Shruti Jayakumar

Reporting trends of randomised controlled trials in heart failure with preserved ejection fraction: a systematic review.

Background Heart failure with preserved ejection fraction (HFpEF) causes significant cardiovascular morbidity and mortality. Current consensus guidelines reflect the neutral results from randomised controlled trials (RCTs). Adequate trial reporting is a fundamental requirement before concluding on RCT intervention efficacy and is necessary for accurate meta-analysis and to provide insight into future trial design. The Consolidated Standards of Reporting Trials (CONSORT) 2010 statement provides a framework for complete trial reporting. Reporting quality of HFpEF RCTs has not been previously assessed, and this represents an important validation of reporting qualities to date. Objectives The aim was to systematically identify RCTs investigating the efficacy of pharmacological therapies in HFpEF and to assess the quality of reporting using the CONSORT 2010 statement. Methods MEDLINE, EMBASE and CENTRAL databases were searched from January 1996 to November 2015, with RCTs assessing pharmacological therapies on clinical outcomes in HFpEF patients included. The quality of reporting was assessed against the CONSORT 2010 checklist. Results A total of 33 RCTs were included. The mean CONSORT score was 55.4% (SD 17.2%). The CONSORT score was strongly correlated with journal impact factor (r=0.53, p=0.003) and publication year (r=0.50, p=0.003). Articles published after the introduction of CONSORT 2010 statement had a significantly higher mean score compared with those published before (64% vs 50%, p=0.02). Conclusions Although the CONSORT score has increased with time, a significant proportion of HFpEF RCTs showed inadequate reporting standards. The level of adherence to CONSORT criteria could have an impact on the validity of trials and hence the interpretation of intervention efficacy. We recommend improving compliance with the CONSORT statement for future RCTs.

Microlobectomy—where do we stand?

Video-assisted thoracoscopic surgery (VATS) have been shown to be superior to open procedures, particularly with regards to pain and post-operative recovery, though high-levels of pain may still be reported due to large intercostal port sizes. Microlobectomy is a novel endoscopic lobectomy technique building on VATS lobectomies, with the principle that there are no intercostal ports larger than 5 mm. CO 2 insufflation is used to improve access to the chest and a 12 mm subxiphoid port is created to function as a utility port and can be extended further to facilitate specimen removal. All instruments utilized are 5 mm in size, including a 5 mm camera. However, a standard 12 mm stapler can be used through the subxiphoid incision, which provides excellent access to all the hilar structures bilaterally. Additionally, newer instruments are being developed to facilitate easier improved dissection of vascular structures and lymph nodes, such as the FlexDex needle holder, which is an articulated endoscopic needle holder facilitating movements in all directions, similar to a robotic instrument. The main advantage of a microlobectomy is reduced post-operative pain and shorter time to mobilisation, enabling a faster recovery. In our experience of microlobectomies, we have had patients successfully discharged on the first post-operative day. The development of a greater variety of 5 mm instruments that are similar to conventional VATS instruments may enable more surgeons globally to adopt the microlobectomy approach.

99m Technetium and methylene blue guided pulmonary nodules resections: preliminary British experience

Background Subcentimetre pulmonary nodules can be challenging to locate either during video-assisted thoracoscopic surgery (VATS) or by open techniques. In an era of increasing computed tomography scan availability the number of nodules that are identified that are suspicious for malignancy is rising, and thoracic surgeons require a reliable method to locate these nodules intraoperatively. Methods Our aim was to evaluate, for the first time in the UK, resection of pulmonary nodules using radioactive dye labelling. Local research ethics approval was obtained and the study was submitted to the Integrated Research Application System (IRAS). All data were prospectively collected in our dedicated thoracic surgical database and analyzed at the conclusion of the study. This represents a consecutive series of patients, from January 2016 and until April 2017, who underwent this procedure at our institution: James Cook University Hospital, Middlesbrough, United Kingdom. The primary outcome measured was successful resection rate of the target nodules. Results Twenty-three patients underwent radiolabeled excision of pulmonary nodules, their average age was 61 years (range, 28-79 years), 13 women and 10 men. The average maximum diameter of the nodule was 8 mm (range, 3-16 mm). All patients underwent successful excision of the target lesion (success rate 100%). One patient (4.3%) sustained pneumothorax following the CT-guided injection of the radio-labelled dye and this required chest drainage prior to general anesthesia. Conclusions We conclude that technetium guided pulmonary nodule resection is a very reliable method for localization and resection of subcentimetre nodules which may be otherwise be difficult to identify.

