Publications by authors named "Tim Mathes"

81 Publications

Factors predicting failure of internal fixations of fractures of the lower limbs: a prospective cohort study.

BMC Musculoskelet Disord 2021 Sep 16;22(1):798. Epub 2021 Sep 16.

Institute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, Building 38, NRW, 51109, Cologne, Germany.

Background: We assessed predictive factors of patients with fractures of the lower extremities caused by trauma. We examined which factors are associated with an increased risk of failure. Furthermore, the predictive factors were set into context with other long-term outcomes, concrete pain and physical functioning.

Methods: We performed a prospective cohort study at a single level I trauma center. We enrolled patients with traumatic fractures of the lower extremities treated with internal fixation from April 2017 to July 2018. We evaluated the following predictive factors: age, gender, diabetes, smoking status, obesity, open fractures and peripheral arterial diseases. The primary outcome was time to failure (nonunion, implant failure or reposition). Secondary outcomes were pain and physical functioning measured 6 months after initial surgery. For the analysis of the primary outcome, we used a stratified (according fracture location) Cox proportional hazard regression model.

Results: We included 204 patients. Overall, we observed failure in 33 patients (16.2 %). Most of the failures occurred within the first 3 months. Obesity and open fractures were associated with an increased risk of failure and decreased physical functioning. None of the predictors showed an association with pain. Age, female gender and smoking of more than ≥ 10 package years increased failure risk numerically but statistical uncertainty was high.

Conclusions: We found that obesity and open fractures were strongly associated with an increased risk of failure. These predictors seem promising candidates to be included in a risk prediction model and can be considered as a good start for clinical decision making across different types of fractures at the lower limbs. However, large heterogeneity regarding the other analyzed predictors suggests that "simple" models might not be adequate for a precise personalized risk estimation and that computer-based models incorporating a variety of detailed information (e.g. pattern of injury, x-ray and clinical data) and their interrelation may be required to significantly increase prediction precision.

Trial Registration: NCT03091114 .
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http://dx.doi.org/10.1186/s12891-021-04688-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8447738PMC
September 2021

False positive rapid antigen tests for SARS-CoV-2 in the real-world and their economic burden.

J Infect 2021 Aug 17. Epub 2021 Aug 17.

Institut für Pathologie, Kliniken der Stadt Köln, Klinikum der Privaten Universität Witten/Herdecke.

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http://dx.doi.org/10.1016/j.jinf.2021.08.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8372488PMC
August 2021

Living conditions and autonomy levels in COPD patients receiving non-invasive ventilation: impact on health related quality of life.

BMC Pulm Med 2021 Aug 3;21(1):255. Epub 2021 Aug 3.

Department of Pneumology, Cologne Merheim Hospital, Kliniken der Stadt Köln gGmbH, Witten/Herdecke University, Faculty of Health/School of Medicine , Ostmerheimer Strasse 200, 51109, Cologne, Germany.

Background: Research on health-related quality of life (HRQL) has become increasingly important in recent decades. However, the impact of both living conditions and the level of autonomy impairments on HRQL in COPD patients receiving non-invasive ventilation (NIV) is still unclear.

Methods: The Severe Respiratory Insufficiency Questionnaire (SRI) was used to measure HRQL in a prospective cohort of COPD patients in whom home NIV was already established. Data on sociodemographics, clinical characteristics and standardized levels of autonomy impairment were evaluated. A multiple linear regression analysis was performed to identify the factors associated with a reduced HRQL.

Results: A total of 137 patients (67.0 ± 7.8 years, 45% female) were assessed. The mean SRI Summary Score was 54.1 ± 16.9 (95%CI: 51.1-57.1; N = 127). Regular ambulatory care was provided in 76% of patients, but only 37% underwent pulmonary rehabilitation. Overall, 69% of patients lived with family members, while 31% lived alone (family situation). Autonomy impairment levels were most serious in 3%, serious in 14%, and significant in 29% of patients, while 54% had no impairments at all. Of note, higher levels of autonomy impairment were markedly associated with lower SRI scores (regression coefficient - 6.5 ± 1.1 per level; P < 0.001). In contrast, family situation (0.2 ± 3.0; P = 0.959), ambulatory care by a respiratory specialist (1.7 ± 3.6; P = 0.638), and pulmonary rehabilitation (- 0.8 ± 3.1; P = 0.802) did not appear to influence HRQL. Possible subgroup effects were evident for the factors "impaired autonomy" and "living in a nursing home" (P = 0.016).

Conclusion: A higher level of autonomy impairment has been identified as the major determinant of reduced HRQL in COPD-patients receiving long-term NIV, particularly in those living in a nursing home. Trial Registration German Clinical Trials Register (DRKS00008759).
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http://dx.doi.org/10.1186/s12890-021-01621-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8330117PMC
August 2021

Perspective of potential patients on the hospital volume-outcome relationship and the minimum volume threshold for total knee arthroplasty: a qualitative focus group and interview study.

