Protocol of a cluster randomized trial to investigate the impact of a type 2 diabetes risk prediction model on change in physical activity in primary care.

BACKGROUND: Little evidence exists on the impact of diabetes risk scores, e.g. on physicians and patient's behavior, perceived risk of persons, shared-decision making and particularly on patient's health. The aim of this study is to investigate the impact of a non-invasive type 2 diabetes risk prediction model in the primary health care setting as component of routine health checks on change in physical activity. METHODS: Parallel group cluster randomized controlled trial including 30 primary care physicians (PCPs) and 300 participants in the region of Düsseldorf and surrounding urban and rural municipalities, West Germany. On cluster level, PCPs will be randomized into intervention or control group using a biased coin minimization technique. Participants in the control group are going to have a routine health check "Check-up 35" which is recommended biannually for all people ≥35 years of age in Germany. In the intervention group, the routine health check is expanded by usage of a non-invasive diabetes risk prediction model (German Diabetes Risk Score). Primary outcome is change in physical activity after 1 year. Secondary outcomes include aspects of targeted counseling, motivation of participant's to change lifestyle, perceived and objectively measured diabetes risk, acceptance of diabetes risk scores, quality of life, depression and anxiety. Patients will be followed over 12 months. Hierarchical or mixed models will be conducted, including a random intercept to adjust for cluster, the respective baseline value, and covariates to compare the groups. DISCUSSION: This pragmatic cluster randomized controlled trial will enhance our knowledge on the clinical impact of diabetes risk scores for the first time in the real-life primary health care setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT03234322 , registered on July 28, 2017.

Impact of applying a diabetes risk score in primary care on change in physical activity: a pragmatic cluster randomised trial.

AIM: There is little evidence of the impact of diabetes risk scores on individual diabetes risk factors, motivation for behaviour changes and mental health. The aim of this study was to investigate the effect of applying a noninvasive diabetes risk score in primary care as component of routine health checks on physical activity and secondary outcomes. METHODS: Cluster randomised trial, in which primary care physicians (PCPs), randomised (1:1) by minimisation, enrolled participants with statutory health insurance without known diabetes, ≥ 35 years of age with a body mass index ≥ 27.0 kg/m2. The German Diabetes Risk Score was applied as add-on to the standard routine health check, conducted in the controls. Primary outcome was the difference in participants' physical activity (International Physical Activity Questionnaire) after 12 months. Secondary outcomes included body mass index, perceived health, anxiety, depression, and motivation for lifestyle change. Analysis was by intention-to-treat principle using mixed models. RESULTS: 36 PCPs were randomised; remaining 30 PCPs (intervention: n = 16; control: n = 14) recruited 315 participants (intervention: n = 153; controls: n = 162). A slight increase in physical activity was observed in the intervention group with an adjusted mean change of 388 (95% confidence interval: - 235; 1011) metabolic equivalents minutes per week. There were no relevant changes in secondary outcomes. CONCLUSIONS: The application of a noninvasive diabetes risk score alone is not effective in promoting physical activity in primary care. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT03234322, registration date: July 31, 2017).

Continuity of care between hospital pharmacies and community pharmacies, and costs avoided: a pilot experience in times of COVID-19 in Spain.

Introduction: In March 2020, due to the pandemic caused by COVID-19, a pilot experience of pharmaceutical continuity of care received by hospital outpatients was launched in Cantabria, a Spanish autonomous community. Thanks to this experience, the medication was dispensed by the hospital pharmacy through the community pharmacy of the patient's choice. Our objective was to estimate the costs avoided by this practice during the months of April and May 2020. Methods: The analysis of the economic impact was carried out in terms of saved costs, from the hospital and from the social perspective. Savings associated with the avoided home delivery of medication and avoided labor productivity losses were calculated, as well as the time associated with avoided trips in monetary terms. Results: A total of 2,249 hospital-dispensed drugs were delivered through the community pharmacy in the analyzed period, with an average of 57.7 daily deliveries. The experience, which involved one hospital and 262 pharmacies of Cantabria, saved patients 93,305 km in trips to the hospital, associated with an average time saving of 1,374 hours. In terms of costs, the hospital saved on shipments by courier, estimated at €30,205, since it was the community pharmacy and the distribution warehouses that delivered the drugs. From a social perspective, this initiative saved €23,309 due to the trips (€8,907) and productivity losses (€14,402) that were avoided. Conclusions: This exceptional situation may be a good opportunity to improve the coordination between hospital pharmacies and community pharmacies in Spain, not only during the pandemic but also in the post-COVID-19 era.

