Cumulative Incidence Of Complications Research Articles

Application value research of swallowing treatment device combined with swallowing rehabilitation training in the treatment of swallowing disorders after stroke.

Stroke is a common disabling disease, whether it is ischemic stroke or hemorrhagic stroke, both can result in neuronal damage, leading to various manifestations of neurological dysfunction. To explore of the application value of swallowing treatment device combined with swallowing rehabilitation training in the treatment of swallowing disorders after stroke. This study selected 86 patients with swallowing disorders after stroke admitted to our rehabilitation department from February 2022 to December 2023 as research subjects. They were divided into a control group (n = 43) and an observation group (n = 43) according to the treatment. The control group received swallowing rehabilitation training, while the observation group received swallowing treatment device in addition to the training. Both groups underwent continuous intervention for two courses of treatment. The total effective rate in the observation group (93.02%) was higher than that in the control group (76.74%) (P = 0.035). After intervention, the oral transit time, swallowing response time, pharyngeal transit time, and laryngeal closure time decreased in both groups compared to before intervention. In the observation group, the oral transit time, swallowing response time, and pharyngeal transit time were shorter than those in the control group after intervention. However, the laryngeal closure time after intervention in the observation group was compared with that in the control group (P = 0.142). After intervention, average amplitude value and duration of the genioglossus muscle group during empty swallowing and swallowing 5 mL of water are reduced compared to before intervention in both groups. After intervention, the scores of the chin-tuck swallowing exercise and the Standardized Swallowing Assessment are both reduced compared to pre-intervention levels in both groups. However, the observation group scores lower than the control group after intervention. Additionally, the Functional Oral Intake Scale scores of both groups are increased after intervention compared to pre-intervention levels, with the observation group scoring higher than the control group after intervention (P < 0.001). The cumulative incidence of complications in the observation group is 9.30%, which is lower than the 27.91% in the control group (P = 0.027). The combination of swallowing therapy equipment with swallowing rehabilitation training can improve the muscle movement level of the genioglossus muscle group, enhance swallowing function, and prevent the occurrence of swallowing-related complications after stroke.

Long-term outcomes of liver transplantation for biliary atresia and results of policy changes: over 20 years of follow-up experience.

Biliary atresia (BA) patients develop chronic liver disease after the Kasai operation and are eventually indicated for liver transplantation (LT). The purposes of this study were to analyze long-term outcomes after LT and risk factors that affect complications to reduce graft failure. Overall, 145 pediatric patients who underwent LT between June 1996 and June 2020 after a diagnosis of BA were included. We performed a retrospective analysis of medical records and evaluated patient and graft survival, cumulative incidence of complications, risk factors, and the results of policy changes. Patient and graft survival rates in over 20 years were 95.8% and 91.0%, respectively. Post-transplantation lymphoproliferative disease was frequently observed in the early period of immunosuppression within the first 1-2 years after LT. The incidence of cholangitis and rejection steadily increased over time. Weight-to-portal vein size was evaluated as a risk factor for cholangitis and bile duct strictures (OR = 12.82, p = 0.006 and OR = 16.54, p = 0.015, respectively). When evaluated using 2013 as a reference point, the split graft indication was expanded and the group that received LT after 2013 had a significantly lower survival over time compared with that of the group that received LT before 2013 (p = 0.006). This study revealed time differences in prevalence of complications. The evaluation of weight-to-duct or vessel size is a more important factor in considering complications than the graft-to-recipient weight ratio. Survival outcomes may have been altered by a policy change that affects the donor type ratio in transplantation.

The Outcomes of Cord Blood Transplantations Infused with Higher Total Number of Nucleated Cells Were Equivalent to Unrelated Bone Marrow Transplantations