BMC Health Serv Res 2021 Jul 2;21(1):633. Epub 2021 Jul 2.

Institute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109, Cologne, Germany.

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.
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http://dx.doi.org/10.1186/s12913-021-06641-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8249216PMC
July 2021

[Invasive and Non-Invasive Home Mechanical Ventilation in Germany - A Rapid Development with Large Regional Differences].

Pneumologie 2021 Jun 25. Epub 2021 Jun 25.

Lungenklinik Merheim, Kliniken der Stadt Köln gGmbH, Witten/Herdecke University, Cologne, Germany.

Background:  The number of patients using home mechanical ventilation (HMV) is steadily increasing in Germany. Detailed data on inpatient initiation and control of HMV are not available. This, however, is absolutely necessary in order to optimize the medical care structures in Germany. Regional diversities must be taken into consideration in order to provide care structures that reflect the local needs.

Method:  The data sets of the German Federal Statistical Office on the OPS (Operation and Procedure Classification System) for HMV from 2008 to 2019 were analysed (N = 572,494).

Results:  Between 2008 and 2019 there was a doubling of the number of HMV initiations and controls. The number of initiations (N = 17,958) and controls (N = 49,140) was highest in 2019. Furthermore, at the state level, the development of HMV is very heterogeneous. Finally, the increases were particularly due to an increase in non-invasively ventilated patients.

Conclusion:  The rapid increase in HMV is reaching capacity limits of the existing healthcare structure. New healthcare structures should provide an integrated approach between outpatient and inpatient care in order to ensure a high quality of care for patients receiving HMV without compromising the human and economic resources of the system.
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http://dx.doi.org/10.1055/a-1509-7014DOI Listing
June 2021

Nearly 80 systematic reviews were published each day: Observational study on trends in epidemiology and reporting over the years 2000-2019.

J Clin Epidemiol 2021 Jun 4;138:1-11. Epub 2021 Jun 4.

Institute for Research in Operative Medicine, Faculty of Health, School of Medicine, Witten/Herdecke University, Cologne, Germany.

Background: Systematic reviews (SRs) are useful tools in synthesising the available evidence, but high numbers of overlapping SRs are also discussed in the context of research waste. Although it is often claimed that the number of SRs being published is increasing steadily, there are no precise data on that. We aimed to assess trends in the epidemiology and reporting of published SRs over the last 20 years.

Methods: A retrospective observational study was conducted to identify potentially eligible SRs indexed in PubMed from 2000 to 2019. From all 572,871 records retrieved, we drew a simple random sample of 4,000. The PRISMA-P definition of SRs was applied to full texts and only SRs published in English were included. Characteristics were extracted by one reviewer, with a 20% sample verified by a second person.

Results: A total of 1,132 SRs published in 710 different journals were included. The estimated number of SRs indexed in 2000 was 1,432 (95% CI: 547-2,317), 5,013 (95% CI: 3,375-6,650) in 2010 and 29,073 (95% CI: 25,445-32,702) in 2019. Transparent reporting of key items increased over the years. About 7 out of 10 named their article a SR (2000-2004: 41.9% and 2015-2019: 74.4%). In 2000-2004, 32.3% of SRs were based in the UK (0% in China), in 2015-2019 24.0% were from China and 10.8% from the UK. Nearly all articles from China (94.9%) conducted a meta-analysis (overall: 58.9%). Cochrane reviews (n = 84; 7.4%) less often imposed language restrictions, but often did not report the number of records and full texts screened and did not name their article a SR (22.6% vs. 73.4%).

Conclusions: We observed a more than 20-fold increase in the number of SRs indexed over the last 20 years. In 2019, this is equivalent to 80 SRs per day. Over time, SRs got more diverse in respect to journals, type of review, and country of corresponding authors. The high proportion of meta-analyses from China needs further investigation.

Study Registration: Open Science Framework (https://osf.io/pxjrv/).
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http://dx.doi.org/10.1016/j.jclinepi.2021.05.022DOI Listing
June 2021

Mesh fixation techniques in primary ventral or incisional hernia repair.

Cochrane Database Syst Rev 2021 May 28;5:CD011563. Epub 2021 May 28.

Department of General, Visceral and Cancer Surgery, HELIOS Klinikum Berlin-Buch, Berlin-Buch, Germany.

Background: The use of a mesh in primary ventral or incisional hernia repair lowers the recurrence rate  and is the accepted standard of care for larger defects. In laparoscopic primary ventral or incisional hernia repair the insertion of a mesh is indispensable. Different mesh fixation techniques have been used and refined over the years. The type of fixation technique is claimed to have a major impact on recurrence rates, chronic pain, health-related quality of life (HRQOL) and complication rates.

Objectives: To determine the impact of different mesh fixation techniques for primary and incisional ventral hernia repair on hernia recurrence, chronic pain, HRQOL and complications.

