"It depends on the people!" - A qualitative analysis of contextual factors, prior to the implementation of digital health innovations for chronic condition management, in a German integrated care network.

Objective: Integrated care and digital health technology interventions are promising approaches to coordinate services for people living with chronic conditions, across different care settings and providers. The EU-funded ADLIFE project intends to provide digitally integrated personalized care to improve and maintain patients' health with advanced chronic conditions. This study conducted a qualitative assessment of contextual factors prior to the implementation of the ADLIFE digital health platforms at the German pilot site. The results of the assessment are then used to derive recommendations for action for the subsequent implementation, and for evaluation of the other pilot sites. Methods: Qualitative interviews with healthcare professionals and IT experts were conducted at the German pilot site. The interviews followed a semi-structured interview guideline, based on the HOT-fit framework, focusing on organizational, technological, and human factors. All interviews were audio recorded, transcribed, and subsequently analysed following qualitative content analysis. Results: The results of the 18 interviews show the interviewees' high openness and motivation to use new innovative digital solutions, as well as an apparent willingness of cooperation between different healthcare professionals. Challenges include limited technical infrastructure and large variability of software to record health data, lacking standards and interfaces. Conclusions: Considering contextual factors on different levels is critical for the success of implementing innovations in healthcare and the transfer into other settings. In our study, the HOT-fit framework proved suitable for assessing contextual factors, when implementing IT innovations in healthcare. In a next step, the methodological approach will be transferred to the six other European pilot sites, participating in the project, for a cross-national assessment of contextual factors.

Prevalence of VOYAGER PAD trial exclusion criteria in unselected patients undergoing lower limb revascularization.

BACKGROUND: The VOYAGER PAD trial investigated data on dual pathway inhibition after lower limb revascularization for peripheral arterial disease (PAD). Multiple exclusion criteria were applied. However, neither data on the prevalence of exclusion criteria nor on the total number of patients screened for inclusion was discussed. METHODS: We performed a single-center prospective observational study in unselected PAD patients undergoing lower limb revascularization. Demographic and disease-specific data was collected. RESULTS: One hundred fifty patients were included with only 29 patients (19.3%) as potential candidates for the VOYAGER PAD study medication. Poorly controlled diabetes or severe uncontrolled hypertension (33.3%), major tissue loss (18.7%), acute limb ischaemia within prior 2 weeks (17.3%) and a history of intracranial hemorrhage, stroke or TIA (16%) were amongst the exclusion criteria most frequently met. Compared to VOYAGER PAD study patients, significant differences regarding sex (36.7% female vs. 25.8%), renal insufficiency (29.0% vs. 20.1%), previous myocardial infarction (16.7% vs. 11.1%) and known carotid artery disease (18.7% vs. 8.6%) revealed. Patients presented significantly more frequently with critical limb ischemia (56.7% vs. 30.4%) and a history of previous peripheral revascularization (72.0% vs. 35.9%). Fewer endovascular interventions (52% vs. 65.5%) and more surgeries (58% vs. 34.5%) were performed. CONCLUSIONS: In unselected patients undergoing revascularization for peripheral arterial disease, the majority presents with characteristics that, at present, preclude prescription of rivaroxaban in addition to aspirin. This patient cohort represents a population with higher rates of comorbidities and more complex vascular interventions, but might also benefit from dual pathway inhibition strategy.

Endosew: new device for laparoscopic running sutures.

PURPOSE: In 2002, the first completely laparoscopic cystectomy and orthotopic ileal neobladder procedure was reported to take more than 10 hours, with the most time-consuming portion being suturing. Therefore, to improve the quality and reduce the time to place running sutures, we developed a new sewing device for laparoscopic use. MATERIALS AND METHODS: We compared running sutures made by hand with those made by machine in the ilea of six pigs. The tightness of the closures was examined and the suturing time recorded. Two animals each were sacrificed after 3, 6, and 9 days, and then the explanted ilea were examined at both the macroscopic and microscopic levels. RESULTS: No animal died during the course of the experiment and no leaks were found postoperatively. Moreover, no significant differences were seen on macroscopic or microscopic examination in the quality of the two sets of sutures. The time taken to place 1 cm of running suture, including initial preparation, was 7.2 and 3 minutes for hand and machine suturing, respectively. The hand sutures were always initially tight, whereas those placed by machine required adjustment to stop leaks on four occasions. CONCLUSION: Using the Endosew device reduces the time needed to place running sutures by 2.4-fold. The quality of the hand- and machine-made sutures was nearly identical at both the macroscopic and microscopic level. Thus, the functionality of this new sewing device is more than satisfactory, and the amount of time saved by using it far outweighs the need for occasional adjustments to stop suture leakage.

A new method to close the gastrotomy by using a cardiac septal occluder: long-term survival study in a porcine model.

INTRODUCTION: Closure of the gastrotomy when performing transgastric procedures is one of the most challenging steps to overcome. Several methods of gastric closure have been described, but a simple and safe technique is still lacking. AIM: To evaluate the technical feasibility and safety of a new method of endoscopic gastric closure using a nitinol septal occluder in a porcine survival model. DESIGN: Endoscopic animal experimental study in a porcine survival model. MATERIALS AND METHODS: In 6 male pigs under general anesthesia, a 1-cm full-thickness gastrotomy was performed on the anterior body of the stomach and closed with a nitinol septal occluder (Occlutech). Postoperative follow-up included endoscopy and laparoscopy at 1, 2, 4, and 6 weeks after the initial procedure and endoscopy alone at weeks 8, 10, and 12. RESULTS: All of the gastrotomy closures with the septal occluder were successful. At follow-up endoscopy and laparoscopy there were no signs of adhesions, peritonitis, or perigastric abscess formation at the gastrotomy site. At 12 weeks, 5 of 6 animals were thriving, with appropriate weight gain. CONCLUSIONS: Endoscopic gastrotomy closure with a septal occluder is technically feasible, safe, and effective in a survival porcine model.