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1.  Custodian for elderly with memory impairment in Sweden – a study of 260 physicians’ statements to the court 
BMC Geriatrics  2014;14:94.
Background
In the modern world with new family structures, international migration and increased life expectancy, there is a growing need for legal ways of assisting elderly with impaired mental capacity to decide about their life and assets. There are few studies about the physician’s role when a court appoints proxies for vulnerable elderly. Many doctors do not know how to assess mental capacity, and most lawyers and judges know little about medicine.
Methods
Applications for a custodian sent to the Stockholm Chief Guardian’ Office in Sweden were used. Physician’s statements to the court for elderly with memory impairment were selected and 260 statements were scrutinized with regard to formal quality, the narrative content and the physician who wrote it.
Results
The quality of the statements varied from one sentence to excellent. Most statements were written by senior family practitioners or geriatricians. Seventeen % of the statements were handwritten and had more formal shortcomings than machine/computer written statements.
The majority of patients needed massive help with daily life and economy. Median age was 84 years of age. MMSE score was given in 20% of the cases and varied from 6–27.A diagnosis of dementia was established in 57%. At the time of application, at least 48% were in a hospital or nursing home and at least 27% were in their private home. Only 5% were living with a spouse or a child. In 53% of the cases, the doctor knew the patient, but in 40% of the cases, the identity of the patient was not confirmed. The physician found that 54% were unable to understand the idea of getting a custodian, but out of those very vulnerable elderly, 20% had signed consent and 57% were considered able to be heard in court.
Conclusions
There is a large variation in the quality of physicians’ statements to the court concerning the mental capacity of elderly patients with cognitive impairment. Many statements have serious short-comings, and the system is not safe. There is a strong need for guide-lines, and additional training for all professionals involved.
doi:10.1186/1471-2318-14-94
PMCID: PMC4161266  PMID: 25160817
Mental capacity; Physician’s statement; Court; Custodian; Capacity assessment; Memory impairment; Dementia; Elderly
2.  Medico-Legal Findings, Legal Case Progression, and Outcomes in South African Rape Cases: Retrospective Review 
PLoS Medicine  2009;6(10):e1000164.
Rachel Jewkes and colleagues examine the processing of rape cases by South African police and courts and show an association between documentation of ano-genital injuries, trials commencing, and convictions in rape cases.
Background
Health services for victims of rape are recognised as a particularly neglected area of the health sector internationally. Efforts to strengthen these services need to be guided by clinical research. Expert medical evidence is widely used in rape cases, but its contribution to the progress of legal cases is unclear. Only three studies have found an association between documented bodily injuries and convictions in rape cases. This article aims to describe the processing of rape cases by South African police and courts, and the association between documented injuries and DNA and case progression through the criminal justice system.
Methods and Findings
We analysed a provincially representative sample of 2,068 attempted and completed rape cases reported to 70 randomly selected Gauteng province police stations in 2003. Data sheets were completed from the police dockets and available medical examination forms were copied. 1,547 cases of rape had medical examinations and available forms and were analysed, which was at least 85% of the proportion of the sample having a medical examination. We present logistic regression models of the association between whether a trial started and whether the accused was found guilty and the medico-legal findings for adult and child rapes. Half the suspects were arrested (n = 771), 14% (209) of cases went to trial, and in 3% (31) of adults and 7% (44) of children there was a conviction. A report on DNA was available in 1.4% (22) of cases, but the presence or absence of injuries were documented in all cases. Documented injuries were not associated with arrest, but they were associated with children's cases (but not adult's) going to trial (adjusted odds ratio [AOR] for having genital and nongenital injuries 5.83, 95% confidence interval [CI] 1.87–18.13, p = 0.003). In adult cases a conviction was more likely if there were documented injuries, whether nongenital injuries alone AOR 6.25 (95% CI 1.14–34.3, p = 0.036), ano-genital injuries alone (AOR 7.00, 95% CI 1.44–33.9, p = 0.017), or both nongenital and ano-genital injuries (AOR 12.34, 95% CI 2.87–53.0, p = 0.001). DNA was not associated with case outcome.
Conclusions
This is the first study, to our knowledge, to show an association between documentation of ano-genital injuries, trials commencing, and convictions in rape cases in a developing country. Its findings are of particular importance because they show the value of good basic medical practices in documentation of injuries, rather than more expensive DNA evidence, in assisting courts in rape cases. Health care providers need training to provide high quality health care responses after rape, but we have shown that the core elements of the medico-legal response require very little technology. As such they should be replicable in low- and middle-income country settings. Our findings raise important questions about the value of evidence that requires the use of forensic laboratories at a population level in countries like South Africa that have substantial inefficiencies in their police services.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Sexual violence has significant short- and long-term mental and physical health consequences for the victim. Estimates of how common rape is vary within and between countries. The World Health Organization (WHO) estimates that between 1% and 12% of women aged 15 or over have experienced sexual violence by a nonpartner. It has also been used as a weapon of war.
The WHO recognises that rape may be committed by a spouse, partner, or acquaintance as well as a stranger, that men can be victims as well as perpetrators, and that coercion need not be physical. It advocates preventing sexual violence through better support for victims, legal and policy changes, educational programmes, and campaigns to change attitudes, and better health care services and training for health care workers.
Health services for victims of rape have two important roles: to assist the victim and to gather evidence for the police and courts. Nonetheless, health services for victims of rape are often poor. Over the last decade, the South African government has taken steps to reduce particularly high rates of sexual violence by broadening the legal definition of rape and improving health services.
Why Was This Study Done?
Previous studies into how useful expert medical evidence is for the police and courts have focused almost exclusively on high-income countries. It is not clear what interventions work best in countries with fewer resources. The researchers wanted to know the impact of medical evidence on how the South African criminal justice system handled cases of rape and attempted rape.
What Did the Researchers Do and Find?
The authors analysed data from police and court files of 1,547 cases of rape or attempted rape first reported in 2003 to a random sample of police stations in Gauteng province, South Africa. They looked for associations between case data and the arrest, charge, trial, and conviction or acquittal of the alleged perpetrator. They included only cases that were closed when they collected data in 2006 and only cases that contained a record of a medical examination of the victim. The researchers used South Africa's then legal definition of rape as “intentional and unlawful vaginal sex with woman without consent.” They analysed cases involving adults and children (aged 0–17 years) separately. They found that the overall conviction rate was very low, with only 3% of adult cases and 7.4% of children's cases resulting in a guilty verdict. Many cases were dropped at each stage of the legal process and DNA evidence was often not collected or, if collected, not analysed. DNA reports were rarely available for the courts. Injuries were not associated with arrests for either adult or children's cases; an arrest took place in 40% of cases without injuries. Child cases were more likely to come to trial if injuries were present, although a guilty verdict was not more likely. The reverse was true in adult cases: the presence or absence of injury was not linked to cases being brought to trial, but if injuries were present, whether genital, nongenital, or both, a conviction was more likely.
What Do These Findings Mean?
One limitation of the research is that the researchers identified statistical associations of events, but this does not prove that one event caused the other. Other possible limitations of the study are that the researchers had access only to cases closed by the police, which may have biased their results, and the quality of the recorded data was very variable. In addition, the research did not consider other factors that may have affected case outcomes, such as how witnesses are perceived in court.
The system to collect and analyse DNA was rarely effective in making evidence available to the courts. It is known from other countries with effective systems that DNA evidence is of no value if the basis of defence is consent; for instance in cases where the accused is an intimate partner of the victim. Injuries appear not to be necessary to secure a conviction but may be seen as useful by the South African courts in corroborating the victim's testimony, at least in adult cases.
The authors conclude that in poor countries, training for nurses and/or doctors who act as forensic medical examiners in how to record injuries and present their evidence in court will be more effective than investing in costly systems for DNA analysis. However, they argue that in South Africa, as a middle-income country with a high proportion of nonintimate partner rapes, there would be benefit in improving the system to collect and analyse DNA evidence rather than abandoning it entirely.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000164.
Further information on rape in South Africa is available from the Tshwaranang Legal Advocacy Centre
Information on rape is also available from the Rape Crisis Cape Town Trust
Emergency rape information, facts about rape, events, legal services, and medical care can be found at the Speakout Web site
The World Health Organization publishes a factsheet on sexual violence, a report on violence and health, as well as guidelines on medico-legal care for victims of sexual violence
doi:10.1371/journal.pmed.1000164
PMCID: PMC2752115  PMID: 19823567
3.  Neuropsychological Correlates of Capacity Determinations in Alzheimer’s Disease: Implications for Assessment 
Objectives
To explore the neuropsychological correlates of the capacity to consent to research and to appoint a research proxy among persons with Alzheimer’s disease.
Design, Setting, and Participants
Interview study of 77 persons with Alzheimer’s disease recruited through an Alzheimer’s disease research center and a memory disorder clinic.
Measurements
The capacity to consent to two research scenarios (a drug randomized clinical trial and a neurosurgical clinical trial) and the capacity to appoint a research proxy were determined by five experienced consultation psychiatrists who rendered categorical judgments based on videotaped interviews of the MacArthur Competence Assessment Tool-Clinical Research (MacCAT-CR) and the Capacity to Appoint a Proxy Assessment (CAPA). Mattis Dementia Rating Scale-2 (DRS-2) was used to assess neuropsychological functioning.
