Integration of digital health applications into the German healthcare system: development of "The DiGA-Care Path".

Introduction: Since 2019 people who have insured in the German statutory health insurance are entitled to use certified apps called the Digitale Gesundheitsanwendungen [Digital Health Applications (DiGAs)]. The prerequisite for this is that an app certified as DiGA and suitable for their diagnosis exists. The DiGA can then either be prescribed by a physician or psychotherapist or requested by the patient from the statutory health insurance fund. Given the novelty of this type of healthcare, the implementation of a DiGA should be closely monitored to identify potential weaknesses and achieve quality improvements. To enable an analysis of the supply of DiGAs step-by-step, we aimed to create the DiGA-Care Path. Methods: We conducted three steps to create the DiGA-Care Path. First, a knowledge base was created based on a structured literature research matched with knowledge gathered from the superordinate research project "QuaSiApps" funded by the German Federal Joint Committee. Second, we aimed to create an "ideal-typical" DiGA-Care Path using a flowchart. Third, based on the first path, a final path was developed using the graphical modeling language "Event-Driven Process Chain." Results: The DiGA-Care Path was developed to depict the supply of DiGAs in Germany. The final path is constituted by a "main path" as well as a corresponding "sub-path". While the "main path" focuses more on the supply environment in which a DiGA is used, the "sub-path" depicts the supply delivered by the DiGA itself. Besides the process itself, the paths include relevant actors to indicate responsibilities for individual process steps. Discussion: The DiGA-Care Path helps to analyze the current supply of DiGAs step-by-step. Thereby, each step can be investigated in detail to identify problems and to detect further steps where quality improvements can be enabled. Depending on the perspective, focused either on the supply environment, or the supply delivered by the DiGA itself, the "main path" or the "sub-path" can be used, respectively. Besides the potential of the DiGA-Care Path to improve the current supply of DiGAs, it can help as an orientation for international policymakers or further stakeholders either to develop their own integration of apps into healthcare systems or for international manufacturers to consider entering the German market.

Corrigendum: Integration of digital health applications into the German healthcare system: development of "The DiGA-Care Path".

[This corrects the article DOI: 10.3389/frhs.2024.1372522.].

Ileal pouch-anal anastomosis for ulcerative colitis and polyposis coli: is the risk of carcinoma formation conclusively averted?

We took biopsies from the ileal pouch mucosa of 26 patients (13 with ulcerative colitis, 13 with polyposis coli) at least 1 year after the newly formed pouch was finally linked to the faecal flow. Histochemical mucin differentiation was carried out in addition to the ordinary stains. All patients underwent colonization of pouch mucosa with goblet cell multiplication, reduction or loss of villi, and formation of crypts. Only 19 patients could be classified morphologically as bearing large bowel mucosa in the ilea] pouch. Patients with one incidence of ulcerative colitis developed one criterion, those with two incidences two criteria, and those with seven incidences three criteria of the original colitic disease. Patients with two incidences of colitis and those with 10 incidences of polyposis coli developed an excess of sialomucine formation, which is known as an obligate pre-cancerosis. These findings prove, that in ileal pouches, even when affected by systemic diseases with extraintestinal manifestations, a new kind of mucosa develops, which is also prediposed to carcinoma formation. Papers reporting adenocarcinoma arising in ileostomy areas as well as in ileoanal anastomosis, and ileal reservoirs, confirm this presumption. Assuming this conclusion, restorative proctocolectomy cannot hinder malignant transformation of intestinal mucosa, but only delay the onset of cancer, thereby making lifelong follow-ups necessary.

Elastofibroma and pre-elastofibroma--a biopsy and autopsy study.

Two biopsy cases of elastofibroma--one unilateral and one bilateral--are described. A study of 100 autopsies revealed 13 elderly patients with elastofibroma. Males (n = 10; 16.9%) were more affected than females (n = 3; 7.3%). Pre-elastofibroma-like morphological changes (e.g. few or many degenerated elastic fibres) were observed in 81% of the autopsies. Minor pre-elastofibroma-like changes were seen in males and major changes predominantly in females. In addition to physiological ageing as yet unknown factors, rather than abnormal elastogenesis or degeneration, seem to be involved in this pseudotumour.

[Surgical therapy of malignant melanoma]. / Zur chirurgischen Therapie des malignen Melanoms.