Search Methods: On 2 October 2020 we searched CENTRAL, MEDLINE (Ovid MEDLINE(R)) Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R)), Ovid Embase, and two trials registries. We also performed handsearches, and contacted experts from the European Hernia Society (EHS).

Selection Criteria: We included randomised controlled trials (RCTs) including adults with primary ventral or incisional hernia that compared different types of mesh fixation techniques (absorbable/nonabsorbable sutures, absorbable/nonabsorbable tacks, fibrin glue, and combinations of these techniques).

Data Collection And Analysis: We extracted data in standardised piloted tables, or if necessary, directly into Review Manager 5. We assessed risks of bias with the Cochrane 'Risk of bias' tool. Two review authors independently selected the publications, and extracted data on results. We calculated risk ratios (RRs) for binary outcomes and mean differences (MDs) for continuous outcomes. For pooling we used an inverse-variance random-effects meta-analysis or the Peto method in the case of rare events. We prepared GRADE 'Summary of findings' tables. For laparoscopic repair we considered absorbable tacks compared to nonabsorbable tacks, and nonabsorbable tacks compared to nonabsorbable sutures as key comparisons.

Main Results: We included 10 trials with a total of 787 participants. The number of randomised participants ranged from 40 to 199 per comparison. Eight studies included participants with both primary and incisional ventral hernia. One study included only participants with umbilical hernia, and another only participants with incisional hernia. Hernia size varied between studies. We judged the risk of bias as moderate to high. Absorbable tacks compared to nonabsorbable tacks Recurrence rates in the groups were similar (RR 0.74, 95% confidence interval (CI) 0.17 to 3.22; 2 studies, 101 participants). It is uncertain whether there is a difference between absorbable tacks and nonabsorbable tacks in recurrence because the certainty of evidence was very low. Evidence suggests that the difference between groups in early postoperative, late follow-up, chronic pain and HRQOL is negligible. Nonabsorbable tacks compared to nonabsorbable sutures At six months there was one recurrence in each group (RR 1.00, 95% CI 0.07 to 14.79; 1 study, 36 participants). It is uncertain whether there is a difference between nonabsorbable tacks and nonabsorbable sutures in recurrence because the certainty of evidence was very low. Evidence suggests that the difference between groups in early postoperative, late follow-up and chronic pain is negligible. We found no study that assessed HRQOL. Absorbable tacks compared to absorbable sutures No recurrence was observed at one year (very low certainty of evidence). Early postoperative pain was higher in the tacks group (VAS 0 - 10: MD -2.70, 95% CI -6.67 to 1.27; 1 study, 48 participants). It is uncertain whether there is a difference between absorbable tacks compared to absorbable sutures in early postoperative pain because the certainty of evidence was very low. The MD for late follow-up pain was -0.30 (95% CI -0.74 to 0.14; 1 study, 48 participants). We found no study that assessed HRQOL. Combination of different fixation types (tacks and sutures) or materials (absorbable and nonabsorbable) There were mostly negligible or only small differences between combinations (e.g. tacks plus sutures) compared to a single technique (e.g. sutures only), as well as combinations compared to other combinations (e.g. absorbable sutures combined with nonabsorbable sutures compared to absorbable tacks combined with nonabsorbable tacks) in all outcomes. It is uncertain whether there is an advantage for combining different fixation types or materials for recurrence, chronic pain, HRQOL and complications, because the evidence certainty was very low or low, or we found no study on important outcomes. Nonabsorbable tacks compared to fibrin sealant The two studies showed different directions of effects: one showed higher rates for nonabsorbable tacks, and the other showed higher rates for fibrin sealant. Low-certainty evidence suggests that the difference between groups in early postoperative, late follow-up, chronic pain and HRQOL is negligible. Absorbable tacks compared to fibrin sealant One recurrence in the tacks group and none in the fibrin sealant group were noted after one year (low certainty of evidence). Early postoperative pain might be slightly lower using tacks (VAS 0 - 100; MD -12.40, 95% CI -27.60 to, 2.80;1 study, 50 participants; low-certainty evidence). The pattern of pain and HRQOL course over time (up to 1 year) was similar in the groups (low certainty of evidence).

Authors' Conclusions: Currently none of the techniques can be considered superior to any other, because the certainty of evidence was low or very low for all outcomes.
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http://dx.doi.org/10.1002/14651858.CD011563.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8160478PMC
May 2021

Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study.

Pilot Feasibility Stud 2021 May 13;7(1):107. Epub 2021 May 13.

Institute for Research in Operative Medicine, Faculty of Health-School of Medicine, University of Witten/Herdecke, Ostmerheimer Str. 200, Building 38, 51109, Cologne, Germany.

Background: Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients' anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements.

Methods: The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact.

Discussion: The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients' competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners' acceptance of evidence-based informed consent forms meeting legal requirements could be increased.

Trial Registration: ClinicalTrials.gov, NCT04669483 . Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571 . Registered 15 December 2020.
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http://dx.doi.org/10.1186/s40814-021-00843-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8116642PMC
May 2021

Measuring test-retest reliability (TRR) of AMSTAR provides moderate to perfect agreement - a contribution to the discussion of the importance of TRR in relation to the psychometric properties of assessment tools.

