Use, applicability, and dissemination of patient versions of clinical practice guidelines in oncology in Germany: a qualitative interview study with healthcare providers.

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

Barriers and facilitators in developing patient versions of clinical practice guidelines - qualitative interviews on experiences of international guideline producers.

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

Does the second opinion directive in Germany reach the patient? A parallel-convergent mixed-methods study.

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

Heterogeneous methodology in the development of patient versions of clinical practice guidelines: a scoping review.

OBJECTIVES: We aimed to gain an overview of the methods and approaches used to develop, disseminate, and implement patient versions of clinical practice guidelines (PVGs). METHODS: We searched PubMed and MEDLINE through Ovid for articles reporting on the development, dissemination, or implementation of PVGs until March 2022. We searched the homepages of guideline organizations, screened the reference lists of the included documents, and asked experts to complement the publications. We narratively synthesized the findings. RESULTS: Of 3,941 publications screened, 27 were included in the study. The identified method reports focused on patient involvement and peer-review processes. The other included publications highlighted the relevance of broad dissemination strategies and emphasized the importance of patient involvement and improving the readability of PVGs by using lay terms and shorter sentences. CONCLUSION: The terminology used for PVGs varies widely. The extent to which the methods were described was heterogeneous. Organizations developing PVGs should make their methods publicly available and use uniform labeling for PVGs in English to improve their use and recognition, not only for other PVG producers but also for patients and the public. A consensus regarding a minimum reporting standard for developing PVGs internationally and developing guiding principles is desirable.

A photograph of the researcher on the invitation letter did not affect the participation rate of a postal survey: a randomized study within a trial (SWAT).

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

Telemedical Second Opinions in Germany: A Customer Survey of an Online Portal.

Introduction: Second medical opinions (SOs) can strengthen patients' certainty in decision making. In Germany, both personally delivered and telemedical SOs (often based on documents only) are provided. Our aim was to analyze the experiences of people who obtained telemedical SOs. We also investigated different routes of SO delivery (personally/by phone/documents only). Materials and Methods: German residents who obtained a telemedical SO via an online portal between January 2016 and February 2019 (n = 1,247) were contacted by post between August and November 2019 up to three times. The results were analyzed descriptively. Results: The 368 participants (response rate 30%) were 54% male, 95% statutory health insured, and 61 years old (median; interquartile range 51-72). Approximately 75% were (rather) satisfied with obtaining the SO via the online portal. The most preferred route of SO delivery was a personally delivered SO, which 80% would (rather) consider, followed by 70% (rather) considering SOs based on documents only and 48% (rather) considering SOs by phone. The most often mentioned advantage of telemedical SOs was independence of time and place, while the most important disadvantage was the standardized process resulting in a lack of direct and personal contact between the patient and the physician. Discussion: Although our results show that SOs (based on documents only) support patients and that patient satisfaction was high, personally delivered SOs were still preferred. Future research on the use of SOs based on documents only (in which patient population and in what situations) is needed.

Information needs of patients undergoing bariatric surgery in Germany: a qualitative study.

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

Attitude toward second opinions in Germany - a survey of the general population.

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

Healthcare delivery and information provision in bariatric surgery in Germany: qualitative interviews with bariatric surgeons.

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

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.

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.

Analysis of second opinion programs provided by German statutory and private health insurance - a survey of statutory and private health insurers.

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

Second opinion programmes in Germany: a mixed-methods study protocol.

INTRODUCTION: Second opinion programmes aim to support the patients' decision-making process and to avoid treatments that are unnecessary from a medical perspective. The German second opinion directive, introduced in December 2018, constitutes a new legal framework in statutory health insurance for seeking second opinions for elective procedures and so far includes tonsillectomy, tonsillotomy, hysterectomy and shoulder arthroscopy. The directive mandates physicians who recommend one of the above-mentioned surgeries to inform their patients of their legal right to visit a certified second opinion provider. Since second opinion programmes are a fairly recent phenomenon in Germany, no comprehensive data are yet available on the degree of implementation, users, potential barriers and their effectiveness. We aim to examine the characteristics and the use of second opinion programmes as well as the needs and wishes from the perspective of (potential) users in Germany, with focus on the decision-making process, the patient-physician relationship and the motivation to seek a second opinion, as well as the role of health literacy. METHODS AND ANALYSIS: Six substudies will include the following stakeholders: (1 and 2) patients with one of the four surgery-indications covered by the directive, (3) patients who electively sought an online-based second opinion, (4) patients with oncological diseases, (5) the general population and (6) medical specialists. A mixed-methods approach will be used, including questionnaires, interviews and focus groups. The data will be evaluated using quantitative descriptive analysis and qualitative content analysis. The integration of the results will take place in the form of a triangulation protocol. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Brandenburg Medical School. The findings will be published in peer-reviewed journals and presented at scientific conferences.

