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Abstract Background Utilizing regional health data goes hand in hand with challenges: can they be used for health planning, are they applicable to the relevant topics? The study explores current data utilization and needs of stakeholders working in regional health services planning. Methods We conducted 16 semi-structured expert-interviews with stakeholders of regional health planning in Brandenburg, a federal state in the north-east of Germany, by telephone or online-meeting tools between 05/2022 and 03/2023. The data were analysed according to qualitative content analysis. Results Utilization of data sources depends on individual knowledge and personnel resources instead of being guided by standardized procedures. Interviewees primarily use internal data; some use many different platforms, studies and reports. Regional health-related data are used for reliable health planning, to prepare resolutions, draft contracts, but also for events and requests from policy makers or the press. Challenges exist in terms of availability, awareness, and acceptance of the data, perceived applicability, the ability to use it and the utilization itself. Many regional health planners indicated they would appreciate a regional integrated cross-organizational data source if the benefits for health planning outweighed the efforts. Discussion Actors in health planning primarily utilized their own data for planning; additional data sources are not available or the level of aggregation is too high, not known by them or are often not used due to a lack of time. A standardized regional monitoring would require the definition of indicators as well as the strengthening of cross-sectoral planning.

Abstract Background Oncological patients have high information needs that are often unmet. Patient versions of oncological clinical practice guidelines (PVG) translate clinical practice guidelines into laypersons’ language and might help to address patients’ information needs. Currently, 30 oncological PVG have been published in Germany and more are being developed. Following a large multi-phase project on oncological PVGs in Germany, recommendations to improve use and dissemination of PVG were adopted in a multi-stakeholder workshop. Methods Organisations representing users of PVGs (patients, medical personnel, and multipliers), creators, initiators/funding organisations of PVGs, and organisations with methodological expertise in the development of clinical practice guidelines or in patient health information were invited to participate. The workshop included a World Café for discussion of pre-selected recommendations and structured consensus procedure for of all recommendations. Recommendations with agreement of > 75% were approved, and in case of ≤ 75% agreement, recommendations were rejected. Results The workshop took place on 24th April 2023 in Cologne, Germany. Overall, 23 people from 24 organisations participated in the discussion. Of 35 suggested recommendations 28 recommendations reached consensus and were approved. The recommendations referred to the topics dissemination (N = 13), design and format (N = 7), (digital) links (N = 5), digitalisation (N = 4), up-to-dateness (N = 3), and use of the PVG in collaboration between healthcare providers and patients (N = 3). Conclusion The practical recommendations consider various perspectives and can help to improve use and dissemination of oncological PVG in Germany. The inclusion of different stakeholders could facilitate the transfer of the results into practice.

Abstract Background People with cancer have high information needs; however, they are often inadequately met. Patient versions of clinical practice guidelines (PVGs), a special form of evidence-based information, translate patient-relevant recommendations from clinical practice guidelines into lay language. To date, little is known about the experience of PVGs from healthcare providers’ perspective in healthcare. This study aims to investigate the use, applicability, and dissemination of PVGs in oncology from the healthcare providers’ perspective in Germany. Methods Twenty semi-structured telephone interviews were conducted with oncological healthcare providers in Germany between October and December 2021. Interviews were recorded and transcribed verbatim. Mayring’s qualitative content analysis with MAXQDA software was utilised to analyse the data. Results A total of 20 healthcare providers (14 female, 6 male), mainly working as psychotherapists/psycho-oncologists and physicians, participated. Most participants (75%) were aware of the existence of PVGs. The content was predominantly perceived as comprehensible and relevant, whereas opinions on the design and format were mixed. The perceived lack of up-to-date information limited participants’ trust in the content. Most felt that PVGs positively impact healthcare owing to the fact that they improve patients’ knowledge about their disease. Additionally, PVGs served as a guide and helped healthcare providers structure physician–patient talks. Healthcare provider’s unawareness of the existence of PVGs was cited as an obstructive factor to its dissemination to patients. Conclusion Limited knowledge of the existence of PVGs among healthcare providers, coupled with alternative patient information, hinders the use and dissemination of PVGs in healthcare. However, the applicability of PVGs seemed to be acceptable owing to their content and good comprehensibility, especially with respect to physician–patient communication.

Background Systematic reviews (SRs) are being published at an accelerated rate. Decision-makers may struggle with comparing and choosing between multiple SRs on the same topic. We aimed to understand how healthcare decision-makers (eg, practitioners, policymakers, researchers) use SRs to inform decision-making and to explore the potential role of a proposed artificial intelligence (AI) tool to assist in critical appraisal and choosing among SRs.Methods We developed a survey with 21 open and closed questions. We followed a knowledge translation plan to disseminate the survey through social media and professional networks.Results Our survey response rate was lower than expected (7.9% of distributed emails). Of the 684 respondents, 58.2% identified as researchers, 37.1% as practitioners, 19.2% as students and 13.5% as policymakers. Respondents frequently sought out SRs (97.1%) as a source of evidence to inform decision-making. They frequently (97.9%) found more than one SR on a given topic of interest to them. Just over half (50.8%) struggled to choose the most trustworthy SR among multiple. These difficulties related to lack of time (55.2%), or difficulties comparing due to varying methodological quality of SRs (54.2%), differences in results and conclusions (49.7%) or variation in the included studies (44.6%). Respondents compared SRs based on the relevance to their question of interest, methodological quality, and recency of the SR search. Most respondents (87.0%) were interested in an AI tool to help appraise and compare SRs.Conclusions Given the identified barriers of using SR evidence, an AI tool to facilitate comparison of the relevance of SRs, the search and methodological quality, could help users efficiently choose among SRs and make healthcare decisions.

Abstract Background Several guideline organizations produce patient versions of clinical practice guidelines (PVGs) which translate recommendations into simple language. A former study of our working group revealed that few guideline organizations publish their methods used to develop PVGs. Clear definitions of PVGs do not prevail and their purposes often remain unclear. We aimed to explore experts’ perspectives on developing, disseminating and implementing PVGs to discuss and incorporate these experiences when consenting on methodological guidance and further improving PVGs. Methods We conducted 17 semi-structured telephone interviews with international experts working with PVGs from September 2021 through January 2022. We conducted the interviews in English or German, they were recorded and transcribed verbatim. We utilized Mayring’s qualitative content analysis with MAXQDA software to analyze the data. Results In two interviews two participants were interviewed at the same time. This resulted in a total of 19 participants from 16 different organizations and eight different countries participated. Most were female (16/19) and their experience in working with PVGs ranged from 1 to 20 years. All follow methodological standards when developing PVGs, but the extent of these standards and their public accessibility differs. Aims and target groups of PVGs vary between organizations. Facilitators for developing PVGs are working with a multidisciplinary team, financial resources, consultation processes and a high-quality underlying CPG. Facilitators for disseminating and implementing PVGs are using various strategies. Barriers, on the other hand, are the lack of these factors. All participants mentioned patient involvement as a key aspect in PVG development. Conclusion The steps in the PVG development process are largely similar across the countries. Focus is placed on the involvement of patients in the development process, although the extent of participation varies. The experts collectively attribute great importance to PVGs overall, but in order to constantly adapt to medical progress and changing conditions, the focus in the future may be more on formats like living guidelines. Although there are different views on the mandatory development of PVGs, there is a consistent call for more transparency regarding the methodology used for PVGs.

Abstract Background A Second Opinion Directive (SOD) was introduced in Germany in December 2018 for elective surgeries such as hysterectomy, tonsillotomy, tonsillectomy, and shoulder arthroscopy. The aim of the SOD is to avoid surgeries which are not medically induced and to support patients in their decision-making process. A physician who indicates an SOD-relevant procedure must inform the patient about the SOD and its specifications. At this time, it is not clear whether physicians provide information about the SOD to patients and whether and how the SOD is implemented in daily practice. Furthermore, nothing is known about how patients react when they are told that they have the right to seek a second opinion according to the SOD. Methods To assess this, we undertook a parallel-convergent mixed-methods study with a qualitative and quantitative phase. Qualitative data were analysed by structured qualitative content analysis and survey data were analysed descriptively. Results 26 interviews were conducted with patients for whom one of the above-mentioned surgeries was indicated. In parallel, a questionnaire survey with 102 patients was conducted. The results show that the SOD is not implemented in Germany for the selected indications because patients were not informed as intended. At the same time, when the right to obtain a second opinion was explained, it seemed to have a positive effect on the physician-patient relationship from patients` perspective. Conclusions It is possible that there is a lack of information for physicians, which in turn leads to an information deficit for patients. Better information for physicians might be part of the solution, but a negative attitude towards the SOD might also result in the low education rate. Therefore, in addition, potential patients or even the general population should be better informed about the possibility of obtaining a second opinion.