Left video-assisted thoracoscopic surgery for hemidiaphragm traumatic rupture repair

Diaphragmatic laceration is not a rare condition after blunt thoraco-abdominal trauma following road traffic accidents. Diagnosis is sometime difficult and clinical presentation devious. Video-assisted thoracic surgery is a safe approach in order to confirm diagnosis and treat, like in this this case of an 86-year-old lady with grade IV injury.

Reporting trends of randomised controlled trials in heart failure with preserved ejection fraction

Background Heart failure with preserved ejection fraction (HFpEF) causes significant cardiovascular morbidity and mortality. Current consensus guidelines reflect the neutral results from randomised controlled trials (RCTs). Adequate trial reporting is a fundamental requirement before concluding on RCT intervention efficacy and is necessary for accurate meta-analysis and to provide insight into future trial design. The Consolidated Standards of Reporting Trials (CONSORT) 2010 statement provides a framework for complete trial reporting. Reporting quality of HFpEF RCTs has not been previously assessed, and this represents an important validation of reporting qualities to date. Objectives The aim was to systematically identify RCTs investigating the efficacy of pharmacological therapies in HFpEF and to assess the quality of reporting using the CONSORT 2010 statement. Methods MEDLINE, EMBASE and CENTRAL databases were searched from January 1996 to November 2015, with RCTs assessing pharmacological therapies on clinical outcomes in HFpEF patients included. The quality of reporting was assessed against the CONSORT 2010 checklist. Results A total of 33 RCTs were included. The mean CONSORT score was 55.4% (SD 17.2%). The CONSORT score was strongly correlated with journal impact factor (r=0.53, p=0.003) and publication year (r=0.50, p=0.003). Articles published after the introduction of CONSORT 2010 statement had a significantly higher mean score compared with those published before (64% vs 50%, p=0.02). Conclusions Although the CONSORT score has increased with time, a significant proportion of HFpEF RCTs showed inadequate reporting standards. The level of adherence to CONSORT criteria could have an impact on the validity of trials and hence the interpretation of intervention efficacy. We recommend improving compliance with the CONSORT statement for future RCTs.

Original research article: Reporting trends of randomised controlled trials in heart failure with preserved ejection fraction: a systematic review

Background Heart failure with preserved ejection fraction (HFpEF) causes significant cardiovascular morbidity and mortality. Current consensus guidelines reflect the neutral results from randomised controlled trials (RCTs). Adequate trial reporting is a fundamental requirement before concluding on RCT intervention efficacy and is necessary for accurate meta-analysis and to provide insight into future trial design. The Consolidated Standards of Reporting Trials (CONSORT) 2010 statement provides a framework for complete trial reporting. Reporting quality of HFpEF RCTs has not been previously assessed, and this represents an important validation of reporting qualities to date. Objectives The aim was to systematically identify RCTs investigating the efficacy of pharmacological therapies in HFpEF and to assess the quality of reporting using the CONSORT 2010 statement. Methods MEDLINE, EMBASE and CENTRAL databases were searched from January 1996 to November 2015, with RCTs assessing pharmacological therapies on clinical outcomes in HFpEF patients included. The quality of reporting was assessed against the CONSORT 2010 checklist. Results A total of 33 RCTs were included. The mean CONSORT score was 55.4% (SD 17.2%). The CONSORT score was strongly correlated with journal impact factor (r=0.53, p=0.003) and publication year (r=0.50, p=0.003). Articles published after the introduction of CONSORT 2010 statement had a significantly higher mean score compared with those published before (64% vs 50%, p=0.02). Conclusions Although the CONSORT score has increased with time, a significant proportion of HFpEF RCTs showed inadequate reporting standards. The level of adherence to CONSORT criteria could have an impact on the validity of trials and hence the interpretation of intervention efficacy. We recommend improving compliance with the CONSORT statement for future RCTs.

