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    Systematic Reviews of Economic Evaluations in Health Technology Assessment: a Review of Characteristics and Applied Methods

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    When making decisions in health care, it is essential to consider economic evidence about an intervention. The objective of this study was to analyze the methods applied for systematic reviews of health economic evaluations (SR-HEs) in HTA and to identify common challenges

    Mesh fixation techniques in primary ventral or incisional hernia repair

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    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 nonabsorbablesutures 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 toabsorbable 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

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

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    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

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

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    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

    Systematic reviews of health economic evaluations: A structured analysis of characteristics and methods applied

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    The number of systematic reviews of health economic evaluations (SR-HEs) is increasing. We aimed at providing a detailed overview of the characteristics and applied methods in recently published SR-HEs

    Systematic reviews of health economic evaluations: a protocol for a systematic review of characteristics and methods applied

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    Abstract Background The number of systematic reviews of economic evaluations is steadily increasing. This is probably related to the continuing pressure on health budgets worldwide which makes an efficient resource allocation increasingly crucial. In particular in recent years, the introduction of several high-cost interventions presents enormous challenges regarding universal accessibility and sustainability of health care systems. An increasing number of health authorities, inter alia, feel the need for analyzing economic evidence. Economic evidence might effectively be generated by means of systematic reviews. Nevertheless, no standard methods seem to exist for their preparation so far. The objective of this study was to analyze the methods applied for systematic reviews of health economic evaluations (SR-HE) with a focus on the identification of common challenges. Methods/design The planned study is a systematic review of the characteristics and methods actually applied in SR-HE. We will combine validated search filters developed for the retrieval of economic evaluations and systematic reviews to identify relevant studies in MEDLINE (via Ovid, 2015-present). To be eligible for inclusion, studies have to conduct a systematic review of full economic evaluations. Articles focusing exclusively on methodological aspects and secondary publications of health technology assessment (HTA) reports will be excluded. Two reviewers will independently assess titles and abstracts and then full-texts of studies for eligibility. Methodological features will be extracted in a standardized, beforehand piloted data extraction form. Data will be summarized with descriptive statistical measures and systematically analyzed focusing on differences/similarities and methodological weaknesses. Discussion The systematic review will provide a detailed overview of characteristics of SR-HE and the applied methods. Differences and methodological shortcomings will be detected and their implications will be discussed. The findings of our study can improve the recommendations on the preparation of SR-HE. This can increase the acceptance and usefulness of systematic reviews in health economics for researchers and medical decision makers. Systematic review registration The review will not be registered with PROSPERO as it does not meet the eligibility criterion of dealing with clinical outcomes

    Going Beyond Counting First Authors in Author Co-citation Analysis

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    The present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed

    Variations on the Author

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    “Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
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