Abstract Background Systematic literature screening is a key component in systematic reviews. However, this approach is resource intensive as generally two persons independently of each other (double screening) screen a vast number of search results. To develop approaches for increasing efficiency, we tested the use of text mining to prioritize search results as well as the involvement of only one person (single screening) in the study selection process. Method Our study is based on health technology assessments (HTAs) of drug and non-drug interventions. Using a sample size calculation, we consecutively included 11 searches resulting in 33 study selection processes. Of the three screeners for each search, two used screening tools with prioritization (Rayyan, EPPI Reviewer) and one a tool without prioritization. For each prioritization tool, we investigated the proportion of citations classified as relevant at three cut-offs or STOP criteria (after screening 25%, 50% and 75% of the citation set). For each STOP criterion, we measured sensitivity (number of correctly identified relevant studies divided by the total number of relevant studies in the study pool). In addition, we determined the number of relevant studies identified per single screening round and investigated whether missed studies were relevant to the HTA conclusion. Results Overall, EPPI Reviewer performed better than Rayyan and identified the vast majority (88%, Rayyan 66%) of relevant citations after screening half of the citation set. As long as additional information sources were screened, it was sufficient to apply a single-screening approach to identify all studies relevant to the HTA conclusion. Although many relevant publications (n = 63) and studies (n = 29) were incorrectly excluded, ultimately only 5 studies could not be identified at all in 2 of the 11 searches (1x 1 study, 1x 4 studies). However, their omission did not change the overall conclusion in any HTA. Conclusions EPPI Reviewer helped to identify relevant citations earlier in the screening process than Rayyan. Single screening would have been sufficient to identify all studies relevant to the HTA conclusion. However, this requires screening of further information sources. It also needs to be considered that the credibility of an HTA may be questioned if studies are missing, even if they are not relevant to the HTA conclusion.

Abstract Background Overviews (i.e., systematic reviews of systematic reviews, meta-reviews, umbrella reviews) are a relatively new type of evidence synthesis. Among others, one reason to conduct an overview is to investigate adverse events (AEs) associated with a healthcare intervention. Overviews aim to provide easily accessible information for healthcare decision-makers including clinicians. We aimed to evaluate the clinical utility of overviews investigating AEs. Methods We used a sample of 27 overviews exclusively investigating drug-related adverse events published until 2021 identified in a prior project. We defined clinical utility as the extent to which overviews are perceived to be useful in clinical practice. Each included overview was assigned to one of seven pharmacological experts with expertise on the topic of the overview. The clinical utility and value of these overviews were determined using a self-developed assessment tool. This included four open-ended questions and a ranking of three clinical utility statements completed by clinicians. We calculated frequencies for the ranked clinical utility statements and coded the answers to the open-ended questions using an inductive approach. Results The overall agreement with the provided statements was high. According to the assessments, 67% of the included overviews generated new knowledge. In 93% of the assessments, the overviews were found to add value to the existing literature. The overviews were rated as more useful than the individual included systematic reviews (SRs) in 85% of the assessments. The answers to the open-ended questions revealed two key aspects of clinical utility in the included overviews. Firstly, it was considered useful that they provide a summary of available evidence (e.g., along with additional assessments, or across different populations, or in different settings that have not been evaluated together in the included SRs). Secondly, it was found useful if overviews conducted a new meta-analysis to answer specific research questions that had not been answered previously. Conclusions Overviews on drug-related AEs are considered valuable for clinical practice by clinicians. They can make available evidence on AEs more accessible and provide a comprehensive view of available evidence. As the role of overviews evolves, investigations such as this can identify areas of value.

Abstract Background Only rigorously prepared analyses can provide the highest level of evidence to inform decision-making. Several recent systematic reviews (SRs) examined the hypothesis that the early introduction of specific allergenic complementary foods (CFs) to infants may lead to a lower incidence of one or more allergic outcomes. However, the methodological rigour and quality of reporting of SRs in this area has not yet been systematically evaluated. Methods We comprehensively searched PubMed, Medline (Ovid), and Web of Science Core Collection on 13th January 2022, using a pre-specified and tested search syntax for SRs with RCT evidence on the early introduction of allergenic CFs as a means for allergy prevention in infants and children. We examined the quality and risk of bias (RoB) using AMSTAR-2 and ROBIS tools, examined adherence to the Preferred Reporting Items for SRs and Meta-Analyses (PRISMA), and checked whether certainty of the evidence was assessed. Results Twelve SRs were included. Application of both tools resulted in similar overall judgements in terms of direction and extent for nine of the 12 SRs. Nine SRs were found to be of critically low to low quality according to AMSTAR-2 and to be at high RoB according to ROBIS. One SR received a moderate quality rating (AMSTAR-2) and high RoB rating (ROBIS). However, for two SRs, judgements between AMSTAR-2 and ROBIS were at stark variance. Only two SRs fully adhered to the PRISMA checklist. Six SRs evaluated the certainty of the body of RCT evidence. Several SRs failed to consider unpublished studies either by an explicit a priori exclusion or by inadequate search strategies. Conclusions Well-conducted SRs are important for decision-making and informing guideline development, the quality of their methodology should therefore be considered. The methodological rigour and the reporting quality of SRs on the timing of CF for allergy prevention must be improved. Registration https://osf.io/7cs4b .

Abstract Health-care decision making should consider the best available evidence, often in the form of systematic reviews (SRs). The number of existing SRs and their overlap make their identification and use difficult. Decision makers often rely on de novo SRs instead of using existing SRs. We describe two cases of duplicate reviews (minimum volume threshold of total knee arthroplasties and lung cancer screening) and one case of duplicate primary data analysis (transcatheter aortic valve implantation). All cases have in common that unintended duplication of research occurred between health authorities and academia, demonstrating a lack of communication and coordination between them. It is important to note that academia and health authorities have different incentives. Academics are often measured by the number of peer-reviewed publications and grants awarded. In contrast, health authorities must comply with laws and are commissioned to deliver a specific report within a defined period of time. Most replication is currently unintended. A solution may be the collaboration of stakeholders commonly referred to as integrated knowledge translation (IKT). The IKT approach means that research is conducted in collaboration with the end users of the research. It requires active collaborations between researchers and decision-makers or knowledge users (clinicians, managers, policy makers) throughout the research process. Wherever cooperation is possible in spite of requirements for independence or confidentiality, legal regulations should facilitate and support collaborative approaches between academia and health authorities.

Abstract Background ‘A Measurement Tool to Assess Systematic Reviews, version 2’ (AMSTAR 2) is a validated 16-item scale designed to appraise systematic reviews (SRs) of healthcare interventions and to rate the overall confidence in their results. This commentary aims to describe the challenges with rating of the individual items and the application of AMSTAR 2 from the user perspective. Discussion A group of six experienced users (methodologists working in different clinical fields for at least 10 years) identified and discussed the challenges in rating of each item and the general use of AMSTAR 2 to appraise SRs. A group discussion was used to develop recommendations on how users could deal with the identified challenges. We identified various challenges with the content of items 2–16 and with the derivation of the overall confidence ratings on AMSTAR 2. These challenges include the need (1) to provide additional definitions (e.g., what constitutes major deviations from SR protocol on item 2), (2) to choose a rating strategy for multiple conditions on single items (e.g., how to rate item 5 if studies were selected in duplicate, but consensus between two authors was not reported), and (3) to determine rules for deriving the confidence ratings (e.g., what items are critical for such ratings). Based on these challenges we formulated specific recommendations for items 2–16 that AMSTAR 2 users could consider before applying the tool. Summary Our commentary adds to the existing literature by providing the first in-depth examination of the AMSTAR 2 tool from the user perspective. The identified challenges could be addressed by additional decision rules including definitions for ambiguous items and guidance for rating of complex items and derivation of confidence ratings. We recommend that a team consensus regarding such decision rules is required before appraisal procedure begins. Trial registration Not applicable.

Abstract Background The volume-outcome relationship, i.e., higher hospital volume results in better health outcomes, has been established for different surgical procedures as well as for certain nonsurgical medical interventions. Accordingly, many countries such as Germany, the USA, Canada, the UK, and Switzerland have established minimum volume standards. To date, there is a lack of systematically summarized evidence regarding the effects of such regulations. Methods To be included in the review, studies must measure any effects connected to minimum volume standards. Outcomes of interest include the following: (1) patient-related outcomes, (2) process-related outcomes, and (3) health system-related outcomes. We will include (cluster) randomized controlled trials ([C]RCTs), non-randomized controlled trials (nRCTs), controlled before-after studies (CBAs), and interrupted time-series studies (ITSs). We will apply no restrictions regarding language, publication date, and publication status. We will search MEDLINE (via PubMed), Embase (via Embase), CENTRAL (via Cochrane Library), CINHAL (via EBSCO), EconLit (via EBSCO), PDQ evidence for informed health policymaking, health systems evidence, OpenGrey, and also trial registries for relevant studies. We will further search manually for additional studies by cross-checking the reference lists of all included primary studies as well as cross-checking the reference lists of relevant systematic reviews. To evaluate the risk of bias, we will use the ROBINS-I and RoB 2 risk-of-bias tools for the corresponding study designs. For data synthesis and statistical analyses, we will follow the guidance published by the EPOC Cochrane group (Cochrane Effective Practice and Organisation of Care (EPOC), EPOC Resources for review authors, 2019). Discussion This systematic review focuses on minimum volume standards and the outcomes used to measure their effects. It is designed to provide thorough and encompassing evidence-based information on this topic. Thus, it will inform decision-makers and policymakers with respect to the effects of minimum volume standards and inform further studies in regard to research gaps. Systematic review registration PROSPERO CRD42022318883

