Closed cannulation of subclavian vein vs open cut-down of cephalic vein for totally implantable venous access port (TIVAP) implantation: protocol for a systematic review and proportional meta-analysis of perioperative and postoperative complications

Background: Totally implantable venous access port (TIVAP) implantation is one of the most often performed operations in general surgery (over 100,000/year in Germany). The two main approaches for TIVAP placement are insertion into the cephalic vein through an open cut-down technique (OCD) or closed cannulation technique of the subclavian vein (CC) with Seldinger technique. Both procedures are performed with high success rates and very low complication frequencies. Because of the low incidence of complications, no single interventional trial is able to report a valid comparison of peri- and postoperative complication frequencies between both techniques. Therefore, the aim of this systematic review is to summarize evidence for peri- and postoperative complication rates in patients undergoing OCD or CC. Methods/Design: A systematic literature search will be conducted in The Cochrane Library, MEDLINE, and Embase to identify randomized controlled trials (RCTs), observational clinical studies (OCS), or case series (CS) reporting peri- and/or postoperative complications of at least one implantation technique. A priori defined data will be extracted from included studies, and methodological quality will be assessed. Event rates with their 95% confidence intervals will be derived taking into account the follow-up time per study by patient-months where appropriate. Pooled estimates of event rates with corresponding 95% confidence intervals will be calculated on the base of the Freeman-Tukey double arcsine transformation within a random effect model framework. Discussion: The findings of this systematic review with proportional meta-analysis will help to identify the procedure with the best benefit/risk ratio for TIVAP implantation. This may have influence on daily practice, and data may be implemented in treatment guidelines. Considering the impact of TIVAP implantation on patients’ well being together with its socioeconomic relevance, patients will benefit from evidence-based treatment and health-care costs may also be reduced. Systematic review registration PROSPERO CRD42013005180

Welches Potenzial bietet die prädiktive Gendiagnostik für die öffentliche Gesundheitsvorsorge? Fragen der Implementierung prädiktiv gendiagnostischerVerfahren in das öffentliche Gesundheitswesen

Prädiktive Gendiagnostik ist die Identifikation krankheitsrelevanter Gene aufgrund derer die Vorhersage des späteren Auftretens oder der Wahrschein-lichkeit des Auftretens einer Krankheit möglich wird. Sie bietet neue und erweiterte Formen der Diagnose und stellt damit neue Ansätze der Therapie und Prävention von Krankheiten in Aussicht. Diese kommen den Bedürfnissen des Gesundheitswesens entgegen, eine hohe Gewissheit und damit Steuerbarkeit der Entstehung und Prognose von Krankheiten zu erlangen. Gendiagnostische Verfahren auf Bevölkerungsebene gewinnen nicht zuletzt als gesundheits- ökonomische Strategien zunehmend an Attraktivität. Die vorliegende Arbeit untersucht den Umgang mit diesem neuen genetischen Wissen, beleuchtet Stand und Perspektiven des Anwendungspotenzials prädiktiver Gendiagnostik sowie die mit diesen Verfahren einhergehenden medizinischen, rechtlichen und sozialen Unsicherheiten. Es soll aufgezeigt werden, inwieweit Ansätze der genetischen Prävention derzeit reelle Chancen für die Verbesserung der öffentlichen Gesundheitsvorsorge bieten und welche Faktoren Eingang in die Entscheidungsfindungen im öffentlichen Gesundheitswesen finden können

Conflicts of interest in randomised controlled surgical trials: systematic review and qualitative and quantitative analysis

