DM', and 'lifestyle'. CONCLUSION: The systematic review provides a valuable overview of available knowledge on the information-seeking behaviour of people with diabetes mellitus, although there are only a few studies. There was a high heterogeneity regarding the research question, design, methods and participants. Although the Internet is often used to seek information, health professionals still play an important role in supporting their patients' information-seeking behaviour. Specific needs of people with diabetes must be taken into consideration. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016037312.

Psychosocial barriers to healthcare use among individuals with diabetes mellitus: A systematic review.

PURPOSE: To conduct a systematic review regarding psychosocial barriers to healthcare use in individuals with diabetes mellitus, using a well-established model of health-service use as a theoretical framework. METHODS: We used database-specific controlled vocabularies and additional free text terms, and conducted searches via MEDLINE, EMBASE, PsycINFO, CINAHL, Web of Science, OVID Journals. Included studies were rated according to the UK National Institute for Health and Care Excellence (NICE) criteria. A narrative data synthesis was conducted, using the Andersen model and developing categories from the included studies. PRINCIPAL RESULTS: In total, 2923 studies were identified, and 15 finally included. We identified barriers according to the main categories "population characteristics", "norms and values", and "healthcare services" on a contextual and individual level, as well as "health status". Frequently reported barriers were "socioeconomic status", and "physician characteristics". Ethnic minorities were frequently analysed and may have specific barriers, e.g. "cultural beliefs" and "language". MAJOR CONCLUSIONS: We identified a broad range of barriers to healthcare use in individuals with diabetes mellitus. However, the number of studies is low. Further research is needed to analyse barriers in more detail considering special subgroups.

Incidence of lower extremity amputations in the diabetic compared with the non-diabetic population: A systematic review.

SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD4201501780.

The Incidence of End-Stage Renal Disease in the Diabetic (Compared to the Non-Diabetic) Population: A Systematic Review.

End-stage renal disease (ESRD) in diabetes is a life threatening complication resulting in a poor prognosis for patients as well as high medical costs. The aims of this systematic review were (1) to evaluate the incidence of ESRD due to all causes and due to diabetic nephropathy in the diabetic population and differences between incidences of ESRD with respect to sex, ethnicity, age and regions, (2) to compare incidence rates in the diabetic and non-diabetic population, and (3) to investigate time trends. The systematic review was conducted according to the PRISMA group guidelines by performing systematic literature searches in the biomedical databases until January 3rd 2015; thirty-two studies were included. Among patients with incident type 1 diabetes the 30-year cumulative incidence ranged from 3.3% to 7.8%. Among patients with prevalent diabetes, incidence rates of ESRD due to all causes ranged from 132.0 to 167.0 per 100,000 person-years, whereas incidence rates of ESRD due to diabetic nephropathy varied from 38.4 to 804.0 per 100,000 person-years. The incidence of ESRD in the diabetic population was higher compared to the non-diabetic population, and relative risks varied from 6.2 in the white population to 62.0 among Native Americans. The results regarding time trends were inconsistent. The review conducted demonstrates the considerable variation of incidences of ESRD among the diabetic population. Consistent findings included an excess risk when comparing the diabetic to the non-diabetic population and ethnic differences. We recommend that newly designed studies should use standardized methods for the determination of ESRD and population at risk.

Incidence of lower extremity amputation in the diabetic compared to the non-diabetic population: a systematic review protocol.

BACKGROUND: Diabetic individuals have a largely increased risk of lower extremity amputation (LEA) compared with non-diabetic patients. Prior systematic reviews of incidence of LEA have some limitations with respect to lack of consensus in the definition of LEA, level of LEA (all, major, minor), and definition of source population (general population or population with diabetes at risk). The purpose of our review is to evaluate the incidence of LEA in the diabetic population and its differences with regard to sex, ethnicity, age, and regions; to compare the incidence rate (IR) in the diabetic and non-diabetic population; and to investigate time trends. METHODS/DESIGN: We will perform a systematic literature search in MEDLINE, Embase, Web of Knowledge, and publisher databases such as Journals@OVID and ScienceDirect. We will develop comprehensive systematic search strategies according to established guidelines for meta-analyses of observational studies in epidemiology (the MOOSE group). Two authors will independently screen abstracts and full text of all references on the basis of inclusion criteria with respect to types of study, types of population, and the main outcome. We will exclude studies if they report solely incidences of LEA among persons with diabetes mellitus when referring to the total population (diabetic and non-diabetic) and not exclusively to the diabetic population. Data extraction and assessment of risk of bias will be undertaken by two review authors working independently. We will assess incidence rate (IR) or cumulative incidence (CumI), relative risk of amputations comparing the diabetic to non-diabetic populations, cause of LEA, and type of diabetes. If we find subsets of studies to be homogeneous enough, we will perform meta-analyses for incidence rates by Poisson generalized linear mixed models (GLMM). SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015017809.