Results
The capacity to appoint a proxy and to consent to the drug randomized clinical trial, as determined by a majority or greater opinion of the 5-psychiatrist panel, were predicted by Conceptualization and Initiation/Perseveration subscales whereas the capacity to consent to a neurosurgical randomized clinical trial was predicted by the Memory subscale. Furthermore, the more lenient individual psychiatrists’ judgments were predicted by the Conceptualization subscale whereas the stricter psychiatrists’ judgments were predicted by the Memory subscale.
Conclusions
How experienced psychiatrists view Alzheimer’s patients’ capacity for consenting to research and for appointing a proxy may be related to the patients’ conceptualization and memory functioning. More explicit and standardized guidance on the role of short term memory in capacity determinations may be useful.
doi:10.1016/j.jagp.2012.11.008
PMCID: PMC3382031  PMID: 23498384
decision-making capacity; neuropsychology; Alzheimer’s disease
4.  Brief report on the experience of using proxy consent for incapacitated adults 
Journal of Medical Ethics  2006;32(1):61-62.
The Medicines for Human Use (Clinical Trials) Regulations 2004, which came into force in the UK in May 2004, cover the conduct of clinical trials on medicinal products. They allow a legal representative (a person not connected with the conduct of the trial) to consent to the participation of incompetent adults in medical research. Currently, very little is known about how such representatives will make their decisions.
We have experience with proxy consent for older adults in a large, national trial. From 2445 potentially eligible but incapacitated patients, proxy, relative assent resulted in trial participation of only 87 (3.6%) patients. The reasons for this were that a large number of incapacitated patients had no relative available for assent (2286), but also a high proportion of relatives approached refused to provide assent (72/159, 45.3%). In comparison, 17.7% of patients declined participation in the trial.
Proxy consent allowed only a small increase in trial recruitment of incapacitated patients. The fact that a greater proportion of relatives than patients refused to provide assent implies that they were more cautious than the patients themselves, or perhaps used different criteria, when making their decision.
In future research involving incapacitated older patients there is likely to be heavy reliance on proxy consent provision by legal representatives. Our findings imply that consent decisions of legal representatives will not necessarily reflect those of patients themselves.
doi:10.1136/jme.2005.012302
PMCID: PMC2563273  PMID: 16373526
assent; incapacitated adults; informed consent; proxy consent
5.  Cross-border reproductive care among French patients: experiences in Greece, Spain and Belgium 
Human Reproduction (Oxford, England)  2013;28(11):3103-3110.
STUDY QUESTION
What are the characteristics, motivation and experience of French patients seeking cross-border reproductive care (CBRC)?
SUMMARY ANSWER
French patients seeking CBRC are same-sex couples, single women who are not eligible for assisted reproduction technologies (ARTs) in France and heterosexual couples seeking oocyte donation due to extremely limited access to this technique in France, while their choice of Greece as a destination is influenced by financial issues.
WHAT IS KNOWN ALREADY
CBRC is a new, increasing, complex and poorly understood phenomenon. A few studies have investigated UK, German or Italian CBRC patients, but none have specifically investigated French patients although France is one of the top four countries of origin of CBRC patients in Europe.
STUDY DESIGN, SIZE, DURATION
A cross-sectional study was carried out in 2010–2012 in three ART centres in Greece, Belgium and Spain in order to investigate French patients treated in these centres. Recruitment was prospective in Greece and Belgium and retrospective in Spain. The overall response rate was 68%, with 128 French patients participating.
PARTICIPANTS/MATERIALS, SETTING, METHODS
French patients filled in a questionnaire. Information was collected on their socio-economic characteristics and their search for ART treatment in France and in other countries.
MAIN RESULTS AND THE ROLE OF CHANCE
In the Belgian centre, 89% of French patients used sperm donation whereas oocyte donation was used by 100% of patients in the Greek centre and 74% of patients in the Spanish centre. The majority (94%) of French patients using sperm donation in Belgium were not legally eligible for access to ART in France as they were same-sex couples or single women, and the main criterion of choice of centre was its geographical proximity (71%). Most of the French patients using oocyte donation in Greece and Spain fulfilled criteria for fully reimbursed oocyte donation treatment in France as they were heterosexual couples (99%) with the woman aged <43 years (65%). For these couples, CBRC was motivated by the extremely limited access to oocyte donation in France. Half of French CBRC patients using oocyte donation in Spain had a low/intermediate occupational level (such as primary school teachers, nurses, administrative officers or sales agents, workers and employees) and this proportion was much higher in Greece (82%, P < 0.01).
LIMITATIONS, REASONS FOR CAUTION
Larger and more wide-ranging studies are needed as this study included only 128 patients who may not be representative of all French CBRC patients, especially because the study was carried out only in three ART centres and these too may not be representative.
WIDER IMPLICATIONS OF THE FINDINGS
CBRC among French patients had been thought to reflect mainly law evasion. This study showed that the reality is much more complex and that CBRC among French patients reflects both law evasion and limited access to oocyte donation in France. It also brings new insight into the characteristics of the patients by suggesting a certain degree of ‘democratization’ in access to such care. However, the choice of centre seemed related to socio-economic characteristics, in that the Greek centre treated a less advantaged population than the Spanish centre.
STUDY FUNDING/COMPETING INTEREST(S)
This study was supported by French public research funds, the Institute Emilie du Châtelet from the Ile-de-France Region, the Biomedicine Agency and the Research Institute of Public Health (IReSP). There are no conflicts of interest.
TRIAL REGISTRATION NUMBER
Not applicable.
doi:10.1093/humrep/det326
PMCID: PMC3795470  PMID: 23943796
assisted reproduction technologies; oocyte donation; cross-border reproductive care; sperm donation; Europe
6.  Medical Decision-making During the Guardianship Process for Incapacitated, Hospitalized Adults: A Descriptive Cohort Study 
Journal of General Internal Medicine  2010;25(10):1003-1008.
Background
It is sometimes necessary for courts to appoint guardians for adult, incapacitated patients. There are few data describing how medical decisions are made for such patients before and during the guardianship process.
Objective
To describe the process of medical decision-making for incapacitated, hospitalized adults for whom court-appointed guardians are requested.
Design
Retrospective, descriptive cohort study.
Measurements
Patients were identified from the legal files of a public, urban hospital. Medical and legal records were reviewed for demographic data, code status, diagnoses, code status orders and invasive procedures and person authorizing the order or procedure, dates of incapacitation and appointment of temporary guardian, reason for guardianship, and documentation of communication with a guardian.
Results
A total of 79 patients met inclusion criteria; 68.4% were male and 56.2% African-American. The median age was 65 years. Of the 71 patients with medical records available 89% of patients had a temporary guardianship petitioned because of the need for placement only. Seventeen patients had a new DNR order written during hospitalization, eight of which were ordered by physicians without consultation with a surrogate decision maker. Overall, 32 patients underwent a total of 81 documented invasive procedures, 16 of which were authorized by the patient, 15 by family or friend, and 11 by a guardian; consent was not required for 39 of the procedures because of emergency conditions or because a procedure was medically necessary and no surrogate decision maker was available.
Conclusions
Although most of the guardianships were requested for placement purposes, important medical decisions were made while patients were awaiting appointment of a guardian. Hospitalized, incapacitated adults awaiting guardianship may lack a surrogate decision maker when serious decisions must be made about their medical care.
doi:10.1007/s11606-010-1351-8
PMCID: PMC2955482  PMID: 20422304
proxy decision-making; court-appointed guardian; incapacitated patients; health care decisions; surrogate decision-making; health care consent
7.  Legal aspects with regard to integrated care: a long way to go 
Introduction
The main purpose of this abstract is to raise awareness of the unsatisfactory legal situation with regard to integrated care. The abstract focuses on two major legal issues. First, I picture the actual legal situation regarding cross-border healthcare. Secondly, I describe the duties care providers and patients may face when entering into integrated care programs.
Cross-border healthcare
Currently, we lack an European legislative framework that regulates cross-border healthcare. One reason for this fact is that Article 152 EC treaty states that “Community Action in the field of public health shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care” [1]. Therefore, it's up to each Member State to provide regulations with regard to cross-border healthcare services. Hence, patients need to deal with various national—often inconsistent—provisions when considering consuming cross-border healthcare. As a consequence, patients easily felt overstrained and the unclear legal situation prevents them from crossing a border to obtain healthcare. This often averts the establishment of integrated care models. As a result, patients lose the opportunity to receive more or different healthcare services and products in Member States other than the State in which they are living or are insured.
Nevertheless, it was the European Court of Justice (ECJ) with its continuous rulings in respect to cross-border healthcare that started with the harmonization process of cross-border healthcare legislation. The ECJ judges have ruled that freedom to cross EU borders for the best and quickest treatment is a right for all [2]. However, litigation before the ECJ suffers from deficiencies in this respect. In particular, the case law of the ECJ on the issue clearly shows the unsatisfactory nature of case-by-case ex post procedures for a complex and developing policy area. Further, litigation always leads to a winner and a loser, but does not foster an iterative, deliberate process in which the optimal accommodation of all affected interests is reached because the ECJ always decides on a particular case [3]. As a consequence, the European Commission has presented a proposal for a directive on the application of patient's rights in cross-border healthcare which reflects the decisions of the ECJ [4]. The aim of the proposed directive is—expressed in simplified terms—to ensure and to clarify the conditions for exercising patient's right to cross-border healthcare, and to create a framework for increasing cooperation between Member States. The proposal directive covers cross-border healthcare irrespective of how it is organised, financed or provided and whether it is private or public. The outcome of the proposed directive would be the reduction of obstacles faced when crossing the border in order to obtain healthcare. In case the proposed directive will be approved and will come into force, a major step in order to enlarge the possibilities to achieve integrated care is done. However, the Member States (e.g. Austria) take a critical stance towards the proposed directive and no one currently knows whether it will ever be approved [5].
