Improvement In Disease-specific Quality Research Articles

Mid-term Outcomes of Nissen Fundoplication Versus Roux-en-y Gastric Bypass for Primary Management of Gastroesophageal Reflux Disease in Patients With Obesity.

The efficacy and outcomes of laparoscopic Nissen fundoplication (LNF) in patients with obesity is controversial. Specifically, concerns regarding long-term outcomes and recurrence in the setting of obesity has led to interest in laparoscopic Roux-en-Y gastric bypass (RYGB). In this retrospective cohort study, we studied patients with obesity who underwent either LNF or RYGB for gastroesophageal reflux disease. Baseline demographics, clinical variables, operative outcomes, and symptom severity scores were compared. Baseline demographics, operative outcomes, and quality-of-life scores were similar. Proton pump inhibitor usage, quality-of-life, symptom severity scores, and satisfaction with the operation were similar between groups at mid-term follow-up. RYGB and LNF produced similar improvements in disease-specific quality of life with similar rates of complications, side effects, and need for reoperation. This demonstrates that RYGB and LNF represent possible options for surgical management of gastroesophageal reflux disease in obese patients.

Evaluation of endoscopic septoplasty outcomes using nasal obstruction symptom evaluation scale

Inroduction: Nasal obstruction is the most common complaint in an average ENT practice, and a deviated nasal septum is the most common cause of nasal obstruction. The deformities of the septum are usually congenital, developmental, traumatic, or iatrogenic in nature with traumatic and iatrogenic being the most common. The aim of the study was to evaluate patient-based outcomes on subjective-based opinion in patients undergoing endoscopic septoplasty. Methods: This study was conducted in a tertiary care hospital setting in western Maharashtra. This was a prospective observational study.The present study was conducted on 50 patients who presented with signs and symptoms attributed to septal deviation who underwent endoscopic septoplasty and followed up in the department of otorhinolaryngology, head and neck surgery, tertiary care hospital, Mumbai, Maharashtra.The results of our study were analyzed on SPSS Software using “Paired t-test”. Results: On the statistical analysis of the Nasal Obstruction Symptom Evaluation score of patients (n = 50) at baseline and at postoperative 3- and 6-month follow-up, mean + standard deviation was 61.2 ± 11.18, 9.1 ± 5.32, and 8.1 ± 4.51, respectively, with P < 0.0001 preoperative and 3-month postoperative follow-up which is highly significant and P > 0.05 for 3- and 6-month follow-up and hence insignificant. Conclusion: Endoscopic septoplasty results in significant improvement in disease-specific quality of life with high patient satisfaction.

Mixed-methods evaluation of a nurse-led allergy clinic model in primary care: Feasibility trial.

It is now widely acknowledged that there are serious shortcomings in allergy care provision for patients seen in primary care. We sought to assess the feasibility of delivering and evaluating a new nurse-led allergy service in primary care, measured by recruitment, retention and estimates of the potential impact of the intervention on disease-specific quality of life. Mixed-methods evaluation of a nurse-led primary care-based allergy clinic in Edinburgh, UK undertaken during the period 2017-2021 with a focus on suspected food allergy and atopic eczema in young children, allergic rhinitis in children and young people, and suspected anaphylaxis in adults. Prior to March 2020, patients were seen face-to-face (Phase 1). Due to COVID-19 pandemic restrictions, recruitment was halted between March-August 2020, and a remote clinic was restarted in September 2020 (Phase 2). Disease-specific quality of life was measured at baseline and 6-12weeks post intervention using validated instruments. Quantitative data were descriptively analysed. We undertook interviews with 16 carers/patients and nine healthcare professionals, which were thematically analysed. During Phase 1, 426/506 (84%) referred patients met the eligibility criteria; 40/46 (87%) of Phase 2 referrals were eligible. Males and females were recruited in approximately equal numbers. The majority (83%) of referrals were for possible food allergy or anaphylaxis. Complete data were available for 338/426 (79%) patients seen in Phase 1 and 30/40 (75%) in Phase 2. Compared with baseline assessments, there were improvements in disease-specific quality of life for most categories of patients. Patients/carers and healthcare professionals reported high levels of satisfaction, this being reinforced by the qualitative interviews in which convenience and speed of access to expert opinion, the qualityof the consultation, and patient/care empowerment were particularly emphasised. This large feasibility trial has demonstrated that it is possible to recruit, deliver and retain individuals into a nurse-led allergy clinic with both face-to-face and remote consultations. Our data indicate that the intervention was considered acceptable to patients/carers and healthcare professionals. The before-after data of disease-specific quality of life suggest that the intervention may prove effective, but this now needs to be confirmed through a formal randomised controlled trial. ClinicalTrials.gov reference NCT03826953.