3 Reporting Quality of Randomised Controlled Trials Investigating Efficacy of Pharmacological Therapies for Heart Failure with Preserved Ejection Fraction

Introduction Randomised controlled trials (RCT) provide the highest level of evidence on healthcare interventions. Accurate interpretation of results and meta-analysis requires adequate reporting. The CONSORT statement, first published in 1996 and later revised in 2001 and 2010, aims to improve reporting quality of RCTs. Heart failure with preserved ejection fraction (HFPEF) is a major cause of morbidity and mortality, comparable to HF with reduced ejection fraction. While many studies have investigated the efficacy of various pharmacological agents, scarcity of consensus guidelines reflects the conflicting results generated from such RCTs. The aims of this study are to: 1) systematically identify RCTs investigating the efficacy of pharmacological therapies in HFPEF, 2) assess reporting quality with CONSORT 2010 statement and 3) identify trends in reporting quality. Methods Medline, EMBASE and CENTRAL were systematically searched from 1 January 1996 to 1 September 2015 using pre-specified inclusion-exclusion criteria (Table 1). Titles and abstracts were assessed for relevance. Full texts were independently assessed by three authors for inclusion. Reporting quality was independently assessed by two authors using the CONSORT 2010 score, with each item scored and weighted equally. An overall reporting quality score was calculated for each study. Statistical analysis was performed with SPSS.Abstract 3 Table 1 Example search strategy and inclusion/exclusion criteria HFPEF search strategy for Ovid MEDLINE(R) 1. Heart failure2. Normal ejection fraction3. Preserved cardiac function4. Preserved ejection fraction5. 1 and 26. 1 and 37. 1 and 48. Diastolic heart failure9. Diastolic dysfunction10. HFPEF11. HFNEF12. or/5–11 Inclusion criteria 1. Randomised controlled trial2. Trial inclusion criteria specifying heart failure signs and symptoms, left ventricular ejection fraction >40%3. Pharmacological intervention with placebo or other pharmacological comparison4. Outcomes including all-cause and cardiovascular mortality, hospitalisation, changes in NYHA class, exercise capacity (6-min walking distance, VO2Max) or quality of life Exclusion criteria 1. Non-English language2. Abstracts or conference publication3. Unpublished studies4. Healthy controls Results Initial search identified 3426 studies; 32 were included in the final analysis. There was inter-observer agreement for 1078 out of 1184 values (91.1%); Cohen’s kappa score for inter-observer variability was 0.85. The mean score was 55.3% (range 23.3--93.8%, SD 17.3%). Under half of published studies (41%, 13/32) did not adequately report more than half of all relevant sections. The best reported criteria, where applicable, were protocol referencing (criterion 24) (100%, 12/12), interim analysis (7b) (100%, 6/6), changes to methods (3b) (100%, 6/6), statistical methods (12a) (96.9%, 31/32) and result interpretation (22) (96.9%, 31/32). The worst reported were reporting of binary outcomes (17b) (0%, 0/7), abstract (1b) (9.4%, 3/32), allocation concealment mechanism (9) (12.5%, 4/32) and trial ending (14b) (12.5%, 4/32) (Figure 1). The reporting scores showed highly significant correlation with journal impact factor (r = 0.54, P < 0.01), 5-year impact factor (r = 0.49, P < 0.01) and publication year (r = 0.49, P < 0.01). Mean scores increased after publication of each updated CONSORT statement: from 41.0% (range 38.7–43.3%, SD 3.3) to 48.6% (30.0--77.8%, SD 14.5) after CONSORT 2001 (p = 0.53), and from 48.6% to 63.3% (23.3–93.8% SD 17.6) after CONSORT 2010 (P = 0.02) (Figure 2).Abstract 3 Figure 1 Percentage of studies adequately reporting each CONSORT 2010 checklist item where applicableAbstract 3 Figure 2 Individual study CONSORT 2010 score (open) grouped by available CONSORT statement (1996, 2001 or 2010) at time of study publication. Mean score (filled) shows increasing mean scores with revisions to CONSORT statement. Increase after introduction of CONSORT 2010 was significant (difference +13.1%, P = 0.02) Conclusion This study identified all RCTs involving pharmacological interventions in HFPEF, and demonstrated that while reporting standards have improved with time, at present the majority of studies do not meet the CONSORT standards for reporting of RCTs. Better compliance is needed.