Giovanna Ricci

Oral drug therapy in elderly with dysphagia: between a rock and a hard place!

Demographic indicators forecast that by 2050, the elderly will account for about one-third of the global population. Geriatric patients require a large number of medicines, and in most cases, these products are administered as solid oral solid dosage forms, as they are by far the most common formulations on the market. However, this population tends to suffer difficulties with swallowing. Caregivers in hospital geriatric units routinely compound in solid oral dosage forms for dysphagic patients by crushing the tablets or opening the capsules to facilitate administration. The manipulation of a tablet or a capsule, if not clearly indicated in the product labeling, is an off-label use of the medicine, and must be supported by documented scientific evidence and requires the patient’s informed consent. Compounding of marketed products has been recognized as being responsible for an increased number of adverse events and medical errors. Since extemporaneous compounding is the rule and not the exception in geriatrics departments, the seriousness and scope of issues caused by this daily practice are probably underestimated. In this article, the potential problems associated with the manipulation of authorized solid oral dosage forms are discussed.

Metabolic syndrome, hypertension, and nervous system injury: Epidemiological correlates

ABSTRACT Metabolic syndrome (MetS) is a common and complex disorder combining hypertension, obesity, dyslipidemia, and insulin resistance. MetS represents a risk factor for changes in cognitive functions in older age, and several studies have suggested that MetS may be linked to dementia. This article reviews the main evidences about the relationship between MetS and neurodegenerative disease. Starting from an epidemiological point of view, the article analyzes medico-social aspects related to MetS, considering the reduction of work capacity and the condition of disability that it involves. Some authors affirm that on the basis of current Italian legislation, it is possible to consider the syndrome as a disability. This is because all the diseases that make up MetS are high-risk clinical pathological conditions. For these reasons, a joint action is required to contain the incidence of MetS, the high social costs, and the loss of productivity related to the syndrome. In conclusion, healthcare initiatives could be adopted in order to increase the understanding of the pathogenic contributions of each element on MetS and how they can be modified. These actions will be useful to reduce healthcare costs and can lead to more effective prevention of metabolic disease, thus promoting good health. Abbreviations: MetS: Metabolic syndrome; WHO: World Health Organization; CVD: cerebrovascular diseases; AD: Alzheimer’s Disease; VaD: Vascular Dementia; IDF: International Diabetes Federation; T2DM: type 2 diabetes mellitus; CAD: coronary artery disease; MCI: mild cognitive impairment; NCDs: Non Communicable Diseases; BMI: Body Mass Index; ICIDH: International classification of impairments, disabilities and handicaps

Medical assistance at the sea: legal and medico-legal problems

BACKGROUND In case of pathologies or accidents on board which require medical intervention but lacking on-board medical or paramedical personnel, the ships captain, or his delegate can contact a Telemedical Maritime Assistance Service (TMAS). International Maritime Organisation considers telemedicine at sea as an integral part of rescue procedures. Five key elements contribute to the delivery of good medical assistance at sea: one or more coordination and rescue centres; the TMAS; the possibility of intervention at sea; an organisation of appropriate institutions on ground and common operating procedures. This paper analyses the responsibility of the ships captain and of the TMAS doctor in case of diseases or injuries on board in the frame of the main important international regulations. RESPONSIBILITY OF THE SHIP CAPTAIN In case of a disease or injury on board a ship, the captain must contact the TMAS as soon as possible. A captain not acting promptly and not doing whatever it is possible for the ill/injured person by consulting the TMAS or a physician and/or not following prescriptions received, could be charged for omission of responsibility. A captain underestimating a medical problem and knowing that the patients condition could worsen, but still not consulting a medical centre for assistance, should be ready to accept the consequences of his choices. RESPONSIBILITY OF THE PHYSICIAN The doctor of TMAS has full responsibility for the diagnosis, prescription and treatment, while the ships captain is responsible for the final decision. Regarding the medical treatment and assistance on board a ship, the TMAS doctor should pay attention not only for the diagnosis, but also for the prognosis. Telemedicine implies that the doctor should make decisions without a clinical examination, often without some additional medical examinations and by maintaining a contact with other people who are in direct contact with the patient. The physician usually has to rely on the account of colleagues of the sick seafarer as far as medical history is concerned. This may make harder to take a decision. CONCLUSIONS The ships captain is guilty if he fails to contact a TMAS in case of diseases or accidents on board. Similar to a traditional relationship between a patient and a physician, the doctor consulted via telecommunication systems is also responsible for his diagnosis and treatment. However, in telemedicine the contrasts with the most basic principles of the traditional medicine are obvious. This makes the delivery of medical care of seafarers on board ships quite complicated.

