Frailty: future prospectives in rehabilitation medicine.

Modern rehabilitation is based on the International Classification of Functioning, Disability and Health (ICF). We will discuss this Classification process in frailty. Frailty is defined as a condition of reduced functional reserve, a state of vulnerability that involves poor recovery of homeostasis and increased susceptibility to stressor mechanisms, with consequent difficulty in returning to the previous condition of balance. Rehabilitation of frailty is reported in the ICF, although, its consensus is not sufficiently addressed due to its recent identification and the limited available information regarding how it should be formulated. Thus, the aim of the present article is to present the current evidence-based rehabilitation strategies applied in management of frailty.

Are patients willing to be informed on the risks and complications associated with the proposed therapy? A survey on informed consent.

INTRODUCTION: Informed consent is essential to the patient-physician relationship. The paternalistic old-time approach used by physicians to achieve the optimal management is changing today; detailed medical information must be disclosed to the patients regarding their health problem. AIM: The aim of this study was to highlight the value of informed consent in the context of medical practice as well as to emphasize its importance through the prism of human rights. MATERIALS AND METHODS: A patient survey was conducted in two public and one private hospitals in Greece. Eighty-three inpatients from the Surgical Departments of Democritus University Hospital of Alexandroupolis (DUHA), Laikon University Hospital of Athens (LUHA) and a private hospital were included in the study. A questionnaire regarding patients' attitude towards informed consent was distributed to patients prior to surgery. RESULTS: The majority of the patients (63.86% in DUHA, 59.38% in LUHA, and 78.95% in the private hospital) opted for full disclosure regarding the course and development of their condition. CONCLUSION: Patients want to be informed about their treatment options and possible complications so that they can make decisions about their treatment after a comprehensive and understandable discussion.

Compassionate Drug Use - Time Arising for a New Law in Bulgaria in the Era of COVID-19.

INTRODUCTION: Despite clinical trials, there are still no approved specific therapies or any vaccine against COVID-19. The only option available is using investigational drugs for compassionate use. The update of the existing regulation regarding compassionate use is to ensure the effective and sustainable development of health policies and technologies over the COVID-19 pandemic and beyond. AIM: The present short communication aimed to highlight the need for early and expanded access to investigational drugs for compassionate use as well as a call for an update of the existing regulation in Bulgaria concerning compassionate use in the era of COVID-19. MATERIALS AND METHODS: In EU and Bulgaria as well, the legal framework for compassionate use was introduced by Article 83 (1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council; in principle, Regulations of the European Parliament and of the Council are mandatory for all Member States. Remdesivir appears to have a favorable clinical and safety profile, as reported in a case involving patients with severe COVID-19 through a compassionate use programme. RESULTS: The overall probability of clinical improvement observed in 36 of 53 COVID-19 patients received intravenous remdesivir as part of a compassionate use programme was 68% (95% CI 40% to 80%). Thirty two patients (60%) demonstrated at least one adverse event, twelve 12 patients (23%) experienced serious adverse events and seven patients (13%) died. CONCLUSION: The global pandemic mandates Bulgarian Drug Agency for a reasonable update of the existing national regulation concerning compassionate use and off-label therapies. In the era of COVID-19, it is important for Bulgarian patients to have early and expanded access to investigational drugs for compassionate use.

Compassionate drug use: an imperative challenge for Bulgarian health system during COVID-19.

•The health care system in Bulgaria faces unprecedented challenges trying to take control over the pandemic of COVID-19.•The existing national regulation in Bulgaria leads to delayed and difficult access to investigational drugs via compassionate use programs.•The COVID-19 pandemic will initiate a dialogue among health policy makers and BDA for the establishment of new health policy and clear national regulation due to higher demand for investigational drugs.

Does the Bulgarian Health Care System Need a Health Ombudsman?

BACKGROUND: The Office of the Ombudsman of the Republic of Bulgaria (ORB) is an independent constitutional body elected by Bul-garian Parliament in 2005. It serves to protect the rights of all citizens, including the rights of patients, children, people with disabilities, minorities, foreigners, etc. Bulgarian healthcare users complain when they feel that the healthcare system (HCS) has failed their needs or they have been recipients of an inappropriate treatment. AIM: The aim of the present study was to analyze the structure and dynamics of all complaints from Bulgarian healthcare users referred to the ORB over a 13-year period (2005 - 2018). MATERIALS AND METHODS: Retrospective documental research was used in the present study. The data included the complaints ob-tained from the official annual reports of the ORB that are available online. Bibliographic and documental searches were also used as sources. The complaints were analyzed by their annual distribution and classified by problem areas in the HCS. RESULTS: Between 2005 and 2018, there were a total of 3288 complaints filed to ORB against HCS. In 2015, 368 complaints were re-ceived by ORB from Bulgarian healthcare users and from various patient organizations concerning problems in the HCS. The filed complaints to ORB increased by 82% in 2016 (n=421). In 2017, the overall number of ORB-referred complaints amounted to 494, and in 2018 their number was as high as 607, which represents an increase by 23% compared to the number of complaints in 2017. CONCLUSION: The great number of complaints referred to ORB about the HCS over the last four years strongly suggests that the institu-tion of the Ombudsman in Bulgaria enjoys high confidence among Bulgarian healthcare users.

Group-based cardiac rehabilitation interventions. A challenge for physical and rehabilitation medicine physicians: a randomized controlled trial.

BACKGROUND: In recent decades, many studies are focused on different training modalities comparison in patients with cardiac diseases. High intensity aerobic interval training (HIAIT) has been considered as an alternative approach to moderate-intensity continuous training (MICT) in rehabilitation of patients with chronic heart failure (CHF). AIM: To highlight the superiority of the modified group-based HIAIT intervention (m-Ullevaal) compared to the moderate-intensity continuous training (MICT), also to encourage physical and rehabilitation medicine (PRM) physicians to apply the m-Ullevaal intervention in routine cardiac rehabilitation (CR) practice. DESIGN: А single-blind, prospective randomized controlled trial. SETTING: Medical Center of Rehabilitation and Sports Medicine, Plovdiv, Bulgaria outpatients were enrolled. POPULATION: One hundred and twenty subjects of both genders, mean age of 63.73±6.68 years, with stable CHF, NYHA classes II to IIIB, were randomly assigned to m-Ullevaal group (N.=60) or to MICT (N.=60) group. Both CR protocols were conducted throughout a 12-week period. METHODS: Functional exercise capacity (FEC), assessed with six-minute walk test, and peak oxygen uptake (VO2peak), left ventricular ejection fraction (LVEF), m-Borg's perceived exertion scale (mBPES), and quality of life (QoL) were outcome measures evaluated. RESULTS: Significant improvement in FEC (P<0.001), LVEF (P<0.001), mBPES and QoL (P<0.001), was observed 12 weeks after both CR interventions (T2). However, the participants performed m-Ullevaal protocol achieved a greater improvement compared to those performed MICT (P<0.001). CONCLUSIONS: The m-Ullevaal protocol seems to be more beneficial and more effective compared to MICT. PRM physicians can efficiently apply the m-Ullevaal protocol in CHF patients rehabilitation. CLINICAL REHABILITATION IMPACT: Group-based HIAIT interventions can be widely applied by PRM physicians in CHF patients rehabilitation.