Abstract Background While interprofessional collaboration (IPC) is widely considered a key element of comprehensive patient treatment, evidence focusing on its impact on patient-reported outcomes (PROs) is inconclusive. The aim of this study was to investigate the association between employee-rated IPC and PROs in a clinical inpatient setting. Methods We conducted a secondary data analysis of the entire patient and employee reported data collected by the Picker Institute Germany in cross-sectional surveys between 2003 and 2016. Individual patient data from departments within hospitals was matched with employee survey data from within 2 years of treatment at the department-level. Items assessing employee-rated IPC (independent variables) were included in Principal Component Analysis (PCA). All questions assessing PROs (overall satisfaction, less discomforts, complications, treatment success, willingness to recommend) served as main dependent variables in ordered logistic regression analyses. Results were adjusted for multiple hypothesis testing as well as patients’ and employees’ gender, age, and education. Results The data set resulted in 6154 patients from 19 hospitals respective 103 unique departments. The PCA revealed three principal components (department-specific IPC, interprofessional organization, and overall IPC), explaining 67% of the total variance. The KMO measure of sampling adequacy was .830 and Bartlett’s test of sphericity highly significant (p

Abstract Background To address the problem of overuse of elective surgery and to support patients in their decision-making process, a Second Opinion Directive was introduced in Germany, which enables patients with statutory health insurance to obtain a second opinion for certain surgical indications. The study aims to identify, based on the experiences of patients who have undergone elective surgery, the role of seeking a second opinion in reaching their decision. Methods Sixty-two patients who had undergone an elective surgery (hysterectomy, tonsillectomy, shoulder arthroscopy) were recruited using purposive sampling and interviewed during October to December 2020. The transcribed interviews were analysed using a framework analysis to create a typology from the patient’s perspective. Results The time spent by patients in making the decision to undergo surgery varies between individuals, and is influenced by factors such as the type of physician-patient relationship, individual patient aspects, prior experiences in the health care system, as well as information needs. Within the framework of the analysis, we were able to identify three patterns of patient types based on the three different time-points or phases when decisions were typically made, with one type being divided into two subtypes: Type 1a: Quick decision making, Type 1b: Overwhelmed quick decision making, Type 2: Time to consider, Type 3: Struggling with the decision. Conclusions Patients who followed a recommendation for elective surgery appreciate having the possibility to seek a second opinion. However, various factors influenced their opting for a second opinion during the decision-making process. Patients have differing information needs, such that a one-size-fits-all second opinion service may not fit adequately for all patients.

Abstract Objective Participant recruitment is one of the main challenges in research. It is suggested that including researcher photographs might increase participation rates, but empirical evidence is lacking. This study within a trial (SWAT) aims to assess whether invitation letters including researcher photographs increase the participation rate in the context of a survey on medical second opinions. Methods Through 25 local register offices in Berlin and Brandenburg (Germany), we identified a random sample of 9990 persons. We randomly assigned our sample to the intervention group (IG) receiving an invitation letter with researcher photographs and control group (CG) receiving an invitation letter without photographs in a 1:1 ratio. Our primary outcome was the participation rate. Furthermore, we compared participants to non-participants’ characteristics. Results Of 9990 invitations, 9797 could be delivered (IG: 4890, CG: 4907). Of these, 1349 (13.8%) participated. There were 682/4890 (13.9%) participants in the IG and 662/4907 (13.5%) in the CG with an odds ratio of 1.030 (95% confidence interval: 0.918–1.156). Additional analyses on non-participant characteristics did not show any differences. Conclusion We could not find any difference in the participation rates. Our study does not confirm the results of previous studies. The length of our questionnaire may have affected our results. Trial registration Queens University Belfast – SWAT Store, SWAT 104.

Abstract Background Restrictions in systematic reviews (SRs) can lead to bias and may affect conclusions. Therefore, it is important to report whether and which restrictions were used. This study aims to examine the use of restrictions regarding language, publication period, and study type, as well as the transparency of reporting in SRs of effectiveness. Methods A retrospective observational study was conducted with a random sample of 535 SRs of effectiveness indexed in PubMed between 2000 and 2019. The use of restrictions and their reporting were analysed using descriptive statistics. Results Of the total 535 SRs included, four out of every ten (41.3%) lacked information on at least one of the three restrictions considered (language, publication period, or study type). Overall, 14.6% of SRs did not provide information on restrictions regarding publication period, 19.1% regarding study type, and 18.3% regarding language. Of all included SRs, language was restricted in 46.4%, and in more than half of the SRs with restricted language (130/248), it was unclear whether the restriction was applied during either the search or the screening process, or both. The restrictions were justified for publication period in 22.2% of the respective SRs (33/149), study type in 6.5% (28/433), and language in 3.2% (8/248). Differences in reporting were found between countries as well as between Cochrane and non-Cochrane reviews. Conclusions This study suggests that there is a lack of transparency in reporting on restrictions in SRs. Authors as well as editors and reviewers should be encouraged to improve the reporting and justification of restrictions to increase the transparency of SRs.

Abstract Background Interprofessional collaboration (IPC) is seen as the “gold standard” of comprehensive care, but credible evidence concerning the effects on patient-reported outcomes (PRO) is lacking. The aim of this systematic review is to study the effect of IPC on PRO in inpatient care. Methods We systematically searched six electronic databases (PubMed, Web of Science/Social Science Citation Index, CENTRAL (Cochrane Library), Current Contents (LIVIVO), CINAHL, and Embase) for studies published between 1997 and 2021. Additional studies were identified through citation tracking, manually searching the Internet and Google Scholar, and consultation of experts. Risk of bias (RoB) was assessed using the RoB 2 tool for randomized controlled trials (RCTs) and ROBINS-I for non-randomized studies (NRS). The included controlled before-and-after study (CBA) was assessed using both the ROBINS-I and the Effective Practice and Organization of Care (EPOC) quality criteria. Results were synthesized through narrative description, grouping, and thematic analysis of extracted data. Results The search yielded 10,213 records, from which 22 studies (16 RCTs, five NRS, and one CBA) fulfilled the inclusion criteria. In all but five studies, RoB was assessed as being high (RoB 2) resp. critical or serious (ROBINS-I). Within these 22 studies, nine inductively derived outcomes were assessed: (i) quality of life, (ii) coping, (iii) functional ability and health status, (iv) psychiatric morbidity, (v) pain, (vi) managing one’s own health care, (vii) treatment success, (viii) satisfaction, and (ix) therapeutic relationship. While some studies do not report effect estimates, and some of the reported effects appear to be imprecisely estimated, the overall results indicate that IPC may affect PRO positively across all outcomes. Conclusions Due to high clinical heterogeneity and high RoB, the question whether IPC affects PRO cannot be answered conclusively. Methodically rigorous studies are needed in order to answer the question of effectiveness of IPC. Systematic review registration PROSPERO CRD42017073900

Abstract Background Systematic reviews (SRs) provide the highest level of evidence and inform evidence-based decision making in health care. Earlier studies found association with industry to be negatively associated with methodological quality of SRs. However, this has not been investigated in SRs on vaccines. Methods We performed a systematic literature search using MEDLINE and EMBASE in March 2020. The results were restricted to those published between 2016 and 2019 with no language restrictions. Study characteristics were extracted by one person and checked by an experienced reviewer. The methodological quality of the SRs was assessed with the AMSTAR 2 tool by multiple reviewers after a calibration exercise was performed. A summary score for each SR was calculated. The Mann-Whitney U test and Fisher’s exact test were performed to compare both groups. Results Out of 185 SRs that met all inclusion criteria, 27 SRs were industry funded. Those were matched with 30 non-industry funded SRs resulting in a total sample size of 57. The mean AMSTAR 2 summary score across all SRs was 0.49. Overall, the median AMSTAR 2 summary score was higher for the non-industry funded SRs than for the industry-funded SRs (0.62 vs. 0.36; p < .00001). Lower ratings for industry funded SRs were consistent across all but one AMSTAR 2 item, though significantly lower only for three specific items. Conclusion The methodological quality of SRs in vaccination is comparable to SRs in other fields, while it is still suboptimal. We are not able to provide a satisfactory explanation why industry funded SRs had a lower methodological quality than non-industry funded SRs over recent years. Industry funding is an important indicator of methodological quality for vaccine SRs and should be carefully considered when appraising SR quality.

Abstract Background Systematic reviews that synthesize safety outcomes pose challenges (e.g. rare events), which raise questions for grading the strength of the body of evidence. This is maybe one reason why in many potentially inappropriate medication (PIM) lists the recommendations are not based on formalized systems for assessing the quality of the body of evidence such as GRADE. In this contribution, we describe specifications and suggest adaptions of the GRADE system for grading the quality of evidence on safety outcomes, which were developed in the context of preparing a PIM-list, namely PRISCUS. Methods We systematically assessed each of the five GRADE domains for rating-down (study limitations, imprecision, inconsistency, indirectness, publication bias) and the criteria for rating-up, considering if special considerations or revisions of the original approach were indicated. The result was gathered in a written document and discussed in a group-meeting of five members with various background until consensus. Subsequently, we performed a proof-of-concept application using a convenience sample of systematic reviews and applied the approach to systematic reviews on 19 different clinical questions. Results We describe specifications and suggest adaptions for the criteria “study limitations”, imprecision, “publication bias” and “rating-up for large effect”. In addition, we suggest a new criterion to account for data from subgroup-analyses. The proof-of-concept application did not reveal a need for further revision and thus we used the approach for the systematic reviews that were prepared for the PRISCUS-list. We assessed 51 outcomes. Each of the proposed adaptions was applied. There were neither an excessive number of low and very low ratings, nor an excessive number of high ratings, but the different methodological quality of the safety outcomes appeared to be well reflected. Conclusion The suggestions appear to have the potential to overcome some of the challenges when grading the methodological quality of harms and thus may be helpful for producers of evidence syntheses considering safety.