The First Year of Noninvasive Remote Telemonitoring in Chronic Heart Failure Is not Cost Saving but Improves Quality of Life: The Randomized Controlled CardioBBEAT Trial.

Introduction: Remote telemonitoring (RTM) for patients with chronic heart failure (HF) holds promise to improve prognosis and well-being beyond the standard of care (SoC). The CardioBBEAT trial assessed the health economic and clinical impact of an interactive bidirectional RTM system (Motiva®) versus SoC for patients with HF and a reduced ejection fraction (HFrEF), in Germany. Methods: This multicenter, randomized controlled trial enrolled 621 patients with HFrEF (mean age 63.0 ± 11.5 years, 88% men). The primary endpoint was the integrated effect of the intervention on total costs and nonhospitalized days alive after 12 months, reported as incremental cost-effectiveness ratio (ICER). Costs (in k€) were based on actual charges of patients' statutory health insurance. Among secondary outcome measures were mortality and disease-specific quality of life. Results: We found a neutral effect on nonhospitalized days alive (RTM mean 341 ± 59 days, SoC 346 ± 45 days; p = 0.298) associated with increased total costs (RTM 18.5 ± 39.5 k€, SoC 12.8 ± 22.0 k€; p = 0.046). This yielded an ICER of -1.15 k€/day. RTM did not impact mortality risk. All quality of life scales were consistently and meaningfully improved in the RTM group at 12 months compared to SoC (all p < 0.01). Conclusions: The first 12 months of RTM were not cost-effective compared to SoC in patients with HFrEF, but associated with a relevant improvement in disease-specific quality of life. The balanced assessment of the potential benefit of RTM requires integration of both the societal and patient perspective. ClinTrials.gov (NCT02293252).

S148: Long-term patient-reported outcomes of laparoscopic magnetic sphincter augmentation versus Nissen fundoplication: a 5-year follow-up study.

Laparoscopic magnetic sphincter augmentation (MSA) has emerged as an alternative to laparoscopic Nissen fundoplication (LNF) for the management of symptomatic gastroesophageal reflux disease (GERD). While short-term outcomes of MSA compare favorably to those of LNF, direct comparisons of long-term outcomes are lacking. We hypothesized that the long-term patient-reported outcomes of MSA would be similar to those achieved with LNF. We tested this hypothesis in a retrospective cohort undergoing primary LNF or MSA between March 2013 and July 2015. The primary outcome was GERD-Health Related Quality of Life (GERD-HRQL) score at long-term follow-up relative to baseline. Secondary outcomes included dysphagia and bloating scores, proton-pump inhibitor (PPI) cessation, reoperations, and overall satisfaction with surgery. 70 patients (25 MSA, 45 LNF) met criteria for study inclusion. MSA patients had lower baseline BMI (median: 27.1 [IQR: 22.7-29.9] versus 30.4 [26.4-32.8], p = 0.02), lower total GERD-HRQL (26 [19-32] versus 34 [25-40], p = 0.02), and dysphagia (2 [0-3] versus 3 [1-4], p = 0.02) scores. Median follow-up interval exceeded 5 years (MSA: 68 [65-74]; LNF: 65months [62-69]). Total GERD-HRQL improved from 26 to 9 after MSA (p < 0.001) and from 34 to 7.5 after LNF (p < 0.01); these scores did not differ between groups (p = 0.68). Dysphagia (MSA: 1 [0-2]; LNF: 0 [0-2], p = 0.96) and bloating (MSA: 1.5 [0.5-3.0]; LNF: 3.0 [1.0-4.0], p = 0.08) scores did not show any statistically significant differences. Device removal was performed in 4 (16%) MSA patients and reoperation in 3 (7%) LNF patients. Eighty-nine percent of LNF patients reported satisfaction with the procedure, compared to 70% of MSA patients (p = 0.09). MSA appears to offer similar long-term improvement in disease-specific quality of life as LNF. For MSA, there was a trend toward reduced long-term bloating compared to LNF, but need for reoperation and device removal may be associated with patient dissatisfaction.