BMC Med Res Methodol 2021 03 11;21(1):51. Epub 2021 Mar 11.

Institute for Research in Operative Medicine, Faculty of Health - School of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, Building 38, 51109, Cologne, Germany.

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.
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http://dx.doi.org/10.1186/s12874-021-01231-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7953720PMC
March 2021

The Severe Respiratory Insufficiency Application (SRI App): a pilot randomised controlled trial.

Thorax 2021 Mar 2. Epub 2021 Mar 2.

Lung Clinic, Kliniken der Stadt Köln gGmbH, Köln, Germany

An application (app) for the Severe Respiratory Insufficiency Questionnaire (SRI) has been designed and developed for mobile devices. In a randomised controlled trial comprising 60 patients with chronic respiratory failure, the app was compared with the classic paper SRI. Thereby, it was shown that the SRI app is a practical tool that is well accepted. Missing values can be completely avoided by using the SRI app. Finally, reliability, convergent and discriminant validities were established. Accordingly, for the individual SRI subscales, Cronbach's alpha ranged between 0.56 and 0.81 (app) and between 0.54 and 0.83 (paper), respectively. The multilingual SRI app is accessible free of charge for non-profit research purposes.
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http://dx.doi.org/10.1136/thoraxjnl-2020-216319DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311098PMC
March 2021

Interrupted time series study found mixed effects of the impact of the Bavarian smoke-free legislation on pregnancy outcomes.

Sci Rep 2021 Feb 18;11(1):4209. Epub 2021 Feb 18.

Institute for Medical Information Processing, Biometry, and Epidemiology - IBE, LMU Munich, Munich, Germany.

In 2007 the German government passed smoke-free legislation, leaving the details of implementation to the individual federal states. In January 2008 Bavaria implemented one of the strictest laws in Germany. We investigated its impact on pregnancy outcomes and applied an interrupted time series (ITS) study design to assess any changes in preterm birth, small for gestational age (primary outcomes), and low birth weight, stillbirth and very preterm birth. We included 1,236,992 singleton births, comprising 83,691 preterm births and 112,143 small for gestational age newborns. For most outcomes we observed unclear effects. For very preterm births, we found an immediate drop of 10.4% (95%CI - 15.8, - 4.6%; p = 0.0006) and a gradual decrease of 0.5% (95%CI - 0.7, - 0.2%, p = 0.0010) after implementation of the legislation. The majority of subgroup and sensitivity analyses confirm these results. Although we found no statistically significant effect of the Bavarian smoke-free legislation on most pregnancy outcomes, a substantial decrease in very preterm births was observed. We cannot rule out that despite our rigorous methods and robustness checks, design-inherent limitations of the ITS study as well as country-specific factors, such as the ambivalent German policy context have influenced our estimation of the effects of the legislation.
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http://dx.doi.org/10.1038/s41598-021-83774-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7892567PMC
February 2021

No inexplicable disagreements between real-world data-based nonrandomized controlled studies and randomized controlled trials were found.

J Clin Epidemiol 2021 05 13;133:1-13. Epub 2021 Jan 13.

Institute for Research in Operative Medicine, Faculty of Health, School of Medicine, Witten/Herdecke University, 51067 Cologne, Germany.

Objectives: We assessed disagreements between nonrandomized controlled studies based on real-world data (NRCS-RWDs) and randomized controlled trials (RCTs).

Study Design And Setting: We systematically searched for studies that compared treatment effect estimates from NRCS-RWDs and RCTs on the same clinical question. We assessed the potential difference between NRCS-RWDs and RCTs related to internal and external validity. We calculated various meta-epidemiological measures to assess agreement. In case of disagreements, we tried to identify the probable causes of disagreements.

Results: We included 12 studies comparing 15 treatment effect estimates of NRCS-RWDs and RCTs. There were many potential causes of disagreement. Ninety-five percent confidence intervals overlapped for 12 of 15 treatment effect estimates. Our analysis on predicted vs. observed overlap showed that there were no more disagreements than expected by chance. We observed only two substantial differences between the 15 treatment effect estimates. In both cases, we identified risk of bias in the NRCS-RWDs as the most probable cause of disagreement.

Conclusion: Our findings suggest that there are clinical questions where the difference in risk of bias between a well-conducted NRCS-RWD and an RCT is negligible. In our analysis, threats to external validity appeared to have no or only a weak impact on the disagreements of treatment effect estimates.
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http://dx.doi.org/10.1016/j.jclinepi.2020.12.019DOI Listing
May 2021

Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS): Results of a Multinational, Randomized, Controlled, and Double-blind Trial.

Ann Surg 2021 01;273(1):57-65

Institut für Forschung in der Operativen Medizin (IFOM), Witten/Herdecke University, Cologne, Germany.

