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Contacting study authors about additional data using email main text versus standardised data request forms – a randomised study within a review (#49)
K. Gooßen1, T. Rombey1, C. M. Kugler1, K. K. De Santis1, D. Pieper1
1 Universität Witten/Herdecke, Institut für Forschung in der Operativen Medizin, Köln, Nordrhein-Westfalen, Deutschland
Systematic evidence syntheses depend on the quality of reporting and completeness of data in included studies. Cochrane guidance recommends that reviewers contact investigators to obtain missing information. The aim of this randomised study within a review (SWAR) was to compare the use of email main text or attachments as strategies for requesting information from study authors.
This SWAR  was embedded within a systematic review (SR) of studies with administrative/registry data investigating hospital volume-outcome relationships in total knee arthroplasty . We randomised all 58 unique corresponding study authors included in the SR to receive personalised email requests for additional information as either email text (‘Email’ group) or attachment with self-developed, standardised data request forms (‘Attachment’ group). The primary outcome was the response rate, the secondary outcomes were the data completeness rate and the reviewer time invested in author contact. Response and data completeness rates were compared using the odds ratio (OR) and 95% confidence interval (CI). Reviewer time was compared using the mean difference and 95% CI.
Of 58 study authors, N=29 were randomised to the Email group and N=29 to the Attachment group. One author in the Attachment group was later excluded from the study because the study was reclassified as ineligible for the SR. Basic characteristics of authors and studies were similar in both groups, but studies in the Email group tended to be more recently published. The response rate was 93% (n/N=27/29) in the Email and 75% (21/28) in the Attachment group (OR=4.5, 95% CI [0.9–24.0]). The completeness rate was 55% (16/29) in the Email and 36% (10/28) in the Attachment group (OR=2.2 [0.8–6.4]). The mean reviewer time (in minutes/author) was shorter in the Email (mean ± standard deviation 20.2±14.4) than in the Attachment group (31.8±14.4), mean difference 11.6 [4.1–19.1].
Personalised email requests elicited high response but only moderate data completeness rates regardless of the method, though both rates tended to be higher in the Email than in the Attachment group. Email requests as text took less reviewer time than creating attachments. Therefore, rather than attachments, we recommend personalised email texts for requesting additional data from study authors. The effectiveness of email text versus data collection forms needs to be validated for authors of studies with other designs, such as randomised controlled trials.
 Goossen K, Rombey T, Pieper D. Contacting authors about additional study data – a randomised study comparing two strategies (SWAR12). https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/SWARFileStore/Filetoupload,949593,en.pdf. Registered January 15, 2020.
The authors declare that they have no conflict of interests.
Stichwörter: Autorenkontakt, Methodik, Reporting, Study Within A Review, Systematische Übersichtsarbeiten
Fast and frugal decision tree for the critical appraisal of systematic reviews in situations with limited time periods (#54)
R. Lorenz1, M. Jenny2, 3, A. Jacobs1, K. Matthias1
1 Gemeinsamer Bundesausschuss, Fachberatung Medizin, Berlin, Berlin, Deutschland
Policy makers in the health care system often have to make decisions on the one hand based on broad and high-quality evidence and on the other hand within limited time periods. Ideally, systematic reviews (SR) summarize the best available evidence and serve as a basis for an informed decision. However, SR are of varying quality. A critical appraisal of SR is necessary to identify high-quality SR, but it is also time consuming in situations with many SR for a specific research question. AMSTAR 2 (Shea et al., 2017) is a valid and moderately reliable critical appraisal instrument and has 16 items, which lead to an overall rating of methodological quality (high, moderate, low or critically low methodological quality). Decision trees offer the possibility to make decisions based on a very limited amount of information. In the present study, we aim to create a fast-and-frugal decision tree to evaluate the methodological quality of a SR with a limited set of items of the AMSTAR 2.
In previous projects, we appraised 118 SR using AMSTAR 2. The research questions were related to interventions in psychiatric disorders. The responses to the 16 items served as cues to predict a binary decision (high or low methodological quality). The decision trees were developed based on the criterion of the overall rating (SR with high and moderate quality ratings were assigned to high quality and low and critically low quality to low quality). We used the fast-and-frugal trees toolbox (Phillips et al., 2017) embedded in the software R.
