scholarly journals O01 PROPHYLACTIC MESH PLACEMENT DURING FORMATION OF AN END-COLOSTOMY LONG TERM RCT ON EFFECTIVENESS AND SAFETY

2021 ◽  
Vol 108 (Supplement_8) ◽  
Author(s):  
Thijs Brandsma ◽  
Bibi Hansson ◽  
Nienke De Jong ◽  
Theo Aufenacker ◽  
Erik van Westreenen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Cost Effective ◽  
Mesh Group ◽  
Prophylactic Mesh ◽  
Permanent Colostomy ◽  
Mesh Placement

Abstract Aim To determine if prophylactic mesh placement is an effective, safe, and cost-effective procedure to prevent parastomal hernia (PSH) formation in the long term. Material and Methods In this multicenter superiority trial patients undergoing formation of a permanent colostomy were randomly assigned to either retromuscular mesh reinforcement or conventional colostomy formation. The primary endpoint was the incidence of a PSH after 5 years. Secondary endpoints were morbidity, mortality, quality of life and cost-effectiveness. Results A total of 150 patients were randomly assigned to the mesh group (n = 72) or non-mesh group (n = 78). For the long term follow up, we could analyse 113 patients since 37 patients were lost to follow-up. After a median follow-up of 60 months (IQR 48.6 – 64.4), 49 patients developed a PSH, 20 (27.8%) in the mesh group and 29 (37.2%) in the non-mesh group (p = 0.22; 95% CI -24 – 5.5). A total of 25 patients developed an incisional hernia, seven in the mesh group (10.4%) versus 18 in the non-mesh group (27.2%) (p = 0.013, 95% CI 3.5 – 30.0). No relevant differences were found in quality of life or cost-effectiveness between both study group. Conclusions Use of a prophylactic retromuscular mesh at the ostomy site delays but not reduces the incidence of PSH after 5 years of follow-up. It leads to less severe PSH according to the EHS and MM classification with fewer repairs needed. Furthermore it causes patients to have fewer stoma related complications necessitating change of appliances and it is safe without any adverse events or increase in morbidity.

scholarly journals Integrated sensor-augmented pump therapy systems [the MiniMed® Paradigm™ Veo system and the Vibe™ and G4® PLATINUM CGM (continuous glucose monitoring) system] for managing blood glucose levels in type 1 diabetes: a systematic review and economic evaluation

2016 ◽  
Vol 20 (17) ◽  
pp. 1-252 ◽  
Author(s):  
Rob Riemsma ◽  
Isaac Corro Ramos ◽  
Richard Birnie ◽  
Nasuh Büyükkaramikli ◽  
Nigel Armstrong ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Type 1 Diabetes ◽  
Cost Effectiveness ◽  
Glucose Monitoring ◽  
Cost Effective ◽  
Over Time

BackgroundIn recent years, meters for continuous monitoring of interstitial fluid glucose have been introduced to help people with type 1 diabetes mellitus (T1DM) to achieve better control of their disease.ObjectiveThe objective of this project was to summarise the evidence on the clinical effectiveness and cost-effectiveness of the MiniMed®Paradigm™ Veo system (Medtronic Inc., Northridge, CA, USA) and the Vibe™ (Animas®Corporation, West Chester, PA, USA) and G4®PLATINUM CGM (continuous glucose monitoring) system (Dexcom Inc., San Diego, CA, USA) in comparison with multiple daily insulin injections (MDIs) or continuous subcutaneous insulin infusion (CSII), both with either self-monitoring of blood glucose (SMBG) or CGM, for the management of T1DM in adults and children.Data sourcesA systematic review was conducted in accordance with the principles of the Centre for Reviews and Dissemination guidance and the National Institute for Health and Care Excellence Diagnostic Assessment Programme manual. We searched 14 databases, three trial registries and two conference proceedings from study inception up to September 2014. In addition, reference lists of relevant systematic reviews were checked. In the absence of randomised controlled trials directly comparing Veo or an integrated CSII + CGM system, such as Vibe, with comparator interventions, indirect treatment comparisons were performed if possible.MethodsA commercially available cost-effectiveness model, the IMS Centre for Outcomes Research and Effectiveness diabetes model version 8.5 (IMS Health, Danbury, CT, USA), was used for this assessment. This model is an internet-based, interactive simulation model that predicts the long-term health outcomes and costs associated with the management of T1DM and type 2 diabetes. The model consists of 15 submodels designed to simulate diabetes-related complications, non-specific mortality and costs over time. As the model simulates individual patients over time, it updates risk factors and complications to account for disease progression.ResultsFifty-four publications resulting from 19 studies were included in the review. Overall, the evidence suggests that the Veo system reduces hypoglycaemic events more than other treatments, without any differences in other outcomes, including glycated haemoglobin (HbA1c) levels. We also found significant results in favour of the integrated CSII + CGM system over MDIs with SMBG with regard to HbA1clevels and quality of life. However, the evidence base was poor. The quality of the included studies was generally low, often with only one study comparing treatments in a specific population at a specific follow-up time. In particular, there was only one study comparing Veo with an integrated CSII + CGM system and only one study comparing Veo with a CSII + SMBG system in a mixed population. Cost-effectiveness analyses indicated that MDI + SMBG is the option most likely to be cost-effective, given the current threshold of £30,000 per quality-adjusted life-year gained, whereas integrated CSII + CGM systems and Veo are dominated and extendedly dominated, respectively, by stand-alone, non-integrated CSII with CGM. Scenario analyses did not alter these conclusions. No cost-effectiveness modelling was conducted for children or pregnant women.ConclusionsThe Veo system does appear to be better than the other systems considered at reducing hypoglycaemic events. However, in adults, it is unlikely to be cost-effective. Integrated systems are also generally unlikely to be cost-effective given that stand-alone systems are cheaper and, possibly, no less effective. However, evidence in this regard is generally lacking, in particular for children. Future trials in specific child, adolescent and adult populations should include longer term follow-up and ratings on the European Quality of Life-5 Dimensions scale at various time points with a view to informing improved cost-effectiveness modelling.Study registrationPROSPERO Registration Number CRD42014013764.FundingThe National Institute for Health Research Health Technology Assessment programme.