Objective: The aim of this study was to investigate the approach (open or laparoscopic) and mesh type (synthetic or biological) in ventral hernias in a clean setting.Summary of Background Data: The level of evidence on the optimal surgical approach and type of mesh in ventral hernia repair is still low.

Methods: Patients with a ventral abdominal hernia (diameter 4-10 cm) were included in this double-blind randomized controlled trial across 17 hospitals in 10 European countries. According to a 2 × 2-factorial design, patients were allocated to 4 arms (open retromuscular or laparoscopic intraperitoneal, with synthetic or Surgisis Gold biological mesh). Patients and outcome assessors were blinded to mesh type used. Major postoperative complication rate (hernia recurrence, mesh infection, or reoperation) within 3 years after surgery, was the primary endpoint in the intention-to-treat population.

Results: Between September 1st, 2005, and August 7th, 2009, 253 patients were randomized and 13 excluded. Six of 61 patients (9.8%) in the open synthetic mesh arm, 15 of 66 patients (22.7%) in the open biological mesh arm, 7 of 64 patients (10.9%) in the laparoscopic synthetic mesh arm and 17 of 62 patients (27.4%) in the laparoscopic biological mesh arm had a major complication. The use of biological mesh resulted in significantly more complications (P = 0.013), also after adjusting for hernia type, body mass index, and study site. The trial was prematurely stopped due to an unacceptable high recurrence rate in the biological mesh arms.

Conclusions: The use of Surgisis Gold biological mesh is not recommended for noncomplex ventral hernia repair.

Trial Registration: This trial was registered at controlled-trials.com (ISRCTN34532248).
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http://dx.doi.org/10.1097/SLA.0000000000004062DOI Listing
January 2021

Evidence and Trends in Burn Wound Debridement: An Evidence Map.

Plast Surg (Oakv) 2020 Nov 11;28(4):232-242. Epub 2020 Jun 11.

Department of Hand, Plastic and Reconstructive Surgery - Burn Center, BG Trauma Center Ludwigshafen/Rhine, Hand and Plastic Surgery, University Heidelberg, Heidelberg, Germany.

Treatment of the burn wound is crucial in care of severely burned patients. Surgical strategies differ in technique and timing of wound excision and are considered to have an impact on morbidity and mortality of burn patients. Most techniques and strategies have been established during the last century and are still standard of care. Nonetheless, several newer techniques have been presented and evaluated recently. To summarize the evidence and trends for eschar removal by burn wound debridement currently available, an evidence map as variant of the systematic review, was prepared. For this purpose, a systematic literature search was performed in the PubMed databases until December 2016. While overall evidence in this domain is low, recent publications focus on optimal timing of wound excision, enzymatic debridement, and hydrosurgery. Several studies report the benefit of an early wound excision in terms of shorter hospital stay, lower wound infection rate, and reduction of postburn metabolic changes. Enzymatic debridement has been shown to be an effective tool for early eschar removal and in addition reduces the need for autografting of the debrided burn wound with a relatively high level of evidence (LoE 2-). Wound debridement by means of hydrosurgery is more precise compared to conventional wound excision and preserves viable dermis, but a positive effect on wound healing or scar formation could not been shown (LoE 2). Furthermore, rarely reported techniques comprise larvae therapy, debridement by laser, and other technical adjuncts, but the level of evidence is limited (LoE 4-/5).
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http://dx.doi.org/10.1177/2292550320928553DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7644827PMC
November 2020

Elective removal vs. retaining of hardware after osteosynthesis in asymptomatic patients-a scoping review.

Syst Rev 2020 10 2;9(1):225. Epub 2020 Oct 2.

Institute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109, Cologne, Germany.

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.
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http://dx.doi.org/10.1186/s13643-020-01488-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7532570PMC
October 2020

Assessing context suitability (generalizability, external validity, applicability or transferability) of findings in evidence syntheses in healthcare-An integrative review of methodological guidance.

Res Synth Methods 2020 Nov 29;11(6):760-779. Epub 2020 Sep 29.

Institute for Research in Operative Medicine, Faculty of Health-School of Medicine, Witten/Herdecke University, Cologne, Germany.

Background: Evidence syntheses provide the basis for evidence-based decision making in healthcare. To judge the certainty of findings for the specific decision context evidence syntheses should consider context suitability (ie, generalizability, external validity, applicability or transferability). Our objective was to determine the status quo and to provide a comprehensive overview of existing methodological recommendations of Health Technology Assessment (HTA) and Systematic Review (SR) producing organizations in assessing context suitability of evidence on effectiveness of health care interventions. Additionally, we analyzed similarities and differences between the recommendations.

Methods: In this Integrative Review we performed a structured search for methods documents from evidence synthesis producing organizations that include recommendations on appraising context suitability in effectiveness assessments. Two reviewers independently selected documents according to predefined eligibility criteria. Data were extracted in standardized and piloted tables by one reviewer and verified by a second reviewer. We performed a thematic analysis to identify and summarize the main themes and categories regarding recommended context suitability assessments.

