Medical Therapy Versus Balloon Sinus Dilation in Adults With Chronic Rhinosinusitis (MERLOT): 12-Month Follow-up

2018 ◽  
Vol 32 (4) ◽  
pp. 294-302 ◽  
Author(s):  
J. Pablo Stolovitzky ◽  
Neelesh Mehendale ◽  
Keith E. Matheny ◽  
William J. Brown ◽  
Anthony A. Rieder ◽  
...  

Background Chronic rhinosinusitis (CRS) is a devastating disease affecting nearly 30 million people in the United States. An interim analysis of data from the present study suggested that, in patients who had previously failed medical therapy, balloon sinus dilation (BSD) plus medical management (MM) provides a significant improvement in the quality of life (QOL) at 24 weeks postprocedure compared to MM alone. Objective The primary objective of this final analysis was to evaluate the durability of treatment effects through the 52-week follow-up. Methods Adults aged 19 and older with CRS who had failed MM elected either BSD plus MM or continued MM. Patients were evaluated at 2 (BSD arm only), 12, 24, and 52 weeks posttreatment. Balloon dilations were performed either as an office-based procedure under local anesthesia or in the operating room per physicians’ and patients’ discretion. The primary end point was change in patient-reported QOL as measured by Chronic Sinusitis Survey (CSS) total score from baseline to the 24-week follow-up. Secondary outcomes including changes in CSS, Rhinosinusitis Disability Index (RSDI), and Sino-Nasal Outcome Test (SNOT) total and subscores, sinus medication usage, missed days of work/school, number of medical care visits, and sinus infections from baseline to the 52-week follow-up are reported here within. Results BSD led to sustained greater improvements in self-reported QOL using the CSS and RSDI total scores with a trend toward improvement in the SNOT-20 total score from baseline to the 52-week follow-up compared to continued MM. There were no changes in medication usage apart from nasal steroid usage for which the MM cohort had an increase in usage. There were no device-related serious adverse events. Conclusion The current analysis highlights the safety, effectiveness, and durability of BSD in CRS patients aged 19 and older who had previously failed MM.

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
L Hitchman ◽  
J Totty ◽  
R Lathan ◽  
M Sidapra ◽  
G Smith ◽  
...  

Abstract Aim The purpose of this mixed methods feasibility study was to assess the feasibility of delivering ESWT to patients with DFUs. It also aimed to explore any potential clinical effect of ESWT on wound healing and investigate whether ESWT may offer any patient reported benefits. Method A single centre mixed methods feasibility study. Patients with a DFU who met the eligibility criteria underwent ESWT 3 times in over 7 days. Primary outcome was feasibility of delivering the intervention. Secondary outcomes included wound size, number of DFU healed at 12 weeks and quality of life. Semi-structured interviews explored participants experience of undergoing ESWT. Results 22.6% (24/106) of patients screened were recruited. The mean attendance to clinic was 90.9% and 65.1% to follow up. The mean score for acceptability and tolerability was 9.86 (SD 0.48, 95% CI 9.62-10.01) and 9.15 (SD 2.57, 95% CI 7.87-10.42) respectively. There were no serious adverse events or side effects. 45.5% of DFU healed during follow up and quality of life scores improved until 8 weeks. Key themes identified from the qualitative interviews were desire for the fast healing, improved quality of life, new treatments must be flexible and accessible on transport. Conclusions This study has shown it is possible to recruit and retain patents into this research. This study supports development of a large randomised control trial to determine the clinical and cost effectiveness of ESWT for DFU healing.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12095-12095
Author(s):  
Joerg Peter Schilling ◽  
Steffi Busch ◽  
Carsten Hielscher ◽  
Martin Holländer ◽  
Julia Klenske ◽  
...  

