CHronic Rhinosinusitis Outcome MEasures (CHROME), developing a core outcome set for trials of interventions in chronic rhinosinusitis.

STATEMENT OF PROBLEM: Evaluating the effectiveness of treatments in chronic rhinosinusitis (CRS) have been limited by both a paucity of high quality randomised trials, and the heterogeneity of outcomes in those that have been reported. Core outcome sets (COS) are an agreed, standardized set of outcomes that should be measured and reported by future trials as a minimum and will facilitate future meta-analysis of trial results in systematic reviews (SRs). We set out to develop a core outcome set for interventions for adults with CRS. METHOD(S) OF STUDY: A long-list of potential outcomes was identified by a steering group utilising a literature review, thematic analysis of a wide range of stakeholders' views and systematic analysis of currently available Patient Reported Outcome Measures (PROMs). A subsequent e-Delphi process allowed 110 patients and healthcare practitioners to individually rate the outcomes in terms of importance, on a Likert scale. MAIN RESULTS: After 2 rounds of the iterative Delphi process, the 54 initial outcomes were distilled down to a final core-outcome set of 15 items, over 4 domains. PRINCIPAL CONCLUSIONS: The authors hope inclusion of these core outcomes in future trials will increase the value of research on interventions for CRS in adults. It was felt important to make recommendations regarding how these outcomes should be measured, although additional work is now required to further develop and revalidate existing outcome measures.

Economic evaluation of a computed tomography directed referral strategy for chronic rhinosinusitis.

BACKGROUND: Chronic rhinosinusitis (CRS) is a prevalent chronic inflammatory disease. The basis of a clinical diagnosis of CRS for primary care physicians (PCPs) is based upon the recognition of a symptom constellation that manifests with the disease. However, because the symptomatology of CRS may overlap with other diagnoses, the referral of patient to the most appropriate specialist may not always occur, leading to further delays in evaluation and treatment. METHODS: Given the emphasis on improving the value of health care in Canada, a decision tree model was designed to evaluate whether an upfront computed tomography (CT) scan of the paranasal sinuses ordered by the PCP for a suspected case of CRS would be more cost-effective when compared to symptom-based specialist referral practice. RESULTS: The CT-based strategy resulted in the patient arriving at the most appropriate specialist 95% (±5%) of the time while the symptom-based referral strategy resulted in the patient arriving at the correct specialist 77% (±18%) of the time. The incremental cost effectiveness ratio (ICER) for the CT-based strategy was $1522 per patient arriving at the correct specialist. CONCLUSION: These results suggest that PCPs can improve the effectiveness of their referrals for CRS by utilising an upfront CT referral strategy. However, it would create an additional cost of approximately $1500 per patient referred. Given these findings, the potential clinical benefits of using an upfront CT scan in the Canadian primary care setting should be further studied to determine the value of the additional money spent to improve the effectiveness of CRS referral.

Endoscopic polypectomy in the clinic: a pilot cost-effectiveness analysis.

OBJECTIVE: The purpose of this pilot economic evaluation was to assess the cost-effectiveness of the endoscopic polypectomy in the clinic (EPIC) procedure compared to formal endoscopic sinus surgery (ESS) for the treatment of select chronic rhinosinusitis (CRS) patients with nasal polyposis. DESIGN: Cost-effectiveness analysis using a Markov decision tree model with a 30-year time horizon. The two comparative treatment groups were as follows: (i) EPIC and (ii) ESS. Costs and effects were discounted at a rate of 3.5%. A probabilistic sensitivity analysis was performed. SETTING: Economic perspective of the Canadian government third-party payer. PARTICIPANTS: CRS patients with nasal polyposis who have predominantly isolated symptoms of nasal obstruction with or without olfactory loss. MAIN OUTCOME MEASURES: Incremental cost per quality adjusted life year (QALY). RESULTS: Over a time period of 30 years, the reference case demonstrated that the ESS strategy cost a total of $21,345 and produced 13.17 QALYs while the EPIC strategy cost a total of $5591 and produced 12.93 QALYs. The ESS versus EPIC incremental cost-effectiveness ratio was $65,641/QALY. The probability that EPIC is cost-effective compared to ESS at a maximum willingness-to-pay threshold of $30,000 and $50,000/QALY is 66% and 60%, respectively. CONCLUSIONS: Outcomes from this study have demonstrated that the EPIC procedure may be a cost-effective treatment strategy for 'select' patients with nasal polyposis. Data from this study were obtained from a small pilot trial, and we feel the results warrant a future randomised controlled trial to strengthen the outcomes.

