Adherence to antihypertensive drugs (AHDs) is crucial for controlling blood pressure (BP). We aimed to determine the effectiveness of measuring AHD concentrations using a dried blood spot (DBS) ...sampling method to identify nonadherence, combined with personalized feedback, in reducing resistant hypertension.
We conducted a multicenter, randomized, controlled trial (RHYME-RCT, ICTRP NTR6914) in patients with established resistant hypertension. Patients were randomized to receive either an intervention with standard of care (SoC) or SoC alone. SoC consisted of BP measurement and DBS sampling at baseline, 3 months (t3), 6 months (t6), and 12 months (t12); AHD concentrations were measured but not reported in this arm. In the intervention arm, results on AHD concentrations were discussed during a personalized feedback conversation at baseline and t3. Study endpoints included the proportion of patients with RH and AHD adherence at t12.
Forty-nine patients were randomized to receive the intervention+SoC, and 51 were randomized to receive SoC alone. The proportion of adherent patients improved from 70.0 to 92.5% in the intervention+SoC arm ( P = 0.008, n = 40) and remained the same in the SoC arm (71.4%, n = 42). The difference in adherence between the arms was statistically significant ( P = 0.014). The prevalence of resistant hypertension decreased to 75.0% in the intervention+SoC arm ( P < 0.001, n = 40) and 59.5% in the SoC arm ( P < 0.001, n = 42) at t12; the difference between the arms was statistically nonsignificant ( P = 0.14).
Personalized feedback conversations based on DBS-derived AHD concentrations improved AHD adherence but did not reduce the prevalence of RH.
Purpose
The aim of this study is to assess cost-effectiveness of general practitioner (GP) versus surgeon-led colon cancer survivorship care from a societal perspective.
Methods
We performed an ...economic evaluation alongside the I CARE study, which included 303 cancer patients (stages I–III) who were randomised to survivorship care by a GP or surgeon. Questionnaires were administered at baseline, 3-, 6-, 12-, 24- and 36-months. Costs included healthcare costs (measured by iMTA MCQ) and lost productivity costs (SF-HLQ). Disease-specific quality of life (QoL) was measured using EORTC QLQ-C30 summary score and general QoL using EQ-5D-3L quality-adjusted life years (QALYs). Missing data were imputed. Incremental cost-effectiveness ratios (ICERs) were calculated to relate costs to effects on QoL. Statistical uncertainty was estimated using bootstrapping.
Results
Total societal costs of GP-led care were significantly lower compared to surgeon-led care (mean difference of − €3895; 95% CI − €6113; − €1712). Lost productivity was the main contributor to the difference in societal costs (− €3305; 95% CI − €5028; − €1739). The difference in QLQ-C30 summary score over time between groups was 1.33 (95% CI − 0.049; 3.15). The ICER for QLQ-C30 was − 2073, indicating that GP-led care is dominant over surgeon-led care. The difference in QALYs was − 0.021 (95% CI − 0.083; 0.040) resulting in an ICER of 129,164.
Conclusions
GP-led care is likely to be cost-effective for disease-specific QoL, but not for general QoL.
Implications for cancer survivors
With a growing number of cancer survivors, GP-led survivorship care could help to alleviate some of the burden on more expensive secondary healthcare services.
Long-term trends in neuroblastoma incidence and survival in unscreened populations are unknown. We explored trends in incidence, stage at diagnosis, treatment and survival of neuroblastoma in the ...Netherlands from 1990 to 2014.
The Netherlands Cancer Registry provided data on all patients aged <18 years diagnosed with a neuroblastoma. Trends in incidence and stage were evaluated by calculating the average annual percentage change (AAPC). Univariate and multivariable survival analyses were performed for stage 4 disease to test whether changes in treatment are associated with survival.