12095 Background: NEPA is a fixed combination antiemetic of the NK1-receptor-antagonist (RA) netupitant and the 5-HT3-RA palonosetron. Primary objective of this prospective non-interventional study in Germany was to assess quality of life of cancer patients (pts) undergoing moderately (MEC) or highly (HEC) emetogenic chemotherapy (CT) who received NEPA for prophylaxis of nausea and vomiting (CINV). Secondary objectives were patient reported outcomes as well as effectiveness and safety of NEPA. Here we report final data of the quality of life analysis. Methods: The study included 2.405 pts in 162 centers receiving 3 consecutive cycles of CT as one or two day MEC or HEC. Primary endpoint was impact of quality of life (QoL) due to vomiting or nausea, documented by Functional Living Index–Emesis (FLIE) questionnaires. Effectiveness was reported in patient diaries. Complete response (CR) was defined as no emesis and no rescue medication (RM). Non-significant nausea (NSN) was no or mild nausea. Adverse events (AEs) were reported on d1–21 of each cycle. Results: 2.173 patients were included in the final analysis (full analysis set; FAS). The majority of patients (n = 1976; 91%) received 1-day chemotherapy, 64% HEC, 36% MEC. Median age was 58 years and the majority (85%) was female. Cancer diagnoses: breast 66%, gastrointestinal 10%, ovarian 7% or lung 5%, other 12%. Chemotherapy: AC 57%, carboplatin 19%, cisplatin 8%, oxaliplatin 8% and other 8%. 84% of pts with HEC and 82% with MEC felt no impact on daily life due to vomiting in cycle 1 remaining constant in C2 and C3. 54% HEC patients and 59% MEC patients reported no impact on daily life due to nausea in cycle 1. CR rates ranged between 81-84% and were comparable between different HEC or MEC. NSN rates in MEC ranged from 75% (MEC) to 62% (HEC). Drug-related AEs were rare with constipation, fatigue, insomnia, and nausea as the most common (in > 1% pts). Conclusions: NEPA was highly effective in the prevention of CINV and maintenance of QoL in this real world study. Over 80% of pts reported that their daily live was not influenced by emesis while nausea was more difficult to control. Effectiveness was high and patients and physicians estimate was comparable.


2019 ◽  
Vol 101-B (3) ◽  
pp. 272-280 ◽  
Author(s):  
F. G. M. Verspoor ◽  
M. J. L. Mastboom ◽  
G. Hannink ◽  
W. T. A. van der Graaf ◽  
M. A. J. van de Sande ◽  
...  

Aims The aim of this study was to evaluate health-related quality of life (HRQoL) and joint function in tenosynovial giant cell tumour (TGCT) patients before and after surgical treatment. Patients and Methods This prospective cohort study run in two Dutch referral centres assessed patient-reported outcome measures (PROMs; 36-Item Short-Form Health Survey (SF-36), visual analogue scale (VAS) for pain, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) in 359 consecutive patients with localized- and diffuse-type TGCT of large joints. Patients with recurrent disease (n = 121) and a wait-and-see policy (n = 32) were excluded. Collected data were analyzed at specified time intervals preoperatively (baseline) and/or postoperatively up to five years. Results A total of 206 TGCT patients, 108 localized- and 98 diffuse-type, were analyzed. Median age at diagnosis of localized- and diffuse-type was 41 years (interquartile range (IQR) 29 to 49) and 37 years (IQR 27 to 47), respectively. SF-36 analyses showed statistically significant and clinically relevant deteriorated preoperative and immediate postoperative scores compared with general Dutch population means, depending on subscale and TGCT subtype. After three to six months of follow-up, these scores improved to general population means and continued to be fairly stable over the following years. VAS scores, for both subtypes, showed no statistically significant or clinically relevant differences pre- or postoperatively. In diffuse-type patients, the improvement in median WOMAC score was statistically significant and clinically relevant preoperatively versus six to 24 months postoperatively, and remained up to five years’ follow-up. Conclusion Patients with TGCT report a better HRQoL and joint function after surgery. Pain scores, which vary hugely between patients and in patients over time, did not improve. A disease-specific PROM would help to decipher the impact of TGCT on patients’ daily life and functioning in more detail. Cite this article: Bone Joint J 2019;101-B:272–280.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jake von Hintze ◽  
Mika Niemeläinen ◽  
Harri Sintonen ◽  
Jyrki Nieminen ◽  
Antti Eskelinen