Introduction: Choosing a suitable donor is essential to achieve a good response for allogeneic hematopoietic cell transplantation (allo-HCT). Several previous studies have compared unrelated bone marrow transplantation (UR-BMT) and cord blood transplantation (CBT), but the results differed among each study, and their superiority has been controversial. The total number of nucleated cells (TNC) in cord blood unit is crucial for CBT to avoid early complications, including engraftment failure. The outcome of CBT may improve by choosing cord blood unit with a higher TNC. Methods: We retrospectively compared the outcomes of CBT with higher TNC (hCBT) and UR-BMT conducted in our institute from January 1st, 2013, to May 31st, 2023. Cut off point of TNC was the median value. The primary endpoint was overall survival (OS), and the secondary endpoints were non-relapse mortality (NRM), cumulative incidence of relapse, and cumulative incidence of complications. Results: We analyzed a total of 316 patients, including 139 patients who underwent CBT and 177 patients who received UR-BMT. The median infused TNC was 2.71 (range, 0.027-6.42) ×10^7/kg. hCBT group included 69 patients. Significantly more patients in the hCBT group had prior allo-HCTs (hCBT: 18.8%, UR-BMT: 5.6%, p=0.003), and hCBT procedures were more frequently conducted since 2018 (hCBT: 66.7%, UR-BMT: 36.7%, p&amp;lt;0.001). For each group, most patients received tacrolimus and short-term methotrexate as graft-versus-host disease prophylaxis (hCBT: 94.2%, UR-BMT: 95.5%, p=0.277). ABO matched donors were more commonly chosen for UR-BMT (hCBT: 24.6%, UR-BMT: 46.3%, p=0.006). Patients with myelodysplastic syndrome underwent UR-BMT more frequently (hCBT: 7.2%, UR-BMT: 20.9%). Patients with a high or very high disease risk index were more frequently included in the hCBT group (hCBT: 37.5%, UR-BMT: 27.9%, p=0.060). Patient sex, age, days from diagnosis to transplantation, and hematopoietic cell transplantation comorbidity index, conditioning intensity were well balanced between each group. The two-year OS of hCBT was equivalent to UR-BMT (hCBT: 53.6%, UR-BMT: 58.9%, p=0.56) (Figure 1). There was no significant difference in the two-year NRM between the two groups (hCBT: 24.9%, UR-BMT: 25.4%, p=0.87). The hCBT group had a lower neutrophil engraftment rate achieved at day 28 (hCBT: 83.0%, UR-BMT: 92.3%, p&amp;lt;0.001). The two-year relapse rate was similar between the hCBT and UR-BMT groups (hCBT: 26.1%, UR-BMT: 18.7%, p=0.34). The cumulative incidence of acute GVHD tended to be lower in the hCBT group (hCBT: 18.2%, UR-BMT: 33.6% at 100 days, p=0.067), and the same results were observed when analyzing grade 2-4 or grade 3-4 acute GVHD. The cumulative incidence of chronic GVHD was significantly lower in the hCBT group (hCBT: 4.7%, UR-BMT: 48.3%, p&amp;lt;0.001), and the cumulative incidence of severe chronic GVHD was also lower in hCBT group (hCBT: 0.0%, UR-BMT: 13.9%, p&amp;lt;0.001). To reduce the impact of patients' characteristics, propensity score matching was conducted. The covariates included prior allo-HCTs, disease risk index, and allo-HCT conducted before 2018 or not. After propensity score matching, a total of 116 patients were included in the analysis with 58 patients for each group. The two-year OS of hCBT was also equivalent to UR-BMT (hCBT: 61.8%, UR-BMT: 55.2%, p=0.43) (Figure 2). The two-year NRM was slightly lower in hCBT group, but it is not significant (hCBT: 19.1%, UR-BMT: 30.1%, p=0.21). The hCBT group had a late neutrophil engraftment (hCBT: 87.0%, UR-BMT: 89.1% at day 28, p&amp;lt;0.001). The two-year relapse rate was similar between the hCBT and UR-BMT groups (hCBT: 25.0%, UR-BMT: 20.0%, p=0.54). The cumulative incidence of acute GVHD was tended to be lower in hCBT group (hCBT: 19.8%, UR-BMT: 38.7% at 100 days, p=0.057) and the cumulative incidence of chronic GVHD was significantly lower in hCBT group (hCBT: 5.3%, UR-BMT: 56.3%, p&amp;lt;0.001). Discussion: This was the first study to validate that the outcomes of CBT with higher TNC were equivalent to UR-BMT. Although the hCBT group experienced later neutrophil engraftment, the rate of neutrophil engraftment achieved at day 28 was comparable to UR-BMT, and a lower incidence rate of chronic GVHD might be attributed to lower NRM. From these findings, hCBT may be a worth considering option for patients requiring allo-HCT.

