Measuring the impact of monoclonal antibody therapies.

Objective: Monoclonal antibody (Mab) treatments have significantly improved the quality and quantity of life, but they are some of the most expensive treatments, resulting in a degree of hesitancy to introduce new Mab agents. A system for estimating the effect of Mab drugs, in general, would optimally inform health strategy and fully realize how a single scientific discovery can deliver health benefits. We evaluated such a method with several well-established Mab regimens. Methods: We selected five different Mab regimens in oncology and rheumatology in England. We carried out two systematic literature reviews and meta-analyses to assess health outcomes (Health Assessment Questionnaire-Disability Index for rheumatoid arthritis; overall mortality for melanoma) from real-world data and compared them to the outcomes from randomized control trials (RCTs). We applied economic modeling to estimate the net monetary benefits for health outcomes for the estimated patient population size for each Mab regimen. Results: Meta-analyses of 27 eligible real-world data (RWD) sets and 26 randomized controlled trial (RCT) sets found close agreement between the observed and expected health outcomes. A Markov model showed the net positive monetary benefit in three Mab regimens and the negative benefit in two regimens. However, because of limited access to NHS data, the economic model made several assumptions about the number of treated patients and the cost of treatment to the NHS, the accuracy of which may affect the estimation of the net monetary benefit. Conclusion: RCT results reliably inform the real-world experience of Mab treatments. Calculation of the net monetary benefit by the algorithm described provides a valuable overall measure of the health impact, subject to the accuracy of data inputs. This study provides a compelling case for building a comprehensive, systematized, and accessible database and related analytics, on all Mab treatments within health services.

Validation and reliability of Global Operative Assessment of Laparoscopic Skills for surgical residents and consultants.

OBJECTIVE: To institute and validate the Global Assessment of Laparoscopic Surgery score as a measure of intraoperative performance. METHODS: The observational study was conducted at the Services Hospital, Lahore, and the National Hospital and Medical Centre, Lahore, from August 1, 2013, to February 28, 2014, and comprised Residents, Senior Registrars and Consultants who were divided into 3 groups. The Junior group comprised Residents from years 1, 2 and3; the Intermediate group had year 4 Residents and Senior Registrars; and the Senior group included Consultants. All participants had their evaluation using Global Assessment of Laparoscopic Surgeryscore while performing dissection of gall bladder from the liver bed during laparoscopic cholecystectomy. SPSS 20 was used for statistical analysis. RESULTS: Of the 24 subjects in the study, 12(50%) were Residents, 6(25%) Senior Registrars and 6(25%) Consultants. The mean score for Junior group was 7.64±0.988, for Intermediate group 16.25±2.602 and for Senior group 22.83±1.169The score was highly reliable with intra-class coefficient 0.96, and internal consistency was excellent with Cronbach's Alpha 0.981. CONCLUSIONS: Global Assessment of Laparoscopic Surgery was found to be a valid and reliable measure of intraoperative laparoscopic skills.

Harmonic Scalpel Versus Electrocautery in Axillary Dissection in Carcinoma Breast.

OBJECTIVE: To compare the results between harmonics scalpel and electrocautery use in axillary dissection for carcinoma breast. STUDY DESIGN: Randomized controlled trial. PLACE AND DURATION OF STUDY: Department of Surgery, Services Hospital, Lahore, from December 2013 to June 2014. METHODOLOGY: Eighty patients fulfilling the inclusion criteria were selected and equally divided in two groups. Axillary dissection for carcinoma breast was performed by using the harmonic scalpel in one group and by using electrocautery in the other group. Total mean axillary drain output and frequency of axillary numbness were noted in both groups and compared. RESULTS: All the patients were females with mean age of 53.52 ± 9.8. Mean axillary drain output in harmonic scalpel group was 167.75 ± 43.90 as compared to 310.00 ± 60.09 in electrocautery group while only 12.5% of patients were positive for axillary numbness in harmonic scalpel group as compared to 100% of patients who were positive for electrocautery group. CONCLUSION: Use of harmonic scalpel in axillary dissection resulted in decreased total mean axillary drain output and lowered frequency of axillary numbness when compared to utilizing electrocautery.

Laparoscopic resection of gastro-intestinal stromal tumour.

