Scientific value of systematic reviews: survey of editors of core clinical journals.

BACKGROUND: Synthesizing research evidence using systematic and rigorous methods has become a key feature of evidence-based medicine and knowledge translation. Systematic reviews (SRs) may or may not include a meta-analysis depending on the suitability of available data. They are often being criticised as 'secondary research' and denied the status of original research. Scientific journals play an important role in the publication process. How they appraise a given type of research influences the status of that research in the scientific community. We investigated the attitudes of editors of core clinical journals towards SRs and their value for publication.¦METHODS: We identified the 118 journals labelled as "core clinical journals" by the National Library of Medicine, USA in April 2009. The journals' editors were surveyed by email in 2009 and asked whether they considered SRs as original research projects; whether they published SRs; and for which section of the journal they would consider a SR manuscript.¦RESULTS: The editors of 65 journals (55%) responded. Most respondents considered SRs to be original research (71%) and almost all journals (93%) published SRs. Several editors regarded the use of Cochrane methodology or a meta-analysis as quality criteria; for some respondents these criteria were premises for the consideration of SRs as original research. Journals placed SRs in various sections such as "Review" or "Feature article". Characterization of non-responding journals showed that about two thirds do publish systematic reviews.¦DISCUSSION: Currently, the editors of most core clinical journals consider SRs original research. Our findings are limited by a non-responder rate of 45%. Individual comments suggest that this is a grey area and attitudes differ widely. A debate about the definition of 'original research' in the context of SRs is warranted

CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer

Background: Current evidence supports a diverting stoma in patients undergoing low anterior resection with total mesorectal excision for rectal cancer as it reduces clinical severity of anastomotic leakage. However, relevant stoma morbidity after rectal cancer surgery exists and has a significant impact on quality of life. Moreover, a diverting stoma has an influence on completeness of chemotherapy but it remains unclear in which way. There is no evidence regarding optimal timing for stoma closure in relation to adjuvant chemotherapy. Two randomised controlled trials have studied early stoma closure after low anterior resection in patients with rectal cancer, one of them showing that early closure around day 8 after resection is possible without increasing morbidity. Methods/Design: CoCStom is a randomised multicentre trial comparing completeness of adjuvant chemotherapy as primary endpoint after early (8–10 days after resection, before starting adjuvant therapy) versus late (~26 weeks after resection and completion of adjuvant therapy) stoma closure in patients with locally advanced rectal cancer undergoing low anterior resection after neoadjuvant therapy. After exclusion of post-operative anastomotic leakage 257 patients from 30 German hospitals are planned to be included in order to assure a power of 80 % for the confirmatory analysis of at least 214 evaluable cases. An absolute increase of 20 % for the rate of completely administered adjuvant chemotherapy is regarded as a clinically meaningful step forward and serves as basis for sample size calculation. Quality of life, stoma-related complications, individual completeness of chemotherapy rate, percentage of patients stopping adjuvant therapy or undergoing dose modifications or delay, oncological outcomes, cumulative days of hospitalisation and number of readmissions, rate of symptomatic anastomotic leaks after stoma closure, mortality, post-operative complications and toxicity of adjuvant chemotherapy are secondary endpoints. Discussion: The CoCStom trial aims to clarify optimal timing of stoma closure in the context of adjuvant chemotherapy. Depending on the results of the trial, patients could benefit either from early or late stoma closure in regard to long term oncological survival due to a higher rate of completeness of adjuvant chemotherapy treatment and thus better effectiveness. Trial registration: German Clinical Trials Register, DRKS00005113 . Registered 28 August 201

Digital Support to Multimodal Community-Based Prehabilitation: Looking for Optimization of Health Value Generation