Influence of Wrap Fixation Technique on the Results of Fundoplication.

Different techniques of wrap fixation in laparoscopic Nissen fundoplication (LNF) have been proposed with of the aim to reduce the complications, but the optimal technique is yet to be determined. The aim of our prospective study was to evaluate several techniques of wrap fixation and determine whether the application of a combined approach to perform wrap fixation reduces the failure rate in short-term and long-term follow-up. One hundred two patients with sliding or paraesophageal hiatal hernia (type I or type II), who underwent antireflux surgery were randomized into 2 groups. In group I, LNF was supplemented with suturing the wrap to the diaphragmatic crura (35 patients) or to the body of stomach (16 patients). This was dependent on the strength of the crura (defined as weak or strong). The control group (51 patients) underwent LNF without wrap fixation. All patients were assessed using a validated symptom and quality of life (gastroesophageal reflux disease-Health Related Quality of Life) questionnaire, 24-hour impedance-pH monitoring, and barium swallow. At the 48-month follow-up, the overall rate of complications was not significantly different between the 2 groups; however, there was a tendency toward a lower frequency of reoperations in the first group (P=0.059). Fixation of the fundoplication of wrap was noted to lead to significantly lower rates of postoperative dysphagia (P<0.05). These patients (group I) were also found to have significant improvement in gastroesophageal reflux disease-Health Related Quality of Life score (from 19.3±13.2 to 4.3±3.9 vs. from 18.7±11.9 to 9.3±7.7). Fixation of the Nissen fundoplication wrap has been shown to have a positive impact on the reduction of postoperative dysphagia and leads to an improvement in disease-specific quality of life.

Quality of Life in Patients with Nasal Obstruction after Septoplasty: A Single Institution Prospective Observational Study.

Introduction Nasal obstruction is a common symptom in otorhinolaryngological practice. It can impact significantly on the quality of life of the individual. Objective The primary goal of the present study was to evaluate quality of life after septoplasty in adults with nasal obstruction. A secondary goal was to assess the effectiveness of septoplasty. Methods This was a single institution prospective observational study. Patients had experienced septal deviation and symptomatic nasal obstruction with no benefit from medical treatment. There were 51 patients who completed the Nasal Obstruction Symptom Evaluation (NOSE-POL) scale as well as theVisual Analogue Scale (VAS) before undergoing septoplasty, 3 months later, and finally 7 months after surgery. Patients evaluated changes in their nasal obstruction and changes in their quality of life using the Clinical Global Impression Scale (CGI-S). Results There was a significant improvement in nasal obstruction after septoplasty. Before septoplasty, the mean score on NOSE was 60.3 ± 20.4; 3 months after surgery, it was 32.9 ± 16.8; and 7 months after surgery it was 39.6 ± 33.2. The VAS results also proved a significant enhancement in nasal obstruction after septoplasty. Patients reported an improvement in nasal obstruction as well as a positive change in quality of life, confirming the effectiveness of septoplasty. Conclusions In patients with deformed septum, septoplasty contributes to high satisfaction of the patient and a compelling improvement in disease-specific quality of life. The NOSE-POL questionnaire is a useful tool for measuring the outcomes of this procedure.

Tobacco use is not associated with increased risk of recurrent reflux 5 years after laparoscopic anti-reflux surgery.