The influence of fracture severity on postoperative outcome and quality of life after locking plate fixation of proximal humeral fractures

Objective: For proximal humeral fractures open reduction und internal fixation (ORIF) with a fixed-angle plate is considered the gold standard for surgical management. However, it can lead to poor functional outcomes and is associated with postoperative complications. Therefore, the purpose of this study was to investigate the influence of fracture severity by applying a new classification (simple versus complex) on clinical outcome and quality of life after ORIF of proximal humerus fractures. Methods: We conducted a prospective clinical study with an average follow-up period of 12 (SD 1) months after ORIF of proximal humeral fractures with a fixed-angle plate. The postoperative function and quality of life was measured using the Oxford Shoulder Score (OSS) and the Constant Score. Data was tested for statistical significance with the Mann-Whitney test and Fisher's exact test. Based on the findings of this study a simplified fracture classification system has been developed.Results: Seventy-two patients with a mean age of 65 years (SD 12) with 69% being males were included. According to the Neer classification, 35% (n=25) non-displaced (“one-part fractures”), 19% (n=14) two-part fractures, 15% (n=11) three-part fractures and 31% (n=22) four-part fractures were detected. Regarding the AO/OTA classification, 18% (n=13) were type A fractures, 43% (n=31) type B and 39% (n=28) type C fractures. From these criteria we derived our own fracture classification, including 50% (n=36) simple and 50% (n=36) severe fractures. Patients with simple fracture types achieved significantly higher total values in the Constant Score as well as the OSS (p=0.008; p=0.013). The cumulative incidence of complications in the entire patient collective was 14% (n=10) with humeral head necrosis (n=5) occurring only in the severe fracture group.Conclusions: The postoperative clinical outcome as well as the incidence of humeral head necrosis after ORIF of proximal humeral fractures with a fixed-angle plate correlates with the fracture type and severity. The newly derived fracture classification into simple and severe fractures is suitable with regard to clinical results and complication rate. However, prospective studies comparing ORIF vs. conservative treatment of proximal humeral fractures of the same severity are required.Level of Evidence: III

Impact of bariatric surgery on the development of diabetic microvascular and macrovascular complications.

While bariatric surgery has been shown to improve type 2 diabetes (DM) control in the obese population, the effect on long-term DM complications has been less thoroughly investigated. The purpose of this study was to assess the development of microvascular and macrovascular complications in obese DM patients undergoing bariatric surgery. New York patients' records from the SPARCS database in years 2006-2012 were used to identify obese patients with DM. Patients undergoing bariatric surgery were compared with patients managed medically, matched for age and gender. Patients were grouped based on baseline presence of controlled or uncontrolled DM and followed over time for the development of micro- and macrovascular complications. Cumulative incidence of complications was estimated with death treated as a competing risk event. Multivariable proportional sub-distribution hazards models were used to compare the risk of complications among different patient groups after adjusting for possible confounding factors. A total of 88,981 patients were reviewed, including 15,585 (18%) that were treated with bariatric surgery. Surgery patients had significantly lower risk of microvascular complications compared to non-surgery patients (controlled diabetes: HR = 0.40, 95% CI 0.37-0.42; uncontrolled diabetes: HR = 0.51, 95% CI 0.37-0.71). Similarly, the surgical patients were noted to have a significantly lower risk for macrovascular complications compared to non-surgery patients (controlled diabetes: HR = 0.43, 95% CI 0.40-0.46; uncontrolled diabetes: HR = 0.44, 95% CI 0.28-0.69). Cumulative incidence of microvascular complications was lower at 1, 5 and 9years for the surgical groups for controlled and uncontrolled DM. Similar trends were observed for the macrovascular complications. Bariatric surgery appears to prevent complications of DM. Bariatric surgery patients with DM experienced significantly lower rates of microvascular and macrovascular complications, compared to non-surgically treated comparison group. Bariatric surgery was noted to offer protective benefits for both complicated and non-complicated DM patients. This reduced rate of complications was sustained in the long term.

