Where to prospectively register a systematic review

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.TU Berlin, Open-Access-Mittel - 202

Prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO): study protocol for a randomized, controlled, outcome assessor-blinded trial

BACKGROUND: Frailty is expressed by a reduction in physical capacity, mobility, muscle strength, and endurance. (Pre-)frailty is present in up to 42% of the older surgical population, with an increased risk for peri- and postoperative complications. Consequently, these patients often suffer from a delayed or limited recovery, loss of autonomy and quality of life, and a decrease in functional and cognitive capacities. Since frailty is modifiable, prehabilitation may improve the physiological reserves of patients and reduce the care dependency 12 months after surgery. METHODS: Patients ≥ 70 years old scheduled for elective surgery or intervention will be recruited in this multicenter, randomized controlled study, with a target of 1400 participants with an allocation ratio of 1:1. The intervention consists of (1) a shared decision-making process with the patient, relatives, and an interdisciplinary and interprofessional team and (2) a 3-week multimodal, individualized prehabilitation program including exercise therapy, nutritional intervention, mobility or balance training, and psychosocial interventions and medical assessment. The frequency of the supervised prehabilitation is 5 times/week for 3 weeks. The primary endpoint is defined as the level of care dependency 12 months after surgery or intervention. DISCUSSION: Prehabilitation has been proven to be effective for different populations, including colorectal, transplant, and cardiac surgery patients. In contrast, evidence for prehabilitation in older, frail patients has not been clearly established. To the best of our knowledge, this is currently the largest prehabilitation study on older people with frailty undergoing general elective surgery. TRIAL REGISTRATION: ClinicalTrials.gov NCT04418271. Registered on 5 June 2020. Universal Trial Number (UTN): U1111-1253-4820 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06401-x

Implementation of Innovative Medical Technologies in German Inpatient Care: Patterns of Utilization and Evidence Development

A Correction to this article was published on 24 January 2022 https://doi.org/10.1186/s13012-022-01187-7Background: Innovative medical technologies are commonly associated with positive expectations. At the time of their introduction into care, there is often little evidence available regarding their benefits and harms. Accordingly, some innovative medical technologies with a lack of evidence are used widely until or even though findings of adverse events emerge, while others with study results supporting their safety and effectiveness remain underused. This study aims at examining the diffusion patterns of innovative medical technologies in German inpatient care between 2005 and 2017 while simultaneously considering evidence development. Methods: Based on a qualitatively derived typology and a quantitative clustering of the adoption curves, a representative sample of 21 technologies was selected for further evaluation. Published scientific evidence on efficacy/effectiveness and safety of the technologies was identified and extracted in a systematic approach. Derived from a two-dimensional classification according to the degree of utilization and availability of supportive evidence, the diffusion patterns were then assigned to the categories “Success” (widespread/positive), “Hazard” (widespread/negative), “Overadoption” (widespread/limited or none), “Underadoption” (cautious/positive), “Vigilance” (cautious/negative), and “Prudence” (cautious/limited or none). Results: Overall, we found limited evidence on the examined technologies regarding both the quantity and quality of published randomized controlled trials. Thus, the categories “Prudence” and “Overadoption” together account for nearly three-quarters of the years evaluated, followed by “Success” with 17%. Even when evidence is available, the transfer of knowledge into practice appears to be inhibited. Conclusions: The successful implementation of safe and effective innovative medical technologies into practice requires substantial further efforts by policymakers to strengthen systematic knowledge generation and translation. Creating an environment that encourages the conduct of rigorous studies, promotes knowledge translation, and rewards innovative medical technologies according to their added value is a prerequisite for the diffusion of valuable health care.TU Berlin, Open-Access-Mittel – 202

Cost-effectiveness of prehabilitation prior to elective surgery compared to usual preoperative care: protocol for a systematic review of economic evaluations