Introduction Several systematic reviews (SRs) have been conducted to determine the effectiveness of early mobilisation in critically ill adults with heterogeneous methodology and results. Redundancy in conducting SRs, unclear justification when leading new SRs or updating, and discordant results of SRs on the same research question may generate research waste that makes it difficult for clinicians to keep up to date with the best available evidence. This meta-research aims to assess the redundancy, methodological and reporting quality, and potential reasons for discordance in the results reported by SRs conducted to determine the effectiveness of early mobilisation in critically ill adult patients.Methods and analysis A meta-research of early mobilisation SRs in critically ill adult patients will be conducted. A search of MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCOhost), Cochrane Library, Epistemonikos and other search resources will be conducted. Two independent reviewers will perform study selection, data extraction and quality appraisal. Discrepancies will be resolved by consensus or a third reviewer. The redundancy of SRs will be assessed by the degree of overlap of primary studies. In addition, the justification for conducting new SRs will be evaluated with the ‘Evidence-Based Research’ framework. The methodological quality of the SRs will be assessed with the A MeaSurement Tool to Assess systematic Reviews 2 tool, and the quality of the reports through compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. To assess the potential reasons for discordance in the results of the SRs considering divergence in results and their interpretation.Ethics and dissemination As meta-research, this study does not involve the participation of people whose rights may be violated. However, this overview will be developed rigorously and systematically to achieve valid and reliable results. The findings of this meta-research study will be presented at conferences and published in a peer-reviewed journal related to rehabilitation, critical care or research methodology.Trial registration number osf.io/kxwq9.

Introduction One of the most conflicting methodological issues when conducting an overview is the overlap of primary studies across systematic reviews (SRs). Overlap in the pooled effect estimates across SRs may lead to overly precise effect estimates in the overview. SRs that focus on exercise-related interventions are often included in overviews aimed at grouping and determining the effectiveness of various interventions for managing specific health conditions. The aim of this systematic methodological review is to describe the strategies used by authors of overviews focusing on exercise-related interventions to manage the overlap of primary studies.Methods and analysis A comprehensive search strategy has been developed for different databases and their platforms. The databases to be consulted will be MEDLINE (Ovid), Embase (Ovid), The Cochrane Database of Systematic Reviews (Cochrane Library) and Epistemonikos. Two reviewers will independently screen the records identified through the search strategy and extract the information from the included overviews. The frequency and the type of overlap management strategies of the primary studies included in the SRs will be considered as the main outcome. In addition, the recognition of the lack of use of any overlap management strategy and the congruence between planning and conducting the overview focusing on overlap management strategies will be assessed. A subgroup analysis will be carried out according to the journal impact factor, year of publication and compliance with the Preferred Reporting Items for Overviews of Reviews statement.Ethics and dissemination This study will not involve human subjects and therefore does not require ethics committee approval. However, the conduct and reporting of the findings of this review will be conducted in a rigorous, systematic and transparent manner, which relates to research ethics.The findings of this review will be presented at scientific conferences and published as one or more studies in peer-review scientific journals related to rehabilitation or research methods.

Introduction Centralisation defined as the reorganisation of healthcare services into fewer specialised units serving a higher volume of patients is a potential measure for healthcare reforms aiming at reducing costs while improving quality. Research on centralisation of healthcare services is thus essential to inform decision-makers. However, so far studies on centralisation report a variability of outcomes, often neglecting outcomes at the health system level. Therefore, this study aims at developing a core outcome set (COS) for studies on centralisation of hospital procedures, which is intended for use in observational as well as in experimental studies.Methods and analysis We propose a five-stage study design: (1) systematic review, (2) focus group, (3) interview studies, (4) online survey, (5) Delphi survey. The study will be conducted from March 2022 to November 2023. First, an initial list of outcomes will be identified through a systematic review on reported outcomes in studies on minimum volume regulations. We will search MEDLINE, EMBASE, CENTRAL, CINHAL, EconLIT, PDQ-Evidence for Informed Health Policymaking, Health Systems Evidence, Open Grey and also trial registries. This will be supplemented with relevant outcomes from published studies on centralisation of hospital procedures. Second, we will conduct a focus group with representatives of patient advocacy groups for which minimum volume regulations are currently in effect in Germany or are likely to come into effect to identify outcomes important to patients. Furthermore, two interview studies, one with representatives of the German medical societies and one with representatives of statutory health insurance funds, as well as an online survey with health services researchers will be conducted. In our analyses of the suggested outcomes, we will largely follow the categorisation scheme developed by the Cochrane EPOC group. Finally, a two-round online Delphi survey with all stakeholder groups using predefined score criteria for consensus will be employed to first prioritise outcomes and then agree on the final COS.Ethics and dissemination This study has been approved by the Research Ethics Committee at the Brandenburg Medical School Theodor Fontane (MHB). The final COS will be disseminated to all stakeholders involved and through peer-reviewed publications and conferences.

Abstract Background Systematic reviews of in-vitro studies, like any other study, can be of heterogeneous quality. The present study aimed to evaluate the methodological quality of systematic reviews of in-vitro dental studies. Methods We searched for systematic reviews of in-vitro dental studies in PubMed, Web of Science, and Scopus databases published up to January 2022. We assessed the methodological quality of the systematic reviews using a modified “A MeaSurement Tool to Assess systematic Reviews” (AMSTAR-2) instrument. The 16 items, in the form of questions, were answered with yes, no, or py (partial yes). Univariable and multivariable linear regression models were used to examine the association between systematic review characteristics and AMSTAR-2 percent score. Overall confidence in the results of the systematic reviews was rated, based on weaknesses identified in critical and non-critical AMSTAR-2 items. Results The search retrieved 908 potential documents, and after following the eligibility criteria, 185 systematic reviews were included. The most researched topics were ceramics and dental bonding. The overall rating for the confidence in the results was critically low in 126 (68%) systematic reviews. There was high variability in the response among the AMSTAR-2 items (0% to 75% positively answered). The univariable analyses indicated dental specialty (p = 0.03), number of authors (coef: 1.87, 95% CI: 0.26, 3.47, p = 0.02), and year of publication (coef: 2.64, 95% CI: 1.90, 3.38, p

Abstract Background Obesity is a worldwide problem with different treatment options. Bariatric surgery is an effective treatment for severe obesity; however, it leads to drastic changes (e.g., changes in everyday life and eating behavior) for patients, which may lead to information needs. Our aim was to identify the information needs of patients undergoing bariatric surgery and to explore the information provision within the healthcare process of bariatric surgery in Germany. Methods We conducted a qualitative study (n = 14 single, semi-structured telephone interviews) between April 2018 and April 2019. The interview guide was designed prior to the interviews and consisted of four main sections (demographic information, pre-/postoperative healthcare provision, information needs). The interviews were transcribed verbatim and analyzed using qualitative content analysis with MAXQDA software. Results There were unmet information needs with two factors (time: pre/postoperative and categories of information: general/specific) to be considered. Due to the patients’ description of information, we categorized information into general (different surgical procedures, general nutritional information) and specific (occurring simultaneously with a problem) information. Most patients felt well informed concerning general information. However, it was pointed out that it was not possible to provide complete information preoperatively, as the need for information only arises when there are postoperative (specific) problems. In addition, there seems to be a high demand for specific postoperative information regarding nutrition and nutrition-related problems. However, patients stated that postoperative nutritional counseling is not reimbursed by health insurance funds. The information conveyed in support groups and the exchange of experiences are highly valued by patients. However, some patients describe the information provided within the support groups as unfiltered, frightening or exaggerated. Conclusion Overall, there were unmet information needs. Reimbursement by health insurance funds could increase the use of postoperative nutritional counseling and thus serve existing information needs. Support groups enable an exchange of experiences and therefore offer low-barrier access to information. Cooperation between support groups and healthcare professionals in information provision could be an approach to improving existing information needs or to avoiding the development of information gaps. Furthermore, the development and implementation of a digital solution for (postoperative) information dissemination could be helpful.

Abstract Objective For assessing cost-effectiveness, Health Technology Assessment (HTA) organisations may use primary economic evaluations (P-HEs) or Systematic Reviews of Health Economic evaluations (SR-HEs). A prerequisite for meaningful results of SR-HEs is that the results from existing P-HEs are transferable to the decision context (e.g, HTA jurisdiction). A particularly pertinent issue is the high variability of costs and resource needs across jurisdictions. Our objective was to review the methods documents of HTA organisations and compare their recommendations on considering transferability in SR-HE. Methods We systematically hand searched the webpages of 158 HTA organisations for relevant methods documents from 8th January to 31st March 2019. Two independent reviewers performed searches and selected documents according to pre-defined criteria. One reviewer extracted data in standardised and piloted tables and a second reviewer checked them for accuracy. We synthesised data using tabulations and in a narrative way. Results We identified 155 potentially relevant documents from 63 HTA organisations. Of these, 7 were included in the synthesis. The included organisations have different aims when preparing a SR-HE (e.g. to determine the need for conducting their own P-HE). The recommendations vary regarding the underlying terminology (e.g. transferability/generalisability), the assessment approaches (e.g. structure), the assessment criteria and the integration in the review process. Conclusion Only few HTA organisations address the assessment of transferability in their methodological recommendations for SR-HEs. Transferability considerations are related to different purposes. The assessment concepts and criteria are heterogeneous. Developing standards to consider transferability in SR-HEs is desirable.