Squeeze bottle versus saline spray after endoscopic sinus surgery for chronic rhinosinusitis: a pilot multicentre trial.

BACKGROUND: There is a need for controlled trials to guide the perioperative management of patients undergoing endoscopic sinus surgery (ESS). The authors performed a pilot multicenter trial to compare two types of saline delivery devices in this population. METHODS: Patients were randomized to high volume saline irrigation with a squeeze bottle and low volume saline spray after ESS in patients with chronic rhinosinusitis (CRS). Surgeons were blinded to treatment, and one-month postoperative scores for sinonasal outcomes [Sinonasal Outcome Test-22 (SNOT-22)] scale, nasal and sinus symptom score (NSS), and perioperative sinus endoscopy (POSE) scale were compared with preoperative scores. RESULTS: Nine centers provided data for 86 patients. All three outcomes measures improved significantly for both groups. Saline spray: SNOT-22 48.8 versus. 23.7, treatment effect 25.1 (95% confidence interval [CI], 17.9-32.2), POSE 21.1 versus. 8.4, treatment effect 12.7 (95% CI, 9.2-16.1), and NSS 8.2 versus 5.0, treatment effect 3.1 (95% CI, 1.4-4.9) pre- and postoperatively, respectively (all p < 0.0001). Squeeze bottle: SNOT-22 49.5 versus 23.6, treatment effect 25.9 (95% CI, 20.3-31.6), POSE 18.6 versus 9.2, treatment effect 9.3, (95% CI 6.7-12.0), and NSS 9.0 versus 5.7, treatment effect 3.3 (95% CI, 2.3-4.3) pre- and postoperatively, respectively (all p < 0.0001). Analysis of variance did not identify a difference between the two treatment groups. Subgroup analysis based on preoperative disease severity did not change the nonassociation of saline bottle with outcome measures. Post hoc sample size calculation determined that 176 patients is required to detect an 8.9-point difference in SNOT-22 scores. CONCLUSION: In this pilot multicenter trial examining patients with chronic rhinosinusitis undergoing ESS, both squeeze bottle and saline spray showed significant improvement in SNOT-22, POSE, and NSS scores at one-month postoperatively. Because the study was nonpowered, we cannot rule out a potential difference between the two treatment groups.

Laparoscopic incisional hernia repair: a review of the literature.

Incisional hernia is a common long-term complication of abdominal surgery. Historically the open repair with or without mesh was the mainstay of treatment. However, many recently published laparoscopic repair studies have challenged surgeons to re-evaluate which technique provides the best short and long-term outcomes. A Medline search of all English-language literature was performed using the keywords 'incisional', 'ventral', 'hernia', 'laparoscopic', and 'open'. Further references were obtained by cross-referencing the bibliography in each paper. Current evidence suggests that the laparoscopic incisional hernia repair is the optimal surgical treatment. A laparoscopic repair appears to shorten hospital stay, decrease perioperative complication rates, and decrease recurrence rates. However, there is no randomized trial utilizing a standardized complication grading system making it difficult to draw a definitive conclusion as to which repair is best.

Molecular mechanisms of hepatic metastasis in colorectal cancer.

BACKGROUND: Colorectal cancer currently accounts for 11% of all cancers in the United States and is the second leading cause of cancer-related death, with the majority of deaths attributable to hepatic metastases. Many new studies are elucidating the complex molecular factors involved in this event, which could be used to generate clinically applicable screening and therapeutic tools. METHODS: An initial Pubmed and Medline literature search using keywords such as, molecular factor, colorectal cancer, hepatic metastasis/es, and main headings, such as angiogenesis, was reviewed. Since there are many molecular factors involved in this process not all could be included in this review. The list of discussed gene products was limited to the most studied factors, identified by the number of references in the literature search, and additional recently discovered gene products with in-vivo evidence of strong metastasis association. RESULTS: Twenty molecular factors were identified and included in the discussion of this review article. The molecular factors were separated into four groups based on their function, they are: proteolysis, adhesion, angiogenesis, and cell survival. All factors have a promising role as a screening or therapeutic target. CONCLUSION: This review has identified the many recent advances in elucidating the pathways involved in colorectal cancer hepatic metastasis. By better understanding the many complex molecular events involved in metastasis, novel screening and therapeutic tools may be developed with the ultimate goal of preventing metastasis and increasing patient survival.