Of the 593 newly diagnosed neuroblastoma cases, 45% was <18 months of age at diagnosis and 52% had stage 4 disease. The age-standardized incidence rate for stage 4 disease increased at all ages from 3.2 to 5.3 per million children per year (AAPC + 2.9%, p < .01). This increase was solely for patients ≥18 months old (3.0–5.4; AAPC +3.3%, p = .01). Five-year OS of all patients increased from 44 ± 5% to 61 ± 4% from 1990 to 2014 (p < .01) and from 19 ± 6% to 44 ± 6% (p < .01) for patients with stage 4 disease. Multivariable analysis revealed that high-dose chemotherapy followed by autologous stem cell rescue and anti-GD2-based immunotherapy were associated with this survival increase (HR 0.46, p < .01 and HR 0.37, p < .01, respectively).
Incidence of stage 4 neuroblastoma increased exclusively in patients aged ≥18 months since 1990, whereas the incidence of other stages remained stable. The 5-year OS of stage 4 patients improved, mostly due to the introduction of high-dose chemotherapy followed by stem cell rescue and immunotherapy.
•The incidence of stage 4 neuroblastoma increased 2.9% per year between 1990 and 2014.•Five-year overall survival of stage 4 patients improved from 19 ± 6% to 44 ± 6%.•High-dose chemotherapy and immunotherapy contributed most to the improved survival.
The incidence of central venous catheter (CVC)-related bloodstream infections is high in patients requiring a long-term CVC. Therefore, infection prevention is of the utmost importance. The aim of ...this study was to provide an updated overview of randomized controlled trials (RCTs) comparing the efficacy of taurolidine containing lock solutions (TL) to other lock solutions for the prevention of CVC-related bloodstream infections in all patient populations. On 15th February 2021, PubMed, Embase and The Cochrane Library were searched for RCTs comparing the efficacy of TLs for the prevention of CVC-related bloodstream infections with other lock solutions. Exclusion criteria were non-RCTs, studies describing <10 patients and studies using TLs as treatment. Risk of bias was evaluated using the Cochrane Risk of Bias 2 tool. A random effects model was used to pool individual study incidence rate ratios (IRRs). Subgroup analyses were performed based on the following factors: CVC indication, comparator lock and bacterial isolates cultured. A total of 14 articles were included in the qualitative synthesis describing 1219 haemodialysis, total parenteral nutrition and oncology patients. The pooled IRR estimated for all patient groups together (nine studies; 918 patients) was 0.30 (95% confidence interval 0.19–0.46), favouring the TLs. Adverse events (10 studies; 867 patients) were mild and scarce. The quality of the evidence was limited due to a high risk of bias and indirectness of evidence. The use of TLs might be promising for the prevention of CVC-related bloodstream infections. Large-scale RCTs are needed to draw firm conclusions on the efficacy of TLs.
Purpose
Resection of pediatric osteosarcoma in the extremities with soft tissue involvement presents surgical challenges due to difficult visualization and palpation of the tumor. Therefore, an ...adequate image-guided surgery (IGS) system is required for more accurate tumor resection. The use of a 3D model in combination with intraoperative tracked ultrasound (iUS) may enhance surgical decision making. This study evaluates the clinical feasibility of iUS as a surgical tool using a porcine cadaver model.
Methods
First, a 3D model of the porcine lower limb was created based on preoperative scans. Second, the bone surface of the tibia was automatically detected with an iUS by a sweep on the skin. The bone surface of the preoperative 3D model was then matched with the bone surface detected by the iUS. Ten artificial targets were used to calculate the target registration error (TRE). Intraoperative performance of iUS IGS was evaluated by six pediatric surgeons and two pediatric oncologic orthopedists. Finally, user experience was assessed with a post-procedural questionnaire.
Results
Eight registration procedures were performed with a mean TRE of 6.78 ± 1.33 mm. The surgeons agreed about the willingness for clinical implementation in their current clinical practice. They mentioned the additional clinical value of iUS in combination with the 3D model for the localization of the soft tissue components of the tumor. The concept of the proposed IGS system is considered feasible by the clinical panel, but the large TRE and degree of automation need to be addressed in further work.
Conclusion
The participating pediatric surgeons and orthopedists were convinced of the clinical value of the interaction between the iUS and the 3D model. Further research is required to improve the surgical accuracy and degree of automation of iUS-based registration systems for the surgical management of pediatric osteosarcoma.