Conflicts of interest may lead to biased trial designs and unbalanced interpretation of study results. We aimed to evaluate the reporting of potential conflicts of interest in full publications of surgical randomised controlled trials (RCTs). A systematic literature search was performed in CENTRAL, MEDLINE and EMBASE (1985–2014) to find all surgical RCTs of medical devices and perioperative pharmacological or nutritional interventions. The information on conflicts of interest was evaluated both quantitatively and qualitatively, and the development of stated conflicts over time was studied. Of 7934 articles, 444 met the inclusion criteria. In 93 of 444 trials (20.9%), conflicts of interest were disclosed. In half of the cases, the information provided was insufficient to permit conclusions regarding possible influence on the trials. Information about conflicts of interest has increased continuously during the last decades (1985–1994: 0%, 1995–2004: 2.8% and 2005–2014: 33.0%; p<0.001). Among the 115 industry-funded trials, industry participation was considered as a potential conflict of interest in 24 cases (20.9%). Over the past three decades, only every 10th trial has provided appropriate information on conflicts of interest. However, transparency is crucial for the reliability of evidence-based medicine. There is an urgent need for the full disclosure of all conflicts of interest in surgical publishing and for transparency regarding cooperation between academia and industry

Self-management in adults after solid-organ transplantation: a scoping review protocol

Introduction After solid-organ transplantation (SOTx), recipients must adhere to a lifelong medical regimen, change their lifestyle and cope with physiological and psychosocial challenges. This requires active participation in their care and self-management abilities. The concept of self-management after SOTx has only been described regarding specific organs and focused on adherence to medical treatment. A comprehensive conceptualisation of self-management entailing all solid organs and beyond medical aspects does not exist. This might lead to unmet self-management support needs of SOTx recipients and hinder a more holistic and integrative approach in self-management support. Therefore, a better understanding of the concept of self-management after SOTx is needed to facilitate a comprehensive evidence base for healthcare providers and researchers. The purpose of this scoping review is to explore existing evidence on self-management in adults after SOTx.Methods and analysis To identify relevant evidence, six electronic databases and three study registers will be searched, supplemented by handsearches, reference checking and expert recommendations. Screening and selection of available evidence will be carried out in a two-step process by two independent reviewers. International evidence published in English or German reporting on adults after heart, lung, liver, pancreas, kidney or small bowel transplantation will be considered. To meet inclusion criteria, articles have to focus on either: self-management, self-management support or recipients’ or healthcare providers’ perspectives of challenges and needs potentially addressable by self-management. Data extraction will be performed by two reviewers independently using a structured form. Data will be analysed descriptively and using content analysis procedures. Findings will be summarised narratively and presented in tabular format.Ethics and dissemination The consultation and approval of an ethics committee is not required for this scoping review. Findings of the scoping review will be published in a peer-reviewed open-access journal and presented at conferences