The actor's duties with respect to integrated care programs
Entering into an integrated care program leads to legal challenges with regard to the actors. In particular, the question which duties are faced when entering into an integrated care program has not been raised yet. Therefore, patients find themselves in situations with a deficit of information and do not see the legal consequences when entering into an integrated care program. Patients often do not realise that they conclude an agreement with a health insurance company. They bind themselves for a certain period (sometimes several years) and they are contractually not allowed to rescind from the agreement. In general, integrated care programs offered from health insurance companies oblige the patient to consult the healthcare providers that are covered from the agreement. As a consequence, in case patients are not satisfied with the healthcare provider because of medical or personal reasons, no change to another healthcare provider is possible. Further, patients always enter into an implied health treatment agreement with the healthcare provider. In turn, healthcare providers do not have any certainties to be appointed from health insurance companies and, therefore, may lose essential revenues. In addition, healthcare providers are obliged to fulfil certain requirements (technical and organisational) in order to be appointed. In case they are not able anymore to continuously fulfil these requirements, health insurance companies may rescind their contracts. Having these issues in mind, one can assume that entering into an integrated care program implies various—often unseen—duties from different perspectives.
Conclusion
At a glance, the legal background of integrated care still raises a lot of unsolved problems both on a national and on a European level. As a next step, legal uncertainties should be made transparent in order to give the actors the possibility to discuss them. A consequence of this public discussion would be a cornerstone for more consumer-friendly healthcare models that would lead to better patient treatment and would enhance integrated healthcare.
PMCID: PMC2807115
cross-border healthcare; legislation; European Court of Justice; patient's rights; legal duties; integrated care program
8.  Developing an efficient scheduling template of a chemotherapy treatment unit 
The Australasian Medical Journal  2011;4(10):575-588.
This study was undertaken to improve the performance of a Chemotherapy Treatment Unit by increasing the throughput and reducing the average patient’s waiting time. In order to achieve this objective, a scheduling template has been built. The scheduling template is a simple tool that can be used to schedule patients' arrival to the clinic. A simulation model of this system was built and several scenarios, that target match the arrival pattern of the patients and resources availability, were designed and evaluated. After performing detailed analysis, one scenario provide the best system’s performance. A scheduling template has been developed based on this scenario. After implementing the new scheduling template, 22.5% more patients can be served.
Introduction
CancerCare Manitoba is a provincially mandated cancer care agency. It is dedicated to provide quality care to those who have been diagnosed and are living with cancer. MacCharles Chemotherapy unit is specially built to provide chemotherapy treatment to the cancer patients of Winnipeg. In order to maintain an excellent service, it tries to ensure that patients get their treatment in a timely manner. It is challenging to maintain that goal because of the lack of a proper roster, the workload distribution and inefficient resource allotment. In order to maintain the satisfaction of the patients and the healthcare providers, by serving the maximum number of patients in a timely manner, it is necessary to develop an efficient scheduling template that matches the required demand with the availability of resources. This goal can be reached using simulation modelling. Simulation has proven to be an excellent modelling tool. It can be defined as building computer models that represent real world or hypothetical systems, and hence experimenting with these models to study system behaviour under different scenarios.1, 2
A study was undertaken at the Children's Hospital of Eastern Ontario to identify the issues behind the long waiting time of a emergency room.3 A 20-­‐day field observation revealed that the availability of the staff physician and interaction affects the patient wait time. Jyväskylä et al.4 used simulation to test different process scenarios, allocate resources and perform activity-­‐based cost analysis in the Emergency Department (ED) at the Central Hospital. The simulation also supported the study of a new operational method, named "triage-team" method without interrupting the main system. The proposed triage team method categorises the entire patient according to the urgency to see the doctor and allows the patient to complete the necessary test before being seen by the doctor for the first time. The simulation study showed that it will decrease the throughput time of the patient and reduce the utilisation of the specialist and enable the ordering all the tests the patient needs right after arrival, thus quickening the referral to treatment.
Santibáñez et al.5 developed a discrete event simulation model of British Columbia Cancer Agency"s ambulatory care unit which was used to study the impact of scenarios considering different operational factors (delay in starting clinic), appointment schedule (appointment order, appointment adjustment, add-­‐ons to the schedule) and resource allocation. It was found that the best outcomes were obtained when not one but multiple changes were implemented simultaneously. Sepúlveda et al.6 studied the M. D. Anderson Cancer Centre Orlando, which is a cancer treatment facility and built a simulation model to analyse and improve flow process and increase capacity in the main facility. Different scenarios were considered like, transferring laboratory and pharmacy areas, adding an extra blood draw room and applying different scheduling techniques of patients. The study shows that by increasing the number of short-­‐term (four hours or less) patients in the morning could increase chair utilisation.
Discrete event simulation also helps improve a service where staff are ignorant about the behaviour of the system as a whole; which can also be described as a real professional system. Niranjon et al.7 used simulation successfully where they had to face such constraints and lack of accessible data. Carlos et al. 8 used Total quality management and simulation – animation to improve the quality of the emergency room. Simulation was used to cover the key point of the emergency room and animation was used to indicate the areas of opportunity required. This study revealed that a long waiting time, overload personnel and increasing withdrawal rate of patients are caused by the lack of capacity in the emergency room.
Baesler et al.9 developed a methodology for a cancer treatment facility to find stochastically a global optimum point for the control variables. A simulation model generated the output using a goal programming framework for all the objectives involved in the analysis. Later a genetic algorithm was responsible for performing the search for an improved solution. The control variables that were considered in this research are number of treatment chairs, number of drawing blood nurses, laboratory personnel, and pharmacy personnel. Guo et al. 10 presented a simulation framework considering demand for appointment, patient flow logic, distribution of resources, scheduling rules followed by the scheduler. The objective of the study was to develop a scheduling rule which will ensure that 95% of all the appointment requests should be seen within one week after the request is made to increase the level of patient satisfaction and balance the schedule of each doctor to maintain a fine harmony between "busy clinic" and "quiet clinic".
Huschka et al.11 studied a healthcare system which was about to change their facility layout. In this case a simulation model study helped them to design a new healthcare practice by evaluating the change in layout before implementation. Historical data like the arrival rate of the patients, number of patients visited each day, patient flow logic, was used to build the current system model. Later, different scenarios were designed which measured the changes in the current layout and performance.
Wijewickrama et al.12 developed a simulation model to evaluate appointment schedule (AS) for second time consultations and patient appointment sequence (PSEQ) in a multi-­‐facility system. Five different appointment rule (ARULE) were considered: i) Baily; ii) 3Baily; iii) Individual (Ind); iv) two patients at a time (2AtaTime); v) Variable Interval and (V-­‐I) rule. PSEQ is based on type of patients: Appointment patients (APs) and new patients (NPs). The different PSEQ that were studied in this study were: i) first-­‐ come first-­‐serve; ii) appointment patient at the beginning of the clinic (APBEG); iii) new patient at the beginning of the clinic (NPBEG); iv) assigning appointed and new patients in an alternating manner (ALTER); v) assigning a new patient after every five-­‐appointment patients. Also patient no show (0% and 5%) and patient punctuality (PUNCT) (on-­‐time and 10 minutes early) were also considered. The study found that ALTER-­‐Ind. and ALTER5-­‐Ind. performed best on 0% NOSHOW, on-­‐time PUNCT and 5% NOSHOW, on-­‐time PUNCT situation to reduce WT and IT per patient. As NOSHOW created slack time for waiting patients, their WT tends to reduce while IT increases due to unexpected cancellation. Earliness increases congestion whichin turn increases waiting time.
Ramis et al.13 conducted a study of a Medical Imaging Center (MIC) to build a simulation model which was used to improve the patient journey through an imaging centre by reducing the wait time and making better use of the resources. The simulation model also used a Graphic User Interface (GUI) to provide the parameters of the centre, such as arrival rates, distances, processing times, resources and schedule. The simulation was used to measure the waiting time of the patients in different case scenarios. The study found that assigning a common function to the resource personnel could improve the waiting time of the patients.
The objective of this study is to develop an efficient scheduling template that maximises the number of served patients and minimises the average patient's waiting time at the given resources availability. To accomplish this objective, we will build a simulation model which mimics the working conditions of the clinic. Then we will suggest different scenarios of matching the arrival pattern of the patients with the availability of the resources. Full experiments will be performed to evaluate these scenarios. Hence, a simple and practical scheduling template will be built based on the indentified best scenario. The developed simulation model is described in section 2, which consists of a description of the treatment room, and a description of the types of patients and treatment durations. In section 3, different improvement scenarios are described and their analysis is presented in section 4. Section 5 illustrates a scheduling template based on one of the improvement scenarios. Finally, the conclusion and future direction of our work is exhibited in section 6.