Abstract Background The purpose of this study was to determine the mid-term clinical, radiographic and health-related quality of life (HRQoL) outcomes and define the survival rate in patients who had undergone revision total knee arthroplasty (TKA) using the single rotating hinged knee (RHK) design. Methods Between January 2004 and December 2013, 125 revision TKAs were performed at our institution using the single RHK implant. We conducted both a retrospective analysis of prospectively collected outcome data of these patients and a prospective follow-up study of all 39 living patients (41 knees). The follow-up phase included an optional extra follow-up visit, PROM questionnaires, and plain radiographs. Results The ten-year Kaplan-Meier survival rate of the revision RHK knees was 81.7% (95% CI 71.9–91.6%) with re-revision for any reason as the endpoint. Overall, 15 knees (12% of the total) underwent re-revision surgery during the follow-up. The median follow-up was 6.2 years (range, 0–12.7 years) post-operatively for the baseline group. One mechanical hinge mechanism-related failure occurred without any history of trauma or infection. At the time of the final follow-up, the majority of patients evinced a fairly good clinical outcome measured with patient-reported outcome measures and none of the components were radiographically loose. Conclusion We found that in patients undergoing complex revision TKA, fairly good functional outcome and quality of life can be achieved using an RHK implant. Further, it seems that in this type of patient cohort, revision TKA using an RHK implant relieves pain more than it improves ability to function. The NexGen® RHK design can be regarded as a suitable option in complex revision TKA.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Salzwedel ◽  
I Koran ◽  
E Langheim ◽  
A Schlitt ◽  
J Nothroff ◽  
...  

Abstract Introduction Comprehensive cardiac rehabilitation (CR) programs based on the bio-psycho-social approach of the international classification of functioning and disease are carried out to achieve improved prognosis, superior health-related quality of life (HRQL) and social integration. We aimed to identify predictors of returning to work (RTW) and HRQL among cardiovascular risk factors and physical performance as well as patient-reported outcome measures (PROMs) modifiable during CR. Methods We designed a prospective observational multi-center study and enrolled 1,586 patients (2017/18) in 12 German rehabilitation centers regardless of their primary allocation diagnoses (e.g. acute myocardial infarction (AMI), coronary artery bypass grafting (CABG), coronary artery disease (CAD), valvular disease). Besides general data (e.g. age, gender, diagnoses), parameters of risk factor management (e.g. smoking, lipid profile, hypertension, lifestyle change motivation), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance), and PROMs (e.g. depression, heart-focused anxiety, HRQL, subjective well-being, somatic and mental health, pain, general self-efficacy, pension desire as well as self-assessment of occupational prognosis using several questionnaires) were documented at CR admission and discharge. 6 months after discharge, status of RTW and HRQL (SF-12) were captured by a follow-up (FU) survey and analyzed in multivariable regression models with multiple imputation of missing values. Results Out of the study participants, 1,262 patients (54±7 years, 77% men) responded to the follow-up survey and could be analyzed regarding the outcome parameters. Most of them were assigned to CR primarily due to AMI (40%) or CAD without myocardial infarction (18%), followed by heart valve diseases in 12% of patients and CABG (8%). 864 patients (69%) returned to work within the follow-up period. Pension desire, negative self-assessed occupational prognosis, heart-focussed anxiety, major life events, smoking and heart failure were negatively associated with RTW, while higher endurance training load, HRQL and work stress were positively associated (Figure 1). HRQL after 6 months was determined more by PROMs (e.g. pension desire, heart-focused anxiety, physical/mental HRQL in SF-12, physical/mental health in indicators of rehab-status questionnaire (IRES-24), stress, well-being in the World Health Organization well-being index and self-efficacy expectations) than by clinical parameters or physical performance. Conclusions Patient-reported outcome measures predominantly influenced RTW and HRQL in heart-disease patients, whereas patients' pension desire and heart-focussed anxiety had a dominant impact on all investigated endpoints. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. Figure 1. Predictors of returning to work Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German pension insurance


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Safstrom ◽  
T.J Jaarsma ◽  
L.N Nordgren ◽  
M.L Liljeroos ◽  
A.S Stomberg