Evaluation of ethical aspects in health technology assessment: more methods than applications?

Health technology assessment (HTA) emerged with the increased need for systematical evaluation of health technologies in the 1970s. From its very beginning, ethics was a constitutive part of HTA, and over the years a wide range of approaches have been suggested to address ethical aspects of health technologies. Despite a vast variety of methodologies in ethics, there is no consensus about the appropriateness of the existing methods. Moreover, while the available methods are many, their applications are few. While methods for addressing ethical issues in HTA have been richly reviewed, their applications are poorly tracked. Hence, a bottom up approach, that is, from practice to theory, may turn out to be as helpful as a top-down review. We need a review of the examples of ethics in HTA so we better can learn how the methods are used in practice, analyze the role of context, and better can assess the merits of the various methods.

Harmonization of ethics in health technology assessment: a revision of the Socratic approach.

BACKGROUND: Ethics has been part of health technology assessment (HTA) from its beginning in the 1970s, and is currently part of HTA definitions. Several methods in ethics have been used in HTA. Some approaches have been developed especially for HTA, such as the Socratic approach, which has been used for a wide range of health technologies. The Socratic approach is used in several ways, and there is a need for harmonization to promote its usability and the transferability of its results. Accordingly, the objective of this study was to stimulate experts in ethics and HTA to revise the Socratic approach. METHODS: Based on the current literature and experiences in applying methods in ethics, a panel of ethics experts involved in HTA critically analyzed the limitations of the Socratic approach during a face-to-face workshop. On the basis of this analysis a revision of the Socratic approach was agreed on after deliberation in several rounds through e-mail correspondence. RESULTS: Several limitations with the Socratic approach are identified and addressed in the revised version which consists of a procedure of six steps, 7 main questions and thirty-three explanatory and guiding questions. The revised approach has a broader scope and provides more guidance than its predecessor. Methods for information retrieval have been elaborated. CONCLUSION: The presented revision of the Socratic approach is the result of a joint effort of experts in the field of ethics and HTA. Consensus is reached in the expert panel on an approach that is considered to be more clear, comprehensive, and applicable for addressing ethical issues in HTA.

Revealing and acknowledging value judgments in health technology assessment.

BACKGROUND: Although value issues are increasingly addressed in health technology assessment (HTA) reports, HTA is still seen as a scientific endeavor and sometimes contrasted with value judgments, which are considered arbitrary and unscientific. This article aims at illustrating how numerous value judgments are at play in the HTA process, and why it is important to acknowledge and address value judgments. METHODS: A panel of experts involved in HTA, including ethicists, scrutinized the HTA process with regard to implicit value judgments. It was analyzed whether these value judgments undermine the accountability of HTA results. The final results were obtained after several rounds of deliberation. RESULTS: Value judgments are identified before the assessment when identifying and selecting health technologies to assess, and as part of assessment. They are at play in the processes of deciding on how to select, frame, present, summarize or synthesize information in systematic reviews. Also, in economic analysis, value judgments are ubiquitous. Addressing the ethical, legal, and social issues of a given health technology involves moral, legal, and social value judgments by definition. So do the appraisal and the decision-making process. CONCLUSIONS: HTA by and large is a process of value judgments. However, the preponderance of value judgments does not render HTA biased or flawed. On the contrary they are basic elements of the HTA process. Acknowledging and explicitly addressing value judgments may improve the accountability of HTA.

[Information on legal issues in health technologies: methodological proposal to identify them in a systematic and comprehensible manner]. / Informationen zu rechtlichen Aspekten von Gesundheitstechnologien: Methodenvorschlag zur systematischen und nachvollziehbaren Identifizierung.