Simulation Model
A simulation model represents the actual system and assists in visualising and evaluating the performance of the system under different scenarios without interrupting the actual system. Building a proper simulation model of a system consists of the following steps.
Observing the system to understand the flow of the entities, key players, availability of resources and overall generic framework.
Collecting the data on the number and type of entities, time consumed by the entities at each step of their journey, and availability of resources.
After building the simulation model it is necessary to confirm that the model is valid. This can be done by confirming that each entity flows as it is supposed to and the statistical data generated by the simulation model is similar to the collected data.
Figure 1 shows the patient flow process in the treatment room. On the patient's first appointment, the oncologist comes up with the treatment plan. The treatment time varies according to the patient’s condition, which may be 1 hour to 10 hours. Based on the type of the treatment, the physician or the clinical clerk books an available treatment chair for that time period.
On the day of the appointment, the patient will wait until the booked chair is free. When the chair is free a nurse from that station comes to the patient, verifies the name and date of birth and takes the patient to a treatment chair. Afterwards, the nurse flushes the chemotherapy drug line to the patient's body which takes about five minutes and sets up the treatment. Then the nurse leaves to serve another patient. Chemotherapy treatment lengths vary from less than an hour to 10 hour infusions. At the end of the treatment, the nurse returns, removes the line and notifies the patient about the next appointment date and time which also takes about five minutes. Most of the patients visit the clinic to take care of their PICC line (a peripherally inserted central catheter). A PICC is a line that is used to inject the patient with the chemical. This PICC line should be regularly cleaned, flushed to maintain patency and the insertion site checked for signs of infection. It takes approximately 10–15 minutes to take care of a PICC line by a nurse.
Cancer Care Manitoba provided access to the electronic scheduling system, also known as "ARIA" which is comprehensive information and image management system that aggregates patient data into a fully-­‐electronic medical chart, provided by VARIAN Medical System. This system was used to find out how many patients are booked in every clinic day. It also reveals which chair is used for how many hours. It was necessary to search a patient's history to find out how long the patient spends on which chair. Collecting the snapshot of each patient gives the complete picture of a one day clinic schedule.
The treatment room consists of the following two main limited resources:
Treatment Chairs: Chairs that are used to seat the patients during the treatment.
Nurses: Nurses are required to inject the treatment line into the patient and remove it at the end of the treatment. They also take care of the patients when they feel uncomfortable.
Mc Charles Chemotherapy unit consists of 11 nurses, and 5 stations with the following description:
Station 1: Station 1 has six chairs (numbered 1 to 6) and two nurses. The two nurses work from 8:00 to 16:00.
Station 2: Station 2 has six chairs (7 to 12) and three nurses. Two nurses work from 8:00 to 16:00 and one nurse works from 12:00 to 20:00.
Station 3: Station 4 has six chairs (13 to 18) and two nurses. The two nurses work from 8:00 to 16:00.
Station 4: Station 4 has six chairs (19 to 24) and three nurses. One nurse works from 8:00 to 16:00. Another nurse works from 10:00 to 18:00.
Solarium Station: Solarium Station has six chairs (Solarium Stretcher 1, Solarium Stretcher 2, Isolation, Isolation emergency, Fire Place 1, Fire Place 2). There is only one nurse assigned to this station that works from 12:00 to 20:00. The nurses from other stations can help when need arises.
There is one more nurse known as the "float nurse" who works from 11:00 to 19:00. This nurse can work at any station. Table 1 summarises the working hours of chairs and nurses. All treatment stations start at 8:00 and continue until the assigned nurse for that station completes her shift.
Currently, the clinic uses a scheduling template to assign the patients' appointments. But due to high demand of patient appointment it is not followed any more. We believe that this template can be improved based on the availability of nurses and chairs. Clinic workload was collected from 21 days of field observation. The current scheduling template has 10 types of appointment time slot: 15-­‐minute, 1-­‐hour, 1.5-­‐hour, 2-­‐hour, 3-­‐hour, 4-­‐hour, 5-­‐hour, 6-­‐hour, 8-­‐hour and 10-­‐hour and it is designed to serve 95 patients. But when the scheduling template was compared with the 21 days observations, it was found that the clinic is serving more patients than it is designed for. Therefore, the providers do not usually follow the scheduling template. Indeed they very often break the time slots to accommodate slots that do not exist in the template. Hence, we find that some of the stations are very busy (mostly station 2) and others are underused. If the scheduling template can be improved, it will be possible to bring more patients to the clinic and reduce their waiting time without adding more resources.
In order to build or develop a simulation model of the existing system, it is necessary to collect the following data:
Types of treatment durations.
Numbers of patients in each treatment type.
Arrival pattern of the patients.
Steps that the patients have to go through in their treatment journey and required time of each step.
Using the observations of 2,155 patients over 21 days of historical data, the types of treatment durations and the number of patients in each type were estimated. This data also assisted in determining the arrival rate and the frequency distribution of the patients. The patients were categorised into six types. The percentage of these types and their associated service times distributions are determined too.
ARENA Rockwell Simulation Software (v13) was used to build the simulation model. Entities of the model were tracked to verify that the patients move as intended. The model was run for 30 replications and statistical data was collected to validate the model. The total number of patients that go though the model was compared with the actual number of served patients during the 21 days of observations.
Improvement Scenarios
After verifying and validating the simulation model, different scenarios were designed and analysed to identify the best scenario that can handle more patients and reduces the average patient's waiting time. Based on the clinic observation and discussion with the healthcare providers, the following constraints have been stated:
The stations are filled up with treatment chairs. Therefore, it is literally impossible to fit any more chairs in the clinic. Moreover, the stakeholders are not interested in adding extra chairs.
The stakeholders and the caregivers are not interested in changing the layout of the treatment room.
Given these constraints the options that can be considered to design alternative scenarios are:
Changing the arrival pattern of the patients: that will fit over the nurses' availability.
Changing the nurses' schedule.
Adding one full time nurse at different starting times of the day.
Figure 2 compares the available number of nurses and the number of patients' arrival during different hours of a day. It can be noticed that there is a rapid growth in the arrival of patients (from 13 to 17) between 8:00 to 10:00 even though the clinic has the equal number of nurses during this time period. At 12:00 there is a sudden drop of patient arrival even though there are more available nurses. It is clear that there is an imbalance in the number of available nurses and the number of patient arrivals over different hours of the day. Consequently, balancing the demand (arrival rate of patients) and resources (available number of nurses) will reduce the patients' waiting time and increases the number of served patients. The alternative scenarios that satisfy the above three constraints are listed in Table 2. These scenarios respect the following rules:
Long treatments (between 4hr to 11hr) have to be scheduled early in the morning to avoid working overtime.
Patients of type 1 (15 minutes to 1hr treatment) are the most common. They can be fitted in at any time of the day because they take short treatment time. Hence, it is recommended to bring these patients in at the middle of the day when there are more nurses.
Nurses get tired at the end of the clinic day. Therefore, fewer patients should be scheduled at the late hours of the day.
In Scenario 1, the arrival pattern of the patient was changed so that it can fit with the nurse schedule. This arrival pattern is shown Table 3. Figure 3 shows the new patients' arrival pattern compared with the current arrival pattern. Similar patterns can be developed for the remaining scenarios too.
Analysis of Results
ARENA Rockwell Simulation software (v13) was used to develop the simulation model. There is no warm-­‐up period because the model simulates day-­‐to-­‐day scenarios. The patients of any day are supposed to be served in the same day. The model was run for 30 days (replications) and statistical data was collected to evaluate each scenario. Tables 4 and 5 show the detailed comparison of the system performance between the current scenario and Scenario 1. The results are quite interesting. The average throughput rate of the system has increased from 103 to 125 patients per day. The maximum throughput rate can reach 135 patients. Although the average waiting time has increased, the utilisation of the treatment station has increased by 15.6%. Similar analysis has been performed for the rest of the other scenarios. Due to the space limitation the detailed results are not given. However, Table 6 exhibits a summary of the results and comparison between the different scenarios. Scenario 1 was able to significantly increase the throughput of the system (by 21%) while it still results in an acceptable low average waiting time (13.4 minutes). In addition, it is worth noting that adding a nurse (Scenarios 3, 4, and 5) does not significantly reduce the average wait time or increase the system's throughput. The reason behind this is that when all the chairs are busy, the nurses have to wait until some patients finish the treatment. As a consequence, the other patients have to wait for the commencement of their treatment too. Therefore, hiring a nurse, without adding more chairs, will not reduce the waiting time or increase the throughput of the system. In this case, the only way to increase the throughput of the system is by adjusting the arrival pattern of patients over the nurses' schedule.
Developing a Scheduling Template based on Scenario 1
Scenario 1 provides the best performance. However a scheduling template is necessary for the care provider to book the patients. Therefore, a brief description is provided below on how scheduling the template is developed based on this scenario.
Table 3 gives the number of patients that arrive hourly, following Scenario 1. The distribution of each type of patient is shown in Table 7. This distribution is based on the percentage of each type of patient from the collected data. For example, in between 8:00-­‐9:00, 12 patients will come where 54.85% are of Type 1, 34.55% are of Type 2, 15.163% are of Type 3, 4.32% are of Type 4, 2.58% are of Type 5 and the rest are of Type 6. It is worth noting that, we assume that the patients of each type arrive as a group at the beginning of the hourly time slot. For example, all of the six patients of Type 1 from 8:00 to 9:00 time slot arrive at 8:00.