Introduction: Preoperative functional capacity is an important predictor of postoperative outcomes. Prehabilitation aims to optimise patients’ functional capacity before surgery to improve postoperative outcomes. As prolonged hospital stay and postoperative complications present an avoidable use of healthcare resources, prehabilitation might also save costs. The aim of this systematic review is to investigate the cost-effectiveness of prehabilitation programmes for patients awaiting elective surgery compared with usual preoperative care. The results will be useful to inform decisions about the implementation of prehabilitation programmes and the design of future economic evaluations of prehabilitation programmes. Methods and analysis: We will search PubMed, Embase, the Centre for Reviews and Dissemination Database, the WHO International Clinical Trials Registry Platform and ClinicalTrials.gov for full or partial economic evaluations of preoperative prehabilitation programmes conducted in any population compared with usual preoperative care. Studies will be included regardless of the type, design and perspective of the economic evaluation, and their publication year, language or status. Initial searches were performed between 30 April and 4 May 2020. Study selection, data extraction and assessment of the included studies’ risk of bias and methodological quality will initially be performed by two independent reviewers and, if agreement was sufficiently high, by one reviewer. We will extract data regarding the included studies’ basic characteristics, economic evaluation methods and cost-effectiveness results. A narrative synthesis will be performed. The primary endpoint will be cost-effectiveness based on cost–utility analyses. We will discuss heterogeneity between the studies and assess the risk of publication bias. The certainty of the evidence will be determined using the Grading of Recommendations, Assessment, Development and Evaluation approach. Ethics and dissemination: Ethics approval is not required as the systematic review will not involve human participants. We plan to present our findings at scientific conferences, pass them on to relevant stakeholder organisations and publish them in a peer-reviewed journal.TU Berlin, Open-Access-Mittel – 202

Video Versus Direct Laryngoscopy for Inpatient Emergency Intubation in Adults

Background: Emergency intubation carries a higher risk of complications than elective airway management. Video laryngoscopy (VL) could potentially improve patient safety. The goal of this study was to determine whether VL is superior to direct laryngoscopy for the emergency intubation of adults in the inpatient setting. Methods: Pertinent studies were retrieved by a systematic literature search in the MEDLINE, Embase, and CENTRAL databases. The selection of studies, data extraction, and assessment of the potential for bias were carried out independently by two of the authors. Effect sizes were reported as odds ratios (OR) or mean differences (MD). The primary endpoint was successful intubation at the first attempt. Further variables were considered as secondary endpoints. Results: 1098 titles and abstracts were retrieved, and the full texts of 43 articles were examined. Eight randomized and controlled trials, with a total of 1796 patients, were analyzed. VL was not found to confer any statistically significant advantage with respect to successful intubation at the first attempt (OR 0.72, 95% confidence interval [0.47; 1.12]) or with respect to the time to successful intubation (MD -8.99 seconds [-24.00; 6.01]). On the other hand, the use of VL was significantly associated with a lower number of intubation attempts (MD -0.17 [-0.31; -0.03]) and with a lower frequency of esophageal intubation (OR 0.27 [0.10; 0.75]). Conclusion: The routine use of VL for airway management in emergency medicine might improve patient safety, as VL is associated with a lower number of intubation attempts and with a lower frequency of esophageal intubation. Further randomized controlled trials are needed before any definitive conclusions can be drawn about the advantages of video laryngoscopy

Clowning in children undergoing potentially anxiety-provoking procedures: a systematic review and meta-analysis

Background: The operation areas of clowns in the medical context are multifaceted. Clowning in children undergoing surgery has been shown to be able to lessen children's anxiety. Hence, our aim was to assess the effectiveness of clowning on anxiety in children undergoing potentially anxiety-provoking procedures. Methods: We searched MEDLINE, CENTRAL, and EMBASE for randomized controlled trials (RCTs) in December 2018. The primary outcome was children's anxiety. We used the Cochrane risk of bias tool to assess risk of bias of the included studies. Results: We found eleven RCTs including 733 children. Their risk of bias was relatively high. Children undergoing clowning were significantly less anxious in preoperative time compared to parental presence or no intervention (mean difference (MD) - 7.16; 95% CI - 10.58, - 3.75) and in operation, induction, or patient room (MD - 20.45; 95% CI - 35.54, - 5.37), but not during mask application or physician examination (MD 2.33; 95% CI -4.82, 9.48). Compared with midazolam, children's anxiety was significantly lower in preoperative time (MD - 7.60; 95% CI - 11.73, - 3.47), but not in the induction room (MD - 9.63; 95% CI - 21.04, 1.77). Conclusions: Clowning seems to lower children's anxiety, but because of the increased risk of bias of included studies and the very low quality of evidence, these results should be considered with caution