Association Between Age and Complications After Outpatient Colonoscopy

There are insufficient data describing the incidence and risk factors of postcolonoscopy complications in older individuals. To assess the association between older age (≥75 years) and the risk of postcolonoscopy complications. This population-based retrospective cohort study included adults (≥50 years) undergoing outpatient colonoscopy between April 2008 and September 2017, identified from Ontario administrative databases. Individuals with inflammatory bowel disease and hereditary colorectal cancer syndromes were excluded. The study population was subdivided into a colorectal cancer screening-eligible cohort (patients aged 50-74 years) and an older cohort (patients aged ≥75 years). The statistical analysis was conducted from December 2018 to September 2019. Older age (≥75 years). The primary outcome was postcolonoscopy complications, defined as the composite of hospitalization or emergency department visits in the 30-day period after the outpatient colonoscopy. Secondary outcomes included incidence of surgically treated colorectal cancer and all-cause mortality at 30 days. Independent variables associated with postcolonoscopy complications were also assessed. The study sample included 38 069 patients; the mean (SD) age was 65.2 (10.1) years, there were 19 037 women (50.0%), and 27 831 patients (73.1%) underwent a first colonoscopy. The cumulative incidence of complications was 3.4% (1310 patients) in the overall population, and it was higher in individuals aged 75 years or older (515 of 7627 patients [6.8%]) than in screening-eligible cohort (795 of 30 443 patients [2.6%]) (P < .001). Independent risk factors for postcolonoscopy complications were age 75 years or older (odds ratio [OR], 2.3; 95% CI, 2.0-2.6), anemia (OR, 1.4; 95% CI, 1.2-1.7), cardiac arrhythmia (OR, 1.7; 95% CI, 1.2-2.2), congestive heart failure (OR, 3.4; 95% CI, 2.5-4.6), hypertension (OR, 1.2; 95% CI, 1.0-1.5), chronic kidney disease (OR, 1.8; 95% CI, 1.1-3.0), liver disease (OR, 4.7; 95% CI, 3.5-6.5), smoking history (OR, 3.2; 95% CI, 2.4-4.3), and obesity (OR, 2.3; 95% CI, 1.2-4.2). The number of previous colonoscopies was associated with a lower risk of complications (OR, 0.9; 95% CI, 0.7-1.0). The incidence of surgically treated colorectal cancer was higher in the older cohort than the screening-eligible cohort (119 patients [1.6%] vs 144 patients [0.5%]; P < .001). All-cause mortality rates were 0.1% overall (39 patients) and 0.1% (19 patients) for individuals aged 50 to 74 years and 0.2% (20 patients) for those aged 75 years and older (P < .001). In this population-based cohort study of individuals living in southern Ontario, age of 75 years and older was associated with a higher risk of 30-day postprocedure complications after outpatient colonoscopy. These findings suggest that the decision to perform a colonoscopy should be carefully considered in patients older than 75 years, especially in the presence of comorbidities. Further studies are needed to better understand the benefits of invasive procedures as opposed to less invasive approaches for colorectal cancer screening and surveillance among older patients.

PDB51 - RESULTS OF THE COSMODIA STUDY: ESTIMATING THE IMPACT ON THE NUMBER OF CLINICAL COMPLICATIONS AND THE ASSOCIATED POTENTIAL FINANCIAL BENEFIT AS A CONSEQUENCE OF BETTER MANAGEMENT OF GLYCAEMIC CONTROL IN PEOPLE WITH TYPE 2 DIABETES IN SPAIN

To estimate the potential benefits in terms of complications avoided and cost reduction if the Spanish health system encouraged switching patient treatment to better glycaemic control for adults with Type 2 diabetes at the target HbA1c of 53 mmol/mol (7%) instead of current practice which on average escalates treatment at 68 mmol/mol (8.4%). The IQVIA Core Diabetes Model was used to model the impact of these changes in respect of micro- and macrovascular complications and the associated costs. Management and complication costs were adapted to Spain in the model which which translates surrogate endpoints into long-term health and economic outcomes. The modelling was based on patient data derived from the SIDIAP-Q population database from Catalonia, taking a random cohort of 10,000 diabetes type 2 patients and dividing it into sub-groups based on their reported HbA1c level. Cumulative incidence of complications over a 25 year period was calculated for the base and comparator cases. Results were extrapolated for the type 2 diabetes population in Spain. The modelling showed that the average cost reduction per person varies depending on basal HbA1c. After 25 years, people with basal HbA1c between 48 and 58 mmol/mol and >75 mmol/mol show an average cost reduction of €6,027 and €11,966, respectively. Applying the per-person cost reduction to the cohorts of the prevalent population in Spain (1,910,374) the overall estimated cost reduction was €14.7 billion over 25 years. The improvements in outcomes resulted in an estimated reduction of more than 1.2 million complications cumulatively over 25 years, of which more than 550,000 relate to diabetic foot and neuropathy. There is scope for considerable cost reductions and avoidance of major complications if, on a population level, better glycaemic control can be achieved among people with type 2 diabetes in Spain by reducing the threshold of HbA1c for treatment intensification.

Change in Functional Impairment, Disability, and Quality of Life Following Operative Treatment for Degenerative Cervical Myelopathy: A Systematic Review and Meta-Analysis.