scholarly journals Cost-effectiveness of a multi-professional case management experiment in Finnish labor market services

2020 ◽  
Author(s):  
Jan Klavus ◽  
Sami Ylistö ◽  
Leena Forma ◽  
Jussi Partanen ◽  
Pekka Rissanen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Labor Market ◽  
Cost Effectiveness ◽  
Well Being ◽  
Quality Of Life Indicators ◽  
Market Intervention ◽  
Psychological Quality Of Life

The study undertook an economic evaluation of a multi-professional case man-agement intervention targeted at long-term unemployed Finns. The cost-effectiveness outcome of the intervention was analyzed in a matched case-control study framework involving a six-month follow-up. Effectiveness was measured by standardized quality of life indicators, and an indicator measuring personal capabilities. Individual level costs were derived from health and social services utilization data. Cost-effectiveness of the intervention was examined in relation to services as usual. The studied labor market intervention was associated with a positive change in the selected quality of life indicators; physical and psychological quality of life improved in the intervention group. Cost-effectiveness in physical quality of life was attained at a willingness to pay of EUR 500 – 700 per effectiveness unit, while cost-effectiveness in psychological quality of life required incremental costs exceeding EUR 1,600. The intervention had no discernible effect on personal capabilities. The study demonstrated that favorable improvements in quality of life could be attained by a rather ‘light’ and moderate-cost service concept. Such well-being improvements may enhance the preparedness for re-employment of individuals with a prolonged unemployment history. However, a longer follow-up of the labor market intervention would be needed to examine the long-term effects on quality of life and employment. Published: Online October 2020.

Long term follow-up in quality of life after mitral valve surgery

2012 ◽  
Vol 60 (S 01) ◽  
Author(s):  
I Kammerer ◽  
M Höhn ◽  
AH Kiessling ◽  
S Becker ◽  
FU Sack
Keyword(s):  
Quality Of Life ◽  
Mitral Valve ◽  
Mitral Valve Surgery ◽  
Valve Surgery ◽  
Long Term Follow Up

scholarly journals Extradural Motor Cortex Stimulation in Parkinson’s Disease: Long-Term Clinical Outcome

2021 ◽  
Vol 11 (4) ◽  
pp. 416
Author(s):  
Carla Piano ◽  
Francesco Bove ◽  
Delia Mulas ◽  
Enrico Di Stasio ◽  
Alfonso Fasano ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Motor Cortex ◽  
Clinical Outcome ◽  
Motor Cortex Stimulation ◽  
Dopaminergic Therapy

