Meta-epidemiological review identified variable reporting and handling of time-to-event analyses in publications of trials included in meta-analyses of systematic reviews.

OBJECTIVES: Previous findings indicate limited reporting of systematic reviews with meta-analyses of time-to-event (TTE) outcomes. We assessed corresponding available information in trial publications included in such meta-analyses. STUDY DESIGN AND SETTING: We extracted data from all randomized trials in pairwise, hazard ratio (HR)-based meta-analyses of primary outcomes and overall survival of 50 systematic reviews systematically identified from the Cochrane Database and Core Clinical Journals. Data on methods and characteristics relevant for TTE analysis of reviews, trials, and outcomes were extracted. RESULTS: Meta-analyses included 235 trials with 315 trial analyses. Most prominently assessed was overall survival (91%). Definitions (61%), censoring reasons (41%), and follow-up specifications (56%) for trial outcomes were often missing. Available TTE data per trial were most frequently survival curves (83%), log-rank P values (76%), and HRs (72%). When trial TTE data recalculation was reported, reviews mostly specified HRs or P values (each 5%). Reviews primarily included intention-to-treat analyses (64%) and analyses not adjusted for covariates (25%). Except for missing outcome data, TTE-relevant trial characteristics, for example, informative censoring, treatment switching, and proportional hazards, were sporadically addressed in trial publications. Reporting limitations in trial publications translate to the review level. CONCLUSION: TTE (meta)-analyses, in trial and review publications, need clear reporting standards.

The effectiveness of clinical guideline implementation strategies in oncology-a systematic review.

IMPORTANCE: Guideline recommendations do not necessarily translate into changes in clinical practice behaviour or better patient outcomes. OBJECTIVE: This systematic review aims to identify recent clinical guideline implementation strategies in oncology and to determine their effect primarily on patient-relevant outcomes and secondarily on healthcare professionals' adherence. METHODS: A systematic search of five electronic databases (PubMed, Web of Science, GIN, CENTRAL, CINAHL) was conducted on 16 december 2022. Randomized controlled trials (RCTs) and non-randomized studies of interventions (NRSIs) assessing the effectiveness of guideline implementation strategies on patient-relevant outcomes (overall survival, quality of life, adverse events) and healthcare professionals' adherence outcomes (screening, referral, prescribing, attitudes, knowledge) in the oncological setting were targeted. The Cochrane risk-of-bias tool and the ROBINS-I tool were used for assessing the risk of bias. Certainty in the evidence was evaluated according to GRADE recommendations. This review was prospectively registered in the International Prospective Register of Systematic Reviews (PROSPERO) with the identification number CRD42021268593. FINDINGS: Of 1326 records identified, nine studies, five cluster RCTs and four controlled before-and after studies, were included in the narrative synthesis. All nine studies assess the effect of multi-component interventions in 3577 cancer patients and more than 450 oncologists, nurses and medical staff. PATIENT-LEVEL: Educational meetings combined with materials, opinion leaders, audit and feedback, a tailored intervention or academic detailing may have little to no effect on overall survival, quality of life and adverse events of cancer patients compared to no intervention, however, the evidence is either uncertain or very uncertain. PROVIDER-LEVEL: Multi-component interventions may increase or slightly increase guideline adherence regarding screening, referral and prescribing behaviour of healthcare professionals according to guidelines, but the certainty in evidence is low. The interventions may have little to no effect on attitudes and knowledge of healthcare professionals, still, the evidence is very uncertain. CONCLUSIONS AND RELEVANCE: Knowledge and skill accumulation through team-oriented or online educational training and dissemination of materials embedded in multi-component interventions seem to be the most frequently researched guideline implementation strategies in oncology recently. This systematic review provides an overview of recent guideline implementation strategies in oncology, encourages future implementation research in this area and informs policymakers and professional organisations on the development and adoption of implementation strategies.

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.

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.

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.