Based on 118 SR, a fast-and-frugal tree that contained only two out of 16 items was identified. These items are related to a published review protocol (item 2) and a list of excluded studies (item 7). When applying this tree, 14 high quality reviews were correctly identified (hit) and none were missed, whereas 94 low quality reviews were correctly identified (correct rejection) and 10 were falsely identified as high quality reviews (false alarms). This is equivalent to a sensitivity of 100% and a specificity of 93%.
The fast-and-frugal decision tree distinguished between high and low quality SR while applying only two items. Therefore, it could save valuable time in situations with a broad evidence base (many SRs) and when decisions have to be made under time pressure. In the next step, this decision tree has to be validated in a larger set. At the conference, we also plan to present the validation results.
Phillips, N. D., Neth, H., Woike, J. K., & Gaissmaier, W. (2017). FFTrees: A toolbox to create, visualize, and evaluate fast-and-frugal decision trees. Judgment and Decision Making, 12(4), 344-368.Shea, B. J., Reeves, B. C., Wells, G., Thuku, M., Hamel, C., Moran, J., ... & Henry, D. A. (2017). AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. bmj, 358, j4008.
Stichwörter: Systematische Reviews, Kritische Bewertung, Entscheidungsbaum, Overview of Reviews
Inconsistent views among systematic review authors toward publishing protocols as peer-reviewed articles: an international survey (#30)
T. Rombey1, L. Puljak2, K. Allers3, J. A. Ruano Ruiz4, D. Pieper1
1 Universität Witten/Herdecke, Institut für Forschung in der Operativen Medizin (IFOM), Köln, Deutschland
For systematic reviews (SRs) to be truly systematic it is essential to define their methods a priori, e.g. by registering them in PROSPERO, the international prospective register for SRs. However, PROSPERO records are not indexed in bibliographic databases nor peer-reviewed. Peer-review serves as a quality assurance measure, hence it is useful to additionally publish a protocol for the SR as a peer-reviewed article. For Cochrane reviews, publishing a protocol is mandatory, but for most non-Cochrane SRs it is optional. Our aim was to explore views of authors of non-Cochrane SRs registered in PROSPERO towards publishing SR protocols as peer-reviewed articles1.
Contact persons of all PROSPERO records for non-Cochrane SRs registered in 2018 (N=12,531) were invited to participate in an anonymous 5-minute online survey that was administered through SurveyMonkey. The main question addressed SR authors’ views towards publishing SR protocols as peer-reviewed articles. Data were analyzed descriptively.
In total, 4,223/12,531 (33.7%) invitees responded, of which 3,739/4,223 (88.5%) completed the survey. Almost half of the respondents had published or planned to publish a protocol for the SR described in their PROSPERO record as a peer-reviewed article (1,811/4,054; 44.7%). The remaining 2,243/4,054 (55.3%) respondents stated that there was no published protocol for their SR and they have not tried or plan to publish one. Of those, 66.4% (1,456/2,192) stated that there was an unpublished protocol that they followed during the conduct of their SR. The respondents had inconsistent views towards publishing protocols as peer-reviewed articles; most agreed that external feedback from peer-reviewers increases SR quality (2,899/3,739; 77.5%) but at the same time agreed that publishing a protocol in a peer-reviewed journal is not necessary if the SR is registered in PROSPERO (2,399/3,739; 64.2%). Respondents’ views towards acceptable manuscript processing times for SR protocols were consistent but far below actual manuscript processing times for SR protocols2.
Although PROSPERO records are not peer-reviewed, many SR authors seem to consider registration in PROSPERO sufficient. Hence, awareness about the benefits of additionally publishing a SR protocol as a peer-reviewed article should be raised. Furthermore, publishers should transform the way manuscripts for protocols are being processed, so that manuscript processing times for SR protocols become acceptable for SR authors.
1. Rombey T, Puljak L, Allers K, Ruano J, Pieper D. Inconsistent views among systematic review authors toward publishing protocols as peer-reviewed articles: an international survey. J Clin Epidemiol. 2020 Jul;123:9-17. doi: 10.1016/j.jclinepi.2020.03.010.
D.P. became a protocol editor of BMC Systematic Reviews in August 2019. All remaining authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this study.
