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1.  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
2.  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
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.  Medical negligence: Coverage of the profession, duties, ethics, case law, and enlightened defense - A legal perspective 
A patient approaching a doctor expects medical treatment with all the knowledge and skill that the doctor possesses to bring relief to his medical problem. The relationship takes the shape of a contract retaining the essential elements of tort. A doctor owes certain duties to his patient and a breach of any of these duties gives a cause of action for negligence against the doctor. The doctor has a duty to obtain prior informed consent from the patient before carrying out diagnostic tests and therapeutic management. The services of the doctors are covered under the provisions of the Consumer Protection Act, 1986 and a patient can seek redressal of grievances from the Consumer Courts. Case laws are an important source of law in adjudicating various issues of negligence arising out of medical treatment.
doi:10.4103/0970-1591.56206
PMCID: PMC2779963  PMID: 19881134
Error of judgment; medical negligence; prior informed consent
5.  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
6.  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
7.  Ethical and legal points of view in parenteral nutrition – Guidelines on Parenteral Nutrition, Chapter 12 
Adequate nutrition is a part of medical treatment and is influenced by ethical and legal considerations. Patients, who cannot be sufficiently fed via the gastrointestinal tract, have the fundamental right to receive PN (parenteral nutrition) even so patients who are unable to give their consent. General objectives in nutrition support are to supply adequate nutrition with regards to the prevention of malnutrition and its consequences (increased morbidity and mortality), and thereby promoting improved outcome and/or quality of life for the patient considering always the patient’s needs and wishes. The requests of the patient to renounce PN should be respected where a signed living will is helpful. During the course of a terminal illness the nutrition has to be adapted individually according to the needs and wishes of a patient in the corresponding phase. Capability of consent should be checked in each individual case and for each measure on an individual basis. Consent should only be accepted if the patient is capable of recognizing the nature, meaning and importance of the intervention as well as the consequences of relinquishment of such an intervention, and is capable to make a self-determined decision. If the patient is not capable of consenting, the patient’s living will is the most important document when determining their assumed will and legally binding. Otherwise a guardian appointed by the patient, or the representative appointed by the court (if the patient has made no provisions) can make the decision.
doi:10.3205/000075
PMCID: PMC2795379  PMID: 20049079
8.  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
9.  Future trends in the legal rights of patients in nursing homes. 
The author discusses the demographic aging of Canada and outlines how the Canadian Constitution and the Charter of Rights and Freedoms are likely to affect the care and treatment of nursing home residents. Because physical freedom and personal autonomy have been given such a high value in the constitution, civil and legal rights will be protected for all residents in nursing homes, and procedural safeguards will become mandatory in the next few years for patients who refuse treatment and for those who are deemed to be incompetent. Physicians and other caregivers will increasingly be removed from the role of substitute decision-maker for incompetent patients, and patient representatives, court-appointed guardians and courts will assume this responsibility. Judicial safeguards such as impartial hearings, appeals to the court and the principles of natural justice will become commonplace in nursing homes.
PMCID: PMC1269268  PMID: 2659158
10.  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
11.  The legal guardians' dilemma: Decision making associated with invasive non-life-saving procedures 
Background
ICU patients frequently undergo non-life-saving invasive procedures. When patient informed consent cannot be obtained, legal guardianship (LG), often from a close relative, may be required by law. The objective of this cohort study was to investigate the attitudes of LGs of ICU patients regarding the process of decision making for invasive non-life-saving procedures.
Methods
The study was conducted from May 2009 until June 2010 in general medical/surgical ICUs in two large Israeli medical centers. All 64 LGs who met the study criteria agreed to participate in the study. Three questionnaires were administered: a demographic data questionnaire, the Family Satisfaction with ICU 34 Questionnaire, and the Attitudes towards the LG Decision Making Process questionnaire, developed by the authors.