Study Design:Systematic review.Objectives:The primary objective of this systematic review was to define the change in impairment, disability, and pain following surgical intervention in patients with degenerative cervical myelopathy (DCM). Secondary objectives included to assess the impact of preoperative disease severity and duration of symptoms on outcomes and to summarize complications associated with surgery.Methods:A systematic literature search was conducted to identify prospective studies evaluating the effectiveness and safety of operative treatment in patients with DCM. Outcomes of interest were functional status, disability, pain, and complications. The quality of each study was evaluated using the Newcastle-Ottawa Scale, and the strength of the overall body of evidence was rated using guidelines outlined by the Grading of Recommendation Assessment, Development and Evaluation (GRADE) Working Group.Results:Of the 385 retrieved citations, 32 met inclusion criteria and are summarized in this review. Based on our results, pooled standard mean differences showed a large effect for improvement in Japanese Orthopaedic Association or modified Japanese Orthopaedic Association score from baseline at short-, medium-, and long-term follow-up: 6 to 12 months (1.92; 95% confidence interval [CI] = 1.41 to 2.43), 13 to 36 months (1.40; 95% CI = 1.12 to 1.67), and ≥36 months (1.92; 95% CI = 1.14 to 2.69) (moderate evidence). Surgery also resulted in significant improvements in Nurick, Neck Disability Index, and Visual Analogue Scale scores (low to very low evidence). The cumulative incidence of complications was low (14.1%; 95% CI = 10.1% to 18.2%).Conclusion:Surgical intervention for DCM results in significant improvements in functional impairment, disability, and pain and is associated with an acceptably low rate of complications.

Indwelling Pleural Catheters for Patients with Hematologic Malignancies. A 14-Year, Single-Center Experience.

Placement of an indwelling pleural catheter is an established modality for symptom relief and pleurodesis in the treatment of malignant pleural effusion. Concerns remain regarding possible infectious complications, risk of hemorrhage, and the rate of pleurodesis with the use of pleural catheters in the treatment of hematologic malignancies. The goals of our study were: (1) to evaluate the safety and cumulative incidence of pleurodesis with indwelling pleural catheters for patients with hematologic malignancies, and (2) to evaluate overall survival of this cohort of patients with pleural effusions. We performed a retrospective review of 172 patients with a hematologic malignancy who underwent placement of an indwelling pleural catheter between September 1997 and August 2011 at the University of Texas MD Anderson Cancer Center in Houston, Texas. A competing risk model analysis was used for complications and pleurodesis. Analysis was based on each patient's first intrapleural catheter. There were 172 patients with lymphoma (58%), acute (16%) or chronic leukemia (16%), or multiple myeloma (10%). The effusions were characterized as malignant (85.5%), infectious (4.1%), volume overload (4.7%), or therapy-related (4.7%). Chylothorax was found in 20.1%. Pleural biopsies were obtained from 13 patients. The cumulative incidence of all complications was 13.6%, and the cumulative incidence of all significant catheter-related complications was 9.5%. The incidence of empyema was 2.9%, and major bleeding (requiring transfusion or intervention) was 1.7%. Thirty-day procedure-associated mortality was 0.6%. The cumulative incidence of pleurodesis at 180 days was 50%, with a median time to pleurodesis of 81 days for the entire cohort. Indwelling pleural catheters appear to be safe for patients with hematologic malignancies. Complications and the cumulative incidence of pleurodesis are comparable to those reported for patients with solid organ malignancies.

Cementless fixation in medial unicompartmental knee arthroplasty: a systematic review.

The aim of this study was to evaluate clinical outcome, failures, implant survival, and complications encountered with cementless fixation in unicompartmental knee arthroplasty (UKA). A systematic review of the literature on cementless fixation in UKA was performed according to the PRISMA guidelines. The following database was comprehensively searched: PubMed, Cochrane, Medline, CINAHL, Embase, and Google Scholar. The keywords "unicompartmental", "unicondylar", "partial knee arthroplasty", and "UKA" were combined with each of the keyword "uncemented", "cementless" and "survival", "complications", and "outcome". The following data were extracted: demographics, clinical outcome, details of failures and revisions, cumulative survival, and complications encountered. The risk of bias of each study was estimated with the MINORS score and a further scoring system based on the presence of the primary outcomes. From a cohort of 63 studies identified using the above methodology, 10 papers (1199 knees) were included in the final review. The mean follow-up ranged from 2 to 11years (median 5years). The 5-year survival ranged from 90 to 99% and the 10-year survival from 92 to 97%. There were 48 revisions with an overall revision rate of 0.8 per 100 observed component-years. The most common cause of failure was progression of osteoarthritis in the retained compartment (0.9%). The cumulative incidence of complications and revisions was comparable to that reported in similar studies on cemented UKAs. The advantages of cementless fixation include faster surgical time, avoidance of cementation errors, and lower incidence of radiolucent lines. Cementless fixation is a safe and effective alternative to cementation in medial UKA. Clinical outcome, failures, reoperation rate, and survival are similar to those reported for cemented implants with lower incidence of radiolucent lines. IV.