Interventions for palliative symptom control in COVID-19 patients

Background Individuals dying of coronavirus disease 2019 (COVI D-19) may experience distressing symptoms such as breathlessness or delirium. Palliative symptom management can alleviate symptoms and improve the quality of life of patients. Various treatment options such as opioids or breathing techniques have been discussed for use in COVID-19 patients. However, guidance on symptom management of COVID-19 patients in palliative care has often been derived from clinical experiences and guidelines for the treatment of patients with other illnesses. An understanding of the effectiveness of pharmacological and non-pharmacological palliative interventions to manage specific symptoms of COVID-19 patients is required. Objectives To assess the efficacy and safety of pharmacological and non-pharmacological interventions for palliative symptom control in individuals with COVID-19. Search methods We searched the Cochrane COVID-19 Study Register (including Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (PubMed), Embase, ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), medRxiv); Web of Science Core Collection (Science Citation Index Expanded, Emerging Sources); CINAHL; WHO COVID-19 Global literature on coronavirus disease; and COAP Living Evidence on COVID-19 to identify completed and ongoing studies without language restrictions until 23 March 2021. We screened the reference lists of relevant review articles and current treatment guidelines for further literature. Selection criteria We followed standard Cochrane methodology as outlined in the Cochrane Handbook for Systematic Reviews of interventions. We included studies evaIuating palliative symptom management for individuals with a confirmed diagnosis of COVID-19 receiving interventions for palliative symptom control, with no restrictions regarding comorbidities, age, gender, or ethnicity. Interventions comprised pharmacologicaI as well as non-pharmacological treatment (e.g. acupressure, physical therapy, relaxation, or breathing techniques). We searched for the following types of studies: randomized controlled trials (RCT), quasi-RCTs, controlled clinical trials, controlled before-after studies, interrupted time series (with comparison group), prospective cohort studies, retrospective cohort studies, (nested) case-control studies, and cross-sectional studies. We searched for studies comparing pharmacological and non-pharmacological interventions for palliative symptom control with standard care. We excluded studies evaIuating palliative interventions for symptoms caused by other terminal ibesses. If studies enroIled populations with or exposed to multiple diseases, we would only include these if the authors provided subgroup data for individuals with COVID-19. We excluded studies investigating interventions for symptom control in a curative setting, for example patients receiving life-prolonging therapies such as invasive ventilation. Data collection and analysis We used a modified version of the Newcastle Ottawa Scale for non-randomized studies of interventions (NRSIs) to assess bias in the included studies. We included the following outcomes: symptom relief (primary outcome); quality of life; symptom burden; satisfaction of patients, caregivers, and relatives; serious adverse events; and grade 3 to 4 adverse events. We rated the certainty of evidence using the GRADE approach. As meta-analysis was not possible, we used tabulation to synthesize the studies and histograms to display the outcomes. Main results Overall, we identified four uncontrolled retrospective cohort studies investigating pharmacological interventions for palliative symptom control in hospitalized patients and patients in nursing homes. None of the studies included a comparator. We rated the risk of bias high across aIl studies. We rated the certainty of the evidence as very low forthe primary outcome symptom relief, downgrading mainEy for high risk of bias due to confounding and unblinded outcome assessors. Pharmacological interventions for palliative symptom control We identified four uncontroIled retrospective cohort studies (five references) investigating pharmacoIogical interventions for paIliative symptom control. Two references used the same register to form their cohorts, and study investigators confirmed a partial overlap of participants. We therefore do not know the exact number of participants, but individual reports included 61 to 2105 participants. Participants received multimodal pharmacological interventions: opioids, neuroleptics, anticholinergics, and benzodiazepines for relieving dyspnea (breathIessness), delirium, anxiety, pain, audible upper airway secretions, respiratory secretions, nausea, cough, and unspecified symptoms. Primary outcome: symptom relief All identified studies reported this outcome. For all symptoms (dyspnea, delirium, anxiety, pain, audible upper airway secretions, respiratory secretions, nausea, cough, and unspecified symptoms), a majority of interventions were rated as completely or partially effective by outcome assessors (treating clinicians or nursing staff). Interventions used in the studies were opioids, neuroIeptics, anticholinergics, and benzodiazepines. We are very uncertain about the effect of pharmacological interventions on symptom relief (very low-certainty evidence) The initiaI rating of the certainty of evidence was low since we only identified uncontrolled NRSIs. Our main reason fordowngradingthe certainty of evidence was high risk of bias due to confounding and unblinded outcome assessors. We therefore did not find evidence to confidently support or refute whether pharmacological interventions may be effective for palliative symptom relief in COVI D-19 patients. Secondary outcomes We planned to include the following outcomes: quality of life; symptom burden; satisfaction of patients, caregivers, and relatives; serious adverse events; and grade 3 to 4 adverse events. We did not find any data for these outcomes, or any other information on the efficacy and safety of used interventions. Non-pharmacological interventions for palliative symptom control None of the identified studies used non-pharmacological interventions for paIliative symptom control. Authors' conclusions We found very low certainty evidence for the efficacy of pharmacological interventions for palliative symptom relief in COVI D-19 patients. We found no evidence on the safety of pharmacological interventions or efficacy and safety of non-pharmacological interventions for palliative symptom control in COVI D-19 patients. The evidence presented here has no specific implications for palliative symptom control in COVID-19 patients because we cannot draw any conclusions about the effectiveness or safety based on the identified evidence. More evidence is needed to guide clinicians, nursing staff, and caregivers when treating symptoms of COVI D-19 patients at the end of life. Specifically, future studies ought to investigate palliative symptom control in prospectively registered studies, using an active-controlled setting, assess patient-reported outcomes, and clearly define interventions. The publication of the results of ongoing studies will necessitate an update of this review. The conclusions of an updated review could differ from those of the present review and may allow for a better judgement regarding pharmacological and non-pharmacological interventions for palliative symptom control in COVI D-19 patients