Results: We included 14 methods documents of 12 organizations in our synthesis. Assessment approaches are very heterogeneous both regarding the general concepts (eg, integration in the evidence synthesis preparation process) and the content of assessments (eg, assessment criteria).

Conclusion: Some heterogeneity seems to be justified because of the need to tailor the assessment to different settings and medical areas. However, most differences were inexplicable. More harmonization is desirable and appears possible.
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http://dx.doi.org/10.1002/jrsm.1453DOI Listing
November 2020

Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized Trial.

Cancers (Basel) 2020 Sep 8;12(9). Epub 2020 Sep 8.

Private Practice Studienpraxis Urologie, 72622 Nürtingen, Germany.

Residual androgen production causes tumor progression in metastatic, castration-resistant prostate cancer (mCRPC) patients. Abiraterone acetate (AA), a prodrug of abiraterone, is an oral CYP-17 inhibitor that blocks androgen production. It was hypothesized that adherence-enhancing measures (AEM) might be beneficial for mCRPC patients receiving abiraterone acetate plus prednisone (AA + P). This multicenter, prospective, 2-arm trial allocated mCRPC patients who were progressive after docetaxel-based chemotherapy or asymptomatic/mildly symptomatic after failure of an androgen deprivation therapy to Arm A (with AEM) or Arm B (without AEM) by center-based cluster-randomization. The primary objective was to assess the influence of AEM on discontinuation rates and medication adherence in mCRPC patients treated with AA + P. A total of 360 patients were allocated to Arm A, and 315 patients to Arm B. At month 3, the rate of treatment discontinuation, not due to disease progression or the start of new cancer therapy, was low in both arms (A: 9.0% vs. B: 7.3%, OR = 1.230). Few patients had a medium/low Morisky Medication Adherence Scale (MMAS-4) score (A: 6.4% vs. B: 9.1%, OR = 0.685). The results obtained did not suggest any clear adherence difference between Arm A and Arm B. In patients with mCRPC taking AA + P medication, adherence seemed to be generally high.
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http://dx.doi.org/10.3390/cancers12092550DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7564106PMC
September 2020

Relationship between volume and outcome for gastroschisis: a systematic review protocol.

Syst Rev 2020 09 2;9(1):203. Epub 2020 Sep 2.

Institute for Research in Operative Medicine, Faculty of Health, School of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, Building 38, 51109, Cologne, Germany.

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 ).
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http://dx.doi.org/10.1186/s13643-020-01462-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7469094PMC
September 2020

A systematic review and time-response meta-analysis of the optimal timing of elective caesarean sections for best maternal and neonatal health outcomes.

BMC Pregnancy Childbirth 2020 Jul 8;20(1):395. Epub 2020 Jul 8.

Institute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109, Cologne, Germany.

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).
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http://dx.doi.org/10.1186/s12884-020-03036-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7341650PMC
July 2020

[Financial contributions to guideline group members from industry: An analysis based on the US Open Payments database].

Z Evid Fortbild Qual Gesundhwes 2020 Aug 15;153-154:39-43. Epub 2020 Jun 15.

Institut für Forschung in der Operativen Medizin, Universität Witten/Herdecke, Witten, Deutschland.

Introduction: Evidence-based clinical practice guidelines are one of the most important sources to inform clinical decision-making. They contain recommendations to support treatment decisions. These recommendations should be free from bias and should only aim to increase patient benefit. To ensure this, recommendations should be free from bias caused by conflicts of interest. When conflicts of interest exist, they should be completely transparent. The aim of this study was to analyze the payments from pharmaceutical and medical device industry to clinical practice guideline panel members (GPM). In addition, we assessed the completeness and accuracy of the GPMs' conflict of interest statements.

Methods: A manual search for international guidelines was conducted on the website of the National Guideline Clearinghouse. We included all available clinical practice guidelines published in 2017. We extracted the names of all guideline group members and identified the payments they had received from industry over the four years preceding the publication using the "open payments" database.

Results: In total, 81 guidelines were identified. We found data on payments for 543 out of 659 GPMs. For 34% of the GPMs, there was no declaration of individual conflicts of interest in either the guideline or related documents. The sum of payments across all guidelines to all GPMs was 10,844,938 USD. The average payment amounted to 19,972 USD and the median 1,227 USD. Sixty two percent of GPMs received at least 500 USD. Of these, 17% stated that they had no conflict of interest to declare.

Discussion: The amount of industrial payments in some subject areas raises doubt about the independence of guideline recommendations. Stricter rules are needed to avoid and manage conflicts of interest of guideline authors. The analysis carried out indicates that conflict of interest involving GPMs is a considerable problem.

Conclusion: GPMs receive sizeable payments from industry. The payments are often inadequately disclosed or not disclosed at all. This threatens the objectivity of the recommendations in clinical practice guidelines.
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http://dx.doi.org/10.1016/j.zefq.2020.05.003DOI Listing
August 2020

Relationship between volume and outcome for surgery on congenital diaphragmatic hernia: A systematic review.