Complications of percutaneous endoscopic gastrostomy in children: Results of an Italian multicenter observational study

BackgroundPercutaneous endoscopic gastrostomy is the preferred way to achieve an artificial feeding route for patients requiring long-term enteral nutrition. Although the procedure is well-standardized, it carries early and late complications. AimTo establish the mortality and morbidity of this technique in a large cohort of children. MethodsA multi-centre prospective clinical data collection from children undergoing percutaneous endoscopic gastrostomy tube implantation has been conducted from January 2004 to December 2007. Previous abdominal surgery was the only exclusion criterion. Follow-up visits were carried out at 1, 3, 6, 12, and 24months after the procedure. Results239 children (males, 55.2%; mean age 6.05±6.1years) were enrolled from nine tertiary Italian centres. Major complications occurred in 8 patients (3.3%). The cumulative incidence of complications was 47.7% at 24months. The presence of thoraco-abdominal deformity was an independent predictor of complications at 12months. No risk factors were identified in association to complications during the 1st tube replacement. ConclusionIn children undergoing percutaneous endoscopic gastrostomy placement minor complications are common, while severe morbidities are rare. Accurate follow up is essential to recognize every complication, in particular when risk factors such as thoraco-abdominal deformity exist.

Self-monitoring of blood glucose (SMBG) for type 2 diabetes patients treated with oral anti-diabetes drugs and with a recent history of monitoring: cost-effectiveness in the US

Objective:Stakeholders in the US and elsewhere are interested in country-specific and cohort-specific information with which to assess the long-term value of self-monitoring of blood glucose (SMBG) for patients with type 2 diabetes mellitus (T2DM) on oral anti-diabetes drugs (OADs). This study modeled the cost-effectiveness of SMBG at frequencies of once, twice, or three times per day for this population, and included those who had used SMBG in the prior year.Research design and methods:Based on clinical findings of a longitudinal Kaiser Permanente study, a validated model was used to project 40-year clinical and economic outcomes for SMBG at (averages of) once, twice, or three times per day versus no SMBG. Baseline HbA1c (7.6%), age and gender represented the Kaiser study ‘prevalent’ SMBG users cohort. Unit costs came primarily from a 2003 published article; inflated to US$2006. Outcomes were discounted at 3% per annum, with sensitivity analyses on discount rates and time horizons. Analyses were conducted from a third-party payer perspective in the US, including only direct costs.Main outcome measures:Primary outcomes were differences in total costs, cumulative incidence of complications, quality-adjusted life years (QALYs); and incremental cost-effectiveness ratios (ICERs).Results:For patients using SMBG once, twice, or three times per day, relative risks over 40 years were lower for 14 of 16 complications and slightly higher for 2 complications. Compared to ‘no SMBG,’ QALYs increased with SMBG frequency: 0.047, 0.116, and 0.132 QALYs for SMBG once, twice, and three times per day, respectively. Some increased costs with SMBG were offset by reductions in costs for several diabetes-related complications. Corresponding ICERs were $26 206, $18 572 and $25 436/QALY gained. Results were most sensitive to time horizon, with SMBG not cost-effective over a 5-year simulation period.Conclusions:Study limitations include the use of relatively short-term observational data, unknown levels of patient adherence, and assumptions regarding the duration of clinical effects. Results showed that compared to no SMBG, base case ICERs for each of the three SMBG frequencies examined were below $30 000, and that a portion of the increased costs associated with SMBG were offset by reductions in complication costs, and by modest increases in QALYs. Results add to the literature addressing the cost-effectiveness of SMBG as a component of care for T2DM patients on OADs, and in particular those with monitoring experience within the previous year.