Treatment Regimens for Immunocompetent Elderly Patients with Primary Central Nervous System Lymphoma: A Scoping Review

Background: Most patients diagnosed with primary central nervous system lymphoma (PCNSL) are older than 60 years. Despite promising treatment options for younger patients, prognosis for the elderly remains poor and efficacy of available treatment options is limited. Materials and Methods: We conducted a scoping review to identify and summarize the current study pool available evaluating different types and combinations of (immuno) chemotherapy with a special focus on HCT-ASCT in elderly PCNSL. Relevant studies were identified through systematic searches in the bibliographic databases Medline, Web of Science, Cochrane Library and ScienceDirect (last search conducted in September 2020). For ongoing studies, we searched ClinicalTrials.gov, the German study register and the WHO registry. Results: In total, we identified six randomized controlled trials (RCT) with 1.346 patients, 26 prospective (with 1.366 patients) and 24 retrospective studies (with 2.629 patients). Of these, only six studies (one completed and one ongoing RCT (with 447 patients), one completed and one ongoing prospective single arm study (with 65 patients), and two retrospective single arm studies (with 122 patients)) evaluated HCT-ASCT. Patient relevant outcomes such as progression-free and overall survival and (neuro-)toxicity were adequately considered across almost all studies. The current study pool is, however, not conclusive in terms of the most effective treatment options for elderly. Main limitations were (very) small sample sizes and heterogeneous patient populations in terms of age ranges (particularly in RCTs) limiting the applicability of the results to the target population (elderly). Conclusions: Although it has been shown that HCT-ASCT is probably a feasible and effective treatment option, this approach has never been investigated within a RCT including a wide range of elderly patients. A RCT comparing conventional (immuno) chemotherapy with HCT-ASCT is crucial to evaluate benefit and harms in an un-biased manner to eventually provide older PCNSL patients with the most effective treatment

Work-related interventions for preventing back pain—protocol for a systematic review and network meta-analysis

Background!#!Back pain is a widespread health problem that accounts for substantial disability and high costs. The workplace is considered to critically affect the occurrence and persistence of back pain and therefore offers an important opportunity for preventive interventions. Various work-related intervention strategies including both single- and multicomponent interventions have been developed and evaluated so far. To determine their effectiveness, a method of analysis is needed that particularly meets the challenges of the multidimensionality and diversity of these interventions. This planned systematic review and network meta-analysis aims to compare the effects of different work-related interventions for preventing non-specific back pain in people within a formal employment-related context.!##!Methods!#!We will search the following databases: CENTRAL, MEDLINE, Web of Science, CINAHL, PsycINFO, PEDro, SPORTDiscus, and Academic Search Premier from their inception onwards, as well as additional sources. Randomized controlled trials (RCTs) and cluster-RCTs will be considered if they (1) include people within a formal employment-related context, (2) include people without back pain or mixed samples (i.e., people with and without back pain), (3) compare one or more work-related preventive intervention(s) to a control condition, and (4) assess non-specific back pain (incidence or/and pain intensity), ability to work (numbers of participants or/and numbers of days absent from work), intervention-related adverse events or/and self-reported satisfaction with the intervention. Random-effects pairwise meta-analyses and frequentist network meta-analyses will be conducted where appropriate. We will calculate summary effect sizes for each comparison of interventions and rank interventions according to their P scores. If feasible, we will conduct additional component network meta-analyses. We plan to conduct subgroup analyses for job exposure, intervention duration, baseline back pain, different localizations of back pain, and gender. Risk of bias will be assessed using RoB 2 and the certainty of the evidence will be rated using the GRADE approach.!##!Discussion!#!This systematic review aims to identify work-related intervention strategies as well as components within work-related interventions that are effective for preventing back pain. We expect the results to provide guidance for selecting the most promising interventions and foster the purposeful use of resources. Additionally, they may inform the development and implementation of work-related interventions as well as the design of future research in this field.!##!Trial registration!#!PROSPERO CRD42021232469