148 patients with malignant melanoma are presented. Localization, prognosis and clinical stadium are summarized. The surgical procedure is still three-dimensional excision. The latitude of defects asks for a specialists surgeon.

[Osteosynthesis procedures in microsurgery]. / Osteosyntheseverfahren bei mikrochirurgischen Eingriffen.

In microsurgery the indications and techniques of osteosynthesis are often different from normal orthopaedic surgery. Simple methods which do not require much time or metal and which guarantee sufficient stability and minimal soft-tissue trauma are preferable. The external fixator has a good indication in the tibia and the plate osteosynthesis in the upper extremity and in the femur. Kirschner wires are useful in peripheral osteosyntheses.

[Treatment of osteomyelitis using free myocutaneous flap in the lower leg]. / Die Behandlung der Osteomyelitis mittels freier myokutaner Lappen am Unterschenkel.

The primary indication for free muscle transfer to the lower leg is post-traumatic osteomyelitis with soft tissue and bony defects. The intention is to provide sufficient soft tissue covering and a new blood supply. Our experience with 24 free muscle transfers to infected areas on the lower leg is presented. The longest bone infection was 25 years. The indications were early bone infections, infected pseudoarthrosis and chronic osteomyelitis. The indications, contra-indications, method and results are reported. Economic and social advantages of the procedure are also discussed.

[Variants in the management of decubitus ulcers]. / Varianten in der Versorgung von Dekubitalgeschwüren.

Decubitus ulcers of the fourth or fifth degree often tend to heal only after years. The result is a bad scar which is unstable and likely to breakdown. It is still surgically correctable, however. The ulcer should be cleaned and after tamponage one should perform excision without opening into the ulcer. Cover can be achieved with either a rotation flap with accompanying muscular padding or a myocutaneous flap. To protect against recurrence, the bone debridement has to be carried out aggressively.

[Tactics and results of surgical treatment of hyperparathyroidism]. / Taktik und Ergebnisse in der operativen Behandlung des Hyperparathyreoidismus.

Following a brief overview on parathyroid surgery, ontogenesis, anatomy and physiology of the parathyroids are described. Clinical symptoms and signs of hyperparathyroidism are as variable as the topography of parathyroid bodies may be. While parathyroid hyperfunction can easily be demonstrated by determination of serum calcium and parathyroid hormone levels, preoperative localization of adenoma or hyperplastic gland remains unsatisfactory in spite of great technical efforts. Therefore, the operative procedure has to be standardized and rational. Methylen blue staining of parathyroid bodies was proven to be helpful. Clinical results of 58 patients are presented.

Treatment of anal fissure: a comparison of three different forms of therapy.

454 patients with a fissure-in-ano were treated by different forms of therapy. In a follow-up we examined 314 patients, 178 of them having been treated by anal stretch, 60 of them by subcutaneous lateral sphincterotomy and 76 of them by conservative measures. Most of the anal stretched patients were free of symptoms. Only few of them had to be treated again for the same disease by their physician. Anal stretch--similar to sphincterotomy--breaks the pathologically raised sphincter tone. We therefore propose anal stretch gently performed over a period of 3-5 minutes under general anaesthesia as the method of choice for the initial treatment of anal fissure. In cases of relapse we recommend lateral sphincterotomy by an experienced operator.

[Measuring the sensitivity before and following breast reduction-plasty in 2 competitive surgical procedures]. / Sensibilitätsmessungen vor und nach Mammareduktionsplastik zweier konkurrierender Operationsverfahren.

All non-operated breasts have an irregular pattern of sensibility. The areola is distinctly more sensitive than its periphery; the nipple has a very low grade of sensitivity. The postoperative sensitivity increases for about 2 years without reaching the former level. The loss of sensitivity is unrelated to the method of operation (Strömberg, Pitanguy). The loss of sensitivity is proportional to the reduction of tissue. Most important is to keep the ability for breast-feeding (sympathetic innervation by the arterior branch of the 4th ramus cutaneous lateralis).

[Deep rectovaginal fistula and incontinence after labor trauma]. / Tiefe rektovaginale Fisteln und Inkontinenz nach Geburtstrauma.

