Colorectal cancer (CRC) is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for ...evaluating surgery is within well-designed randomized controlled trials (RCTs); however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard "core" set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery.
The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals) from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods). Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78%) centers, including 90 professionals, and 97 out of 267 (35%) patients. Second round response rates were high for all stakeholders (>80%). Analysis of responses lead to 45 and 23 outcome domains being retained after the first and second surveys, respectively. Consensus meetings generated agreement on a 12 domain COS. This constituted five perioperative outcome domains (including anastomotic leak), four quality of life outcome domains (including fecal urgency and incontinence), and three oncological outcome domains (including long-term survival).
This study used robust consensus methodology to develop a core outcome set for use in colorectal cancer surgical trials. It is now necessary to validate the use of this set in research practice.
Synthesis of patient-reported outcome (PRO) data is hindered by the range of available PRO measures (PROMs) composed of multiple scales and single items with differing terminology and content. The ...use of core outcome sets, an agreed minimum set of outcomes to be measured and reported in all trials of a specific condition, may improve this issue but methods to select core PRO domains from the many available PROMs are lacking. This study examines existing PROMs and describes methods to identify health domains to inform the development of a core outcome set, illustrated with an example.
Systematic literature searches identified validated PROMs from studies evaluating radical treatment for oesophageal cancer. PROM scale/single item names were recorded verbatim and the frequency of similar names/scales documented. PROM contents (scale components/single items) were examined for conceptual meaning by an expert clinician and methodologist and categorised into health domains. A patient advocate independently checked this categorisation.
Searches identified 21 generic and disease-specific PROMs containing 116 scales and 32 single items with 94 different verbatim names. Identical names for scales were repeatedly used (for example, 'physical function' in six different measures) and others were similar (overlapping face validity) although component items were not always comparable. Based on methodological, clinical and patient expertise, 606 individual items were categorised into 32 health domains.
This study outlines a methodology for identifying candidate PRO domains from existing PROMs to inform a core outcome set to use in clinical trials.
Abstract Objective To systematically review audio-visual (AV) interventions for promoting informed consent (IC) in clinical practice and to consider the impact of reading age adjustment. Methods ...Systematic review of randomized controlled trials (RCTs) comparing AV interventions to standard IC in clinical practice. Outcomes included recall (immediate <1 day; intermediate 1–14 days; late >14 days), satisfaction and anxiety. Data were synthesized using random effects meta-analyses. Comparisons were made between studies that did and did not adjust for participant reading age. Results Of 11,813 abstracts screened, 29 RCTs were eligible (30 intervention arms). Interventions included videos ( n = 17), computer programs ( n = 5), electronic presentations ( n = 3), compact discs ( n = 3) and websites ( n = 2). Meta-analysis showed AV interventions improved immediate recall (standardized mean difference SMD 0.64, 95% confidence interval CI 0.45–0.85). Results for intermediate and late recall were too heterogeneous to synthesize. AV interventions did not consistently affect either satisfaction or anxiety. Adjusting the reading age of interventions improved immediate recall (reading age interventions: adjusted SMD 1.21, 95%CI 0.81–1.61; non-reading age adjusted SMD 0.51, 95%CI 0.36–0.66). Conclusion AV interventions, especially those adjusted for participant reading age, improve immediate information recall for IC. Practice implications Wider use of AV aids is justified when obtaining IC in clinical practice.
OBJECTIVES
Video-assisted thoracoscopic surgery (VATS) for thymoma has uncertain safety and effectiveness in comparison with trans-sternal resection. This feasibility study compared short- and ...mid-term outcomes for patients undergoing these two procedures, highlights weaknesses in current research and makes recommendations for long-term technological evaluations in this field.
METHODS
Consecutive thymoma cases between 2004 and 2010 were identified. Patients were divided into two groups according to surgical approach (Group I trans-sternal; Group II VATS) and comparisons were made between groups. The primary outcome was overall survival. Secondary outcomes included operative morbidity and mortality, hospital stay, recurrence rate and disease-free survival.
RESULTS
Thirty-nine patients were included (Group I: n = 22 vs Group II: n = 17). There were no differences between groups at baseline for all measured covariates. No deaths occurred within 30 days of surgery. More patients in Group I developed complications (Group I: n = 10 vs Group II: n = 3; P = 0.093), while hospital stay was shorter in Group II (Group I: 6.4 ± 4.6 days vs Group II: 4.4 ± 1.8 days; P = 0.030). Five-year overall survival (Group I: 93.8 ± 6.1% vs Group II: 83.3 ± 11.2%; P = 0.425), 5-year disease-free survival (Group I: 71.0 ± 15.3% vs Group II: 83.3 ± 11.2%; P = 0.827) and recurrence rates at final follow-up (Group I: n = 2 vs Group II: n = 1; P = 0.363) were similar between the groups.