Study protocol for a mixed methods exploratory investigation of aftercare services for gestational diabetes in women to develop a new patient-centred model in Germany: the GestDiNa_basic study.

INTRODUCTION: Women with gestational diabetes mellitus (GDM) have a higher risk of developing type 2 diabetes mellitus compared with women who never had GDM. Consequently, the question of structured aftercare for GDM has emerged. In all probability, many women do not receive care according to the guidelines. In particular, the process and interaction between obstetrical, diabetic, gynaecological, paediatric and general practitioner care lacks clear definitions. Thus, our first goal is to analyse the current aftercare situation for women with GDM in Germany, for example, the participation rate in aftercare diabetes screening, as well as reasons and attitudes stated by healthcare providers to offer these services and by patients to participate (or not). Second, we want to develop an appropriate, effective and patient-centred care model. METHODS AND ANALYSIS: This is a population-based mixed methods study using both quantitative and qualitative research approaches. In various working packages, we evaluate data of the GestDiab register, of the Association of Statutory Health Insurance Physicians of North Rhine and the participating insurance companies (AOK Rheinland/Hamburg, BARMER, DAK Gesundheit, IKK classic, pronova BKK). In addition, quantitative (postal surveys) and qualitative (interviews) surveys will be conducted with randomly selected healthcare providers (diabetologists, gynaecologists, paediatricians and midwives) and affected women, to be subsequently analysed. All results will then be jointly examined and evaluated. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of the Faculty of Medicine, Heinrich-Heine-University Düsseldorf (Ethics Committee No.: 2019-738). Participants of the postal surveys and interviews will be informed in detail about the study and the use of data as well as the underlying data protection regulations before voluntarily participating. The study results will be disseminated through peer-reviewed journals, conferences and public information. TRIAL REGISTRATION NUMBER: DRKS00020283.

[Do decision-makers in the German healthcare system misjudge the situation of a branch office? - Motivation of physicians to set up in a GP's practice in the area of the Association of Statutory Health Insurance Physicians North-Rhine]. / Schätzen Entscheider im Gesundheitswesen die Niederlassungssituation falsch ein?

BACKGROUND: The aim of the study was to illustrate motives for a GP's branch from the current point of view by branch (expectations fulfilled) and before branch (motivation). In addition, obstructive or beneficial factors of a branch should be identified. METHODS: Using a mixed-methods approach (focus groups, individual interviews) with the target group were used in the qualitative part of experiences, opinions and motivations for the GP's branch and, after evaluation, a pre-tested questionnaire was used. A full survey of 675 identified GPs from the database of the Association of Statutory Health Insurance Physicians North Rhine was carried out. These had settled in the last 5 years before the survey period (09/2015). The questionnaire sent by post contained 17 questions on settlement motivation and 11 biographical aspects. RESULTS: The number of evaluable data records was 437 (64.7 %). The highest approval values, in the sense of conducive to settlement motivation, were "discontinuation of services in the hospital" (97.2 %) and "being one's own boss" (96.2 %). Rights and duties as a "panel physician" (8.5 %), and the "emergency service for panel physicians/on-call service" (22.7 %) were perceived as more of an obstacle. In terms of fulfilling expectations, the "discontinuation of services" (95.6 %) and the "diversity of age groups to be treated" (88.9 %) emerged. A total of 97 % would settle down again, regardless of the degree to which their wishes were fulfilled, and almost ¾ would only decided to work as family doctors after they had completed their studies. CONCLUSIONS: The fact that escaping from the stationary sector is the main driving force behind the settlement must be thought-provoking. Since this survey approach was not based on specialist groups or the level of training, but on a complete survey of established persons over a five-year period, it can be stated that the current incentive structures of a branch should be rethought due to the age structure of the interviewees.

Strategies for Improving Influenza Vaccination Rates in Patients with Chronic Renal Disease.