The numbers of patients from each type is distributed in such a way that it respects all the constraints described in Section 1.3. Most of the patients of the clinic are from type 1, 2 and 3 and they take less amount of treatment time compared with the patients of other types. Therefore, they are distributed all over the day. Patients of type 4, 5 and 6 take a longer treatment time. Hence, they are scheduled at the beginning of the day to avoid overtime. Because patients of type 4, 5 and 6 come at the beginning of the day, most of type 1 and 2 patients come at mid-­‐day (12:00 to 16:00). Another reason to make the treatment room more crowded in between 12:00 to 16:00 is because the clinic has the maximum number of nurses during this time period. Nurses become tired at the end of the clinic which is a reason not to schedule any patient after 19:00.
Based on the patient arrival schedule and nurse availability a scheduling template is built and shown in Figure 4. In order to build the template, if a nurse is available and there are patients waiting for service, a priority list of these patients will be developed. They are prioritised in a descending order based on their estimated slack time and secondarily based on the shortest service time. The secondary rule is used to break the tie if two patients have the same slack. The slack time is calculated using the following equation:
Slack time = Due time - (Arrival time + Treatment time)
Due time is the clinic closing time. To explain how the process works, assume at hour 8:00 (in between 8:00 to 8:15) two patients in station 1 (one 8-­‐hour and one 15-­‐ minute patient), two patients in station 2 (two 12-­‐hour patients), two patients in station 3 (one 2-­‐hour and one 15-­‐ minute patient) and one patient in station 4 (one 3-­‐hour patient) in total seven patients are scheduled. According to Figure 2, there are seven nurses who are available at 8:00 and it takes 15 minutes to set-­‐up a patient. Therefore, it is not possible to schedule more than seven patients in between 8:00 to 8:15 and the current scheduling is also serving seven patients by this time. The rest of the template can be justified similarly.
doi:10.4066/AMJ.2011.837
PMCID: PMC3562880  PMID: 23386870
9.  Ethical and legal constraints to children’s participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial 
BMC Medical Ethics  2012;13:17.
Background
Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.
Findings
In Zimbabwe the parental informed consent document for children participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians.
Conclusion
The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers.
doi:10.1186/1472-6939-13-17
PMCID: PMC3521203  PMID: 22818109
10.  Stem cell therapy: from evidence-based medicine to emotion-based medicine? The long Italian way for a scientific regulation 
On 23 May 2013, the Italian health minister decided to endorse a law regarding controversial stem cell-based therapies in 32 young terminally ill patients, shocking many scientists. According to the international scientific community, these therapies could be dangerous because they were not rigorously tested in humans. This decision was made after many days of media and judiciary pressure. Several lawsuits regarding stem cell-based therapies were brought before the judiciary districts of different Italian regions. We analyzed the Italian legal context regarding the field of pharmaceutical and medical devices, including the European Union trend. A national database - commonly used to manage legal materials for professional or educational purposes or both - was used to find relevant legal cases involving stem cell-based therapies. Stem cell-based therapies endorsed by the new Italian law have been the subject of an important discussion not only in the scientific community but also in various courts. We found several legal actions filed by parents in order to make stem cells available to their young children, who had serious neurodegenerative diseases. The majority of the analyzed legal disputes were settled in favor of the applicants, whereas only two decisions (Courts of Justice of Rome and Florence) rejected the complaint because of the absence of sufficient scientific data regarding stem cell-based therapies. The present Italian situation is influencing the destiny of future young patients and strongly impacting public and institutional opinion. It is a practical example of the complexity of the decision of not providing unapproved scientific stem cell-based therapies when medicine does not have any other alternative therapies.
doi:10.1186/scrt333
PMCID: PMC3854710  PMID: 24456690
11.  Advance Health Care Directives and “Public Guardian”: The Italian Supreme Court Requests the Status of Current and Not Future Inability 
BioMed Research International  2014;2014:576391.
Advance health care decisions animate an intense debate in several European countries, which started more than 20 years ago in the USA and led to the adoption of different rules, based on the diverse legal, sociocultural and philosophical traditions of each society. In Italy, the controversial issue of advance directives and end of life's rights, in the absence of a clear and comprehensive legislation, has been over time a subject of interest of the Supreme Court. Since 2004 a law introduced the “Public Guardian,” aiming to provide an instrument of assistance to the person lacking in autonomy because of an illness or incapacity. Recently, this critical issue has once again been brought to the interest of the Supreme Court, which passed a judgment trying to clarify the legislative application of the appointment of the Guardian in the field of advance directives.
doi:10.1155/2014/576391
PMCID: PMC3963218  PMID: 24729977
12.  Medical Evidence of Human Rights Violations against Non-Arabic-Speaking Civilians in Darfur: A Cross-Sectional Study 
PLoS Medicine  2012;9(4):e1001198.
Alexander Tsai and colleagues review medical records from the Amel Centre, Sudan, to assess consistency between recorded medical evidence and patient reports of human rights violations by the Government of Sudan and Janjaweed forces.
Background
Ongoing conflict in the Darfur region of Sudan has resulted in a severe humanitarian crisis. We sought to characterize the nature and geographic scope of allegations of human rights violations perpetrated against civilians in Darfur and to evaluate their consistency with medical examinations documented in patients' medical records.
Methods and Findings
This was a retrospective review and analysis of medical records from all 325 patients seen for treatment from September 28, 2004, through December 31, 2006, at the Nyala-based Amel Centre for Treatment and Rehabilitation of Victims of Torture, the only dedicated local provider of free clinical and legal services to civilian victims of torture and other human rights violations in Darfur during this time period. Among 325 medical records identified and examined, 292 (89.8%) patients from 12 different non-Arabic-speaking tribes disclosed in the medical notes that they had been attacked by Government of Sudan (GoS) and/or Janjaweed forces. Attacks were reported in 23 different rural council areas throughout Darfur. Nearly all attacks (321 [98.8%]) were described as having occurred in the absence of active armed conflict between Janjaweed/GoS forces and rebel groups. The most common alleged abuses were beatings (161 [49.5%]), gunshot wounds (140 [43.1%]), destruction or theft of property (121 [37.2%]), involuntary detainment (97 [29.9%]), and being bound (64 [19.7%]). Approximately one-half (36 [49.3%]) of all women disclosed that they had been sexually assaulted, and one-half of sexual assaults were described as having occurred in close proximity to a camp for internally displaced persons. Among the 198 (60.9%) medical records that contained sufficient detail to enable the forensic medical reviewers to render an informed judgment, the signs and symptoms in all of the medical records were assessed to be consistent with, highly consistent with, or virtually diagnostic of the alleged abuses.
Conclusions
Allegations of widespread and sustained torture and other human rights violations by GoS and/or Janjaweed forces against non-Arabic-speaking civilians were corroborated by medical forensic review of medical records of patients seen at a local non-governmental provider of free clinical and legal services in Darfur. Limitations of this study were that patients seen in this clinic may not have been a representative sample of persons alleging abuse by Janjaweed/GoS forces, and that most delayed presenting for care. The quality of documentation was similar to that available in other conflict/post-conflict, resource-limited settings.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Conflict in the Darfur region of Sudan between Arabic- and non-Arabic-speaking tribes over the past decade has resulted in a severe humanitarian crisis. According to the United Nations, more than 2.7 million people have fled from their homes to camps for internally displaced persons (IDPs) or to refugee camps in neighboring Chad, and up to 300,000 people have died from war, hunger, and disease since the conflict started. The origins of this conflict go back many years, but in 2003, organized rebel forces began attacking government targets, accusing the Government of Sudan (GoS) of oppressing black Africans in favor of Arabs. In response, the GoS attacked the rebel forces, but some observers allege it also targeted non-Arabic-speaking civilians, in contravention of international laws of war. Observers have also accused the GoS of having links with the Janjaweed militias, nomadic Arabs who attack settled black farmers, although the GoS denies any such links. Indeed, reports of systematic, targeted assaults on non-Arabic-speaking civilians, of large-scale disruption of rural livelihoods, and of deliberate consignment to living conditions likely to cause death have prompted some observers to accuse the GoS of genocide (violent crimes committed against a national, ethnical, racial, or religious group with the intention of destroying that group) and the International Criminal Court to issue arrest warrants for the allegedly responsible authorities.
Why Was This Study Done?
Most investigations of claims of violence against civilians in Darfur have relied on self-reported data gathered from people living in refugee camps outside Sudan. Because these data could be biased, in this cross-sectional study (a study that characterizes a population at a single point in time), the researchers investigate the nature and geographic scope of alleged abuses against civilians in Darfur and endeavor to substantiate these allegations by analyzing the medical records of patients attending the Amel Centre for Treatment and Rehabilitation of Victims of Torture in Nyala, South Darfur. Opened in 2004, this center provided free clinical and legal services to civilians affected by human rights violations. Its staff fled in 2009 because of increasingly dangerous working conditions; the medical records used in this study were sent out of Sudan before the staff fled.
What Did the Researchers Do and Find?