Results
The sample consisted of 64 LGs. Most participants were married (n = 56, 87.5%), male (n = 33, 51.6%), who had either a high school (n = 24, 37.5%) or college (n = 19, 29.7%) education, and were at a mean age of 49.2 (±11.22). Almost all of the procedures performed were tracheotomies (n = 63, 98.4%). About two-thirds of the LGs preferred decisions to be made by the medical staff after discussing options with them (n = 42, 65.6%) and about three-fifths stated that decisions could be made without the need for the appointment of an LG (n = 37, 57.8%). Attitudes towards ease of obtaining information and honesty of information were more positive compared to those of consistency and understanding of information.
Conclusions
The legal guardianship process requires better communication and more understandable information in order to assist LGs in making decisions for others in at times vague and stressful situations.
doi:10.1186/2045-4015-1-36
PMCID: PMC3467171  PMID: 23006738
ICU; Legal guardian; Decision making; Invasive procedures; Relatives; Tracheotomy
12.  Cancer patient perceptions on the ethical and legal issues related to biobanking 
Background
Understanding the perception of patients on research ethics issues related to biobanking is important to enrich ethical discourse and help inform policy.
Methods
We examined the views of leukemia patients undergoing treatment in clinics located in the Princess Margaret Hospital in Toronto, Ontario, Canada. An initial written survey was provided to 100 patients (64.1% response rate) followed by a follow-up survey (62.5% response rate) covering the topics of informed consent, withdrawal, anonymity, incidental findings and the return of results, ownership, and trust.
Results
The majority (59.6%) preferred one-time consent, 30.3% desired a tiered consent approach that provides multiple options, and 10.1% preferred re-consent for future research. When asked different questions on re-consent, most (58%) reported that re-consent was a waste of time and money, but 51.7% indicated they would feel respected and involved if asked to re-consent. The majority of patients (62.2%) stated they had a right to withdraw their consent, but many changed their mind in the follow-up survey explaining that they should not have the right to withdraw consent. Nearly all of the patients (98%) desired being informed of incidental health findings and explained that the information was useful. Of these, 67.3% of patients preferred that researchers inform them and their doctors of the results. The majority of patients (62.2%) stated that the research institution owns the samples whereas 19.4% stated that the participants owned their samples. Patients had a great deal of trust in doctors, hospitals and government-funded university researchers, moderate levels of trust for provincial governments and industry-funded university researchers, and low levels of trust towards industry and insurance companies.
Conclusions
Many cancer patients surveyed preferred a one-time consent although others desired some form of control. The majority of participants wanted a continuing right to withdraw consent and nearly all wanted to be informed of incidental findings related to their health. Patients had a great deal of trust in their medical professionals and publically-funded researchers as opposed to profit-based industries and insurance companies.
doi:10.1186/1755-8794-6-8
PMCID: PMC3599691  PMID: 23497701
Biobank; Tissue repository; Cancer patient perspectives; Consent; Withdrawal; Anonymity; Incidental findings; Return of results; Ownership; Trust
13.  Ethical and legal implications of whole genome and whole exome sequencing in African populations 
BMC Medical Ethics  2013;14:21.
Background
Rapid advances in high throughput genomic technologies and next generation sequencing are making medical genomic research more readily accessible and affordable, including the sequencing of patient and control whole genomes and exomes in order to elucidate genetic factors underlying disease. Over the next five years, the Human Heredity and Health in Africa (H3Africa) Initiative, funded by the Wellcome Trust (United Kingdom) and the National Institutes of Health (United States of America), will contribute greatly towards sequencing of numerous African samples for biomedical research.