A cost-effectiveness analysis of pioglitazone plus metformin compared with rosiglitazone plus metformin from a third-party payer perspective in the US

ABSTRACTObjective: The long-term cost-effectiveness of using pioglitazone plus metformin (Actoplusmet) compared with rosiglitazone plus metformin (Avandamet) in treating type 2 diabetes (T2DM) was assessed from a US third-party payer perspective.† Actoplusmet is a trade name of Takeda Pharmaceuticals North America, Inc., Deerfield, IL, USA‡ Avandamet is a trade name of GlaxoSmithKline, Research Triangle, NC, USAResearch design and methods: Clinical efficacy (change in HbA1c and lipids) and baseline cohort parameters were extracted from a 12-month, randomized clinical trial (Derosa et al., 2006) evaluating the efficacy and tolerability of pioglitazone versus rosiglitazone, both in addition to metformin, in adult T2DM patients with insufficient glucose control (n = 96). A Markov-based model was used to project clinical and economic outcomes over 35 years, discounted at 3% per annum. Costs for complications were taken from published sources. Base-case assumptions were assessed through several sensitivity analyses.Main outcome measures: Outcomes included incremental life-years, quality-adjusted life-years (QALYs), total direct medical costs, cumulative incidence of complications and associated costs, and incremental cost–effectiveness ratios (ICERs).Results: Compared to rosiglitazone plus metformin, pioglitazone plus metformin was projected to result in a modest improvement in 0.187 quality-adjusted life-years. Over patients’ lifetimes, total direct medical costs were projected to be marginally lower with pioglitazone plus metformin (difference –$526.), largely due to reduced CVD complication costs. While costs were higher among renal, ulcer/amputation/neuropathy, and eye complications in the pioglitazone plus metformin group, the cost savings for CVD complications outweighed their economic impact. Pioglitazone plus metformin was found to be a dominant long-term treatment strategy in the US compared to rosiglitazone plus metformin. Sensitivity analyses showed findings to be robust under almost all scenarios, including short-term time horizons, 6% discounting, removal of individual lipid parameters, and modifications of patient cohort to more closely represent a US T2DM population. Pioglitazone plus metformin was no longer dominant with 0% discounting, with 25% reduction in its HbA1c effects, or with a 15% increase in its acquisition price.Conclusions: Under a range of assumptions and study limitations around cohorts, clinical effects, and treatment patterns, this long-term analysis showed that pioglitazone plus metformin, when compared to rosiglitazone plus metformin, was a dominant treatment strategy within the US payer setting. Results were driven by the combination of modest differences in QALYs and modest savings in total complication costs over 35 years.

Cost-effectiveness of diabetes case management for low-income populations.

To evaluate the cost-effectiveness of Project Dulce, a culturally specific diabetes case management and self-management training program, in four cohorts defined by insurance status. Clinical and cost data on 3,893 persons with diabetes participating in Project Dulce were used as inputs into a diabetes simulation model. The Center for Outcomes Research Diabetes Model, a published, peer-reviewed and validated simulation model of diabetes, was used to evaluate life expectancy, quality-adjusted life expectancy (QALY), cumulative incidence of complications and direct medical costs over patient lifetimes (40-year time horizon) from a third-party payer perspective. Cohort characteristics, treatment effects, and case management costs were derived using a difference in difference design comparing data from the Project Dulce program to a cohort of historical controls. Long-term costs were derived from published U.S. sources. Costs and clinical benefits were discounted at 3.0 percent per annum. Sensitivity analyses were performed. Incremental cost-effectiveness ratios of $10,141, $24,584, $44,941, and $69,587 per QALY gained were estimated for Project Dulce participants versus control in the uninsured, County Medical Services, Medi-Cal, and commercial insurance cohorts, respectively. The Project Dulce diabetes case management program was associated with cost-effective improvements in quality-adjusted life expectancy and decreased incidence of diabetes-related complications over patient lifetimes. Diabetes case management may be particularly cost effective for low-income populations.

Long-term clinical and cost outcomes of treatment with biphasic insulin aspart 30/70 versus insulin glargine in insulin naïve type 2 diabetes patients: cost-effectiveness analysis in the UK setting