BACKGROUND: Rules and regulations form the framework of Health Technology Assessments. Legal issues are directly associated with the technology (as patents/licenses) or to the patients and their basic rights (as autonomy). In order to identify the regulations of interest as well as the relevant publications in a systematic and transparent way a specific methodological approach is required. In the absence of adapted methods, our objective was to develop a methodological approach to the systematic retrieval of information on legal issues. RESULTS: No publications on adapted methods could be identified. We therefore developed a procedure following the workflow of information retrieval for effectiveness assessments. This workflow consists of 8 steps: 0. pre-search: identification of the relevant rules, regulations and patient-related issues, 1. translation of the search question, 2. concept building, 3. identification of synonyms, 4. selection of relevant information sources, 5. design of the search strategies, 6. execution and quality check, 7. saving the results and reporting. CONCLUSIONS: There are numerous publications on legal issues associated with health technologies. Specifically adapted procedures are qualified to identify them in a systematic and transparent manner using the appropriate sensitivity and precision. A wider application seems to be reasonable in order to further test its practicality against more topics and to modify the proposed method if indicated.

Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: a systematic literature review.

BACKGROUND: An effectiveness assessment on ASCT in locally advanced and metastatic breast cancer identified serious ethical issues associated with this intervention. Our objective was to systematically review these aspects by means of a literature analysis. METHODS: We chose the reflexive Socratic approach as the review method using Hofmann's question list, conducted a comprehensive literature search in biomedical, psychological and ethics bibliographic databases and screened the resulting hits in a 2-step selection process. Relevant arguments were assembled from the included articles, and were assessed and assigned to the question list. Hofmann's questions were addressed by synthesizing these arguments. RESULTS: Of the identified 879 documents 102 included arguments related to one or more questions from Hofmann's question list. The most important ethical issues were the implementation of ASCT in clinical practice on the basis of phase-II trials in the 1990s and the publication of falsified data in the first randomized controlled trials (Bezwoda fraud), which caused significant negative effects on recruiting patients for further clinical trials and the doctor-patient relationship. Recent meta-analyses report a marginal effect in prolonging disease-free survival, accompanied by severe harms, including death. ASCT in breast cancer remains a stigmatized technology. Reported health-related-quality-of-life data are often at high risk of bias in favor of the survivors. Furthermore little attention has been paid to those patients who were dying. CONCLUSIONS: The questions were addressed in different degrees of completeness. All arguments were assignable to the questions. The central ethical dimensions of ASCT could be discussed by reviewing the published literature.

Reporting and presenting information retrieval processes: the need for optimizing common practice in health technology assessment.

BACKGROUND: Information retrieval (IR) in health technology assessment (HTA) calls for transparency and reproducibility, but common practice in the documentation and presentation of this process is inadequate in fulfilling this demand. OBJECTIVES: Our objective is to promote good IR practice by presenting the conceptualization of retrieval and transcription readable to non-information specialists, and reporting of effectively processed search strategies. METHODS: We performed a comprehensive database search (04/2010) to synthesize the current state-of-the-art. We then developed graphical and tabular presentation methods and tested their feasibility on existing research questions and defined recommendations. RESULTS: No generally accepted standard of reporting of IR in HTA exists. We, therefore, developed templates for presenting the retrieval conceptualization, database selection, and additional hand-searching as well as for presenting search histories of complex and lengthy search strategies. No single template fits all conceptualizations, but some can be applied to most processes. Database interface providers report queries as entered, not as they are actually processed. In PubMed, the huge difference between entered and processed query is shown in "Details." Quality control and evaluation of search strategies using a validated tool such as the PRESS checklist is suboptimal when only entry-query based search histories are applied. CONCLUSIONS: Moving toward an internationally accepted IR reporting standard calls for advances in common reporting practices. Comprehensive, process-based reporting and presentation would make IR more understandable to others than information specialists and facilitate quality control.

Information on ethical issues in health technology assessment: how and where to find them.

BACKGROUND: Comprehensive health technology assessments (HTAs) include thorough reflections on ethical issues associated with health technologies, their use, and value-based decisions in the assessment process. As methods of information retrieval for effectiveness assessments are not applicable to information retrieval on ethical issues, a specific methodological approach is necessary. OBJECTIVES: In the absence of existing adapted methods, our objective was to develop a methodological approach for the systematic retrieval of information on ethical issues related to health technologies. METHOD AND RESULTS: A literature search was conducted to verify the non-existence of published comprehensive methodological approaches for the information retrieval on ethical issues for HTAs, and resulted in no hits. We, therefore, developed a step-by-step workflow following the workflow of information retrieval for effectiveness assessments: Step 1: Translation of the search question using the PICO scheme and additional components. Step 2: Concept building by modeling and linking search components. Step 3: Identification of synonyms in all relevant languages. Step 4: Selection of relevant information sources. Step 5: Design of search strategies for bibliographic databases. Step 6: Execution of search strategies and information seeking, including hand-searching. Step 7: Saving of retrieval results and standardized reporting of the process and results. Step 8: Final quality check and calculation of precision and recall. CONCLUSIONS: Systematic searching for information on ethical issues related to health technologies can be performed following the common retrieval workflow for effectiveness assessments, but should be performed separately applying adapted procedures and search terms on ethical issues relevant to the research question.