CONCLUSION
VATS thymectomy for thymoma is feasible, safe and has comparable mid-term oncological outcomes to trans-sternal thymectomy. Future research is required to evaluate long-term oncological outcomes of VATS thymectomy for thymoma in national registries and randomized, controlled trials.
Long-term outcomes of concomitant aortic and mitral valve repair Vohra, Hunaid A., MRCS, MD, FRCS (CTh), FETCS; Whistance, Robert N., MRCS; Hechadi, Jawad, MD ...
The Journal of thoracic and cardiovascular surgery,
08/2014, Letnik:
148, Številka:
2
Journal Article
Recenzirano
Odprti dostop
Objective To evaluate the short- and long-term outcomes of concomitant aortic (AVr) and mitral (MVr) valve repair. Methods This retrospective analysis of prospectively collected data identified ...patients who had undergone AVr and MVr surgery from March 1996 to October 2009. Patients were included if they had undergone combined repair on the aortic and mitral valves. Excluded were those <18 years in whom valve replacement was performed. Data were collected on the short-term morbidity and mortality (<30 postoperative days), long-term survival, and freedom from valve-related events and echocardiographic outcomes. Results A total of 65 patients underwent AVr and MVr (mean age, 56.4 ± 15.8 years, 46 men). Preoperatively, 30 patients (46.1%) had aortic insufficiency (AI) >2+, 20 patients had AI ≥2+ with aortic dilatation (30.7%), and 4 patients (6.1%) had aortic dilatation only. Of the 65 patients, 57 had tricuspid (87.6%) and 8 had bicuspid aortic valves (12.3%). All patients had mitral insufficiency preoperatively. One in-hospital death occurred (1.5%). At discharge, no patient had AI >2+ versus 30 patients preoperatively ( P < .001), and 7 patients had AI >1+ versus 61 patients preoperatively ( P < .001). At discharge, the mean left ventricular end-diastolic diameter was 48 ± 7 mm versus 59 ± 9 mm preoperatively ( P < .007), and the mean left ventricular end-systolic diameter was 33 ± 5 mm versus 38 ± 14 mm preoperatively ( P = .36). The mean clinical follow-up duration was 62 ± 45 months (median, 50; range, 1-177). At the latest follow-up visit, 17 patients were New York Heart Association class ≥2 versus 52 patents preoperatively ( P < .001). Four cardiac deaths occurred, and at 1, 5, and 10 years, the freedom from cardiac death was 100%, 93.4% ± 3.7%, and 88.5% ± 5.9%, respectively. Eight valve reinterventions were required, and the freedom from valve reintervention at 1, 5, and 10 years was 95.3% ± 2.6%, 91.6% ± 3.6%, and 78.4% ± 8.0%, respectively. At 1, 5, and 10 years, the freedom from AI 2+ was 98.2% ± 1.7%, 93.4% ± 3.7%, and 88.3% ± 5.8% and the freedom from mitral insufficiency 2+ was 96.4% ± 2.4%, 93.3% ± 3.8%, and 93.3% ± 3.8%, respectively. Conclusions Concomitant AVr/MVr is associated with acceptable survival and freedom from valve reintervention.
Valve repair has emerged as an important intervention for the management of bicuspid aortic valve disease. This systematic review aims to assess the safety, efficacy and durability of bicuspid aortic ...valve repair. Initial searches yielded 682 abstracts, reduced by de-duplication to 370, of which 56 full papers were accessed and 30 met the inclusion criteria. Overall, 163 unique outcomes for bicuspid aortic valve-preserving surgery were reported on 280 occasions. Bicuspid aortic valve-preserving surgery exhibited low operative mortality (0.0-5.2%), excellent 5-year survival (82-100%) and 43-100% 5-year freedom from reoperation. Bicuspid aortic valve repair is safe and efficacious, but concerns regarding its durability necessitate further standardized outcome assessments.
The aim of this study was to investigate the early and late outcomes of patients undergoing pulmonary embolectomy for acute massive pulmonary embolus.
Twenty-one patients (15 male, 6 female) ...underwent pulmonary embolectomy at our institution between March 2001 and July 2010. The median age was 55 years (range, 24 to 70 years). Of these, 9 patients presented with out-of-hospital cardiac arrest and 8 presented with New York Heart Association class III or IV. Sixteen patients underwent preoperative transthoracic echocardiography, which showed evidence of right ventricular dilatation in all, whereas in 14 patients (66.6%) pulmonary artery pressures were significantly elevated with moderate to severe tricuspid regurgitation. The median preoperative Euroscore was 9 (range, 3 to 16), and 11 patients (52.1%) received systemic thrombolysis preoperatively. There were 6 salvage (28.5%), 10 emergency (47.6%), and 5 urgent (23.8%) procedures. Concomitant procedures were performed in 3 patients (14.2%), and surgery was performed without the use of cardiopulmonary bypass in 3 patients (14.2%). The median follow-up was 38 months (range, 0 to 114 months).