Oral nutrition interventions in hospitalised older people at nutritional risk: a network meta-analysis of individual participant data

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To assess in hospitalised older people with (risk of) malnutrition the effects of different nutrition interventions (e.g. supportive interventions, nutritional counselling, food modifications, oral nutritional supplements, comprehensive individualised nutritional interventions or combined approaches) compared to control groups (usual care, placebo or health education materials) on patient-relevant outcomes, and to rank the effects of the different treatments by using a network meta-analysis with individual participant data

Extração de incisivo inferior: uma opção de tratamento ortodôntico Lower incisor extraction: an orthodontic treatment option

A exodontia de um incisivo inferior pode ser considerada uma opção valiosa na busca de excelência nos resultados ortodônticos para obtenção de máxima função, estética e estabilidade. O objetivo deste estudo foi reunir informações referentes às indicações, contraindicações, vantagens, desvantagens e estabilidade dos resultados obtidos nos tratamentos realizados com extração de um incisivo inferior. Essa opção de tratamento pode ser indicada em más oclusões com discrepância de volume dentário anterior devido a incisivos superiores estreitos e/ou incisivos inferiores largos. É contraindicada em más oclusões sem discrepância anterior ou com discrepâncias ocasionadas por incisivos superiores largos e/ou incisivos inferiores estreitos. A literatura sugere maior estabilidade pós-tratamento quando comparada com a opção de extrações de pré-molares. Além do diagnóstico cuidadoso, obtido com a colaboração do set-up, a habilidade e a experiência clínica do profissional são importantes para o sucesso dos resultados ortodônticos alcançados com essa opção de tratamento<br>Lower incisor extraction can be regarded as a valuable option in the pursuit of excellence in orthodontic results in terms of function, aesthetics and stability. The aim of this study was to gather information about the indications, contraindications, advantages, disadvantages and stability of the results achieved in treatments performed with lower incisor extraction. This treatment option may be indicated in malocclusions with anterior dental volume discrepancy due to narrow maxillary incisors and/or large mandibular incisors. It is contraindicated in malocclusions without anterior discrepancy or with discrepancies caused by large maxillary incisors and/or narrow mandibular incisors. The literature suggests this method affords improved posttreatment stability compared with premolar extraction. As well as a careful diagnosis, established with the aid of a diagnostic setup, professional skills and clinical experience are instrumental in achieving successful orthodontic results with this treatment optio

Prophylactic mesh placement for the PREvention of paraSTOmal hernias: The PRESTO systematic review and meta-analysis

<div><p>Background</p><p>Parastomal hernia (PH) is the most common complication after ostomy formation. Prophylactic mesh placement may be effective in reducing the rate of PH at the stoma site. The aims of this systematic review were to summarize the evidence with regard to the safety and effectiveness in comparison with the standard procedure without mesh placement and to identify important risk constellations.</p><p>Method</p><p>A systematic literature search was performed in PubMed, EMBASE and the Cochrane library with no language or date restrictions. Randomized (RCTs) and non-randomized controlled trials (nRCTs) were included. The main outcomes of interest were PH (primary outcome) rate and stoma-related complications (secondary outcomes) such as stenosis or fistula. Statistical analysis included meta-analyses of pooled data and subgroup analyses.</p><p>Results</p><p>Eleven trials (eight RCTs; three nRCTs) with a total of 755 patients were included. PH rate varied from 0% to 59% in the intervention and from 20% to 94% in the control group. RCTs showed a significant reduction of PH rate in the mesh group (OR 0.24; 95% CI 0.10 to 0.58, p = 0.034), whereas included nRCTs did not. No significant differences were observed in postoperative complication rates. Subgroup analyses showed superiority of non-absorbable meshes and sublay mesh positioning in open surgery.</p><p>Conclusion</p><p>Prophylactic mesh placement is safe and reduces PH rate. A recommendation for prophylactic non-absorbable meshes in a sublay position can be made for patients undergoing open colorectal operations with end-ostomies. Further research endeavors should focus on patient-oriented outcomes, not only PH rate, with respect to tailored treatment in specific patient populations.</p></div