Abstract Background Prospective registration aims to reduce bias in the conduct and reporting of research and to increase transparency. In addition, prospective registration of systematic reviews is argued to help preventing unintended duplication, thereby reducing research waste. PROSPERO was launched in 2011 as the first prospective register for systematic reviews. While it has long been the only option to prospectively register systematic reviews, recently there have been new developments. Our aim was to identify and characterize current options to prospectively register a systematic review to assist review authors in choosing a suitable register. Methods To identify systematic review registers, we independently performed internet searches in January 2021 using keywords related to systematic reviews and prospective registration. “Registration” was defined as the process of entering information about a planned systematic review into a database before starting the systematic review process. We collected data on the characteristics of the identified registries and contacted the responsible party of each register for verification of the data related to their registry. Results Overall, we identified five options to prospectively register a systematic review: PROSPERO, the Registry of Systematic Reviews/Meta-Analyses in Research Registry, and INPLASY, which are specific to systematic reviews, and the Open Science Framework Registries and protocols.io, which represent generic registers open to any study type. Detailed information on each register is presented in tables in the main text. Regarding the systematic-review-specific registries, authors have to trade-off between the costs of registration and the processing time of their registration record. All registers provide an option to search for systematic reviews already registered in the register. However, it is unclear how useful these search functions are. Conclusion Authors can prospectively register their systematic review in five registries, which come with different characteristics and features. The research community should discuss fair and sustainable financing models for registers that are not operated by for-profit organizations.

Abstract Background Second medical opinions (SOs) can assist patients in making informed treatment decisions and improve the understanding of their diagnosis. In Germany, there are different approaches to obtain a structured SO procedure: SO programs by health insurers and SOs according to the SO Directive. Through a direct survey of the population, we aimed to assess how structured SOs should be provided to fulfil patients’ needs. Methods A stratified sample of 9990 adults (≥18 years) living in the federal states of Berlin and Brandenburg (Germany) were initially contacted by post in April and sent a reminder in May 2020. The survey results were analyzed descriptively. Results Among 1349 participants (response rate 14%), 56% were female and the median age was 58 years (interquartile range (IQR) 44–69). Participants wanted to be informed directly and personally about the possibility of obtaining an SO (89%; 1201/1349). They preferred to be informed by their physician (93%; 1249/1349). A majority of participants would consider it important to obtain an SO for oncological indications (78%; 1049/1349). Only a subset of the participants would seek an SO via their health insurer or via an online portal (43%; 577/1349 and 16%; 221/1349). A personally delivered SO was the preferred route of SO delivery, as 97% (1305/1349) would (tend to) consider this way of obtaining an SO. Participants were asked to imagine having moderate knee pain for years, resulting in a treatment recommendation for knee joint replacement. They were requested to rate potential qualification criteria for a physician providing the SO. The criteria rated to be most important were experience with the recommended diagnosis/treatment (criterion (very) important for 93%; 1257/1349) and knowledge of the current state of research (criterion (very) important for 86%; 1158/1349). Participants were willing to travel 60 min (median; IQR 60–120) and wait 4 weeks (median; IQR 2–4) for their SO in the hypothetical case of knee pain. Conclusion In general, SOs were viewed positively. We found that participants have clear preferences regarding SOs. We propose that these preferences should be taken into account in the future design and development of SO programs.

IntroductionAdult and pediatric patients admitted to intensive care units (ICUs) requiring invasive ventilatory support, sedation, and muscle blockade may present neuromusculoskeletal deterioration. Different physical rehabilitation interventions have been studied to evaluate their effectiveness in improving critically ill patients' outcomes. Given that many published systematic reviews (SRs) aims to determine the effectiveness of different types of physical rehabilitation interventions, it is necessary to group them systematically and assess the methodological quality of SRs to help clinicians make better evidence-based decisions. This overview of SRs (OoSRs) aims to map the existing evidence and to determine the effectiveness of physical rehabilitation interventions to improve neuromusculoskeletal function and other clinical outcomes in adult and pediatric critically ill patients.MethodsAn OoSRs of randomized and non-randomized clinical trials involving critically ill adult and pediatric patients receiving physical rehabilitation intervention will be conducted. A sensitive search of MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCOhost), Cochrane Library, Epistemonikos, and other search resources will be conducted. Two independent reviewers will conduct study selection, data extraction, and methodological quality assessment. Discrepancies will be resolved by consensus or a third reviewer. The degree of overlap of studies will be calculated using the corrected covered area. The methodological quality of the SRs will be measured using the AMSTAR-2 tool. The GRADE framework will report the certainty of evidence by selecting the "best" SR for each physical rehabilitation intervention and outcome.DiscussionThe findings of this overview are expected to determine the effectiveness and safety of physical rehabilitation interventions to improve neuromusculoskeletal function in adult and pediatric critically ill patients based on a wide selection of the best available evidence and to determine the knowledge gaps in this topic by mapping and assessing the methodological quality of published SRs.Registration numberCRD42023389672.

Abstract Background Previous research on data extraction methods in systematic reviews has focused on single aspects of the process. We aimed to provide a deeper insight into these methods by analysing a current sample of reviews. Methods We included systematic reviews of health interventions in humans published in English. We analysed 75 Cochrane reviews from May and June 2020 and a random sample of non-Cochrane reviews published in the same period and retrieved from Medline. We linked reviews with protocols and study registrations. We collected information on preparing, piloting, and performing data extraction and on use of software to assist review conduct (automation tools). Data were extracted by one author, with 20% extracted in duplicate. Data were analysed descriptively. Results Of the 152 included reviews, 77 reported use of a standardized extraction form (51%); 42 provided information on the type of form used (28%); 24 on piloting (16%); 58 on what data was collected (38%); 133 on the extraction method (88%); 107 on resolving disagreements (70%); 103 on methods to obtain additional data or information (68%); 52 on procedures to avoid data errors (34%); and 47 on methods to deal with multiple study reports (31%). Items were more frequently reported in Cochrane than non-Cochrane reviews. The data extraction form used was published in 10 reviews (7%). Use of software was rarely reported except for statistical analysis software and use of RevMan and GRADEpro GDT in Cochrane reviews. Covidence was the most frequent automation tool used: 18 reviews used it for study selection (12%) and 9 for data extraction (6%). Conclusions Reporting of data extraction methods in systematic reviews is limited, especially in non-Cochrane reviews. This includes core items of data extraction such as methods used to manage disagreements. Few reviews currently use software to assist data extraction and review conduct. Our results can serve as a baseline to assess the uptake of such tools in future analyses.

Abstract Background The global prevalence of diabetes is nearly 9%, with an upward trend in type 2 diabetes mellitus (T2DM) and gestational diabetes (GDM). Although evidence shows that vulnerable groups are affected disproportionally, these groups are difficult to reach in terms of preventive measures. Currently, there is no gold standard regarding communication strategies and/or public awareness campaigns. Methods We conducted a scoping review in September 2019. Two reviewers independently screened the results of the electronic literature search in several databases, including Medline, EMBASE, and PsycINFO. Extracted data were charted, categorized, and summarized. Results All of the included articles (n=24) targeted T2DM; none targeted GDM. We identified the following five different vulnerable groups within the identified studies: migrants (n=9), ethnic groups such as African Americans (n=8), people with low socioeconomic status (n=3), older people (n=1), and people in need of care (n=1). Three categories of communication strategies were identified as follows: adapted diabetes prevention programs (n=21), community health workers (n=5), and technical approaches (n=9). Conclusion We found different approaches for preventive interventions for T2DM. Some of these approaches were already adapted to known barriers. Communication strategies should be adapted to barriers and facilitating factors to increase participation and motivation.

Abstract Background Total knee arthroplasty (TKA) is performed to treat end-stage knee osteoarthritis. In Germany, a minimum volume threshold of 50 TKAs/hospital/year was implemented to ensure outcome quality. This study, embedded within a systematic review, aimed to investigate the perspectives of potential TKA patients on the hospital volume-outcome relationship for TKA (higher volumes associated with better outcomes). Methods A convenience sample of adults with knee problems and heterogeneous demographic characteristics participated in the study. Qualitative data were collected during a focus group prior to the systematic review (n = 5) and during telephone interviews, in which preliminary results of the systematic review were discussed (n = 16). The data were synthesised using content analysis. Results All participants (n = 21) believed that a hospital volume-outcome relationship exists for TKA while recognising that patient behaviour or the surgeon could also influence outcomes. All participants would be willing to travel longer for better outcomes. Most interviewees would choose a hospital for TKA depending on reputation, recommendations, and service quality. However, some would also choose a hospital based on the results of the systematic review that showed slightly lower mortality/revision rates at higher-volume hospitals. Half of the interviewees supported raising the minimum volume threshold even if this were to increase travel time to receive TKA. Conclusions Potential patients believe that a hospital volume-outcome relationship exists for TKA. Hospital preference is based mainly on subjective factors, although some potential patients would consider scientific evidence when making their choice. Policy makers and physicians should consider the patient perspectives when deciding on minimum volume thresholds or recommending hospitals for TKA, respectively.