Gastro-Intestinal Stromal Tumours are rare tumours, constituting less than 1% of gastrointestinal tumours. They are the most common mesenchymal origin tumours of gastro-intestinal tract. Tyrosine kinase c-kit oncogene mutation is found in all cases. These tumours are sensitive to imatinib. They are usually noted incidentally on endoscopy or present with haematemesis after ulceration. We are reporting the laparoscopic resection of GIST in a 67 year old male who had presented with haematemesis. He was found to have a gastric polyp on endoscopy. Endoscopic ultra-soundshowed the tumour to be arising from the submucosa. Histo-pathology showed the tumour to be GIST. Patient is currently undergoing chemotherapy.

Biodegradable Synthetic Polyurethane Foam Nasal Packing After Septoplasty.

OBJECTIVE: To determine the usefulness of biodegradable Synthetic Polyurethane Foam (SPF) nasal packing as an adjunct to day-case septoplasty. STUDY DESIGN: Comparative, observational case series. PLACE AND DURATION OF STUDY: Aberdeen Royal Infirmary, University of Aberdeen, Scotland, UK, in the year 2011. METHODOLOGY: One-hundred consecutive patients who underwent septoplasty and received SPF packing in 2010 were prospectively audited while one-hundred consecutive patients undergoing septoplasty in the year 2000 were studied retrospectively. Data collected include demographics, type of operation and duration of hospital stay. Excel and SPSS were used for data collection and analysis. RESULTS: In the year 2000, the average age of the patients was 40.6 years. There were 37 females and 63 males. One patient returned home the same day, 22 stayed one night, 69 spent two nights and 8 stayed more than two nights in hospital for their operation. The average length of stay was 1.84 nights. In 2010, the average age of patients was 37.86 years, with 31 patients being female and 69 male. All patients in this cohort received SPF packing postoperatively. Seventy-three patients went home the same day, 24 patients stayed one night and 3 patients spent two nights in hospital for their operation. Average length of hospital stay was 0.3 nights. Results were statistically significant (p < 0.001). CONCLUSION: SPF was a useful nasal packing option after septoplasty and inferior turbinate surgery, which enabled the surgeons to carry out this surgery safely as a day-case procedure.

Laparoscopic cystgastrostomy: A Pakistani perspective.

Laparoscopic Pancreatic Pseudocyst (PP) surgery can be performed via anterior or posterior cystogastrostomy, endoscopy-assisted surgery and cystojejunostomy. We conducted a prospective analysis of our patients undergoing laparoscopic cystogastrostomy to analyse the merits and demerits of the procedure. In a period of 3 years from January 2010 to December 2012 all the patients who underwent laparoscopic drainage of pancreatic pseudocysts were prospectively analysed. A total of 12 patients underwent a transgastric anterior cystogastrostomy with a stoma size of 4.5cms. There was no intraoperative or postoperative bleeding or leakage on anastomotic lines. Post-op pain score on the first post-op day was 4 (2-5) on the Visual Analogue Scale (VAS). Average hospital stay was 4.1±2.3 days. All patients had complete resolution of symptoms on follow-up. Follow-up computed tomography (CT) scans on 8 patients showed complete resolution of the cysts. Laparoscopic cystogastrostomy is a safe and feasible method and provides efficient drainage of PP.

Mesh fixation vs. non-fixation in total extra peritoneal mesh hernioplasty.

OBJECTIVE: To compare mesh fixation with non-fixation and its effect on outcome. METHODS: The interventional prospective study was conducted at the National Hospital & Medical Centre, Lahore from January 2007 to December 2008. After the two-year intervention period, the patients were followed up for 5 years. The selected patients were divided into two groups. In group 1, mesh fixation was performed with metal non-absorbable tackers and in group II no fixation of mesh was performed. Patients were followed up at 6, 12, 24 and 60 months. RESULTS: Of the 63 patients in the study, 32(50.7%) were in group I and 31(49.2% in group II. The Mean pain score in group I was 4.7±0.683 and 4.1±0.860 in group II (p< 0.001). Urinary retention was more common in group 1 (p>0.05), while recurrence was more common in group II (p>0.05). CONCLUSIONS: Pain was significantly less in the non-fixation group, while urinary retention and recurrence were not significantly increased. Non-fixation is a viable option for total extraperitoneal mesh hernioplasty and should be preferred over mesh fixation.