Previous investigations have reported on the motor benefits and safety of chronic extradural motor cortex stimulation (EMCS) for patients with Parkinson’s disease (PD), but studies addressing the long-term clinical outcome are still lacking. In this study, nine consecutive PD patients who underwent EMCS were prospectively recruited, with a mean follow-up time of 5.1 ± 2.5 years. As compared to the preoperatory baseline, the Unified Parkinson’s Disease Rating Scale (UPDRS)-III in the off-medication condition significantly decreased by 13.8% at 12 months, 16.1% at 18 months, 18.4% at 24 months, 21% at 36 months, 15.6% at 60 months, and 8.6% at 72 months. The UPDRS-IV decreased by 30.8% at 12 months, 22.1% at 24 months, 25% at 60 months, and 36.5% at 72 months. Dopaminergic therapy showed a progressive reduction, significant at 60 months (11.8%). Quality of life improved by 18.0% at 12 months, and 22.4% at 60 months. No surgical complication, cognitive or behavioral change occurred. The only adverse event reported was an infection of the implantable pulse generator pocket. Even in the long-term follow-up, EMCS was shown to be a safe and effective treatment option in PD patients, resulting in improvements in motor symptoms and quality of life, and reductions in motor complications and dopaminergic therapy.

Comparative Analysis of Patients with Robotic Hiatal Hernia Repairs with and without Collis Gastroplasty

2021 ◽  
pp. 000313482198905
Author(s):  
John A. Perrone ◽  
Stephanie Yee ◽  
Manrique Guerrero ◽  
Antai Wang ◽  
Brian Hanley ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Statistical Analysis ◽  
Hospital Stay ◽  
Hiatal Hernia ◽  
Collis Gastroplasty ◽  
Significant Difference ◽  
Related Quality

Introduction After extensive mediastinal dissection fails to achieve adequate intra-abdominal esophageal length, a Collis gastroplasty(CG) is recommended to decrease axial tension and reduce hiatal hernia recurrence. However, concerns exist about staple line leak, and long-term symptoms of heartburn and dysphagia due to the acid-producing neoesophagus which lacks peristaltic activity. This study aimed to assess long-term satisfaction and GERD-related quality of life after robotic fundoplication with CG (wedge fundectomy technique) and to compare outcomes to patients who underwent fundoplication without CG. Outcomes studied included patient satisfaction, resumption of proton pump inhibitors (PPI), length of surgery (LOS), hospital stay, and reintervention. Methods This was a single-center retrospective analysis of patients from January 2017 through December 2018 undergoing elective robotic hiatal hernia repair and fundoplication. 61 patients were contacted for follow-up, of which 20 responded. Of those 20 patients, 7 had a CG performed during surgery while 13 did not. There was no significant difference in size and type of hiatal hernias in the 2 groups. These patients agreed to give their feedback via a GERD health-related quality of life (GERD HRQL) questionnaire. Their medical records were reviewed for LOS, length of hospital stay (LOH), and reintervention needed. Statistical analysis was performed using SPSS v 25. Satisfaction and need for PPIs were compared between the treatment and control groups using the chi-square test of independence. Results Statistical analysis showed that satisfaction with outcome and PPI resumption was not significantly different between both groups ( P > .05). There was a significant difference in the average ranks between the 2 groups for the question on postoperative dysphagia on the follow-up GERD HRQL questionnaire, with the group with CG reporting no dysphagia. There were no significant differences in the average ranks between the 2 groups for the remaining 15 questions ( P > .05). The median LOS was longer in patients who had a CG compared to patients who did not (250 vs. 148 min) ( P = .01). The LOH stay was not significantly different ( P > .05) with a median length of stay of 2 days observed in both groups. There were no leaks in the Collis group and no reoperations, conversions, or blood transfusions needed in either group. Conclusion Collis gastroplasty is a safe option to utilize for short esophagus noted despite extensive mediastinal mobilization and does not adversely affect the LOH stay, need for reoperation, or patient long-term satisfaction.

scholarly journals Long-term outcome and quality of life after CNS cavernoma resection: eloquent vs. non-eloquent areas

2021 ◽  
Author(s):  
Loay Shoubash ◽  
Jörg Baldauf ◽  
Marc Matthes ◽  
Michael Kirsch ◽  
Matthias Rath ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Preoperative Evaluation ◽  
Patient Counseling ◽  
Surgical Morbidity ◽  
Term Outcome ◽  
Long Term Outcome