Tobacco use worsens gastrointestinal reflux disease (GERD). Smoking cessation improves GERD symptoms, but its impact on the efficacy of laparoscopic anti-reflux surgery (LARS) is unclear. In this retrospective cohort study, we hypothesized that non-smokers would demonstrate greater long-term improvements in disease-specific quality of life than active smokers. Data were maintained in an IRB-approved prospective database, and patients were stratified according to tobacco use. Postoperative follow-up occurred in clinic and long-term follow-up via telephone interview. Outcomes measured were gastroesophageal health-related quality of life (GERD-HRQL) and GERD symptom scale (GERSS) scores, proton pump inhibitor (PPI) cessation, and satisfaction with surgery. Two hundred and thirty-five patients underwent primary LARS, and 31 (13%) were active smokers with 18 median pack-years [10-30]. Baseline PPI use (96% vs. 94%, p=0.64), presence of a hiatal hernia (79% vs. 68%, p=0.13), esophagitis (28% vs. 45%, p=0.13), and DeMeester score (41.9 vs. 33.6, p=0.47) were similar. Baseline GERD-HRQL and GERSS scores and their post-surgical decreases were also similar between groups. PPI cessation was achieved in 92% of non-smokers and 94% of smokers (p=0.79), and GERD-HRQL scores decreased to 4 [1-7] and 5 [0-12], respectively (p=0.53). After 59 [25-74] months, GERD-HRQL scores were 5 [2-11] and 2 [0-13] (p=0.61) and PPI cessation was maintained in 69% and 79% of patients (p=0.59). Satisfaction with surgery was similar between smokers and non-smokers (88% vs. 87%, p=0.85). Female gender was significantly associated withincreased improvements in GERD-HRQL (p<0.01) and GERSS scores (p=0.04) postoperatively but not at long-term follow-up. Patients without a hiatal hernia were less likely to achieve long-term PPI cessation compared to those with a hernia (OR 0.23, p<0.01). After 5years, smokers demonstrate similar symptom resolution, PPI cessation rates, and satisfaction with surgery as non-smokers. Active smoking does not appear to negatively impact long-term symptomatic outcomes of LARS.

Changes in the disease-specific quality of life following Dor fundoplication. A multicentre cross-sectional study

BackgroundGastrooesophageal reflux disease (GERD) is a spectrum of symptoms arising from the laxity of the cardio-oesophageal junction. Anti-reflux surgery is reserved for patients with refractory GERD. Anterior partial fundoplication (Dor) is a regularly performed anti-reflux surgery in Malaysia. We intend to determine the improvement in disease-specific quality of life in our patients after surgery. MethodsA multicentre cross-sectional study was conducted to assess patients’ improvement in disease-specific quality of life after Dor fundoplication. Ethics approval was obtained from our institutional review board. Patients between the ages of 18 and 65 years who underwent Dor fundoplication within the past five years were assessed using the GERD HRQL as well as the VISICK score via telephone interview. We excluded cases of revision surgery. ResultsOut of 129 patients screened, 55 patients were included. We found a significant improvement in patients’ GERD HRQL score with the pre-operative mean score of 28.3 ± 9.39 and 6.55 ± 8.52 post-operatively, p < 0.01.50.9% of patients reported a VISICK score of 1. However, we noticed a deterioration in the GERD HRQL and VISICK score in patients followed up four years after surgery. This consisted of 25.5% of total patients. ConclusionDor Fundoplication improves the overall disease-specific quality of life in patients with refractory GERD in the short term period. Recurrence of symptoms causing a deterioration in the quality of life is seen in patients followed up beyond four years of index surgery.