Discussion
Funding agencies and journals often require submission of genomic data from research participants to databases that allow open or controlled data access for all investigators. Access to such genotype-phenotype and pedigree data, however, needs careful control in order to prevent identification of individuals or families. This is particularly the case in Africa, where many researchers and their patients are inexperienced in the ethical issues accompanying whole genome and exome research; and where an historical unidirectional flow of samples and data out of Africa has created a sense of exploitation and distrust. In the current study, we analysed the implications of the anticipated surge of next generation sequencing data in Africa and the subsequent data sharing concepts on the protection of privacy of research subjects. We performed a retrospective analysis of the informed consent process for the continent and the rest-of-the-world and examined relevant legislation, both current and proposed. We investigated the following issues: (i) informed consent, including guidelines for performing culturally-sensitive next generation sequencing research in Africa and availability of suitable informed consent documents; (ii) data security and subject privacy whilst practicing data sharing; (iii) conveying the implications of such concepts to research participants in resource limited settings.
Summary
We conclude that, in order to meet the unique requirements of performing next generation sequencing-related research in African populations, novel approaches to the informed consent process are required. This will help to avoid infringement of privacy of individual subjects as well as to ensure that informed consent adheres to acceptable data protection levels with regard to use and transfer of such information.
doi:10.1186/1472-6939-14-21
PMCID: PMC3668248  PMID: 23714101
African populations; Ethical; legal; and societal issues; Next generation sequencing; Whole genome and whole exome sequencing
14.  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
15.  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
16.  Prevalence, Distribution, and Impact of Mild Cognitive Impairment in Latin America, China, and India: A 10/66 Population-Based Study 
PLoS Medicine  2012;9(2):e1001170.
A set of cross-sectional surveys carried out in Cuba, Dominican Republic, Peru, Mexico, Venezuela, Puerto Rico, China, and India reveal the prevalence and between-country variation in mild cognitive impairment at a population level.
Background
Rapid demographic ageing is a growing public health issue in many low- and middle-income countries (LAMICs). Mild cognitive impairment (MCI) is a construct frequently used to define groups of people who may be at risk of developing dementia, crucial for targeting preventative interventions. However, little is known about the prevalence or impact of MCI in LAMIC settings.
Methods and Findings
Data were analysed from cross-sectional surveys established by the 10/66 Dementia Research Group and carried out in Cuba, Dominican Republic, Peru, Mexico, Venezuela, Puerto Rico, China, and India on 15,376 individuals aged 65+ without dementia. Standardised assessments of mental and physical health, and cognitive function were carried out including informant interviews. An algorithm was developed to define Mayo Clinic amnestic MCI (aMCI). Disability (12-item World Health Organization disability assessment schedule [WHODAS]) and informant-reported neuropsychiatric symptoms (neuropsychiatric inventory [NPI-Q]) were measured. After adjustment, aMCI was associated with disability, anxiety, apathy, and irritability (but not depression); between-country heterogeneity in these associations was only significant for disability. The crude prevalence of aMCI ranged from 0.8% in China to 4.3% in India. Country differences changed little (range 0.6%–4.6%) after standardization for age, gender, and education level. In pooled estimates, aMCI was modestly associated with male gender and fewer assets but was not associated with age or education. There was no significant between-country variation in these demographic associations.
Conclusions
An algorithm-derived diagnosis of aMCI showed few sociodemographic associations but was consistently associated with higher disability and neuropsychiatric symptoms in addition to showing substantial variation in prevalence across LAMIC populations. Longitudinal data are needed to confirm findings—in particular, to investigate the predictive validity of aMCI in these settings and risk/protective factors for progression to dementia; however, the large number affected has important implications in these rapidly ageing settings.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Currently, more than 35 million people worldwide have dementia, a group of brain disorders characterized by an irreversible decline in memory, problem solving, communication, and other “cognitive” functions. Dementia, the commonest form of which is Alzheimer's disease, mainly affects older people and, because more people than ever are living to a ripe old age, experts estimate that, by 2050, more than 115 million people will have dementia. At present, there is no cure for dementia although drugs can be used to manage some of the symptoms. Risk factors for dementia include physical inactivity, infrequent participation in mentally or socially stimulating activities, and common vascular risk factors such as high blood pressure, diabetes, and smoking. In addition, some studies have reported that mild cognitive impairment (MCI) is associated with an increased risk of dementia. MCI can be seen as an intermediate state between normal cognitive aging (becoming increasingly forgetful) and dementia although many people with MCI never develop dementia, and some types of MCI can be static or self-limiting. Individuals with MCI have cognitive problems that are more severe than those normally seen in people of a similar age but they have no other symptoms of dementia and are able to look after themselves. The best studied form of MCI—amnestic MCI (aMCI)—is characterized by memory problems such as misplacing things and forgetting appointments.