[Systematic search for information on ethical issues in HTA reports on medical technologies or interventions]. / Systematische Gewinnung von Informationen zu ethischen Aspekten in HTA-Berichten zu medizinischen Technologien bzw. Interventionen.

BACKGROUND: The aim of a health technology assessment (HTA) is the complete and comprehensive evaluation of a medical technology or intervention. This includes the consideration of ethical aspects associated with the use of a medical technology or with the technology evaluation process. In this context, ethics, as a moral philosophy, embraces issues of autonomy, beneficence, non-maleficence, and justice. OBJECTIVES: Presentation of the working steps to retrieve information on ethical aspects; documentation and description of the various information sources available, as well as of the search terms and strategies tailored to the respective information sources. PROCEDURES: In addition to well-known national and international information sources such as bibliographic databases for HTA, biomedical sciences (e.g., MEDLINE), social sciences, and psychology, ethics databases are also used in the retrieval of information, which is performed analogously to the working steps applied in the retrieval of information for the evaluation of a health technology's clinical benefit. The databases allow search queries that present a combination of thesaurus and free-text terms or those that exclusively consist of free-text terms. The search results are completed by supplementary handsearching of ethics journals, websites of HTA institutions and institutions/organisations with key activities involving ethics and, if necessary, requests to ethics experts. CONCLUSION: Although the search for information on ethical issues of medical technologies is performed according to the same procedures as those that are followed in clinical benefit assessments, specific search strategies and additional specialist information sources are needed.

Interventions for increasing uptake in screening programmes.

INTRODUCTION: Opportunities for the early detection of disease are not sufficiently being taken advantage of. Specific interventions could increase the uptake of prevention programmes. A comprehensive analysis of effectiveness and cost-effectiveness of these interventions with reference to Germany is still needed. OBJECTIVES: This report aimed to describe and assess interventions to increase uptake in primary and secondary prevention and to explore the assessment of their cost-effectiveness. METHODS: 29 scientific databases were systematically searched in a wide strategy. Additional references were located from bibliographies. All published systematic reviews and primary studies were assessed for inclusion without language restrictions. Teams of two reviewers identified the literature, extracted data and assessed the quality of the publications independently. RESULTS: Four HTA reports and 22 systematic reviews were identified for the medical evaluation covering a variety of interventions. The economic evaluation was based on two HTA-reports, one meta-analysis and 15 studies. The evidence was consistent for the effectiveness of invitations and reminders aimed at users, and for prompts aimed at health care professionals. These interventions were the most commonly analysed. (Financial) Incentives for users and professionals were identified in a small number of studies. Limited evidence was available for cost-effectiveness showing incremental costs for follow-up reminders and invitations by telephone. Evidence for ethical, social and legal aspects pointed to needs in vulnerable populations. DISCUSSION: The material was heterogeneous regarding interventions used, study populations and settings. The majority of references originated from the United States and focused on secondary prevention. Approaching all target groups by invitations and reminders was recommended to increase uptake in prevention programmes in general. CONCLUSIONS: Further research should aim to focus on primary prevention. Future research should also focus on specific interventions aiming to include vulnerable target groups and individuals, who have not previously made use of opportunities for prevention.

[Ethical aspects of short health technology assessments--a systematic review]. / Ethische Aspekte in Kurz-HTA-Berichten--eine systematische Ubersicht.

Ethical aspects are of high relevance to Short Health Technology Assessments (HTAs). We therefore conducted a systematic review to find out to what extent ethical aspects have been considered in previous Short HTAs. We included articles whose title or abstract suggested that it was a "short", "rapid" or "brief" assessment published in German, English, or French. 272 out of 513 Short HTAs were included. Twenty-five publications (9%) explicitly mentioned ethical aspects, 32 publications (12%) dealt with ethical aspects without explicitly addressing them as 'ethical', 208 publications (76%) did not consider ethical aspects and in another 7 publications (3%) ethical aspects were not relevant. Short HTAs are regularly used to assess sparsely evaluated and/or emerging technologies for which a particular need for an ethical assessment can be assumed. However, the majority of the Short HTAs included in this review did not consider ethical aspects. In this article we therefore suggest a set of key words that will allow authors of Short HTAs to do a systematic literature search for ethical papers in their respective subject of investigation.