The in-hospital mortality was 19% (n = 4). Postoperative complications included stroke (n = 3, 14.2%), lower respiratory tract infection (n = 6, 28.5%), wound infection (n = 3, 14.2%), acute renal failure requiring hemofiltration (n = 4, 19%), and supraventricular tachyarrhythmias (n = 4, 19%). At discharge, transthoracic echocardiography showed mild to moderate right ventricular dysfunction and dilatation in 11 survivors (64.7%). Two patients died during follow-up, and actuarial survival at 5 years was 76.9% ± 10.1% and at 8 years was 51.2% ± 22.0%. At final follow-up, 11 of the 15 survivors (73.3%) were New York Heart Association class I, and no patients required further intervention.
Patients who undergo surgery for massive pulmonary embolism have an acceptable outcome despite being high-risk.
The aim of this study was to investigate the overall outcome of adult patients undergoing redo-mitral valve replacement (redo-MVR) at our institution. Forty-nine patients (24 males) underwent ...redo-MVR with either bioprosthetic (n = 24) or mechanical valves (n = 25) between January 2000 and 2010. Median age of patients was 63 years (range 21-80 years), and the mean additive EuroSCORE was 12 ± 4. Median time to re-operation was 8.2 ± 6.6 years for first time redo-MVR and 6.4 ± 5.6 years for second-time redo-MVR. Indications included prosthetic endocarditis (n = 22), para-prosthetic leak (n = 12), structural valve degeneration (n = 8), prosthetic valve thrombosis (n = 6) and malignancy (n = 1). The mean follow-up was 47.5 ± 37.0 months (range 0.1-112.3 months). In-hospital mortality was 12% (n = 6). Mean hospital stay was 17 ± 11 days (range 8-50 days). Actuarial survival at 1 and 5 years was 81 ± 5% and 72 ± 6%, respectively. Three patients required re-intervention: two for prosthetic valve endocarditis and one for para-prosthetic leak. Multivariate analysis showed that overall survival was associated with the LVEF < 50% (P < 0.001), concomitant AVR (P < 0.001) and urgent surgery (P = 0.03).
OBJECTIVES
Significant mitral regurgitation (MR) may arise from isolated annular dilatation secondary to lone atrial fibrillation (AF) and associated atrial remodelling. The aim of the present study ...is to assess the outcome of surgery for this condition.
METHODS
Between November 2007 and July 2011, 20 patients underwent mitral valve (MV) repair for severe MR secondary to AF. The median age of patients was 77.5 years (45-82 years) and the mean pre-operative duration of AF was 84.6 ± 92 months. The left ventricle was moderately (ejection fraction 30-50%; n = 6) or severely (<30%; n = 1) impaired in seven patients pre-operatively. Mean logistic EuroSCORE was 8.1 ± 5.9 and mean follow-up was 18.0 ± 12.5 months.
RESULTS
All operations were elective. Concomitant anti-arrhythmic procedures (maze procedure, pulmonary vein isolation) or left atrial (LA) appendage amputation were performed in all patients; tricuspid valve repair was undertaken in 12 patients and coronary artery bypass grafting in 2 patients. Ring annuloplasty was performed in all patients. The median ring size was 30 mm (range 24-36 mm). On-table transoesophageal echocardiography post-repair showed mild residual MR in two patients and no MR in the remainder. There were no cases of systolic anterior motion. There was one re-exploration for bleeding. No patients required haemofiltration or suffered from stroke and deep sternal wound infections. There was no in-hospital mortality. At discharge mean left ventricular (LV) end-diastolic diameter was 4.8 ± 0.7 cm compared with 5.6 ± 0.7 cm pre-operatively (P < 0.005), while mean LV end-systolic diameter was 3.2 ± 0.8 cm when compared with 4.0 ± 0.7 cm pre-operatively (P < 0.005). The mean LA size was 5.2 ± 1.0 cm when compared with 6.1 ± 1.6 cm pre-operatively (P = 0.03). There was mild MR in two patients, but none in the rest. The mean MV area was 3.0 ± 0.7 cm2. The mean systolic pulmonary artery pressure was 40.4 ± 15.5 mmHg when compared with 54.1 ± 12.2 mmHg pre-operatively (P = 0.02). Seventeen patients (85%) were in NYHA class I/II at latest follow-up (P < 0.0001 vs pre-operatively). During follow-up, there were no thrombo-embolic complications, re-operation, endocarditis or deaths.
CONCLUSIONS
MV annuloplasty for annular dilatation secondary to AF has a good mid-term outcome.
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