Introduction and insights from the first application of a GRADE adaption for evidence synthesis on harms (in subgroups) (#58)
T. Mathes1, N. Mann2, A. Sönnichsen3, P. Thürmann2, D. Pieper1
1 Universität Witten/Herdecke, Abteilung für Evidenzbasierte Versorgungsforschung, Cologne, Deutschland
As part of the update of the German/Austrian list on potentially inadequate medications for elderly patients (PRISCUS) we performed systematic reviews (SRs) on adverse events in the elderly for various medications. Evidence on harms frequently originates from non-randomized studies (NRS) and is often highly statistically imprecise. In addition, harms are often subgroup specific (eg. elderly population) and thus information from subgroup analysis must be considered. When rating the certainty of evidence (CoE) aplying the GRADE standard methodological challenges occur. First, CoE might tend to be systematically lower for harms compared to benefits. Second, differences in CoE can be diluted because of floor effects, particularly “very low” CoE ratings.We introduce a GRADE adaption for situations, where only harms are assessed with the aim to tackle the abovementioned challenges.
We systematically assessed each of the GRADE criteria for common problems arising when assessing harms. Criteria were adapted if the adaption could be supported by epidemiological reasoning. We piloted the adaptions using a convenience sample of 3 SRs and subsequently proofed our concept by applying the approach to 15 SRs.
The main adaptions were (reasoning):
In addition, we rated up the CoE if the p-value of a test for interaction from a well-designed subgroup analysis was <0.05.
Our study suggests that there is potential for developing adaptions of the GRADE criteria, which can overcome the challenges of assessing harms. Further research is necessary to develop consensus recommendations for rating the CoE on harms.
BMBF Förderkennzeichen 01KX1812
Stichwörter: potentially inadequate medications, GRADE
What is the ‘early’ in early palliative care in clinical oncology? Results of a systematic review. (#32)
S. Nadolny1, 2, E. S. Gaßmann1, H. M. Buiting3, J. Schildmann1
1 Martin Luther University Halle-Wittenberg, Institute for History and Ethics of Medicine, Interdisciplinary Center for Health Sciences, Halle (Saale), Sachsen-Anhalt, Deutschland
Initiating palliative care, early in the disease process is nowadays highly advocated in oncology. However, there is considerable controversy about the timing and nature of these palliative care interventions . In addition, palliative care has been widely established as standard care in oncology. We want to analyze the variables of the interventions on so called ‘early palliative care’ interventions for adult patients in clinical oncology care to illicit congruent as well as conflicting elements embedded in scientific studies that aim to evaluate the effectiveness of palliative care.
We conducted a systematic review searching Medline, Cinahl and Central up to May 2020. We included studies on early palliative care for adult patients in the clinical oncology setting which labelled themselves as ‘early palliative care’. Included study designs were (non) randomized-controlled trials (RCTs), cohort studies, controlled before-after studies and interrupted time series. We analyzed the interventions according to the domains of the Template of Intervention Description and Replication (TIDieR). We did not perform a standardized risk of bias assessment. Prospero ID: 2344324.
We identified 3315 articles. After removing duplicates, we screened 2222 articles and included 20 RCTs and one cohort study in the analysis. Most studies covered the USA (n=10) and focused on multiple forms of cancer (n=15) rather than one specific type (n=6). There is considerable heterogeneity in the different domains of TIDIER with the timing spanning from the onset of therapy to the onset of end-of-life care. The content of the interventions covers communication, symptom management, psychosocial care, prevention approaches, advance care planning and case management elements. Further details of the ongoing analysis are going to be presented at the conference.
Given the differing needs of patients with cancer and the specific skills needed for the different services offered under the label of ‘early palliative care’, it seems important to clarify the goal and nature of early palliative care. It is important to clearly distinguish between services provided by specialist palliative care professionals compared to basic palliative care skills which can be provided in standard oncology .
 Schildmann J, Nadolny S, Buiting HM. What Do We Mean By "Palliative" or "Oncologic Care"? Conceptual Clarity Is Needed for Sound Research and Good Care. J Clin Oncol. 2020;38:2814–5. doi:10.1200/JCO.20.00658.
The authors declare that they have no known conflicts of interest
Stichwörter: Palliative Care, Early Palliative Care, Oncology, Systematic Review