Evaluation of quality of life after Functional Endoscopic Sinus Surgery (FESS) in chronic rhinosinusitis patients in Menoufia Governorate

Background: Chronic rhinosinusitis has a great impact on the quality of life. Functional endoscopic sinus surgery is the treatment of choice for chronic rhinosinusitis refractory to medical treatment as it allows restoring ventilation and mucociliary clearance. Sino- Nasal Outcome Test 22 questionnaire has been used for evaluating changes in symptoms and predicting the extent of postoperative outcome. Objective: The aim of the study was to evaluate how functional endoscopic sinus surgery affects the outcome in patients’ symptom profile and quality of life.Patients and Methods: 60 patients indicated for functional endoscopic sinus surgery from March 2017 till December 2018. This prospective study was carried out at the Otorhinolaryngology Department at El-Menoufia University Hospital. For all patients, the Sino-Nasal Outcome Test–22 was completed before and three months after Functional Endoscopic sinus surgery. Results: 60 patients were enrolled in this study (34 Males and 26 Females) aged from 25 to 40 years old with a mean age of 32.9 ± 5.3. The results of the statistical analysis showed that functional endoscopic sinus surgery reduced the Sino-Nasal Outcome Test–22 questionnaire score with a statistically high significant result (P ≤ 0.001).Conclusion: Functional endoscopic sinus surgery statistical significant improvements in disease-specific quality of life for patients with chronic rhinosinusitis

Laparoscopic Nissen fundoplication improves disease-specific quality of life in patients with gastroesophageal reflux disease and functional gastroesophageal outflow obstruction.

The optimal management of functional esophagogastric junction outflow obstruction (EJOO) remains controversial particularly in the setting of concomitant gastroesophageal reflux disease (GERD). There remains a paucity of data regarding the outcomes of laparoscopic Nissen fundoplication (LNF) in this patient population. We hypothesized that GERD patients with manometric findings of EJOO on preoperative manometry do not have increased rates of postoperative dysphagia compared to those with normal or hypotensive LES pressures. This retrospective cohort study of patients undergoing LNF for GERD compared outcomes in patients with and without functional EJOO (fEJOO). The outcomes of interest included disease-specific quality of life improvement, dysphagia scores, and the need for endoscopic dilation following fundoplication. Two hundred and eleven patients underwent LNF for GERD and 15 (7.1%) were classified as having fEJOO. Baseline GERD-HRQL [30.0 (21.5-37) vs. 31 (21-37), p = 0.57] were similar between fEJOO and control patients, respectively. There was no difference in baseline dysphagia scores [3.5 (2-5) vs. 2.0 (1-4), p = 0.64] between the two groups. Postoperative GERD-HRQL [5.0 (2-13) vs. 4.0 (1-8), p = 0.59] scores did not differ between fEJOO and control patients at 6-week follow-up. One year after surgery, GERD-HRQL [8.0 (3-9) vs. 4.5 (2-13), p = 0.97] did not differ between groups. Dysphagia rates were similar at 6-week (p = 0.78) and 1-year follow-ups (p = 0.96). The need for dilation at 1year following fundoplication was similar in both cohorts (13%, p = 0.96). GERD patients with functional EJOO achieved similar improvements in disease-specific quality of life without increased incidence of dysphagia postoperatively.

Active mind-body movement therapies as an adjunct to or in comparison with pulmonary rehabilitation for people with chronic obstructive pulmonary disease.

Background: Active mind‐body movement therapies (AMBMTs), including but not limited to yoga, tai chi, and qigong, have been applied as exercise modalities for people with chronic obstructive pulmon ...

Long-term reported outcomes of transoral incisionless fundoplication: an 8-year cohort study.

Transoral incisionless fundoplication (TIF) offers an endoscopic approach to the treatment of gastroesophageal reflux disease (GERD). Controlled trials have demonstrated the short-term efficacy of this procedure, but long-term follow-up studies are lacking. The objective of this study was to evaluate the long-term impact of TIF on disease-specific quality of life and antisecretory medication use. We performed retrospective cohort study of all patients undergoing TIF between 2007 and 2014 in a large academic medical center. Reflux symptoms and quality of life were assessed using the gastroesophageal reflux disease health-related quality of life (GERD-HRQL) questionnaire at baseline, short-term, and long-term follow-up. Fifty-seven patients with a median age of 46 (37-59) years and an average BMI of 28.8 ± 4.9kg/m2 underwent TIF during the study period. Sixty percent of the patients were female, and all were taking a PPI at least daily. At a median follow-up interval of 97months, twelve patients had undergone subsequent laparoscopic antireflux surgery (LARS). Of those who had not, 23 had complete long-term follow-up data for analysis and were included in the study. Seventy-three percent reported daily acid-reducing medication use, and the median GERD-HRQL score was 10 (6-14) compared to 24 (15-28) at baseline (p < 0.01). Seventy-eight percent of these patients expressed satisfaction or neutral feelings about their GERD management. There were no significant differences in the baseline characteristics of patients who underwent LARS during the study period and those who did not. This study demonstrates that TIF can produce durable improvements in disease-specific quality of life in some patients with symptomatic GERD. The majority of patients resumed daily PPI therapy during the study period, but with significantly improved GERD-HRQL scores compared to baseline and increased satisfaction with their medical condition.