Exercise/physical activity and health outcomes: an overview of Cochrane systematic reviews.

BACKGROUND: Sedentary lifestyle is a major risk factor for noncommunicable diseases such as cardiovascular diseases, cancer and diabetes. It has been estimated that approximately 3.2 million deaths each year are attributable to insufficient levels of physical activity. We evaluated the available evidence from Cochrane systematic reviews (CSRs) on the effectiveness of exercise/physical activity for various health outcomes. METHODS: Overview and meta-analysis. The Cochrane Library was searched from 01.01.2000 to issue 1, 2019. No language restrictions were imposed. Only CSRs of randomised controlled trials (RCTs) were included. Both healthy individuals, those at risk of a disease, and medically compromised patients of any age and gender were eligible. We evaluated any type of exercise or physical activity interventions; against any types of controls; and measuring any type of health-related outcome measures. The AMSTAR-2 tool for assessing the methodological quality of the included studies was utilised. RESULTS: Hundred and fifty CSRs met the inclusion criteria. There were 54 different conditions. Majority of CSRs were of high methodological quality. Hundred and thirty CSRs employed meta-analytic techniques and 20 did not. Limitations for studies were the most common reasons for downgrading the quality of the evidence. Based on 10 CSRs and 187 RCTs with 27,671 participants, there was a 13% reduction in mortality rates risk ratio (RR) 0.87 [95% confidence intervals (CI) 0.78 to 0.96]; I2 = 26.6%, [prediction interval (PI) 0.70, 1.07], median effect size (MES) = 0.93 [interquartile range (IQR) 0.81, 1.00]. Data from 15 CSRs and 408 RCTs with 32,984 participants showed a small improvement in quality of life (QOL) standardised mean difference (SMD) 0.18 [95% CI 0.08, 0.28]; I2 = 74.3%; PI -0.18, 0.53], MES = 0.20 [IQR 0.07, 0.39]. Subgroup analyses by the type of condition showed that the magnitude of effect size was the largest among patients with mental health conditions. CONCLUSION: There is a plethora of CSRs evaluating the effectiveness of physical activity/exercise. The evidence suggests that physical activity/exercise reduces mortality rates and improves QOL with minimal or no safety concerns. TRIAL REGISTRATION: Registered in PROSPERO ( CRD42019120295 ) on 10th January 2019.

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

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.

Inter-review agreement of risk-of-bias judgments varied in Cochrane reviews.

OBJECTIVES: The objective of the study was to measure the level of agreement between Cochrane reviews of overlapping randomized controlled trials (RCTs) regarding risk-of-bias (RoB) judgments. STUDY DESIGN AND SETTING: On November 5, 2017, the Cochrane Database of Systematic Reviews was searched for Cochrane reviews on tobacco. Reviews that included overlapping RCTs were included. RoB judgments were extracted from RoB tables using automated data scraping with manual verification and adjustments. Agreement between the reviews was calculated using Conger's generalized kappa coefficient (κ) and raw agreement (a). RESULTS: We included 53 Cochrane reviews of 376 RCTs. For the RoB domain "random sequence generation," the level of agreement between the reviews was substantial with κ = 0.63 (95% confidence interval: 0.56 to 0.71; a = 0.80). There was slight-to-moderate agreement between the reviews regarding the domains "allocation concealment": κ = 0.51 (0.41 to 0.61), a = 0.75; "blinding": κ = 0.19 (0.02 to 0.37), a = 0.52; "blinding of outcome assessment": κ = 0.43 (0.14 to 0.72) a = 0.67; and "incomplete outcome data": κ = 0.15 (-0.03 to 0.32), a = 0.64. For "blinding of participants and personnel" and "selective reporting", κ could not be calculated. The raw agreement was 0.40 and 0.42, respectively. CONCLUSION: The level of agreement between Cochrane reviews regarding RoB judgments ranged from slight to substantial depending on the RoB domain. Further investigations regarding reasons for variation and interventions to improve agreement are needed.

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. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016039045.