Abstract Background There are several healthcare professionals involved in health information provision regarding bariatric surgery, such as bariatric surgeons, nutritionists, and medical doctors in outpatient settings. Trustworthy health information supports patients in understanding their diagnosis, treatment decisions, and possible prognosis. Therefore, it is necessary to provide health information on bariatric surgery. This study has two distinct objectives. The first is to outline the delivery of healthcare regarding bariatric surgery in Germany. The second is to describe the information provision within healthcare delivery. Methods We conducted 15 semi-structured telephone interviews with bariatric surgeons between April 2018 and February 2019. The interviews were audio recorded and transcribed verbatim. The interview guide consisted of four sections (information about the clinic/surgeon and surgical procedures, preoperative procedure, postoperative procedure, information needs). The transcribed interviews were analyzed using qualitative content analysis supported by MAXQDA software. Results The pre- and postoperative processes differed substantially between clinics. Additionally, every bariatric clinic had its own information provision concept. There were several cost-related issues the surgeons claimed to be relevant for patients, such as nutritional blood tests or postoperative psychotherapy. These issues were often caused by unclearness of responsibility within the medical disciplines involved. Conclusion Healthcare delivery in bariatric surgery in Germany is heterogeneous in terms of pre- and postoperative care. Therefore, preoperative information provision between the clinics differs. The impact of this heterogeneous healthcare delivery and information provision on patients’ information needs regarding bariatric surgery should be further investigated among patients and other healthcare professionals involved.

Abstract Background Overviews often identify and synthesise a large number of systematic reviews on the same topic, which is likely to lead to overlap (i.e. duplication) in primary studies across the reviews. Using a primary study result multiple times in the same analysis overstates its sample size and number of events, falsely leading to greater precision in the analysis. This paper aims to: (a) describe types of overlapping data that arise from the same primary studies reported across multiple reviews, (b) describe methods to identify and explain overlap of primary study data, and (c) present six case studies illustrating different approaches to manage overlap. Methods We first updated the search in PubMed for methods from the MOoR framework relating to overlap of primary studies. One author screened the studies titles and abstracts, and any full-text articles retrieved, extracted methods data relating to overlap of primary studies and mapped it to the overlap methods from the MOoR framework. We also describe six case studies as examples of overviews that use specific overlap methods across the steps in the conduct of an overview. For each case study, we discuss potential methodological implications in terms of limitations, efficiency, usability, and resource use. Results Nine methods studies were found and mapped to the methods identified by the MOoR framework to address overlap. Overlap methods were mapped across four steps in the conduct of an overview – the eligibility criteria step, the data extraction step, the assessment of risk of bias step, and the synthesis step. Our overview case studies used multiple methods to reduce overlap at different steps in the conduct of an overview. Conclusions Our study underlines that there is currently no standard methodological approach to deal with overlap in primary studies across reviews. The level of complexity when dealing with overlap can vary depending on the yield, trends and patterns of the included literature and the scope of the overview question. Choosing a method might be dependent on the number of included reviews and their primary studies. Gaps in evaluation of methods to address overlap were found and further investigation in this area is needed.

Abstract Background To develop and test an approach to test reproducibility of SRs. Methods Case study. We have developed an approach to test reproducibility retrospectively while focusing on the whole conduct of an SR instead of single steps of it. We replicated the literature searches and drew a 25% random sample followed by study selection, data extraction, and risk of bias (ROB) assessments performed by two reviewers independently. These results were compared narratively with the original review. Results We were not able to fully reproduce the original search resulting in minor differences in the number of citations retrieved. The biggest disagreements were found in study selection. The most difficult section to be reproduced was the RoB assessment due to the lack of reporting clear criteria to support the judgement of RoB ratings, although agreement was still found to be satisfactory. Conclusion Our approach as well as other approaches needs to undergo testing and comparison in the future as the area of testing for reproducibility of SRs is still in its infancy.

Abstract Published protocols have the potential to reduce bias in the conduct and reporting of systematic reviews (SR). When reporting the results of a completed SR, the question might arise whether text used in the protocol can also be used in the completed SR? Does this constitute text recycling, plagiarism, or even copyright infringement? In theory, no major changes to the protocol will be expected for the introduction and methods sections if the SR is completed in time. The benefits of maintaining the introduction and methods section of a protocol in the published SR are straightforward. Authors will require less time for writing up the completed SR. Potential benefits can also be expected for peer reviewers and editors. However, reusing text can be described as self-plagiarism. The question to be answered is whether this type of self-plagiarism is acceptable when copying text used previously (as would be the case when copying text from the protocol and pasting it into the subsequent completed SR)? The “traditional answer” to this question is “yes” because authors should not get credit for one piece of work for more than one time unless the work is cited appropriately. In contrast, we propose that in this context, it seems to be fully acceptable from a scientific and ethical perspective. As such, authors should not be accused of plagiarism in this case, but rather be encouraged to be efficient. However, legal issues need to be taken into consideration (e.g., copyright). We hope to stimulate a discussion on this topic among authors, readers, editors, and publishers.

Abstract Background An intestinal ostomy is an artificial bowel opening created on the skin. Procedure-related mortality is extremely rare. However, the presence of an ostomy may be associated with significant morbidity. Complications negatively affect the quality of life of ostomates. Preoperative stoma site marking can reduce stoma-related complications and is recommended by several guidelines. However, there is no consensus on the procedure and recommendations are based on low-quality evidence. The objective of the systematic review will be to investigate if preoperative stoma site marking compared to no preoperative marking in patients undergoing intestinal stoma surgery reduces or prevents the rate of stoma-related complications. Methods We will include (cluster-) randomised controlled trials and cohort studies that involve patients with intestinal ostomies comparing preoperative stoma site marking to no preoperative marking and report at least one patient-relevant outcome. For study identification, we will systematically search MEDLINE/PubMed, EMBASE, CENTRAL and CINHAL as well as Google Scholar, trial registries, conference proceedings and reference lists. Additionally, we will contact experts in the field. Two reviewers will independently perform study selection and data extraction. Outcomes will be prioritised based on findings from telephone interviews with five ostomates and five ostomy and wound nurses prior to conducting the review. Outcomes may include but are not limited to stoma-related complications (infection, parastomal abscess, hernia, mucocutaneous separation, dermatological complications, stoma necrosis, stenosis, retraction and prolapse) or other patient-relevant postoperative endpoints (quality of life, revision rate, dependence on professional care, mortality, length of stay and readmission). We will use the ROBINS-I or the Cochrane risk of bias tool to assess the risk of bias of the included studies. We will perform a meta-analysis and assess the certainty of evidence using the GRADE approach. Discussion With the results of the systematic review, we aim to provide information for future clinical guidelines and influence clinical routine with regard to preoperative stoma site marking in patients undergoing ostomy surgery. When the evidence of our systematic review is low, it would still be a useful basis for future clinical trials by identifying data gaps. Systematic review registration PROSPERO registration number: CRD42021226647

Abstract Background Second medical opinions can give patients confidence when choosing among treatment options and help them understand their diagnosis. Health insurers in several countries, including Germany, offer formal second opinion programs (SecOPs). We systematically collected and analyzed information on German health insurers’ approach to SecOPs, how the SecOPs are structured, and to what extent they are evaluated. Methods In April 2019, we sent a questionnaire by post to all German statutory (n = 109) and private health insurers (n = 52). In September 2019, we contacted the nonresponders by email. The results were analyzed descriptively. They are presented overall and grouped by type of insurance (statutory/private health insurer). Results Thirty one of One hundred sixty one health insurers (response rate 19%) agreed to participate. The participating insurers covered approximately 40% of the statutory and 34% of the private health insured people. A total of 44 SecOPs were identified with a median of 1 SecOP (interquartile range (IQR) 1–2) offered by a health insurer. SecOPs were in place mainly for orthopedic (21/28 insurers with SecOPs; 75%) and oncologic indications (20/28; 71%). Indications were chosen principally based on their potential impact on a patient (22/28; 79%). The key qualification criterion for second opinion providers was their expertise (30/44 SecOPs; 68%). Second opinions were usually provided based on submitted documents only (21/44; 48%) or on direct contact between a patient and a doctor (20/44; 45%). They were delivered after a median of 9 days (IQR 5–15). A median of 31 (IQR 7–85) insured persons per year used SecOPs. Only 12 of 44 SecOPs were confirmed to have conducted a formal evaluation process (27%) or, if not, plan such a process in the future (10/22; 45%). Conclusion Health insurers’ SecOPs focus on orthopedic and oncologic indications and are based on submitted documents or on direct patient-physician contact. The formal evaluation of SecOPs needs to be expanded and the results should be published. This can allow the evaluation of the impact of SecOPs on insured persons’ health status and satisfaction, as well as on the number of interventions performed. Our results should be interpreted with caution due to the low participation rate.