J Pediatr Surg 2020 Dec 1;55(12):2555-2565. Epub 2020 Apr 1.

Institute for Research in Operative Medicine, Faculty of Health, School of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, Building 38, 51109 Cologne, Germany.

Background: Congenital diaphragmatic hernia (CDH) is a rare and life-threatening anomaly that needs surgical therapy after clinical stabilization of the neonate. Given an existing volume-outcome relationship for other high-risk, low volume procedures, we aimed at examining the relationship between hospital or surgeon volume and outcomes for surgery on CDH.

Methods: We conducted a systematic search in multiple databases in September 2019 and searched for additional literature. We assessed risk of bias of included studies using ROBINS-I and synthesized results in a structured narrative way using GRADE.

Results: We included 5 cohort studies on hospital volume. Results for in-hospital mortality, one-year mortality and length of stay are inconclusive. The certainty of the evidence was very low for all outcomes, due to risk of bias, inconsistency and imprecision. We did not identify any study on surgeon volume.

Conclusion: Due to the very low certainty of the evidence it is uncertain whether higher hospital volume is associated with favorable outcomes for neonates undergoing surgery for CDH. There is no evidence on the relationship between surgeon volume and outcomes. Future studies should use more rigorous methodology and analyze additional outcomes to allow for more meaningful inferences.

Level Of Evidence: III SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42018090231).
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http://dx.doi.org/10.1016/j.jpedsurg.2020.03.025DOI Listing
December 2020

Epidemiology and reporting characteristics of non-Cochrane updates of systematic reviews: A cross-sectional study.

Res Synth Methods 2020 May 22;11(3):471-483. Epub 2020 Apr 22.

Institute for Research in Operative Medicine, Witten/Herdecke University, Cologne, Germany.

Background: It is important that systematic reviews (SRs) are up-to-date, otherwise they cannot be relied upon to guide decision-making in practice and policy. Our aim was to investigate epidemiological, descriptive and reporting characteristics of a cross-section of recently published updates of SRs.

Methods: A SR update was defined as a new edition of a SR, either published by the same or new authors. We searched PubMed for SR updates published from January 01, 2016 to January 22, 2018 and included a random sample of n = 100 non-Cochrane updates of SRs on interventions reported in English.

Results: Most SR updates had a corresponding author from the United Kingdom, United States, or Canada (in total 48/100) and dealt with nonpharmacological interventions (63/100). The SR updates were published a median of 5 years (interquartile range [IQR] 3-7) after the previous SR and included a median of 19 (IQR 9-28) studies. 31/100 SR updates reported that the conclusion had changed since the previous version. Only 51/100 SR updates used the term "update" in the title and none reported having based the decision to update the previous SR on an existing method/decision tool. The number of newly included studies and participants and the number of studies and participants included in/from the previous SR were often not reported.

Conclusions: The included non-Cochrane updates were frequently missing important information that would be expected to be present in a SR update. Thus, structured and detailed reporting guidance specific to SR updates is needed. It should focus particularly on appropriate labeling and justification of updates, and how to incorporate information regarding the previous SR.
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http://dx.doi.org/10.1002/jrsm.1409DOI Listing
May 2020

Hospital volume-outcome relationship in total knee arthroplasty: protocol for a systematic review and non-linear dose-response meta-analysis.

Syst Rev 2020 02 20;9(1):38. Epub 2020 Feb 20.

Institute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109, Cologne, Germany.

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.
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http://dx.doi.org/10.1186/s13643-020-01295-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7033909PMC
February 2020

[Memorandum Registry for Health Services Research: Update 2019].

Gesundheitswesen 2020 Mar 18;82(3):e39-e66. Epub 2020 Feb 18.

Medizinische Hochschule Brandenburg (MHB), Neuruppin.

Health registries could be used to analyze questions concerning routine practice in healthcare. Therefore, registries are a core method in health services research. The German Network for Health Services Research (Deutsches Netzwerk Versorgungsforschung, DNVF) promotes the quality of registries by scientific exchange, organization of advanced training, and recommendations in the form of a memorandum "Registry for Health Services Research". The current recommendations are an update of the memorandum's first version of 2010. The update describes the capabilities and aims of registries in health services research. Furthermore, it illustrates the state-of-the-art in designing and implementing health registries. The memorandum provides developers the methodological basis to ensure high quality health registries. It further provides users of health registries with insights that enable assessing the quality of data and results of health registries. Finally, funding agencies and health policy actors can use the quality criteria to establish a framework for the financing and legislative requirements for health registries. The memorandum provides first a definition of health registries and presents an overview of their utility in health services research and health care improvement. Second, several areas of methodological importance for the development and operation of health registries are presented. This includes the conceptual and preliminary design, implementation, technical organization of a health registry, statistical analysis, reporting of results, and data protection. From these areas, criteria are deduced to allow the assessment of the quality of a health registry. Finally, a checklist is presented.
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http://dx.doi.org/10.1055/a-1083-6417DOI Listing
March 2020

[Increasing the efficiency of guideline production: a narrative review].