Prehabilitation has shown its potential for most intra-cavity surgery patients on enhancing preoperative functional capacity and postoperative outcomes. However, its large-scale implementation is limited by several constrictions, such as: i) unsolved practicalities of the service workflow, ii) challenges associated to change management in collaborative care; iii) insufficient access to prehabilitation; iv) relevant percentage of program drop-outs; v) need for program personalization; and, vi) economical sustainability. Transferability of prehabilitation programs from the hospital setting to the community would potentially provide a new scenario with greater accessibility, as well as offer an opportunity to effectively address the aforementioned issues and, thus, optimize healthcare value generation. A core aspect to take into account for an optimal management of prehabilitation programs is to use proper technological tools enabling: i) customizable and interoperable integrated care pathways facilitating personalization of the service and effective engagement among stakeholders; ii) remote monitoring (i.e. physical activity, physiological signs and patient-reported outcomes and experience measures) to support patient adherence to the program and empowerment for self-management; and, iii) use of health risk assessment supporting decision making for personalized service selection. The current manuscript details a proposal to bring digital innovation to community-based prehabilitation programs. Moreover, this approach has the potential to be adopted by programs supporting long-term management of cancer patients, chronic patients and prevention of multimorbidity in subjects at risk

A toolbox for a structured risk-based prehabilitation program in major surgical oncology

Prehabilitation is a multimodal concept to improve functional capability prior to surgery, so that the patients’ resilience is strengthened to withstand any peri- and postoperative comorbidity. It covers physical activities, nutrition, and psychosocial wellbeing. The literature is heterogeneous in outcomes and definitions. In this scoping review, class 1 and 2 evidence was included to identify seven main aspects of prehabilitation for the treatment pathway: (i) risk assessment, (ii) FITT (frequency, interventions, time, type of exercise) principles of prehabilitation exercise, (iii) outcome measures, (iv) nutrition, (v) patient blood management, (vi) mental wellbeing, and (vii) economic potential. Recommendations include the risk of tumor progression due to delay of surgery. Patients undergoing prehabilitation should perceive risk assessment by structured, quantifiable, and validated tools like Risk Analysis Index, Charlson Comorbidity Index (CCI), American Society of Anesthesiology Score, or Eastern Co-operative Oncology Group scoring. Assessments should be repeated to quantify its effects. The most common types of exercise include breathing exercises and moderate- to high-intensity interval protocols. The program should have a duration of 3–6 weeks with 3–4 exercises per week that take 30–60 min. The 6-Minute Walking Testing is a valid and resource-saving tool to assess changes in aerobic capacity. Long-term assessment should include standardized outcome measurements (overall survival, 90-day survival, Dindo–Clavien/CCI®) to monitor the potential of up to 50% less morbidity. Finally, individual cost-revenue assessment can help assess health economics, confirming the hypothetic saving of $8 for treatment for$1 spent for prehabilitation. These recommendations should serve as a toolbox to generate hypotheses, discussion, and systematic approaches to develop clinical prehabilitation standards

Management of colorectal anastomotic leakage using endoscopic negative pressure therapy with or without protective ostomy: a retrospective study

Purpose!#!Management of colorectal anastomotic leakage (AL) is patient-oriented and requires an interdisciplinary approach. We analyzed the management of AL according to its severity and presence of ostomy and proposed a therapy algorithm.!##!Methods!#!We identified all patients who underwent colorectal surgery and developed an AL in our clinic between 2012 and 2017. The management of AL was retrospectively analyzed according to the severity grade: asymptomatic (A), requesting interventional or antibiotic therapy (B), undergoing re-operation (C). The groups were compared according to the leakage characteristics, presence of ostomy, and patient clinical conditions.!##!Results!#!We identified 784 consecutive patients meeting the inclusion criteria. Of these, 10.8% experienced an AL (A = 18%, B = 48%, and C = 34%). The rate of successful ostomy closure was 100% (A), 68% (B), and 62% (C), respectively. Within group B, 91% of the patients were treated solely by endoscopic negative pressure therapy (ENPT), whereas 37% of the patients within group C required ENPT in addition to surgery. Seven cases within group B (17%) required no protective ostomy (nOB) during ENPT which was itself shorter and required less cycles in comparison to group B with ostomy (OB) (p = 0.017 and 0.111, respectively). Moreover, the leakage distance to anal verge was higher in the OB subgroup (p < 0.001).!##!Conclusion!#!ENPT for the treatment of colorectal AL is efficient in combination with operative revision or protective ostomy. In selected patients, it is feasible also in the absence of a protective ostomy