Abstract Background Systematic Reviews (SRs) can build the groundwork for evidence-based health care decision-making. A sound methodological quality of SRs is crucial. AMSTAR (A Measurement Tool to Assess Systematic Reviews) is a widely used tool developed to assess the methodological quality of SRs of randomized controlled trials (RCTs). Research shows that AMSTAR seems to be valid and reliable in terms of interrater reliability (IRR), but the test retest reliability (TRR) of AMSTAR has never been investigated. In our study we investigated the TRR of AMSTAR to evaluate the importance of its measurement and contribute to the discussion of the measurement properties of AMSTAR and other quality assessment tools. Methods Seven raters at three institutions independently assessed the methodological quality of SRs in the field of occupational health with AMSTAR. Between the first and second ratings was a timespan of approximately two years. Answers were dichotomized, and we calculated the TRR of all raters and AMSTAR items using Gwet’s AC1 coefficient. To investigate the impact of variation in the ratings over time, we obtained summary scores for each review. Results AMSTAR item 4 (Was the status of publication used as an inclusion criterion?) provided the lowest median TRR of 0.53 (moderate agreement). Perfect agreement of all reviewers was detected for AMSTAR-item 1 with a Gwet’s AC1 of 1, which represented perfect agreement. The median TRR of the single raters varied between 0.69 (substantial agreement) and 0.89 (almost perfect agreement). Variation of two or more points in yes-scored AMSTAR items was observed in 65% (73/112) of all assessments. Conclusions The high variation between the first and second AMSTAR ratings suggests that consideration of the TRR is important when evaluating the psychometric properties of AMSTAR.. However, more evidence is needed to investigate this neglected issue of measurement properties. Our results may initiate discussion of the importance of considering the TRR of assessment tools. A further examination of the TRR of AMSTAR, as well as other recently established rating tools such as AMSTAR 2 and ROBIS (Risk Of Bias In Systematic reviews), would be useful.

Abstract Background Surgical site infection (SSI) describes an infectious complication of surgical wounds. Although SSI is thought to be preventable, it still represents a major cause of morbidity and substantial economic burden on the health system. Wound irrigation (WI) might reduce the level of bacterial contamination, but current data on its role in reducing or preventing SSI is conflicting. Our aim was to investigate the effectiveness of WI with normal saline prior to wound closure for the reduction of SSI in patients undergoing abdominal surgery. Methods We conducted a systematic literature search in MEDLINE, EMBASE, and CENTRAL from inception to present, and cross-checked the reference lists of all included primary studies and relevant systematic reviews. (Quasi-) randomized controlled trials (RCTs) investigating the rate of SSI when using normal saline vs. no irrigation prior to wound closure following abdominal surgery were included. Primary outcome was the rate of SSI, secondary outcome the mean length of hospital stay (LOS). Results Four RCTs including a total of 1194 patients were included for analysis. All studies compared wound irrigation with normal saline with no wound irrigation prior to wound closure. Their risk of bias was moderate. The relative risk of developing a SSI was lower when wound irrigation with normal saline was performed prior to wound closure although the effect was not statistically significant (risk ratio 0.73, 95%-confidence level: 0.37 to 1.43). Similarly, there was no difference in the LOS amongst both intervention arms. Conclusion This systematic review could not identify an advantage for routine irrigation of abdominal wounds with normal saline over no irrigation prior to wound closure in preventing or reducing the rate of SSI. Systematic review registration PROSPERO registry number CRD42018082287 .

Abstract Background Sedentary lifestyle is a major risk factor for noncommunicable diseases such as cardiovascular diseases, cancer and diabetes. It has been estimated that approximately 3.2 million deaths each year are attributable to insufficient levels of physical activity. We evaluated the available evidence from Cochrane systematic reviews (CSRs) on the effectiveness of exercise/physical activity for various health outcomes. Methods Overview and meta-analysis. The Cochrane Library was searched from 01.01.2000 to issue 1, 2019. No language restrictions were imposed. Only CSRs of randomised controlled trials (RCTs) were included. Both healthy individuals, those at risk of a disease, and medically compromised patients of any age and gender were eligible. We evaluated any type of exercise or physical activity interventions; against any types of controls; and measuring any type of health-related outcome measures. The AMSTAR-2 tool for assessing the methodological quality of the included studies was utilised. Results Hundred and fifty CSRs met the inclusion criteria. There were 54 different conditions. Majority of CSRs were of high methodological quality. Hundred and thirty CSRs employed meta-analytic techniques and 20 did not. Limitations for studies were the most common reasons for downgrading the quality of the evidence. Based on 10 CSRs and 187 RCTs with 27,671 participants, there was a 13% reduction in mortality rates risk ratio (RR) 0.87 [95% confidence intervals (CI) 0.78 to 0.96]; I 2 = 26.6%, [prediction interval (PI) 0.70, 1.07], median effect size (MES) = 0.93 [interquartile range (IQR) 0.81, 1.00]. Data from 15 CSRs and 408 RCTs with 32,984 participants showed a small improvement in quality of life (QOL) standardised mean difference (SMD) 0.18 [95% CI 0.08, 0.28]; I 2 = 74.3%; PI -0.18, 0.53], MES = 0.20 [IQR 0.07, 0.39]. Subgroup analyses by the type of condition showed that the magnitude of effect size was the largest among patients with mental health conditions. Conclusion There is a plethora of CSRs evaluating the effectiveness of physical activity/exercise. The evidence suggests that physical activity/exercise reduces mortality rates and improves QOL with minimal or no safety concerns. Trial registration Registered in PROSPERO ( CRD42019120295 ) on 10th January 2019.

Introduction An increasing growth of systematic reviews (SRs) presents notable challenges for decision-makers seeking to answer clinical questions. In 1997, an algorithm was created by Jadad to assess discordance in results across SRs on the same question. Our study aims to (1) replicate assessments done in a sample of studies using the Jadad algorithm to determine if the same SR would have been chosen, (2) evaluate the Jadad algorithm in terms of utility, efficiency and comprehensiveness, and (3) describe how authors address discordance in results across multiple SRs.Methods and analysis We will use a database of 1218 overviews (2000–2020) created from a bibliometric study as the basis of our search for studies assessing discordance (called discordant reviews). This bibliometric study searched MEDLINE (Ovid), Epistemonikos and Cochrane Database of Systematic Reviews for overviews. We will include any study using Jadad (1997) or another method to assess discordance. The first 30 studies screened at the full-text stage by two independent reviewers will be included. We will replicate the authors’ Jadad assessments. We will compare our outcomes qualitatively and evaluate the differences between our Jadad assessment of discordance and the authors’ assessment.Ethics and dissemination No ethics approval was required as no human subjects were involved. In addition to publishing in an open-access journal, we will disseminate evidence summaries through formal and informal conferences, academic websites, and across social media platforms. This is the first study to comprehensively evaluate and replicate Jadad algorithm assessments of discordance across multiple SRs.

Abstract Background Data extraction forms link systematic reviews with primary research and provide the foundation for appraising, analysing, summarising and interpreting a body of evidence. This makes their development, pilot testing and use a crucial part of the systematic reviews process. Several studies have shown that data extraction errors are frequent in systematic reviews, especially regarding outcome data. Methods We reviewed guidance on the development and pilot testing of data extraction forms and the data extraction process. We reviewed four types of sources: 1) methodological handbooks of systematic review organisations (SRO); 2) textbooks on conducting systematic reviews; 3) method documents from health technology assessment (HTA) agencies and 4) journal articles. HTA documents were retrieved in February 2019 and database searches conducted in December 2019. One author extracted the recommendations and a second author checked them for accuracy. Results are presented descriptively. Results Our analysis includes recommendations from 25 documents: 4 SRO handbooks, 11 textbooks, 5 HTA method documents and 5 journal articles. Across these sources the most common recommendations on form development are to use customized or adapted standardised extraction forms (14/25); provide detailed instructions on their use (10/25); ensure clear and consistent coding and response options (9/25); plan in advance which data are needed (9/25); obtain additional data if required (8/25); and link multiple reports of the same study (8/25). The most frequent recommendations on piloting extractions forms are that forms should be piloted on a sample of studies (18/25); and that data extractors should be trained in the use of the forms (7/25). The most frequent recommendations on data extraction are that extraction should be conducted by at least two people (17/25); that independent parallel extraction should be used (11/25); and that procedures to resolve disagreements between data extractors should be in place (14/25). Conclusions Overall, our results suggest a lack of comprehensiveness of recommendations. This may be particularly problematic for less experienced reviewers. Limitations of our method are the scoping nature of the review and that we did not analyse internal documents of health technology agencies.

Abstract Background Osteosynthesis is the internal fixation of fractures or osteotomy by mechanical devices (also called hardware). After bone healing, there are two options: one is to remove the hardware, the other is to leave it in place. The removal of the hardware in patients without medical indication (elective) is controversially discussed. We performed a scoping review to identify evidence on the elective removal of hardware in asymptomatic patients compared to retaining of the hardware to check feasibility of performing a health technology assessment. In addition, we wanted to find out which type of evidence is available. Methods A systematic literature search was performed in PubMed, Embase, EconLit, and CINAHL (November 2019). We included studies comparing asymptomatic patients with an internal fixation in the lower or upper extremities whose internal fixation was electively (without medical indication) removed or retained. We did not restrict inclusion to any effectiveness/safety outcome and considered any comparative study design as eligible. Study selection and data extraction was performed by two reviewers. Results We identified 13476 titles/abstracts. Of these, we obtained 115 full-text publications which were assessed in detail against the inclusion criteria. We included 13 studies (1 RCT, 4 cohort studies, 8 before-after studies) and identified two ongoing RCTs. Nine assessed the removal of the internal fixation in the lower extremities (six of these syndesmotic screws in ankle fractures only) and two in the upper extremities. One study analysed the effectiveness of hardware removal in children in all types of extremity fractures. Outcomes reported included various scales measuring functionality, pain and clinical assessments (e.g. range of motion) and health-related quality of life. Conclusions We identified 13 studies that evaluated the effectiveness/safety of hardware removal in the extremities. The follow up times were short, the patient groups small and the ways of measurement differed. In general, clinical heterogeneity was high. Evidence on selected topics, e.g. syndesmotic screw removal is available nevertheless not sufficient to allow a meaningful assessment of effectiveness.