Abstract Background Since healthcare systems are increasingly complex and often fragmented, continuity of care after hospitalization is a priority to increase patient safety and satisfaction. Aim Describe factors related to continuity of care in patients hospitalized due to cardiac conditions. Methods This cross-sectional multicenter study enrolled patients 6 weeks after hospitalization due to cardiac conditions. A total of 993 patients were included (mean age 72.2 (SD 10.4), males 66%) with AMI (35%), AF (25%), angina (21%) and HF (17.3%). Patients completed the Patient Continuity of Care Questionnaire, a questionnaire based on the definition that continuity of care is “the extent to which a series of health care services is experienced as connected and coherent and is consistent with a patient's health needs and personal circumstances”. The total score of the questionnaire ranges from 6 to 30, higher score indicating higher continuity and a score <24 indicating insufficient continuity. Cronbach's alpha on the total PCCQ was 0.94. Correlations between PCCQ and quality of life, depression, anxiety, perceived control and health care utilization were estimated using spearman rang correlation. Results Insufficient continuity of care ranged between 47% to 59% in the different diagnosis groups, which the highest continuity in the AMI group and lowest in patients with atrial fibrillation. In patients hospitalized due to AMI (n=355, mean age 71 (± 11), 70% men), continuity of care was related to higher perceived control, higher quality of life, a good financial situation, being a man, no symptoms of anxiety or depression (ᚹ range 0.17–0.26 p≤0.002). A low score on the PCCQ were associated with follow-up visit to a nurse in primary care after hospitalization (ᚹ −0.12 p=0.033). In patients hospitalized due to angina (n=210, mean age 73 (± 9), 74% men), continuity of care was related to higher perceived control, higher quality of life and no depressive symptoms (ᚹ range between 0.20 and 0.26 p=0.005). In patients with AF, (n=255, mean age 71 (± 10.), 58% men), continuity of care was related to having had contact by telephone with a nurse-led AF clinic, higher perceived control, higher quality of life and not being depressed (ᚹ range between 0.14–0.25 p=0.03). In patients with HF, (n=173, mean age 77 (±8) 59% men), continuity was related to male ender, younger age, follow-up in a nurse-led HF clinic and not being anxious (ᚹ range between 0.16 and 0.22 p=0.004–0.047). Low total score on PCCQ correlated to having had telephone contact with nurse in primary care (ᚹ −0.24 p=0.002). Conclusion Almost half of all patient reported insufficient continuity of care. Perceived control, quality of life, and symptoms of depression were related to higher continuity of care in all diagnose groups except heart failure. Further, there was a correlation between continuity and follow-up visits or contact by telephone with nurse-led clinics in all diagnose groups except angina. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Medical Research Council of Southeast Sweden, Centre for Clinical Research Sörmland


2019 ◽  
Vol 161 (5) ◽  
pp. 890-896 ◽  
Author(s):  
Katie M. Phillips ◽  
Eric Barbarite ◽  
Lloyd P. Hoehle ◽  
David S. Caradonna ◽  
Stacey T. Gray ◽  
...  

Objective Acute exacerbation of chronic rhinosinusitis (AECRS) is associated with significant quality-of-life decreases. We sought to determine characteristics associated with an exacerbation-prone phenotype in chronic rhinosinusitis (CRS). Study Design Cross-sectional. Setting Tertiary care rhinology clinic. Subjects Patients with CRS (N = 209). Methods Patient-reported number of sinus infections, CRS-related antibiotics, and CRS-related oral corticosteroids taken in the last 12 months were used as metrics for AECRS frequency. Sinonasal symptom burden was assessed with the 22-item Sinonasal Outcome Test (SNOT-22). Ninety patients reporting 0 for all AECRS metrics were considered to have had no AECRS in the prior 12 months. A total of 119 patients reported >3 on at least 1 AECRS metric and were considered as having an exacerbation-prone phenotype. Characteristics associated with patients with an exacerbation-prone phenotype were identified with exploratory regression analysis. Results An exacerbation-prone phenotype was positively associated with comorbid asthma (adjusted odds ratio [ORadj] = 3.68, 95% CI: 1.42-9.50, P = .007) and SNOT-22 (ORadj = 1.06, 95% CI: 1.04-1.09, P < .001). Polyps were negatively associated (ORadj = 0.27, 95% CI: 0.11-0.68, P = .005) with an exacerbation-prone phenotype. SNOT-22 score ≥24 identified patients with an exacerbation-prone phenotype with a sensitivity of 93.3% and a specificity of 57.8%. Having either a SNOT-22 score ≥24 with a nasal subdomain score ≥12 or a SNOT-22 score ≥24 with an ear/facial discomfort subdomain score ≥3 provided >80% sensitivity and specificity for detecting patients prone to exacerbation. Conclusions In total, these results point to a CRS exacerbation-prone phenotype characterized by high sinonasal disease burden with comorbid asthma but interestingly without polyps.


2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
I Hovdenak Jakobsen ◽  
D Kjaer