Purpose
The aim of this study was to evaluate whether implementation of a comprehensive quality improvement program was associated with improved outcomes in patients undergoing oncological colorectal ...surgery in a non-academic, non-referral community hospital.
Methods
The quality improvement program (QIP) was introduced in January 2011 and consisted of the following interventions: (1) avoidance of postoperative nonsteriodal anti-inflammatory drugs; (2) normovolemia was pursued pre- and postoperatively; (3) non-resectional surgery if possible, in patients over 80 with ASA 3 or 4 classification; and (4) a standardized, postoperative surveillance protocol was introduced, with CRP determination day 2 and 4, and if necessary subsequent abdominal CT with rectal contrast to reduce delay in diagnosis of complications. From a prospectively maintained database of 488 patients undergoing colorectal surgery between 2009 and 2014, postoperative outcomes of patients operated before and after implementation of the program were compared.
Results
The severe complication rate (Clavien-Dindo >3b) decreased significantly (25.0 vs. 13.7 %;
p
< .001) after implementation of the QIP program. The mortality rate dropped from 8.7 to 2.6 % (
p
= .003). The percentage of anastomotic leakage was 9.6% before QIP implementation and 4.2% after (
p
= .013). Median length of hospital stay decreased from 9 (IQR 5–19) to 7 days (IQR 4–12) (
p
< .001). Multivariate analyses showed that surgery after implementation of the program was a strong independent predictor for less major complications (OR 0.54, 95 % CI 0.32–0.88).
Conclusions
A significant decrease in major complications and mortality was observed after introduction of a relative simple quality improvement program.
Lymph node metastasis (LNM) is possible after endoscopic resection of early esophageal adenocarcinoma (EAC). This study aimed to develop and internally validate a prediction model that estimates the ...individual risk of metastases in patients with pT1b EAC.
A nationwide, retrospective, multicenter cohort study was conducted in patients with pT1b EAC treated with endoscopic resection and/or surgery between 1989 and 2016. The primary end point was presence of LNM in surgical resection specimens or detection of metastases during follow-up. All resection specimens were histologically reassessed by specialist gastrointestinal pathologists. Subdistribution hazard regression analysis was used to develop the prediction model. The discriminative ability of this model was assessed using the c-statistic.
248 patients with pT1b EAC were included. Metastases were seen in 78 patients, and the 5-year cumulative incidence was 30.9 % (95 % confidence interval CI 25.1 %-36.8 %). The risk of metastases increased with submucosal invasion depth (subdistribution hazard ratio SHR 1.08, 95 %CI 1.02-1.14, for every increase of 500 μm), lymphovascular invasion (SHR 2.95, 95 %CI 1.95-4.45), and for larger tumors (SHR 1.23, 95 %CI 1.10-1.37, for every increase of 10 mm). The model demonstrated good discriminative ability (c-statistic 0.81, 95 %CI 0.75-0.86).
A third of patients with pT1b EAC experienced metastases within 5 years. The probability of developing post-resection metastases was estimated with a personalized predicted risk score incorporating tumor invasion depth, tumor size, and lymphovascular invasion. This model requires external validation before implementation into clinical practice.
Surgical treatment of pediatric chest wall tumors requires accurate surgical planning and tumor localization to achieve radical resections while sparing as much healthy tissue as possible. Augmented ...Reality (AR) could facilitate surgical decision making by improving anatomical understanding and intraoperative tumor localization.
We present our clinical experience with the use of an AR system for intraoperative tumor localization during chest wall resections. Furthermore, we present the pre-clinical results of a new registration method to improve our conventional AR system.
From January 2021, we used the HoloLens 2 for pre-incisional tumor localization during all chest wall resections inside our center. A patient-specific 3D model was projected onto the patient by use of a five-point registration method based on anatomical landmarks. Furthermore, we developed and pre-clinically tested a surface matching method to allow post-incisional AR guidance by performing registration on the exposed surface of the ribs.
Successful registration and holographic overlay were achieved in eight patients. The projection seemed most accurate when landmarks were positioned in a non-symmetric configuration in proximity to the tumor. Disagreements between the overlay and expected tumor location were mainly due to user-dependent registration errors. The pre-clinical tests of the surface matching method proved the feasibility of registration on the exposed ribs.