BACKGROUND: The influenza vaccination rate among older and chronically ill patients in Germany has declined in the past decade in spite of vaccination campaigns. METHODS: The influenza vaccination rate among persons with chronic renal disease was studied with the aid of billing data from various Associations of Statutory Health Insurance Physicians (Kassenärztliche Vereinigungen, ASHIPs) in Germany. It was tested in a randomized controlled trial whether a written vaccination appeal, sent by physicians to patients, led to an increase in the vaccination rate. It was tested in a further such trial whether the vaccination rate among patients with renal disease could be improved by an appeal for vaccination that was sent by the ASHIPs to the treating nephrologists. Finally, it was also tested in a prospective interventional study whether the vaccination rate could be improved by an appeal for vaccination sent by a health- insurance carrier directly to the patients. RESULTS: In 2012-2017, the vaccination rate among persons with chronically impaired renal function ranged from 41.1% to 46.9%; it ranged from 31.7% to 33.7% in kidney transplant recipients and from 42.7% to 44.7% in dialysis patients. An appeal for vaccination that was sent from physicians to patients raised the vaccination rate by 8.3% in the intervention group compared to the control group (p = 0.03; number needed to treat [NNT]: 13). On the other hand, an appeal for vaccination that was sent to the nephrologists lowered the vaccination rate by 0.8% in the intervention group compared to the control group. Finally, an appeal for vaccination that was sent by the health-insurance fund to the patients raised the vaccination rate by 3.2% (p<0.001; NNT: 32). CONCLUSION: Fewer than half of all patients with chronic renal failure in Germany are vaccinated against influenza. The vaccination rate was found to be increased only after an appeal for vaccination that was sent directly to the patients. A letter sent to the treating physicians had no positive effect at all.

Reparación protésica de una hernia lumbar postraumática en un adulto / Prosthetics repair of a post-traumatic lumbar hernia in an adult

Se describe el caso clínico de un paciente de 45 años de edad, quien sufrió accidente laboral por objeto metálico romo, que le ocasionó trauma contuso en región lumbosacra derecha. A los 30 días de dicho trauma, notó aumento de volumen en la zona afectada y acudió a la consulta de cirugía herniaria del Hospital General Universitario Dr Juan Bruno Zayas Alfonso, donde clínicamente se le diagnosticó una hernia lumbar derecha postraumática. Fue operado de forma electiva con anestesia orotraqueal. Se realizó profilaxis antimicrobiana y antitrombótica; además, se implantó prótesis preperitoneal de polipropileno. No hubo complicaciones perioperatorias y el paciente tuvo seguimiento durante 3 años, sin recurrencias

The case report of a 45 years patient who had an industrial accident with a blunt metallic object that caused him bruised trauma in the right lumbosacral region is described. After 30 days of this trauma, he noticed increase of volume in the affected area and went to the hernia surgery service of Dr Juan Bruno Zayas Alfonso University General Hospital, where he was clinically diagnosed with a right post-traumatic lumbar hernia. He was operated in an elective way with orotracheal anesthesia. Antimicrobian and antithrombotic prophylaxis was carried out; also, a polypropylene preperitoneal prosthesis was implanted. There were not perioperative complications and the patient had follow up during 3 years, without recurrences

Fundamentos técnicos y resultados de la reparación protésica novedosa de hernias incisionales grandes / Technical basics and results of the prosthetics original repair of large incisional hernias

Introducción: la hernia incisional grande tiene una elevada recurrencia a pesar del uso de mallas. Objetivo: describir una técnica para la reparación de defectos de la pared abdominal de más de 15-20 cm de diámetro. Métodos: se realizó un estudio descriptivo, cuantitativo, retrospectivo - prospectivo y longitudinal de 62 pacientes operados mediante esta técnica en el Hospital General Universitario Dr Juan Bruno Zayas Alfonso de Santiago de Cuba, desde 2003 hasta 2015. Resultados: predominaron el sexo femenino, el grupo etario de 45-65 años, la hipertensión arterial como comorbilidad con cirugía abdominal ginecológica previa, localización infraumbilical del sitio herniario, hernioplastia de Bendavid y abdominoplastia como cirugía asociada. Tuvo mayor incidencia la anestesia general endotraqueal como método anestésico, la complicación posoperatoria más relevante fue el seroma; no hubo mortalidad, ni recurrencias. Conclusiones: este es un método seguro y eficaz para la reparación de grandes defectos herniarios de la pared abdominal anterior