AbstractThe aim of this study is to analyze the long-term quality of life after surgery of cavernoma. A monocentric retrospective study was conducted on 69 patients with cavernoma treated microsurgically between 2000 and 2016. The eloquence was adopted from Spetzler-Martin definition. A most recent follow-up was elicited between 2017 and 2019, in which the quality of life (QoL) was evaluated with the Short Form-12 questionnaire (SF12). Forty-one lesions were in eloquent group (EG), 22 in non-eloquent group (NEG), 3 in orbit, and 3 in the spinal cord. Postoperative worsening of the modified Rankin scale (mRS) occurred in 19.5% of cases in EG versus 4.5% in NEG. After a mean follow-up of 6.5 years (SD 4.6), the neurological status was better or unchanged compared to baseline in 85.4% of EG and 100% of NEG. Regarding QoL assessment of 44 patients (EG n = 27, NEG n = 14) attended the last follow-up. Patients after eloquent cavernoma resection reported a non-inferior QoL in most SF12 domains (except for physical role) compared to NEG. However, they reported general health perception inferior to norms, which was affected by the limited physical and emotional roles. At a late follow-up, the surgical morbidity was transient in the NEG and mostly recovered in the EG. The QoL comparison between eloquent and non-eloquent cavernomas created interesting and new data after prolonged follow-up. These results add value for decision-making as well as patient counseling for future encountered cases. Preoperative evaluation of QoL is recommended for future studies to assess QoL dynamics.

scholarly journals P181 Long-term improvement in axial spondyloarthritis clinical outcomes following 2-weeks of intensive education and rehabilitation: results from the Bath residential rehabilitation programme

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Rosie Barnett ◽  
Anita McGrogan ◽  
Matthew Young ◽  
Charlotte Cavill ◽  
Mandy Freeth ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Rehabilitation Programme ◽  
Spinal Mobility ◽  
The Impact

Abstract Background/Aims  Axial spondyloarthritis (axSpA) is a chronic rheumatic condition, characterised by inflammatory back pain - often associated with impaired function and mobility, sleep disturbance, fatigue, and reduced quality of life. Despite the vast advances in pharmacological treatments for axSpA over the last few decades, physical activity and rehabilitation remain vital for effective disease management. At the Royal National Hospital for Rheumatic Diseases in Bath (RNHRD), the 2-week inpatient axSpA rehabilitation programme has been integral to axSpA care since the 1970’s. Prior research has demonstrated significant short-term improvements in spinal mobility (BASMI), function (BASFI) and disease activity (BASDAI) following course attendance. However, the long-term outcomes are yet to be evaluated in this unique cohort. Methods  Since the early 1990’s, clinical measures of spinal mobility, function and disease activity have been routinely collected at the RNHRD at all clinical appointments through administration of the BASMI, BASFI and BASDAI, respectively. Dates of attending the axSpA course and standard clinical and treatment follow-up data were also collected. Multiple linear regression models were used to investigate the impact of course attendance on final reported BASMI, BASDAI and BASFI scores (final score=most recent). Length of follow-up was defined as time between first and last recorded BASMI. Results  Of the 203 patients within the Bath SPARC200 cohort, 77.8% (158/203) had attended at least one rehabilitation course throughout follow-up. 70.0% (140/203) of patients were male. The mean duration of follow-up was 13.5 years (range 0-35 years); 28.1% (57/203) of individuals with 20+ years of follow-up. Course attendance (yes versus no) significantly reduced final BASMI score by 0.84 (p = 0.001, 95%CI -1.31 to -0.37) and final BASDAI score by 0.74 (p = 0.018, 95%CI -1.34 to -0.13). Although course attendance reduced final BASFI by 0.45 (95%CI -1.17 to 0.28), this relationship did not reach significance (p = 0.225). Whilst minimally clinically important difference (MCID) is, to our knowledge, yet to be defined for BASMI, MCIDs were achieved long-term for both BASDAI and BASFI - defined by van der Heijde and colleagues in 2016 as 0.7 and 0.4 for BASDAI and BASFI, respectively. Conclusion  These results provide novel evidence to support the integral role of education, physical activity and rehabilitation in the management of axSpA. Future work should investigate additional outcomes of critical importance to patients and clinicians, such as fatigue, quality of life and work productivity. Furthermore, a greater understanding of the factors that confound these outcomes may provide insights into those patients who may most benefit from attending a 2-week rehabilitation course. In addition to facilitating identification of those patients who may require additional clinical support. Disclosure  R. Barnett: None. A. McGrogan: None. M. Young: None. C. Cavill: None. M. Freeth: None. R. Sengupta: Honoraria; Biogen, Celgene, AbbVie, Novartis, MSD. Grants/research support; Novartis, UCB.

scholarly journals Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair

Hernia ◽  
2021 ◽  
Author(s):  
M. M. J. Van Rooijen ◽  
T. Tollens ◽  
L. N. Jørgensen ◽  
T. S. de Vries Reilingh ◽  
G. Piessen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hernia Repair ◽  
Hernia Recurrence ◽  
Recurrence Rates ◽  
Elective Repair ◽  
Significant Difference ◽  
Grade 3

Abstract Introduction Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. Methods A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. Results Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. Conclusion After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. Trial registration Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.

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