Critical review of sham surgery clinical trials: Confounding factors analysis

Objective Sham surgery (placebo surgery) is an intervention that omits the step thought to be therapeutically necessary. In surgical clinical trials, sham surgery serves an analogous purpose to placebo drugs, neutralizing biases such as the placebo effect. A critical review was performed to study the statistical relevance of the clinical trials about sham surgery in the light of potential confounding factors. Materials and methods For the critical review 52 articles were included. The possible confounding factors have been studied using a structured interpretative research form designed by the authors. This form includes the following ten confounding factors: I), lack of homogeneity among inclusion/exclusion criteria. II), false double blind. III), lack of post-surgery double blind. IV), power of the study. V), sample characteristics. VI), lost patients to Follow-up. VII), gender distribution. VIII), age equilibrium. IX), lack of psychological patient evaluation. X), lack of psychiatric patient evaluation. In most of the studies, at least one confounding factor was present. Results The analysis of the confounding factors showed that they could influence the reliability of the surgical placebo effects. Conclusions The validity of sham surgery should be reconsidered.

The Effect of the Association between Donepezil and Choline Alphoscerate on Behavioral Disturbances in Alzheimer’s Disease: Interim Results of the ASCOMALVA Trial

BACKGROUND Behavioral and psychological symptoms of dementia (BPSD) are a group of psychological reactions, psychiatric symptoms, and behaviors commonly found in Alzheimers disease (AD). Four clusters of BPSD have been described: mood disorders (depression, anxiety, and apathy), psychotic symptoms (delusions and hallucinations), aberrant motor behaviors (pacing, wandering, and other purposeless behaviors), and inappropriate behaviors (agitation, disinhibition, and euphoria). Most of them are attributed to acetylcholine deficiency. OBJECTIVE To evaluate if a higher amount of acetylcholine obtained by associating donepezil and choline alphoscerate might have a favorable effect on BPSD. METHODS BPSD were measured at baseline and after 24 months in 113 mild/moderate AD patients, included in the double-blind randomized trial ASCOMALVA, by the Neuropsychiatric Inventory (NPI). Two matched groups were compared: group A treated with donepezil (10 mg/day) plus choline alphoscerate (1200 mg/day), and group B treated with donepezil (10 mg/day) plus placebo. RESULTS Data of NPI revealed a significant decrease of BPSD severity and distress of the caregiver in patients of group A compared with group B. Mood disorders (depression, anxiety and apathy) were significantly decreased in subjects treated with donepezil and choline alphoscerate, while their severity and frequency was increased in the other group. CONCLUSIONS Patients treated with donepezil plus choline alphoscerate showed a lower level of behavioral disturbances than subjects treated with donepezil only, suggesting that the association can have beneficial effects.

A Proposed Road Map for the Ethical Evaluation of Sham (Placebo) Surgery.

Objective: The study proposes a possible roadmap for the ethical assessment of sham surgery clinical trials (CTs), focusing on methodological aspects, as a result of the lack of this type of practical tool in the literature/practice. Background: Surgical procedures are frequently conducted without closely controlled studies. For this reason, these procedures are less rigorous than those for drug/device clinical trials. The aim of a sham (placebo) surgery CT is to carry out a surgical CT with a legitimate control group. The use of sham surgery is controversial from an ethical point of view. Methods: This evaluation system is set up according to ICH/GCP, World Medical Association Declaration of Helsinki, CONSORT 2010 standards. The proposed roadmap is based on the following 4 steps/levels: safety/clinical indications; adequacy of trial methodology/design adopted for a sham surgery CT; specific informed consent, and economic issues. Results: A flowchart is proposed which can be used at two levels: as a basic guideline for the design of a surgical protocol representing a benchmark level of care; and a multiaxial assessment considering the first two sources of morality of human acts according to Aristotelian ethics: the object of the act (step 1) and some of its circumstances (steps 2–4). Conclusions: The use of a placebo and of double-blind control groups in surgery CTs would improves the quality of results, providing that an accurate ethical assessment procedure is in place, firstly to ensure patient safety and secondly to prevent abuses/procedural biases. Future testing of the proposed flowchart is outlined.