Z Evid Fortbild Qual Gesundhwes 2019 Oct 26;146:1-6. Epub 2019 Sep 26.

Institut für Forschung in der Operativen Medizin, Abteilung Evidenzbasierte Versorgungsforschung, Universität Witten/Herdecke, Köln, Deutschland.

Background: The development of high-quality clinical practice guidelines is laborious and time-consuming. New methods have become available to streamline this process. However, the awareness of these methods should be improved.

Methods: Selective literature search in PubMed/MEDLINE und Embase.

Results: Simple tools such as surveys or voting systems can facilitate the organization, planning and communication. Adequate methods should be used to prioritize all potential questions that should be addressed in the guideline. Published or ongoing international guidelines and systematic reviews can be used meaningfully for the planned guideline. In the case of guideline updates, it should be determined whether all parts of the guideline require an update of the evidence. The need for an update should be investigated. The concept of living guidelines has the biggest potential to provide gains in efficiency. Living guidelines are continuously updated based on new evidence instead of being regularly updated at a predefined time.

Conclusions: New methods allowing for more efficient guideline production have been developed and, in part, already been introduced. Before starting with the production of a guideline (or its update), the potential advantages and disadvantages/risks of the corresponding methods should be balanced.
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http://dx.doi.org/10.1016/j.zefq.2019.08.004DOI Listing
October 2019

The effect of platelet transfusion in patients with traumatic brain injury and concomitant antiplatelet use: a systematic review and meta-analysis.

Transfusion 2019 11 18;59(11):3536-3544. Epub 2019 Sep 18.

Institute for Research in Operative Medicine, University Witten/Herdecke, Cologne, Germany.

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http://dx.doi.org/10.1111/trf.15526DOI Listing
November 2019

An algorithm for the classification of study designs to assess diagnostic, prognostic and predictive test accuracy in systematic reviews.

Syst Rev 2019 09 3;8(1):226. Epub 2019 Sep 3.

Institute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109, Cologne, Germany.

Results of medical tests are the main source to inform clinical decision making. The main information to assess the usefulness of medical tests for correct discrimination of patients are accuracy measures. For the estimation of test accuracy measures, many different study designs can be used. The study design is related to the clinical question to be answered (diagnosis, prognosis, prediction), determines the accuracy measures that can be calculated and it might have an influence on risk of bias. Therefore, a clear and consistent distinction of the different study designs in systematic reviews on test accuracy studies is very important. In this paper, we propose an algorithm for the classification of study designs of test accuracy, that compare the results of an index test (the test to be evaluated) with the results of a reference test (the test whose results are considered as correct/the gold standard) studies in systematic reviews.
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http://dx.doi.org/10.1186/s13643-019-1131-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6720081PMC
September 2019

Nocebo effects of a simplified package leaflet compared to unstandardised oral information and a standard package leaflet: a pilot randomised controlled trial.

Trials 2019 Jul 26;20(1):458. Epub 2019 Jul 26.

Institute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109, Cologne, Germany.

Background: The term "nocebo effect" describes the phenomenon that the mere knowledge and anticipation of possible negative consequences of an intervention can increase the probability of experiencing these consequences. Our objective was to assess whether different information presentations on adverse events (AEs) in package information leaflets (PILs) could influence the nocebo effect.

Methods: We included patients undergoing orthopaedic surgery in this pilot randomised controlled trial (pRCT). Patients were assigned by random, computerised and centralised allocation to one of three groups: Simplified-PIL, No-PIL or Standard-PIL on ibuprofen. The Simplified-PIL was written in plain language, and AEs were reported with a focus on avoiding biased risk perception. Only the outcome assessment was blinded.

Results: We included 35, 33 and 34 patients in the Simplified-PIL, No-PIL and Standard-PIL groups, respectively. All patients were included in the intention-to-treat analysis. Six patients in the Simplified-PIL, four in the No-PIL and eight in the Standard-PIL group reported an AE. This corresponds to relative risks of 0.80 (95% confidence interval (CI) 0.27-1.90) for the Simplified-PIL and 0.50 (95% CI 0.14-1.46) for the No-PIL compared with the Standard-PIL group. The Simplified-PIL increased knowledge, reduced anxiety and improved adherence, although statistical uncertainty was high for all of these outcomes.

Conclusions: This pRCT provides the first hints on the way information on AEs is reported in PILs can affect the nocebo effect. This pRCT shows that a definitive RCT is feasible. If the results are confirmed in a definitive large RCT, a revision of the current practice for designing PILs should be considered.

Trial Registration: ClinicalTrials.gov identifier: NCT03428035. Registered 2 February 2018.
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http://dx.doi.org/10.1186/s13063-019-3565-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6660653PMC
July 2019
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