Transabdominal laparoscopic retroperitoneal neurectomy for chronic pain after inguinal hernia repair and appendicectomy –a matched-pair study

Abstract Background Chronic debilitating pain is a rare but significant cause of postoperative morbidity after inguinal surgery. Such pain is usually of neuropathic origin and frequently caused by intraoperative nerve damage. In this retrospective matched-pair study we analysed results of a minimal-invasive approach to neurectomy on quality of life and pain relief. Methods From March 2010 to January 2012, 9 patients developing chronic neuropathic pain after inguinal hernia repair (8 patients) or open appendicectomy (one patient) were operated using a laparoscopic transabdominal approach in our department. Clinical examinations and specific questionnaires on pain and quality of life (PainDetect, SF-36) were completed 6 months to 3 years after neurectomy. Every patient was matched with one patient without chronic pain. Results Seven of nine patients had severe or very severe pain before neurectomy, two had mild pain but refused a conservative treatment. Four patients were free of pain after neurectomy, three described an improved pain status, whereas two did not observe any change in pain. Within a follow-up period of 14,3 months, no deterioration of pain or other complications were observed. Patients who underwent neurectomy had significantly lower quality of life compared to the control group. No postoperative complications were observed. Conclusions Laparoscopic transabdominal neurectomy represents a possible surgical approach in treating patients with chronic disabling postoperative groin pain requiring surgery. This technique was feasible, safe, and effective in our series to relieve chronic debilitating pain in the majority of our patients with comparable results to other published approaches

Influence of complete administration of adjuvant chemotherapy cycles on overall and disease-free survival in locally advanced rectal cancer: post hoc analysis of a randomized, multicenter, non-inferiority, phase 3 trial

Abstract Background A randomized trial demonstrated that capecitabine is at least as effective as fluorouracil in the adjuvant treatment of patients with locally advanced rectal cancer. However, not all patients receive all planned cycles of chemotherapy. Therefore it is of interest how complete or partial administration of chemotherapy influences oncological outcome. Methods A post hoc analysis of a trial with 401 randomized patients, nine being excluded because of missing data, was performed. 392 patients (197 - capecitabine, 195 - fluorouracil) could be analyzed regarding the number of administered adjuvant chemotherapy cycles. In the subgroup of 361 patients with an overall survival of at least six months, five-year overall and disease-free survival were analyzed in respect to completion (complete vs. incomplete) of chemotherapy cycles. Survival rates and curves were calculated and compared using the log-rank test. The effect of completion of chemotherapy was adjusted for relevant confounding factors. Results Two hundred fifty-one (64.0%) of analyzed patients received all postoperative scheduled cycles. Five-year overall survival was significantly better in these patients compared to the incomplete group (76.0 vs. 60.6%, p < 0.0001). Of 361 patients with an overall survival of at least six months, 251(69.5%) patients received all cycles. Five-year overall survival was also significantly better than in the incomplete group (76.0 vs. 66.4%, p = 0.0073). Five-year disease free survival was numerically better (64.9 vs. 58.7%, p = 0.0646; HR [not all cycles vs. all cycles] = 1.42 95% CI: [0.98, 2.07]). Cox regression models show a non-significant better OS (p = 0.061) and DFS (p = 0.083), if chemotherapy cycles were administered completely. Conclusion Complete administration of chemotherapy cycles was associated with improved five-year overall and disease-free survival in patients with locally advanced rectal cancer

Prehabilitation, making patients fit for surgery – a new frontier in perioperative care

Optimizing a patients’ condition before surgery to improve the postoperative outcome can be achieved by using prehabilitation; preoperative interventions focusing on modifiable risk factors to improve the physical, nutritional, and mental status of the patient. A multimodal, multidisciplinary approach induces a synergistic effect between the various interventions and affects the outcome postoperatively. While awaiting higher-quality evidence, the worldwide implementation of prehabilitation programs has started, resulting in a true revolution in perioperative care

Status of systematic reviews – results of survey of journal editors.

*<p>multiple answers possible.</p