The role of sinus surgery in sleep outcomes.

Poor sleep is associated with reduced health, increased morbidity, and increased mortality. Chronic rhinosinusitis (CRS) is one of the most prevalent chronic diseases in the United States, affecting up to 16% of the U.S. It has been linked to poor sleep with up to 75% of patients with CRS reporting reduced sleep. Yet there has been little examining the improvement in sleep following surgical treatment of patients with CRS. In this review, we examine the current knowledge on the association between sleep and CRS as well as review the current data examining the role of sinus surgery. After a structured literature search, we conclude that an evolving body of research demonstrates that sleep is compromised in the majority of patients with CRS. Following surgical treatment of CRS, there is a significant improvement in reported sleep quality that is correlated with subsequent improvement in disease-specific quality of life. Furthermore, we acknowledge that additional research characterizing both objective and subjective measures of sleep following surgical treatment is still needed. Additional investigation is required to better elucidate the underlying pathophysiology of the relationship between sleep dysfunction and CRS.

Combination inhaled steroid and long-acting beta₂-agonist in addition to tiotropium versus tiotropium or combination alone for chronic obstructive pulmonary disease.

The long-acting bronchodilator tiotropium and single-inhaler combination therapy of inhaled corticosteroids and long-acting beta2-agonists (ICS/LABA) are commonly used for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Combining these treatments, which have different mechanisms of action, may be more effective than administering the individual components. To assess relative effects of the following treatments on markers of exacerbations, symptoms, quality of life and lung function in patients with COPD.• Tiotropium plus LABA/ICS versus tiotropium.• Tiotropium plus LABA/ICS versus LABA/ICS. We searched the Cochrane Airways Group Specialised Register of Trials (April 2015), ClinicalTrials.gov (www.ClinicalTrials.gov), the World Health Organization (WHO) trials portal and reference lists of relevant articles. We included parallel, randomised controlled trials (RCTs) lasting three months or longer conducted to compare ICS and LABA combination therapy in addition to inhaled tiotropium versus tiotropium alone or combination therapy alone. We independently assessed trials for inclusion, then extracted data on trial quality and outcome results. We contacted study authors to ask for additional information. We collected trial information on adverse effects. Tiotropium plus LABA/ICS versus tiotropiumWe included six studies (1902 participants) with low risk of bias that compared tiotropium in addition to inhaled corticosteroid and long-acting beta2-agonist combination therapy versus tiotropium alone. Investigators found no statistically significant differences in mortality between treatments (odds ratio (OR) 1.80, 95% confidence interval (CI) 0.55 to 5.91; two studies; 961 participants), a reduction in all-cause hospitalisations with the use of combined therapy (tiotropium + LABA/ICS) (OR 0.61, 95% CI 0.40 to 0.92; two studies; 961 participants; number needed to treat for an additional beneficial outcome (NNTB) 19.7, 95% CI 10.75 to 123.41). The effect on exacerbations was heterogeneous among trials and was not meta-analysed. Health-related quality of life measured by St. George's Respiratory Questionnaire (SGRQ) showed a statistically significant improvement in total scores with use of tiotropium + LABA/ICS compared with tiotropium alone (mean difference (MD) -3.46, 95% CI -5.05 to -1.87; four studies; 1446 participants). Lung function was significantly different in the combined therapy (tiotropium + LABA/ICS) group, although average benefit with this therapy was small. None of the included studies included exercise tolerance as an outcome.A pooled estimate of these studies did not show a statistically significant difference in adverse events (OR 1.16, 95% CI 0.92 to 1.47; four studies; 1363 participants), serious adverse events (OR 0.86, 95% CI 0.57 to 1.30; four studies; 1758 participants) and pneumonia (Peto OR 1.62, 95% CI 0.54 to 4.82; four studies; 1758 participants). Tiotropium plus LABA/ICS versus LABA/ICSOne of the six studies (60 participants) also compared combined therapy (tiotropium + LABA/ICS) versus LABA/ICS therapy alone. This study was affected by lack of power; therefore results did not allow us to draw conclusions for this comparison. In this update, we found new moderate-quality evidence that combined tiotropium + LABA/ICS therapy compared with tiotropium plus placebo decreases hospital admission. Low-quality evidence suggests an improvement in disease-specific quality of life with combined therapy. However, evidence is insufficient to support the benefit of tiotropium + LABA/ICS for mortality and exacerbations (moderate- and low-quality evidence, respectively). Of note, not all participants enrolled in the included studies would be candidates for triple therapy according to current international guidance.Compared with the use of tiotropium plus placebo, tiotropium + LABA/ICS-based therapy does not increase undesirable effects such as adverse events or serious non-fatal adverse events.