Our results prove the applicability of AR guidance for the pre- and post-incisional localization of pediatric chest wall tumors during surgery. The system has the potential to enable intraoperative 3D visualization, hereby facilitating surgical planning and management of chest wall resections.
IV
Treatment Study
•What is currently known about this topic?
Augmented Reality is a visualization technique that can give a direct impression of the patient's anatomy in 3D and therefore has great potential within surgical applications.•What new information is contained in this article?
This article presents the clinical application and further development of an AR system for intraoperative tumor localization during pediatric chest wall resections.
Background
Early detection of anastomotic leakage (AL) after colorectal surgery followed by timely reintervention is of crucial importance. The aim of this study was to investigate the accuracy of ...computed tomography (CT) imaging for AL and the effects of delay in reintervention after a false-negative CT.
Methods
All files from patients who had colorectal surgery with primary anastomoses between 2009 and 2014 were reviewed. The predictive value of CT scanning for AL was determined and correlated with short-term postoperative patient outcomes. In addition, factors predictive of false-negative scans were assessed.
Results
Six hundred and twenty-eight patient files were reviewed. In total, a CT scan was performed in 127 patients. Overall, leakage was seen in 49 patients (7.8%). The positive and negative predictive values were 78 and 88%, respectively. Sensitivity was 73% and specificity 91%. In patients with a true-positive CT (
n
= 24), reintervention followed after a median interval of 0 days (IQR 1), whereas this was 1 day (IQR 2) in the false-negative group (
n
= 11) (
p
< 0.05). This was associated with a significantly increased mortality rate (1/24 = 4.2% vs 5/11 = 45.5%) (
p
< 0.005), an increased length of hospital stay median 28 days (IQR 26) vs 54 days (IQR 20) (
p
< 0.05).
Conclusions
Delayed reintervention after false-negative CT scanning is associated with a high mortality rate and a significant increase in length of hospital stay.
Introduction: Six to eight children are diagnosed with a malignant liver tumour yearly in the Netherlands. The majority of these tumours are hepatoblastoma (HB) and hepatocellular carcinoma (HCC), ...for which radical resection, often in combination with chemotherapy, is the only curative treatment option. We investigated the surgical outcome of children with a malignant liver tumour in a consecutive cohort in the Netherlands. Methods: In this nationwide, retrospective observational study, all patients (age < 18 years) diagnosed with a malignant liver tumour, who underwent partial liver resection or orthotopic liver transplantation (OLT) between January 2014 and April 2021, were included. Children with a malignant liver tumour who were not eligible for surgery were excluded from the analysis. Data regarding tumour characteristics, diagnostics, treatment, complications and survival were collected. Outcomes included major complications (Clavien−Dindo ≥ 3a) within 90 days and disease-free survival. The results of the HB group were compared to those of a historical HB cohort. Results: Twenty-six children were analysed, of whom fourteen (54%) with HB (median age 21.5 months), ten (38%) with HCC (median age 140 months) and one with sarcoma and a CNSET. Thirteen children with HB (93%) and three children with HCC (30%) received neoadjuvant chemotherapy. Partial hepatic resection was possible in 19 patients (12 HB, 6 HCC, and 1 sarcoma), whilst 7 children required OLT (2 HB, 4 HCC, and 1 CNSET). Radical resection (R0, margin ≥ 1.0 mm) was obtained in 24 out of 26 patients, with recurrence only in the patient with CNSET. The mean follow-up was 39.7 months (HB 40 months, HCC 40 months). Major complications occurred in 9 out of 26 patients (35% in all, 4 of 14, 29% for HB). There was no 30- or 90-day mortality, with disease-free survival after surgery of 100% for HB and 80% for HCC, respectively. Results showed a tendency towards a better outcome compared to the historic cohort, but numbers were too small to reach significance. Conclusion: Survival after surgical treatment for malignant liver tumours in the Netherlands is excellent. Severe surgical complications arise in one-third of patients, but most resolve without long-term sequelae and have no impact on long-term survival.
PDF