The commonest cause of traumata to the organ of continence is the injury during childbirth. Specially after negligent or missing reconstruction apart from incontinence rectovaginal fistulas can arise. This report deals with 24 incontinent women with a perineal laceration. After delivery 17 women had developed a low rectovaginal fistula. In addition to clinical recording of the incontinence, the proctological examination including anal manometry was carried out before and 25 months after surgery on an average. All patients get the same operation: Section of the anterior commissure, cutting out the fistula if necessary, separated suture of the animalic and voluntary sphincter, vaginal plasty. Preoperative resting pressure was 30 cm H2O and the voluntary pressure 46 cm H2O-on an average. Postoperative there was an increase to 61 cm H2O for the resting pressure and to 77 cm H2O for the voluntary pressure. 22 patients reported an improvement. 13 women are completely continent, 7 x soiling, 2 x incontinence for flatus, one incontinence for liquid stool and one stool incontinence were found. One fistula occurred again during follow up. Our surgical procedure compared with others has the advantage to give similar results avoiding protective colostoma. Besides the option for an other surgical procedure is still remained.

[Violation of patient education responsibility. Implications and outlook]. / Aufklärungspflichtverletzung. Implikationen und Aussichten.

In both jurisdiction and medical science, given conditions require appropriate intervention, which may in turn result in norms being created. Norms, however, counteract individuality. An essential prerequisite for free decision--making is an absolute awareness of all possibilities available. Therefore the physician/surgeon too, is obliged to impart all relevant information to the patient prior to an operation to enable the patient to reach a decision, either to agree to or refuse the operation. This process of information transfer may sometimes fail on one or both sides. Treatment errors are usually classified according to scientific medical practice. In the case of "breach to duty in information patient" the final decision is the judges. As judicial decisions are not foreseeable, the communication between patient and surgeon thus becomes standardized and doctors tend to become defensive, resulting in the information becoming even more extensive covering all possible situations. There is no guarantee of success in surgery. Selective perception on the part of the patient is unavoidable and confidence in the relationship between patient and surgeon is beneficial to the patient's rehabilitation. Therefore, we should strive to decriminalize the preoperative talk held between surgeon and patient.

[Possibilities and limits of scores. Theoretical considerations about scores]. / Moglichkeiten und grenzen von scores. Theoretische Uberlegungen ueber scores.

Scores are intended to facilitate an accurate appreciation of the overall situation from a few characteristic, reasonably weighted parameters. This definite result in the form of a score means a reduction of reality. For the individual it cannot reasonably be applied in practice. Despite a long list of problems and limitations, a score can describe a collective and thus make it comparable to some extent. Because of the different compositions of the collectives, the value of scores for quality control is limited. The more physiological variables a score contains the more difficult it is to distinguish between the effect of therapy and the clinical course. Therefore, repeated measurement of scores is not useful to verify a therapeutic effect, but it can indicate a trend regarding the endpoint.

[Patient education: what does the patient know, what does he want to know? Thrombosis and wound infection]. / Aufklärungsgespräch: Was weiss der Patient, was will er wissen? Thrombose und Wundinfektion.

UNLABELLED: The manners of which preoperative informations are given to a patient depend on several different points. So not only the patient's education, his knowledge of medical items and his intelligence are important, but also the juridical situation and the doctor's ability to explain the situation in a way the patient is able to understand. The aim of this study was to evaluate the patient's previous knowledge about two major complications in surgery--thrombosis and wound infection. Beside this it was looked for the importance of confidence in the doctor and previous information about the operation. PATIENTS AND METHOD: 117 patients aged 16 to 87 years were tested anonymous by a standardised questionnaire. RESULTS: There is only little knowledge about the time a thrombosis develops, embolism, a wound infection and their consequences. On the other side, more than 50% of the patients were able to explain correctly the symptoms of thrombosis and the time a wound infection occurs. There was a correlation between the statement of knowledge about thrombosis (p < 0.01) and wound infection (p < 0.01) and the ability of correct explanation. Almost 90% of the patients thought that information about the operation is as important as the confidence in their surgeon. More than two third of the patients wanted to be informed about "everything" that possibly could happen. The main sources of information were neighbours, friends, the press, books and at last the doctor. CONCLUSION: There wasn't any influence of former surgeries, the awareness of complications or education on the active knowledge of the patients. Therefore we think that the way of giving explanation to a patient should help reducing fear of an uncomfortable situation and take account to the patients need for information. Thus, the patient will be able to make a real decision.