Between September 28, 2004, and December 31, 2006, 325 patients were seen at the Amel Centre. According to their medical records, 292 patients from 12 different non-Arabic-speaking tribes alleged that they had been attacked by GoS or Janjaweed forces in rural areas across Darfur. Nearly all the patients reported that they had been attacked in the absence of active armed conflict between GoS/Janjaweed forces and rebel groups. Half of them claimed that they had been beaten, two-fifths reported gunshot wounds, a third reported destruction or theft of property, and nearly a third reported involuntary detainment. Half of the 73 women seen at the center disclosed that they had been sexually assaulted, often near IDP camps. Only 198 medical records contained sufficient detail to enable the researchers to determine whether the documented medical evidence was consistent with the alleged abuses. However, in all these cases, the researchers judged that the medical evidence was consistent with, highly consistent with, or virtually diagnostic of the alleged abuses.
What Do These Findings Mean?
These findings provide credible medical evidence that is consistent with torture and other human rights violations being inflicted on non-Arabic-speaking civilians in Darfur from 2004 to 2006. These findings cannot be used to estimate the population incidence of attacks on civilians or to corroborate claims of assailants' identities or of genocidal intent. Moreover, their accuracy may be affected by several limitations of this study. For example, during the study period, only patients who obtained a medical evidence form from the police were permitted to receive treatment from an authorized medical officer; obtaining such a form likely represented a considerable hurdle to accessing health care services. Nevertheless, the widespread, organized, and sustained pattern of attacks documented in this study is consistent with the possibility that the actions of Janjaweed and GoS forces during the conflict in Darfur may constitute war crimes, crimes against humanity, and/or acts of genocide. Importantly, these findings also highlight the need to provide adequate protection for health professionals working in countries affected by internal conflicts.
Additional Information
Please access these web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001198.
The African UnionUnited Nations Mission in Darfur (UNAMID) provides background information and up-to-date news about the ongoing conflict in Darfur Amnesty International, which campaigns for human rights, provides background information and news about the current situation in Darfur
The Save Dafur Coalition also provides detailed information about the situation in Darfur Physicians for Human Rights, a non-profit organization that mobilizes health professionals to advance health, dignity, and justice, is calling for security in Darfur and compensation and restitution for survivors of the conflict
Wikipedia has pages on Darfur and on genocide (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
Details on warrants of arrest issued by the International Criminal Court in response to the situation in Dafur are available
doi:10.1371/journal.pmed.1001198
PMCID: PMC3317898  PMID: 22509136
13.  The Noncompliant Patient in Psychiatry: The Case For and Against Covert/Surreptitious Medication 
Mens Sana Monographs  2010;8(1):96-121.
Nonadherence to treatment continues to be one of psychiatry’s greatest challenges. To improve adherence and thus improve the care of patients, clinicians and patients’ family members sometimes resort to hiding medication in food or drink, a practice referred to as covert/ surreptitious medication. The practice of covert drug administration in food and beverages is well known in the treatment of psychiatrically ill world-wide but no prevalence rates exist. Covert medication may seem like a minor matter, but it touches on legal and ethical issues of a patient’s competence, autonomy, and insight. Medicating patients without their knowledge is not justifiable solely as a shortcut for institutions or families wishing to calm a troublesome patient and thus alleviate some of the burdens of care giving. The paramount principle is ensuring the well-being of a patient who lacks the competence to give informed consent. Ethically, covert/surreptitious administration can be seen as a breach of trust by the doctor or by family members who administer the drugs. Covert medication contravenes contemporary ethical practice. Legally, treatment without consent is permissible only where common law or statute provides such authority. The practice of covert administration of medication is not specifically covered in the mental health legislation in developing countries. Many of the current dilemmas in this area have come to public attention because of two important developments in medical ethics and the law - the increasing importance accorded to respect for autonomy and loss of the parens patriae jurisdiction of the courts [parens patriae means ‘parent of the country’; it permitted a court to consent or refuse treatment on behalf of an ‘incapacity’, or alternatively to appoint a guardian with such powers].
doi:10.4103/0973-1229.58822
PMCID: PMC3031933  PMID: 21327173
Covert medication; Surreptitious prescribing; Informed Consent; Substitute Decision-Maker; Best Interests; Autonomy; Dignity; Competency; Advance directives
14.  A Randomised, Blinded, Placebo-Controlled Trial in Dementia Patients Continuing or Stopping Neuroleptics (The DART-AD Trial)  
PLoS Medicine  2008;5(4):e76.
Background
There have been increasing concerns regarding the safety and efficacy of neuroleptics in people with dementia, but there are very few long-term trials to inform clinical practice. The aim of this study was to determine the impact of long-term treatment with neuroleptic agents upon global cognitive decline and neuropsychiatric symptoms in patients with Alzheimer disease.
Methods and Findings
Design: Randomised, blinded, placebo-controlled parallel two-group treatment discontinuation trial.
Setting: Oxfordshire, Newcastle and Gateshead, London and Edinburgh, United Kingdom.
Participants: Patients currently prescribed the neuroleptics thioridazine, chlorpromazine, haloperidol trifluoperazine or risperidone for behavioural or psychiatric disturbance in dementia for at least 3 mo.
Interventions: Continue neuroleptic treatment for 12 mo or switch to an identical placebo.
Outcome measures: Primary outcome was total Severe Impairment Battery (SIB) score. Neuropsychiatric symptoms were evaluated with the Neuropsychiatric Inventory (NPI).
Results: 165 patients were randomised (83 to continue treatment and 82 to placebo, i.e., discontinue treatment), of whom 128 (78%) commenced treatment (64 continue/64 placebo). Of those, 26 were lost to follow-up (13 per arm), resulting in 51 patients per arm analysed for the primary outcome. There was no significant difference between the continue treatment and placebo groups in the estimated mean change in SIB scores between baseline and 6 mo; estimated mean difference in deterioration (favouring placebo) −0.4 (95% confidence interval [CI] −6.4 to 5.5), adjusted for baseline value (p = 0.9). For neuropsychiatric symptoms, there was no significant difference between the continue treatment and placebo groups (n = 56 and 53, respectively) in the estimated mean change in NPI scores between baseline and 6 mo; estimated mean difference in deterioration (favouring continue treatment) −2.4 (95% CI −8.2 to 3.5), adjusted for baseline value (p = 0.4). Both results became more pronounced at 12 mo. There was some evidence to suggest that those patients with initial NPI ≥ 15 benefited on neuropsychiatric symptoms from continuing treatment.
Conclusions
For most patients with AD, withdrawal of neuroleptics had no overall detrimental effect on functional and cognitive status. Neuroleptics may have some value in the maintenance treatment of more severe neuropsychiatric symptoms, but this benefit must be weighed against the side effects of therapy.
Trial registration: Cochrane Central Registry of Controlled Trials/National Research Register (#ISRCTN33368770).
In a randomized trial of patients with dementia, Clive Ballard and colleagues show that withdrawal of neuroleptics had no overall detrimental effect, and by some measures improved, functional and cognitive status.
Editors' Summary
Background
The number of people with dementia (currently 25 million worldwide) is expected to increase by 5 million each year. The risk of dementia, including Alzheimer disease, increases sharply with age: Alzheimer's Disease International estimates that 1.4% of people 65–69 have dementia, whereas almost a full quarter of those over the age of 85 years are affected. Almost all older dementia patients will experience, along with the cognitive and functional decline typical of the illness, some neuropsychiatric symptoms. These symptoms can include agitation, aggression, and psychosis, and are often devastating for the older patient and his or her family and caregiver. Managing these symptoms is often a prime concern for health-care providers and families. Neuroleptics (sometimes called antipsychotics) are the class of drugs often used to manage or control neuropsychiatric problems, but there have been questions about their safety and appropriateness. Safety concerns involve risk of stroke, parkinsonism, sedation, edema, and chest infections but also include a worsening of cognitive decline with prolonged use of neuroleptics.
Why Was the Study Done?
Previous studies on the effectiveness and safety of neuroleptics in older people have been short term. Ballard and colleagues wanted to study over a longer period of time the impact of neuroleptic drugs on elderly patients with dementia. Specifically, they wanted to know if being on a neuroleptic was associated with more cognitive decline than coming off the drug. They also wanted to investigate whether discontinuing the drug exacerbated any neuropsychiatric symptoms, Parkinson disease-like symptoms, or other functional, language, and cognition difficulties frequently associated with dementia.
What Did the Researchers Do and Find?
The researchers recruited older patients with Alzheimer disease from across England who had been on neuroleptics for at least three months. They randomised patients to one of two groups: the first group continued taking the same neuroleptic at the same dosage level while the second group was switched to an identical-looking placebo. The researchers assessed the patients' cognitive status and neuropsychiatric symptoms upon their entry into the study. Six and 12 months later the researchers assessed any cognitive decline and the level of neuropsychiatric and other problems that patients were experiencing.
At both 6 and 12 months, the researchers found that there were no differences between the two groups (continued treatment and placebo) in terms of cognitive decline. The placebo group may have had less cognitive decline, but this was not statistically significant. They also found no overall differences between the two groups in the change in the number of neuropsychiatric symptoms over these time periods. Patients with severe neuropsychiatric problems at the outset of the trial did better on continued neuroleptic therapy, but this advantage was not statistically significant. There was a significant decline on the verbal fluency language tests among the patients who continued on their neuroleptic.
What Do these Findings Mean?