Systemic and topical antibiotics for chronic rhinosinusitis.

Systemic and topical antibiotics for chronic rhinosinusitis.

Assessment of quality of life after endoscopic sinus surgery for chronic rhinosinusitis

Chronic rhinosinusitis is a disease of undefined etiology that significantly impacts the quality of life of its patients. Various studies carried out in countries other than Brazil have shown endoscopic sinus surgery as an effective means of treating this condition. ObjectiveThis study aims to analyze, with the aid of SNOT-20, the association between endoscopic sinus surgery and disease-specific quality of life of Brazilian patients treated for chronic rhinosinusitis accompanied or not by nasal polyps. Materials and MethodsThis prospective study enrolled patients submitted to endoscopic sinus surgery after drug therapy failed to improve their symptoms. They were assessed based on questionnaire SNOT-20p before and 12 months after surgery. Improvement on total scores and on the five items deemed more important by each patient were assessed. The study also looked into the correlation between preoperative scores and postoperative improvement and if there were any gender-related improvement differences. ResultsForty-three patients aged 44 (19), md (IQR), 65% of whom (26/43) were males. Statistically significant improvement was seen on SNOT-20 and SNOT-20(5+) and a correlation was established between preoperative scores and postoperative improved scores (p<0.001). No gender-related differences were observed in quality of life. ConclusionEndoscopic sinus surgery in patients with chronic rhinosinusitis is associated with statistically significant improvements in disease-specific quality of life.

Multicentre prospective clinical application of the T14 paediatric outcome tool.

This study aimed to measure changes in disease-specific quality of life in children following tonsillectomy or adenotonsillectomy. A multicentre prospective cohort study was performed involving seven ENT departments in England. A total of 276 children entered the study over a 2-month period: 107 underwent tonsillectomy and 128 adenotonsillectomy. Forty-one children referred with throat problems initially managed by watchful waiting were also recruited. The follow-up period was 12 months. Outcome measures were the T14, parental impressions of their child's quality of life and the number of days absent from school. One-year follow-up data were obtained from 150 patients (52 per cent). The mean baseline T14 score in the non-surgical group was significantly lower (T14 = 23) than in the tonsillectomy group (T14 = 31) or the adenotonsillectomy group (T14 = 35; p < 0.001). There was a significant improvement in the T14 scores of responders in all groups at follow up. The effect size was 1.3 standard deviations (SD) for the non-surgical group, 2.1 SD for the tonsillectomy group and 1.9 SD for the adenotonsillectomy group. Between-group differences did not reach statistical significance. A third of children in the non-surgical group underwent surgery during the follow-up period. Children who underwent surgical intervention achieved a significant improvement in disease-specific quality of life. Less severely affected children were managed conservatively and also improved over 12 months, but 1 in 3 crossed over to surgical intervention.