Cognitive Assessment of Patients With Alzheimer's Disease by Telemedicine: Pilot Study

Background Approximately 46.8 million people are living with dementia worldwide and their number will grow in the next years. Any potential treatment should be administered as early as possible because it is important to provide an early cognitive assessment and to regularly monitor the mental function of patients. Information and communication technologies can be helpful to reach and follow patients without displacing them, but there may be doubts about the reliability of cognitive tests performed by telemedicine. Objective The purpose of this study was to evaluate the reliability of the Mini Mental State Examination (MMSE) and the Alzheimer’s Disease Assessment Scale cognitive subscale (ADAS-cog) tests administered in hospital by videoconference to patients with mild to moderate Alzheimers disease. Methods The tests were administered to 28 Alzheimers disease outpatients (8 male, mean age 73.88, SD 7.45 years; 20 female mean age 76.00, SD 5.40 years) recruited and followed in the Alzheimer’s Unit of the A Cardarelli National Hospital (Naples, Italy) at baseline and after 6, 12, 18, and 24 months of observation. Patients were evaluated first face-to-face by a psychologist and then, after 2 weeks, by another psychologist via videoconference in hospital. Results This study showed no differences in the MMSE and ADAS-cog scores when the tests were administered face-to-face or by videoconference, except in patients with more pronounced cognitive deficits (MMSE<17), in which the assessment via videoconference overestimated the cognitive impairment (face to face, MMSE mean 13.9, SD 4.9 and ADAS-cog mean 9.0, SD 3.8; videoconference, MMSE mean 42.8, SD 12.5 and ADAS-cog mean 56.9, SD 5.5). Conclusions We found that videoconferencing is a reliable approach to document cognitive stability or decline, and to measure treatment effects in patients with mild to moderate dementia. A more extended study is needed to confirm these results.

Care for the Person, Protection of Health and Respect for the will of the Patient in Italy: Support Administration as a Tool to Jointly Promote Health and Respect for Autonomy in Incompetent Patients.

In Italy, advance health care directives are a subject of considerable debate in both legal theory and practice. This debate focuses in particular not only on the appropriateness of approving ad hoc statutory regulations but also on the extent to which similar advance indications of a person’s wishes are applicable under the existing legal system, albeit in the absence of a law regulating them. The authors of this paper consider, in particular, guidelines relating to the possible use of the mechanism of support administration (amministrazione di sostegno) (Law No. 6/2004) as a procedure to be used for the legal recognition of advance health care directives, particularly in the light of the legal provision for the possible designation in advance of a support administrator by a beneficiary in anticipation of an eventual situation of incapacity. This underlines how the concept of health does not only exist in the abstract, but must be measured in relation to the particular patient in the particular situation and how beneficence and respect for autonomy are both essential elements in the choices aimed at promoting the health and the wellbeing of its citizens. Significance for public health The concept of health includes not only the physical, but also the psychosocial dimension in accordance with the will of people. The reference to the personal concept of quality of life, values, ethical and religious opinions of each subject are key components underlying the decision-making process concerning a given patient in a given clinical condition: the concept of health does not only exist in the abstract, but must be measured in relation to the specific patient in the specific situation. The authors analyse the Italian debate about the possible designation in advance of the support administrator on the part of the beneficiary in anticipation of a potential situation of incapacity, as a tool to enforce advance care directives, to show how beneficence and respect for autonomy are both essential elements in the choices of the legal system aimed at promoting the health and the wellbeing of its citizens.