Introduction: the large incisional hernia has a high recurrence in spite of the use of meshes. Objective: to describe a technique for the repair of the abdominal wall defects of more than 15-20 cm in diameter. Methods: a descriptive, quantitative, retrospective - prospective and longitudinal study of 62 patients operated by means of this technique was carried out in the Dr Juan Bruno Zayas Alfonso University General Hospital in Santiago de Cuba, from 2003 to 2015. Results: there was a prevalence of the female sex, 45-65 years age group, hypertension as comorbidity with previous gynecological abdominal surgery, infraumbilical localization of the hernial site, Bendavid hernioplasty and abdominoplasty as associated surgery. The endotraqueal general anesthetic as anesthetic method had a higher incidence, the most outstanding postoperative complication was the serous complication; there was neither mortality, nor recurrences. Conclusions: this is a safe and effective method for the repair of large hernial defects of the front abdominal wall

Hernioplastia incisional y abdominoplastia simultáneas como métodos quirúrgicos seguros y eficaces / Simultaneous incisional hernioplasty and abdominoplasty as effective and safe surgical methods

Introducción: la hernioplastia-abdominoplastia simultáneas producen resultados clínicos-estéticos favorables en pacientes con exceso de piel y tejido graso en abdomen inferior. Objetivo: evaluar los resultados de estos métodos quirúrgicos. Método: se efectuó un estudio prospectivo de 16 pacientes operadas de hernia incisional y abdomen péndulo en el Hospital General Universitario Dr Juan Bruno Zayas Alfonso de Santiago de Cuba, durante el bienio 2015-2016. Resultados: predominaron la hernia infraumbilical, el anillo de 10-15 centímetros, las técnicas de dermolipectomía y Rives, así como el seroma como complicación posoperatoria. La edad media fue de 40 años; se realizó profilaxis antimicrobiana y antitrombótica. Se usó la prótesis de polipropileno en 100,0 por ciento de las afectadas. Conclusión: la eventroplastia y abdominoplastia son métodos seguros y eficaces en pacientes adecuadamente seleccionados

Introduction: simultaneous hernioplasty-abdominoplasty provoque favorable clinic-cosmetic results in patients with excess skin and adipose tissue in the lower abdomen. Objective: to evaluate the results of these surgical methods. Method: a prospective study of 16 operated patients with incisional hernia and pendulum abdomen was carried out in Dr Juan Bruno Zayas Alfonso University General Hospital in Santiago de Cuba, during 2015-2016. Results: There was a prevalence of the imphraumbilical hernia, 10-15 cm ring, dermolipectomy and Rives technique, as well as seroma as postoperative complication. The mean age was 40 years; antimicrobian and antithrombotic prophylaxis were carried out. The polypropylene prosthesis was used in 100 percent of the affected patients. Conclusion: eventroplasty and abdominoplasty are safe and effective methods in patients adequately selected

Hernioplastia de Jean Rives en pacientes con hernia inguinofemoral / Jean Rives´ hernioplasty in patients with inguinofemoral hernia

Se efectuó un estudio descriptivo, longitudinal y observacional sobre los primeros 120 pacientes operados de hernia inguinal con la técnica de hernioplastia de Jean Rives en el Hospital General Docente Dr Juan Bruno Zayas Alfonso de Santiago de Cuba, desde enero de 2001 hasta igual mes de 2009. En la serie, 56,6 por ciento de sus integrantes eran hombres, con una edad media de 64,4 años; en tanto 50,8 por ciento del total presentaban hernias primarias, con predominio del estadio III-B de la clasificación de Nyhus. Como profilaxis antibiótica predominó la cefazolina (67,5 por ciento); y como material protésico, el polipropilene (73,3 por ciento). Se utilizó anestesia local y sedación en 56,6 por ciento de la casuística. Las complicaciones posoperatorias representaron 2,4 por ciento y no se produjo recurrencia herniaria. El mencionado procedimiento es seguro y eficaz para la reparación quirúrgica de las hernias inguinocrurales.

A descriptive, longitudinal, and observational study on the first 120 patients surgically treated due to inguinal hernia using Jean Rives´hernioplasty technique at Dr Juan Bruno Zayas Alfonso Teaching General Hospital in Santiago de Cuba was carried out from January, 2001 to January, 2009. In the series, 56,6 percent of its members were male, having a mean age of 64,4 years; meanwhile 50,8 percent out of the total had primary hernias, with a prevalence of III-B stage according to Nyhus classification. Cefazolin (67,5 percent) and polypropilene (73,3 percent) prevailed as antibiotic prophylaxis and prosthesis material, respectively. Local anesthesia and sedation were used in 56,6 percent of the case material. Postoperative complications represented 2,4 percent and no hernia recurrence was observed. The aforementioned procedure is safe and effective to carry out the reparative surgery of the inguinocrural hernias.