A descriptive analysis of the characteristics and the peer review process of systematic review protocols published in an open peer review journal from 2012 to 2017

Abstract Background An a priori design is essential to reduce the risk of bias in systematic reviews (SRs). To this end, authors can register their SR with PROSPERO, and/or publish a SR protocol in an academic journal. The latter has the advantage that the manuscript for the SR protocol is usually peer-reviewed. However, since authors ought not to begin/continue the SR before their protocol has been accepted for publication, it is crucial that SR protocols are processed in a timely manner. Our main aim was to descriptively analyse the peer review process of SR protocols published in ‘BMC Systematic Reviews’ from 2012 to 2017. Methods We systematically searched MEDLINE via PubMed for all SR protocols published in ‘BMC Systematic Reviews’ between 2012 and 2017, except for protocols for overviews, scoping reviews or realist reviews. Data were extracted from the SR protocols and Open Peer Review reports. For each round of peer review, two researchers judged the extent of revision (minor/major) based on the reviewer reports. Their content was further investigated by two researchers in a random 10%-sample using PRISMA-P as a guideline. All data were analysed descriptively. Results We identified 544 eligible protocols published in ‘BMC Systematic Reviews’ between 2012 and 2017. Of those, 485 (89.2%) also registered the SR in PROSPERO, the majority (87.4%) before first submission of the manuscript for the SR protocol (median 49 days). The absolute number of published SR protocols increased from 2012 to 2017 (21 vs 145 protocols), as did the median processing time (61 vs 142 days from submission to acceptance) and the proportion of protocols requiring a major revision after first peer review (19.1% vs 52.4%). Reviewer comments most frequently addressed the PRISMA-P item ‘Eligibility criteria’. Overall, 76.0% of the reviewer comments suggested more transparency. Conclusions The number of published SR protocols increased over the years, but so did the processing time. In 2017, it took several months from submission to acceptance, which is critical from an author’s perspective. New models of peer review such as post publication peer review for SR protocols should be investigated. This could probably be realized with PROSPERO

Facilitators and barriers to the implementation of prehabilitation for frail patients into routine health care: a realist review

Abstract Background Despite evidence supporting the effectiveness of prehabilitation as a new preoperative care pathway to optimise perioperative outcomes, its implementation into routine health care is widely pending. Frail patients might particularly benefit from prehabilitation interventions, but facilitating and hindering factors need to be considered in the implementation process. Thus, our aim was to derive a programme theory on what prehabilitation programmes work for frail patients in what circumstances and why. Methods Following Pawson’s realist review approach, preliminary programme theories on facilitators and barriers were established. General and topic-specific databases were searched systematically for facilitators and barriers to the implementation of prehabilitation for frail patients. Articles were included if they dealt with multimodal prehabilitation programmes prior to surgery in a frail population and if they contained information on facilitators and barriers during the implementation process in the full text. Based on these articles, refined programme theories were generated. Results From 2,609 unique titles, 34 were retained for the realist synthesis. Facilitating factors included the individualisation of prehabilitation programmes to meet the patients’ needs and abilities, multimodality, adaption to the local setting and health care system, endorsement by an ambassador and sharing of responsibilities among a multidisciplinary team. Central barriers for frail patients were transportation, lack of social support, and inadequate, overwhelming information provision. Conclusions Implementing prehabilitation as a new care pathway for frail patients requires organisational readiness and adaptability to the local setting. On an individual level, a clear understanding of responsibilities and of the intervention’s goal among patients and providers are necessary. Added attention must be paid to the individualisation to fit the needs and restrictions of frail patients. This makes prehabilitation a resource-intense, but promising intervention for frail surgery patients. Trial registration PROSPERO (CRD42022335282)

Cost-effectiveness of prehabilitation prior to elective surgery: A systematic review of economic evaluations

The aim of this systematic review was to synthesise the evidence on the cost-effectiveness of prehabilitation programmes for patients awaiting elective surgery compared with usual preoperative care to inform decisions about the implementation of prehabilitation programmes and to guide the design of future rigorous economic evaluations of prehabilitation programmes