Oxycodone/Naloxone PR: A Review in Severe Refractory Restless Legs Syndrome.

An oral, fixed-dose combination of prolonged-release (PR) oxycodone with PR naloxone (Targin(®), Targiniq(®), Targinact(®); hereafter referred to as oxycodone/naloxone PR) is approved in Europe for the second-line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome (RLS), after failure of dopaminergic therapy. Coadministration of naloxone represents a targeted approach to counteracting opioid-induced bowel dysfunction without compromising therapeutic efficacy; because of its very low oral bioavailability, naloxone blocks the action of oxycodone at opioid receptors locally in the gut. The efficacy of oxycodone/naloxone PR in patients with severe RLS inadequately controlled by previous (mainly dopaminergic) treatment has been demonstrated in RELOXYN, a 12-week, randomized, double-blind study with a 40-week open-label extension. In this pivotal study, oxycodone/naloxone PR significantly improved RLS symptoms compared with placebo from week 2 onwards; a beneficial effect of oxycodone/naloxone PR was maintained through 1 year of treatment. Furthermore, improvements in RLS symptoms in oxycodone/naloxone PR recipients were accompanied by similarly sustained improvements in disease-specific quality of life and subjective sleep variables. Oxycodone/naloxone PR was generally well tolerated, with a treatment-related adverse event profile (e.g. gastrointestinal disorders, CNS disorders, fatigue and pruritus) that was consistent with that expected for opioid therapy. Notably, there were no confirmed cases of augmentation among oxycodone/naloxone PR recipients throughout the course of the study. Results from the well-designed RELOXYN trial have thus demonstrated the value of oxycodone/naloxone PR as a second-line therapy for severe refractory RLS; further investigation of this combination product as a first-line treatment for severe RLS is now warranted.

PMS65 - Impact On Health Status And Disease Specific Quality Of Life Of Tofacitinib In Patients With Inadequate Response To Non-Biological Disease-Modifying Antirheumatic Drugs (Dmard) Versus Anti-Tumor Necrosis Factor Drugs (Anti-Tnf) In Colombia

To analyze the impact on health status and disease specific quality of life with tofacitinib for rheumatoid arthritis in patients with inadequate response to a non-biological DMARD vs anti-TNF in Colombia. We use the change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) as effectiveness measure and grouped by disease severity levels (0.5 difference) in order to infer the changes in Quality of Live obtained with Tofacitinib and the anti-TNF available in Colombia (adalimumab, certolizumab, etanercept, golimumab and infliximab). Comparison between anti-TNF and tofacitinib (5mg BID) was done directly to adalimumab (heat-to-heat study) and indirectly (Bucher´s indirect comparisons adjusted method) using methotrexate as reference therapy against the rest anti-TNF. The relationship between the health status and Quality of life improvement were taken from Péntek M 2008 and projected at 52 weeks through a discrete event model that simulates six cohorts of 1,000 patients (each per treatment option). The model´s result were tested by randomly changing the HAQ levels (basal and weekly mean change) and utility gains assuming a normal distribution. The results obtained with the anti-TNF’s were grouped and weighted given their market share as reported in the SISMED by the Health Ministry. Percent reduction in HAQ-DI score at 3, 6, 9 and 12 months from baseline were 61.9, 48.7, 65.2 and 53.2% with tofacitinib; and 49.5, 42.7, 57.1 and 47.1% with anti–TNF (t test at 52 weeks, p<0.001). As result of these reductions, quality of life at week 52 increased from 0.50 to 0.78 (0.28) with tofacitinib and from 0.5 to 0.70 (0.20) with anti-TNF. The superior reduction in HAQ-DI scale at 52 weeks obtained with tofacitinib in RA patients with inadequate response to a non-biological DMARD results in a greater improvement in disease specific quality of life, compared to anti-TNF available in Colombia.