The researchers report perhaps the first trial of this duration on continued versus withdrawn neuroleptic treatment among older dementia patients. The findings do not indicate any benefit of continuing neuroleptic therapies in older patients on either cognitive or neuropsychiatric outcomes. The researchers conclude that neuroleptics, with their known safety issues, should not be used as first-line treatment to manage problems such as agitation or aggression. For older dementia patients whose neuropsychiatric symptoms are not remedied by nonpharmaceutical treatments, the researchers advise caution. More studies are urgently needed to find better solutions to help older patients with dementia who have agitation, aggression, and psychosis.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050076.
Alzheimer's Disease International is an umbrella organisation of organisations worldwide
The Alzheimer's Research Trust in the UK is a charity funding research to cure or prevent dementias
The US National Institutes of Aging has information on Alzheimer Disease in English and Spanish
Two governmental regulatory agencies—the Medicines and Healthcare Products Regulatory Agency in the UK and the Food and Drug Administration in the US—offer information about antipsychotics in people with dementia
doi:10.1371/journal.pmed.0050076
PMCID: PMC2276521  PMID: 18384230
15.  Current trends for medico-legal disputes related to functional nasal surgery in Italy 
SUMMARY
The problem of professional liability in case of adverse outcomes or failures secondary to surgery is very sensitive in many countries of the European Community. In Italy, a recent sentence of the Supreme Court concerning a patient who underwent septoplasty raised considerable doubts in relation to the guidance to be followed in disputes related to an alleged professional liability, further exacerbating the juridical orientation of recent years in this context. This ruling involves any surgery, as well as rhinologic surgery, and calls into question most regulatory and legal principles that have traditionally been adopted by the Italian Civil Law. The sentence states that the plaintiff is only required to document the failure of surgical treatment, but not the breach of the duty of care by the surgeon, thus shifting the burden of proof to the physician-debtor. It also considers that, in assessing the degree of negligence, reference should be made to the qualifications of the surgeon, according to principles that are not covered by current regulations, denying that in general surgery (i.e., not with aesthetic purposes) the surgeon must only to act with diligence and need not guarantee a favourable outcome. This series of statements, complementing one another and evolving more unfavourably towards physicians, facilitate legal disputes for speculative purposes through complainants, with obvious health and socio-economic implications.
PMCID: PMC4035843  PMID: 24882932
Medical liability; Nasal surgery; Duty of care
16.  “To patent or not to patent? the case of Novartis’ cancer drug Glivec in India” 
Background
Glivec (imatinib mesylate), produced by the pharmaceutical company Novartis, is prescribed in the case of Chronic Myeloid Leukemia, one of the most common blood cancers in eastern countries. After more than a decade of legal battles surrounding its patentability, the Supreme Court of India gave its final decision on April 1st of 2013, rejecting the appeal of the Swiss giant drug manufacturer. In 2006, the Indian Patent Office first refused Glivec’s patent under Section 3(d) of the Indian Patent Act arguing that it was only a modified version of an existing drug, Imatinib, and therefore that the drug was not innovative. Novartis replied filing legal challenges against the Indian government but the final verdict in April of 2013 ends the battle. Indeed, the Supreme Court stated that even if the bioavailability of the drug was improved, it did not demonstrate enhanced efficacy and that Glivec was not patentable.
Methods
The research primarily focused on journal, newspaper and magazine articles relevant to the time frame of the lawsuit (from 1994 to 2013) as well as news searches through Google, Factiva, ProQuest, PubMed, and YouTube where press articles from court verdicts were obtained by using the following keywords: “India”, “Novartis”, “Glivec”, “Patent”, “Novartis Case”, and “Supreme Court of India”. The data sources were interpreted and analyzed according to the authors’ own prior knowledge and understanding of the exigencies of the TRIPS Agreement.
Results
This case illuminates how India is interpreting international law to fit domestic public health needs.
Conclusions
The Novartis case arguably sets an important precedent for the global pharmaceutical industry and ideally will help improve access to lifesaving medicines in the developing world by demanding that patient health needs supersede commercial interests. The Supreme Court of India’s decision may affect the interpretation of the article of the TRIPS Agreement, which states members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.
doi:10.1186/1744-8603-10-3
PMCID: PMC3884017  PMID: 24393270
India; Novartis; Glivec; Patents; Generic drugs; TRIPS agreement; Drug industry; Pharmaceuticals
17.  Finding Fault? Exploring Legal Duties to Return Incidental Findings in Genomic Research 
The Georgetown law journal  2014;102:795-843.
The use of whole-genome sequencing in biomedical research is expected to produce dramatic advances in human health. The increasing use of this powerful, data-rich new technology in research, however, will inevitably give rise to incidental findings (IFs)—findings with individual health or reproductive significance that are beyond the aims of the particular research—and the related questions of whether and to what extent researchers have an ethical obligation to return IFs. Many have concluded that researchers have an ethical obligation to return some findings in some circumstances but have provided vague or context-dependent approaches to determining which IFs must be returned and when. As a result, researchers have started returning IFs inconsistently, giving rise to concerns about legal liability in circumstances in which notification could have potentially prevented injury. Although it is clear that ethical guidance should not be automatically codified as law and that crafting ethical obligations around legal duties can be inappropriate, the ethical debate should not proceed unaware of the potential legal ramifications of advancing and implementing an ethical obligation to return IFs.
This Article assesses the legal claims that could be brought for a researcher’s failure to return IFs. The potential for researchers to be held liable in tort is still uncertain and turns largely on a number of factors—including customary practice and guidance documents—that are still in flux. Unlike medical care, which has a well-defined duty into which evolving scientific knowledge about genetics and genomics can readily be incorporated, a researcher’s duty to return IFs is less well defined, making it difficult to determine at the outset whether and when legal liability will attach.
This Article advocates for a clearer, ethically sound standard of requiring that researchers disclose in the informed consent document which approach to offering IFs will be taken. This approach enables participants to know at the outset which findings, if any, will be returned, allows researchers to ascertain when their failure to appropriately return incidental findings will give rise to liability, and enables courts to make determinations that will produce more consistent legal guidance.
PMCID: PMC4207216  PMID: 25346543
18.  Factors associated with nonattendance at clinical medicine scheduled outpatient appointments in a university general hospital 
Introduction
Nonattendance at scheduled outpatient appointments for primary care is a major health care problem worldwide. Our aim was to estimate the prevalence of nonattendance at scheduled appointments for outpatients seeking primary care, to identify associated factors and build a model that predicts nonattendance at scheduled appointments.
Methods
A cohort study of adult patients, who had a scheduled outpatient appointment for primary care, was conducted between January 2010 and July 2011, at the Italian Hospital of Buenos Aires. We evaluated the history and characteristics of these patients, and their scheduling and attendance at appointments. Patients were divided into two groups: those who attended their scheduled appointments, and those who did not. We estimated the odds ratios (OR) and corresponding 95% confidence intervals (95% CI), and generated a predictive model for nonattendance, with logistic regression, using factors associated with lack of attendance, and those considered clinically relevant. Alternative models were compared using Akaike’s Information Criterion. A generation cohort and a validation cohort were assigned randomly.
Results
Of 113,716 appointments included in the study, 25,687 were missed (22.7%; 95% CI: 22.34%–22.83%). We found a statistically significant association between nonattendance and age (OR: 0.99; 95% CI: 0.99–0.99), number of issues in the personal health record (OR: 0.98; 95% CI: 0.98–0.99), time between the request for and date of appointment (OR: 1; 95% CI: 1–1), history of nonattendance (OR: 1.07; 95% CI: 1.07–1.07), appointment scheduled later than 4 pm (OR: 1.30; 95% CI: 1.24–1.35), and specific days of the week (OR: 1.00; 95% CI: 1.06–1.1). The predictive model for nonattendance included characteristics of the patient requesting the appointment, the appointment request, and the actual appointment date. The area under the receiver operating characteristic curve of the predictive model in the generation cohort was 0.892 (95% CI: 0.890–0.894).
Conclusion
Evidence related to patient characteristics, and the identification of appointments with a higher likelihood of nonattendance, should promote guided strategies to reduce the rate of nonattendance, as well as to future research on this topic. The use of predictive models could further guide management strategies to reduce the rate of nonattendance.
doi:10.2147/PPA.S51841
PMCID: PMC3826940  PMID: 24235820
nonattendance; appointments; schedules
19.  Medical Malpractice: The Experience in Italy 
At the present time, legal actions against physicians in Italy number about 15,000 per year, and hospitals spend over €10 billion (~US$15.5 billion) to compensate patients injured from therapeutic and diagnostic errors. In a survey summary issued by the Italian Court for the Rights of the Patient, between 1996 and 2000 orthopaedic surgery was the highest-ranked specialty for the number of complaints alleging medical malpractice. Today among European countries, Italy has the highest number of physicians subject to criminal proceedings related to medical malpractice, a fact that is profoundly changing physicians’ approach to medical practice. The national health system has paid increasingly higher insurance premiums and is having difficulty finding insurance companies willing to bear the risk of monetary claims alleging medical malpractice. Healthcare costs will likely worsen as Italian physicians increasingly practice defensive medicine, thereby overutilizing resources with the goal of documenting diligence, prudence, and skill as defenses against potential litigation, rather than aimed at any patient benefit. To reduce the practice of defensive medicine and healthcare costs, a possible solution could be the introduction of an extrajudicial litigation resolution, as in other civil law countries, and a reform of the Italian judicial system on matters of medical malpractice litigation.
doi:10.1007/s11999-008-0582-z
PMCID: PMC2628502  PMID: 18985423
20.  Preservation of the Capacity to Appoint a Proxy Decision Maker: Implications for Dementia Research 
Archives of General Psychiatry  2011;68(2):214-220.