Abstract   Esophageal and gastric cancers are aggressive diseases. Due to extensive treatment, many patients experience adverse effects such as dysphagia, dumping, pain, fatigue, fear of recurrence and depression—all negatively impacting quality of life (QoL). The purpose of this study is to develop and test a follow-up model for patients after surgery for esophageal and gastric cancer. The model targets handling of adverse effects and psychosocial distress, aiming at improving patients’ QoL and functional level. Methods Development of the model follows recognized principles for complex interventions by the Medical Research Counsil. Extensive patient involvement is included in the development process, by means of a national patient advisory board. The assumed effect of the new model will be tested in a national two-part prospective study, executed before and after national implementation of the model, in both parts including approximately200 patients. Participants will be recruited prior to surgery, and follow-up is one year. Patient-reported data will be collected pre-operatively, at 3, 6, 9 and 12 months postoperatively, along with clinical and sociodemographic data. Results Development of the follow-up model after surgery will be completed in august 2020 and inclusion of patients for the prospective study part one, before implementation of the model, will commence summer 2020. Conclusion The perspectives of this study may be crucial for future follow-up of esophageal and gastric cancer patients. First, the extensive patient involvement in developing the model will ensure a patient-centred approach to follow-up. And second, the follow-up studies will provide important and up-to-date knowledge about clinical and patient-reported outcomes in a population-based, national cohort.


2018 ◽  
Vol 34 (2) ◽  
pp. 118-125 ◽  
Author(s):  
Jonathon Judkins ◽  
Irena Laska ◽  
Judith Paice ◽  
Priya Kumthekar

Purpose: The primary objective of this study was to quantify cancer family caregiver (FCG) quality of life (QOL) in a Southern Albanian population and to determine whether differences exist between 4 domains of QOL (physical, psychological, social, and spiritual). This study also sought to compare QOL in our cohort to QOL in historical studies that used the same survey instrument, and to examine correlations between demographic characteristics and QOL to identify any high-risk groups. Methods: A sample of 40 FCGs was recruited at the Mary Potter Palliative Care Clinic in Korçe, Albania. Each participant completed the City of Hope Quality of Life (Family Version), a validated 37-question instrument that measures caregiver well-being in 4 domains: physical, psychological, social, and spiritual well-being. Results: There were no significant differences between the composite scores of the 4 QOL domains in our study. However, there were differences when comparing self-reported QOL between domains (“Rate your overall physical/psychological/social/spiritual well-being”). The QOL measured in our study was significantly lower than in 3 studies from the United States that used the same questionnaire. There were no significant correlations between demographic groups and QOL. Conclusions: This study examines the impact that the paucity of palliative services has on the QOL of Albanian cancer FCGs. Although there were no domains of QOL or demographic groups identified in our study that were faring significantly worse than others, the poor overall QOL provides further evidence to support the continued development of palliative services for both patients and family members in Albania.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
B Hudzik ◽  
A Budaj ◽  
M Gierlotka ◽  
A Witkowski ◽  
W Wojakowski ◽  
...  

Abstract Introduction 2017 ESC Guidelines for the management of ST-elevation myocardial infarction (STEMI) patients have called for the assessment of the quality of care to establish measurable quality indicators in order to ensure that every patient with STEMI receives the best possible care. We investigated the quality indicators of health care services in Poland provided to STEMI patients. Methods The Polish Registry of Acute Coronary Syndromes (PL-ACS) is an ongoing, nationwide, multicenter, prospective, observational study of consecutively hospitalized patients with the whole spectrum of ACS in Poland. For the purpose of assessing quality indicators, we included 8,279 patients from the PL-ACS Registry hospitalized with STEMI between January 1 and December 31, 2018. Results All emergency medical services (EMS) are equipped with ECG/defibrillators. 408 of 8,279 patients (4.9%) arrived at PCI center by self-transport, 4,791 patients (57.9%) patients arrived at PCI center by direct EMS transport, and 2,900 patients (37.2%) were transferred from non-PCI facilities. Whilst 95.1% of STEMI patients arriving in the first 12 hours received reperfusion therapy, the rates of timely reperfusion were much lower (ranging from 39.4% to 55.0% for various STEMI pathways). 7,807 patients (94.3%) underwent PCI as a mode of primary reperfusion strategy. The median left ventricular ejection fraction (LVEF) was 46% and was assessed before discharge in 86.0% of patients. 489 of 8,279 patients (5.9%) died during hospital stay. Optimal medical therapy is prescribed in 50–85% of patients depending on various clinical settings. Only one in two STEMI patient is enrolled in a cardiac rehabilitation program at discharge. No patient-reported outcomes were recorded in the PL-ACS Registry. Figure 1 Conclusions The results of this study identified areas of healthcare systems that require solid improvement. These include prehospital ECG decision strategy, direct transport to PCI center, timely reperfusion, guidelines-based medical therapy (in particular in patients with heart failure), referral to cardiac rehabilitation/secondary prevention programs. More importantly, we recognized an urgent need for the initiation of recording quality indicators associated with patient-reported outcomes.


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