Abstract Background Gastroschisis is a congenital anomaly that needs surgical management for repositioning intestines into the abdominal cavity and for abdominal closure. Higher hospital or surgeon volume has previously been found to be associated with better clinical outcomes for different especially high-risk, low volume procedures. Therefore, we aim to examine the relationship between hospital or surgeon volume and outcomes for gastroschisis. Methods We will perform a systematic literature search from inception onwards in Medline, Embase, CENTRAL, CINAHL, and Biosis Previews without applying any limitations. In addition, we will search trial registries and relevant conference proceedings. We will include (cluster-) randomized controlled trials (RCTs) and prospective or retrospective cohort studies analyzing the relationship between hospital or surgeon volume and clinical outcomes. The primary outcomes will be survival and mortality. Secondary outcomes will be different measures of morbidity (e.g., severe gastrointestinal complications, gastrointestinal dysfunctions, and sepsis), quality of life, and length of stay. We will systematically assess risk of bias of included studies using RoB 2 for individually or cluster-randomized trials and ROBINS-I for cohort studies, and extract data on the study design, patient characteristics, case-mix adjustments, statistical methods, hospital and surgeon volume, and outcomes into standardized tables. Title and abstract screening, full text screening, critical appraisal, and data extraction of results will be conducted by two reviewers independently. Other data will be extracted by one reviewer and checked for accuracy by a second one. Any disagreements will be resolved by discussion. We will not pool results statistically as we expect included studies to be clinically and methodologically very diverse. We will conduct a systematic synthesis without meta-analysis and use GRADE for assessing the certainty of the evidence. Discussion Given the lack of a comprehensive summary of findings on the relationship between hospital or surgeon volume and outcomes for gastroschisis, this systematic review will put things right. Results can be used to inform decision makers or clinicians and to adapt medical care. Systematic review registration Open Science Framework (DOI: https://doi.org/10.17605/OSF.IO/EX34M ; https://doi.org/10.17605/OSF.IO/HGPZ2 )

Abstract Background The rate of caesarean sections (CS) has increased in the last decades to about 30% of births in high income countries. Many CSs are electively planned without an urgent medical reason for mother or child. An early CS though may harm the newborn. Our aim was to evaluate the gestational time point after the 37 + 0 week of gestation (WG) (after prematurity = term) of performing an elective CS with the lowest morbidity for mother and child by assessing the time course from 37 + 0 to 42+ 6 WG. Methods We performed a systematic literature search in MEDLINE, EMBASE, CENTRAL and CINAHL in November 2018. We included studies that compared different time points of elective CS at term no matter the reason for elective CS. Our primary outcomes were the rate of admissions to the neonatal intensive care unit (NICU), neonatal death and maternal death in early versus late term elective CS. Various binary and dose response random effects meta-analyses were performed. Results We identified 35 studies including 982,749 women. Except one randomised controlled trial, all studies were cohort studies. We performed a linear time-response meta-analysis on the primary outcome NICU admission on 14 studies resulting in a decrease of the relative risk (RR) to 0.63 (95% CI 0.56, 0.71) from 37 + 0 to 39 + 6 WG. RR for neonatal death showed a decrease to 39 + (0–6) WG (RR 0.59 95% CI 0.43 to 0.83) and increase from then on (RR 2.09 95% CI 1.18 to 3.70) assuming a U-shape course and using a cubic spline model for meta-analysis of four studies. We only identified one study analyzing maternal death resulting in RR of 0.38 (95% CI 0.04 to 3.40) for 37 + 0 + 38 + 6 WG versus ≥39 + 0 WG. Conclusion Our systematic review showed that elective CS (primary and repeated) before the 39 + 0 WG lead to more NICU admissions and neonatal deaths, although death is rare and increases again after 39 + 6 WG. We did not find enough evidence on maternal outcomes. There is a need for more research, considering maternal outcomes to provide a balanced decision between neonatal and maternal health. Systematic review registration Registered in PROSPERO (CRD42017078231).

Abstract Background When conducting an Overviews of Reviews on health-related topics, it is unclear which combination of bibliographic databases authors should use for searching for SRs. Our goal was to determine which databases included the most systematic reviews and identify an optimal database combination for searching systematic reviews. Methods A set of 86 Overviews of Reviews with 1219 included systematic reviews was extracted from a previous study. Inclusion of the systematic reviews was assessed in MEDLINE, CINAHL, Embase, Epistemonikos, PsycINFO, and TRIP. The mean inclusion rate (% of included systematic reviews) and corresponding 95% confidence interval were calculated for each database individually, as well as for combinations of MEDLINE with each other database and reference checking. Results Inclusion of systematic reviews was higher in MEDLINE than in any other single database (mean inclusion rate 89.7%; 95% confidence interval [89.0–90.3%]). Combined with reference checking, this value increased to 93.7% [93.2–94.2%]. The best combination of two databases plus reference checking consisted of MEDLINE and Epistemonikos (99.2% [99.0–99.3%]). Stratification by Health Technology Assessment reports (97.7% [96.5–98.9%]) vs. Cochrane Overviews (100.0%) vs. non-Cochrane Overviews (99.3% [99.1–99.4%]) showed that inclusion was only slightly lower for Health Technology Assessment reports. However, MEDLINE, Epistemonikos, and reference checking remained the best combination. Among the 10/1219 systematic reviews not identified by this combination, five were published as websites rather than journals, two were included in CINAHL and Embase, and one was included in the database ERIC. Conclusions MEDLINE and Epistemonikos, complemented by reference checking of included studies, is the best database combination to identify systematic reviews on health-related topics.

Abstract Background As of 2015, second opinions are legally implemented in Germany. However, empirical results from German second opinion programs are lacking. The aim of this study was to examine several aspects within a population of a German second opinion program. Methods Study population consisted of patients who sought a second opinion in the period from August 2011 to December 2016. Multivariate logistic regression and ANOVA were used to examine differences in patient characteristics, differentiated by agreement of initial therapy recommendation and second opinion. Follow-up points for patient satisfaction and HRQoL were defined at 1, 3 and 6 months after obtaining the second opinion. Results Total number of patients who sought a second opinion was 1414. Most common indications concerned the knee (37.3%), spine (27.3%), hip (11.5%) and shoulder (10.1%). The independent specialists did not confirm the initial therapy recommendations in two out of three cases. The type of indication influenced the agreement between initial therapy recommendation and the second opinion significantly (p = 0.035). The second opinion and the offered service was highly valued by the patients (89%). Conclusions The second opinion offers patients the possibility to confirm a medical indication independently and support patients in their decision making process. Reasons for the large discrepancy between initial therapy recommendation and second opinion should be addressed in future research.

Abstract Background Knee osteoarthritis is a common, chronic condition and main contributor to global disability. Total knee arthroplasty (TKA) is the most successful treatment for end-stage knee osteoarthritis. It is assumed that in the field of surgery, there is a relationship between hospital volume and health outcomes and that higher hospital volume results in better health outcomes. As a consequence, minimum volume thresholds have been implemented in Germany for various procedures, including TKA (50 procedures per year). To date, it is unclear whether minimum volume thresholds truly result in better outcomes. The objective of this study will be to quantify the relationship between hospital volume and patient-relevant outcomes in patients undergoing TKA. Methods We will include published or unpublished (cluster-) randomized controlled trials and prospective or retrospective cohort studies that involve patients with primary and/or revision TKA, report at least two different hospital volumes and report at least one patient-relevant outcome. To identify studies, we will systematically search (from inception onwards) PubMed/MEDLINE, Embase, CENTRAL, and CINAHL, as well as trial registers, conference proceedings, and reference lists. We will also contact experts in the field. Study selection and data extraction will be performed by two reviewers independently. The primary outcome will be rate of early revision. Secondary outcomes will include rate of revision > 1 year, mortality, length of stay, readmission rate, surgical complications, adverse events and health-related quality of life. We will assess the risk of bias of the included studies using ROBINS-I or the Cochrane risk of bias tool. Both a linear and a non-linear dose-response meta-analyses will be performed. We will use the GRADE approach to evaluate our confidence in the cumulative evidence. We will incorporate patients’ needs, goals and preferences into our recommendations by consulting three focus groups, each consisting of eight participants. Discussion The findings of our systematic review will probably be limited by the design of the included studies. We do not expect to identify any (cluster-) randomized controlled trials that meet our inclusion criteria. Therefore, the best available evidence included in our systematic review will most likely consist of cohort studies only. We anticipate that the results of this study will inform future health policy decisions in Germany regarding the minimum volume threshold for TKA. Systematic review registration: PROSPERO CRD42019131209