To evaluate the long-term clinical and cost outcomes associated with biphasic insulin aspart 30/70 (BIAsp 30/70, premixed 30% soluble and 70% protaminated insulin aspart in one injection) compared to insulin glargine treatment in insulin-naïve type 2 diabetes patients failing oral antidiabetic agents in the UK, based on findings recently reported from the INITIATE clinical trial. The CORE Diabetes Model, a published, peer-reviewed and validated model of diabetes, was used to evaluate life expectancy, quality-adjusted life expectancy, cumulative incidence of complications and direct medical costs over patient lifetimes. The model simulates the range of diabetic complications and disease progression within a series of sub-models (cardiovascular disease, neuropathy, renal and eye disease) based on published data. Baseline cohort characteristics (54.5% male, mean age 52.45 years, mean diabetes duration 9 years, mean HbA(1c) 9.77%) and treatment effects were based on INITIATE. Costs were derived from published UK sources. The analysis was run over a 35-year time horizon (patient lifetime) from a third party payer perspective. Costs and clinical benefits were discounted at 3.5% per annum. Sensitivity analyses were performed. BIAsp 30/70 was associated with projected improvements in discounted life expectancy (0.19 +/- 0.20 years) and quality-adjusted life expectancy (0.19 +/- 0.14 quality-adjusted life years [QALYs]), as well as a reduced incidence of retinopathy and nephropathy complications, versus glargine. Total lifetime direct costs were 1319 pounds higher with BIAsp 30/70 than with glargine leading to an incremental cost-effectiveness ratio of 6951 pounds per QALY gained. This study is the first to address the long-term health economic implications of treating type 2 diabetes patients failing oral anti-diabetics with a biphasic insulin mix versus long-acting insulin. Our projections indicate that improved HbA1c levels with BIAsp 30/70 treatment are associated with improvements in life expectancy and quality-adjusted life expectancy, and that BIAsp 30/70 represents excellent value for money compared to insulin glargine in the UK.

The clinical characteristics and outcome of intraabdominal abscess in Crohn's disease.

We aimed to elucidate the incidence and natural course of abdominal abscess complicating Crohn's disease (CD). Of 352 patients with CD who were observed at our hospital between 1985 and October 2001, we studied 35 patients (9.9%) with abscesses in the mid-abdominal region (the abdominal wall, peritoneal cavity, retroperitoneum, and subphrenic region). The cumulative incidence of complication with an abscess was 9% and 25%, respectively, 10 and 20 years after CD onset. Of the 35 CD patients with abscess, 60% had had surgery by the time of the present study. The age when the abscess developed was 30.1 +/- 8.1 years, and the duration of illness from the onset of CD until development of an abscess was 10.8 +/- 6.3 years (range, 0-29 years). The location of involvement was: abdominal wall, n = 14 (40%); peritoneal cavity, n = 10 (29%); retroperitoneum or iliopsoas, n = 9 (26%); and subphrenic region, n = 2 (6%). In terms of location of abscess, it occurred most often on the right side (65.7%). Almost all abscesses occurred near the site of an anastomosis. Diseased segments of the bowel responsible for abscess formation were categorized radiographically as showing mild stenosis (6.5%), intermediate stenosis and/or simple fistula (41.9%), and severe stenosis and/or multiple fistulas (51.6%). Conservative treatment (including drainage of abscess) alone was effective in 7 patients (20%) and surgery was needed in 28 patients (80%). During the 5.3-year follow-up after treatment for the abdominal abscess, 9 of the 35 patients (26%) had recurrence of an abscess, mostly within 3 years. Abscess formation was noted in about 10% of patients with CD, with 46% of abscesses occurring in a diseased bowel segment near an anastomotic site. Of the diseased bowel segments responsible for abscess formation, half had neither severe stenosis nor multiple fistulas. Almost all patients underwent surgery for the abscess, and, in more than a quarter of the patients, there was recurrence within a few years after surgery.

Pseudocysts in acute nonalcoholic pancreatitis: incidence and natural history.

Epidemiological studies on pancreatic pseudocysts are retrospective analyses on alcoholic patients. The aims of this study were to investigate the incidence, natural history, and predictors of the appearance and disappearance of pancreatic fluid collections and pseudocysts after nonalcoholic acute pancreatitis. We carried out a prospective cohort study in a series of 926 patients with acute pancreatitis. Pancreatic fluid collections or pseudocysts were treated only after complications. We studied pancreatic fluid collections from 83 patients (8.9%): 48 of whom developed pseudocysts (5.1%). Both were less frequent after biliary pancreatitis (P < 0.0001). In the first 60 days of follow-up, patients with fluid collections or pseudocysts showed more complications than spontaneous disappearance; two of them died. After the 60th day, spontaneous disappearance was more frequent, and at one year the cumulative incidence of complications and spontaneous disappearance was 36% and 56%, respectively. A total of 33 patients with fluid collection needed interventional treatment (surgery or percutaneous or endoscopic drainage). Pseudocysts that were small (<5 cm) or developed in the tail had a higher incidence of spontaneous disappearance: 22/24 (91.7%) and 11/12 (91.7%), respectively. In conclusion, fluid collections and pseudocysts after non-alcoholic pancreatitis have a low incidence of complications and mortality with a high rate of spontaneous disappearance. We suggest treating them only after complications.