Context
Research involving persons with impaired decision-making capacity, such as persons with Alzheimer’s disease, remains ethically challenging, especially when the research involves significant risk. If subjects incapable of consenting to research studies were still able to appoint a research proxy, it would allow for an appointed surrogate, rather than a de facto surrogate, to represent the subject.
Objective
To assess the extent to which persons with Alzheimer’s disease retain their capacity to appoint a research proxy.
Design, Setting, and Participants
188 persons with Alzheimer’s disease were interviewed for their capacity to appoint a proxy (CAP) for research and to provide consent to two hypothetical research scenarios, a lower risk randomized clinical trial testing a new drug (drug RCT) and a higher risk randomized clinical trial testing neurosurgical cell implants using a sham control condition (neurosurgical RCT). Categorical capacity status for each subject was determined by independent videotape reviews of capacity interviews by five experienced psychiatrists.
Main Outcome Measures
Categorical capacity determinations for the capacity to appoint a research proxy, capacity to consent to a drug RCT, and capacity to consent to a neurosurgical RCT.
Results
37.7% (40/106) of those deemed incapable of consenting to the drug RCT and 54.4% (86/157) of those deemed incapable of consenting to the neurosurgical RCT were still found capable of appointing a research proxy. Very few subjects (7/186, 3.8%) were deemed capable of consenting to the neurosurgical RCT by all five psychiatrists.
Conclusion
A substantial proportion of AD subjects thought incapable of consenting to lower or to higher risk studies have preserved capacity for appointing a research proxy. Since so few subjects are found to be unequivocally capable of providing independent consent to higher risk AD research, providing for an appointed surrogate even after the onset of AD, which might best be done in the very early stages of the illness, may help address key ethical challenges to AD research.
doi:10.1001/archgenpsychiatry.2010.191
PMCID: PMC3349937  PMID: 21300949
21.  Legal obligation of physicians to disclose information to patients. 
Obtaining a patient's consent is a routine daily process for physicians, although many are unaware of the scope of this legal obligation. In 1980 the Supreme Court of Canada changed the law relating to informed consent; promotion of patient autonomy shifted the focus from a standard of professional disclosure to one of a "reasonable patient." Physicians have a legal obligation to disclose to patients specific information, the scope of which is determined by a court on the basis of a reasonable patient's expectation and the circumstances of the case. This gives rise to many controversies in the practice of clinical medicine. It is difficult for physicians to know which treatment risks require disclosure, since this is decided by a court in a retrospective analysis of the evidence. Will the court recognize exceptions to the duty of disclosing information? If several health care professionals are involved in a patient's care who has the duty to disclose information? Can this duty be delegated? This paper provides physicians with guidelines that are consistent with the promotion of patient autonomy and comply with the doctrine of informed consent. In addition, it suggests ways of improving awareness of the doctrine and procedures to ease its application.
PMCID: PMC1453086  PMID: 1998927
22.  Deliberative Assessment of Surrogate Consent in Dementia Research 
Background
Research involving incapacitated persons with dementia involves complex scientific, legal, and ethical issues, making traditional surveys of layperson views regarding the ethics of such research challenging. We therefore assessed the impact of democratic deliberation (DD)—involving balanced, detailed education and peer deliberation—on the views of those responsible for persons with dementia.
Methods
178 community-recruited caregivers or primary decision-makers for persons with dementia were randomly assigned to either an all-day DD session group or a control group. Educational materials used for the DD session were vetted for balance and accuracy by an interdisciplinary advisory panel. We assessed the acceptability of family surrogate consent for dementia research (‘surrogate-based research’ or SBR) from a societal policy perspective as well as from the more personal perspectives of deciding for a loved one or for oneself (surrogate and self perspectives), assessed at baseline, immediately post-DD session, and a month after DD date, for 4 research scenarios of varying risk-benefit profiles.
Results
At baseline, a majority in both DD and control groups supported a policy of family consent for dementia research for all research scenarios. The support for a policy of family consent for SBR increased for the DD group, but not for the control group; the change in the DD group was maintained one month later. In the DD group, there were transient changes in attitudes from surrogate or self perspectives; in the control group, there were no changes from baseline in attitude toward surrogate consent from any perspective.
Conclusions
Intensive, balanced, and accurate education along with peer deliberation provided by democratic deliberation leads to a sustained increase in support for a societal policy of family consent for dementia research among those responsible for dementia patients.
doi:10.1016/j.jalz.2009.06.001
PMCID: PMC2889138  PMID: 20188635
Alzheimer’s Disease; informed consent; deliberative democracy; bioethics; research ethics; surrogate-based research; impaired decision-making capacity
23.  Making decisions for people with dementia who lack capacity: qualitative study of family carers in UK 
Objective To identify common difficult decisions made by family carers on behalf of people with dementia, and facilitators of and barriers to such decisions, in order to produce information for family carers about overcoming barriers.
Design Qualitative study to delineate decision areas through focus groups and complexity of decision making in individual interviews.
Setting Community settings in London.
Participants 43 family carers of people with dementia in focus groups and 46 carers who had already made such decisions in individual interviews.
Results Family carers identified five core problematic areas of decision making: accessing dementia related health and social services; care homes; legal-financial matters; non-dementia related health care; and making plans for the person with dementia if the carer became too ill to care for them. They highlighted the difficulties in making proxy decisions, especially against active resistance, and their altered role of patient manager while still a family member. Families devised strategies to gain agreement in order to ensure that the person with dementia retained dignity.
Conclusions The following strategies helped with implementation of decisions: introducing change slowly; organising legal changes for the carer as well as the patient; involving a professional to persuade the patient to accept services; and emphasising that services optimised, not impeded, independence. To access services, carers made patients’ general practice appointments, accompanied them to the surgery, pointed out symptoms, gained permission to receive confidential information, asked for referral to specialist services, and used professionals’ authority to gain patients’ agreement. End of life decisions were particularly difficult. They were helped by knowledge of the person with dementia’s previous views, clear prognostic information, and family support. Information sheets to help carers to overcome barriers to proxy decision making have been developed; their impact in practice has yet to be evaluated.
doi:10.1136/bmj.c4184
PMCID: PMC2923693  PMID: 20719843
24.  What to Disclose? Revisiting Informed Consent 
Background
The requirement of obtaining informed consent before medical procedures is well established. With patients having greater access to information through information technology and owing to other factors, disclosure that goes beyond the traditional elements of the risks, benefits, and alternatives to an intervention is demanded from physicians.
Questions/purposes
We asked if modern informed consent doctrine encompasses such physician-specific variables like professional experience, health, disability, training, qualifications, disciplinary history, FDA-regulatory status pertaining to a medical device, physician research and financial interests, and statistics related to medical outcomes.
Methods
We searched two major legal databases and identified court opinions and legal reviews that have examined the scope of physician disclosure while obtaining informed consent. From this information, we summarized the prevailing state of informed consent law.
Results
Despite the expansion of information available to patients, courts have been hesitant to expand the informed consent doctrine to encompass physician-specific variables. Exceptions involve cases in which such variables directly impacted medical care and the patient could demonstrate their relevance in the informed consent process.
Conclusions
Judicial decisions have subtly expanded the doctrine of informed consent beyond its traditional limits, at least in some cases. As informed consent law continues to develop, physicians should ask if information would be material to a reasonable patient while making medical decisions; if so, such information should be disclosed.
doi:10.1007/s11999-011-2232-0
PMCID: PMC3314757  PMID: 22215479
Medicine & Public Health; Conservative Orthopedics; Orthopedics; Sports Medicine; Surgery; Surgical Orthopedics; Medicine/Public Health, general
25.  Patients' rights--why the Australian courts have rejected 'Bolam'. 
Journal of Medical Ethics  1995;21(1):5-8.
This point of view compares the issue of informed patient consent primarily as it operates in Australia and the United Kingdom. It affords an overview, also, of the applicable law in the United States and Canada. It particularly focuses on the legal test to be applied to patient consent as established in the Bolam case in the United Kingdom. The case, following its approval by the House of Lords, holds that the negligent standard in patient consent situations is to be determined, in cases of dispute, in accordance with standards as viewed by a proper body of competent medical practitioners. By contrast, the law in the United States is premised on the notion of the fundamental right of patients to determine what should or should not be done with their own bodies. In Australia the Bolam test has been rejected by the High Court of Australia following earlier decisions in the State Supreme Courts. The Australian courts did not accept that the setting of standards by the medical profession was an acceptable way of determining the entitlements of a patient who has suffered harm. The author places this discussion in the context of greater community awareness of medical procedures, the heightened accountability of professionals and the increasing practice of having a substantial patient input into medical decisions. He also suggests that the differing social and professional attitudes to authority and fundamental rights to be found between Australia and the United Kingdom have influenced the outcome of the cases in the higher courts of both countries. He suggests that the Bolam test is an illustration of the tendency of authority in the United Kingdom to believe that 'Nanny know best'.
PMCID: PMC1376523  PMID: 7776350

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