Why Was This Study Done?
Much of the expected increase in dementia will occur in low and middle income countries (LAMICs) because these countries have rapidly aging populations. Given that aMCI is frequently used to define groups of people who may be at risk of developing dementia, it would be useful to know what proportion of community-dwelling older adults in LAMICs have aMCI (the prevalence of aMCI). Such information might help governments plan their future health care and social support needs. In this cross-sectional, population-based study, the researchers estimate the prevalence of aMCI in eight LAMICs using data collected by the 10/66 Dementia Research Group. They also investigate the association of aMCI with sociodemographic factors (for example, age, gender, and education), disability, and neuropsychiatric symptoms such as anxiety, apathy, irritability, and depression. A cross-sectional study collects data on a population at a single time point; the 10/66 Dementia Research Group is building an evidence base to inform the development and implementation of policies for improving the health and social welfare of older people in LAMICs, particularly people with dementia.
What Did the Researchers Do and Find?
In cross-sectional surveys carried out in six Latin American LAMICS, China, and India, more than 15,000 elderly individuals without dementia completed standardized assessments of their mental and physical health and their cognitive function. Interviews with relatives and carers provided further details about the participant's cognitive decline and about neuropsychiatric symptoms. The researchers developed an algorithm (set of formulae) that used the data collected in these surveys to diagnose aMCI in the study participants. Finally, they used statistical methods to analyze the prevalence, distribution, and impact of aMCI in the eight LAMICs. The researchers report that aMCI was associated with disability, anxiety, apathy, and irritability but not with depression and that the prevalence of aMCI ranged from 0.8% in China to 4.3% in India. Other analyses show that, considered across all eight countries, aMCI was modestly associated with being male (men had a slightly higher prevalence of aMCI than women) and with having fewer assets but was not associated with age or education.
What Do These Findings Mean?
These findings suggest that aMCI, as diagnosed using the algorithm developed by the researchers, is consistently associated with higher disability and with neuropsychiatric symptoms in the LAMICs studied but not with most sociodemographic factors. Because prevalidated and standardized measurements were applied consistently in all the countries and a common algorithm was used to define aMCI, these findings also suggest that the prevalence of aMCI varies markedly among LAMIC populations and is similar to or slightly lower than the prevalence most often reported for European and North American populations. Although longitudinal studies are now needed to investigate the extent to which aMCI can be used as risk marker for further cognitive decline and dementia in these settings, the large absolute numbers of older people with aMCI in LAMICs revealed here potentially has important implications for health care and social service planning in these rapidly aging and populous regions of the world.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001170.
Alzheimer's Disease International is the international federation of Alzheimer associations around the world; it provides links to individual associations, information about dementia, and links to three World Alzheimer Reports; information about the 10/66 Dementia Research Group is also available on this web site
The Alzheimer's Society provides information for patients and carers about dementia, including information on MCI and personal stories about living with dementia
The Alzheimer's Association also provides information for patients and carers about dementia and about MCI, and personal stories about dementia
A BBC radio program that includes an interview with a man with MCI is available
MedlinePlus provides links to further resources about MCI and dementia (in English and Spanish)
doi:10.1371/journal.pmed.1001170
PMCID: PMC3274506  PMID: 22346736
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.  Some legal aspects of mental capacity. 
BMJ : British Medical Journal  1996;313(7050):156-158.
This article discusses some practical matters which arise when competence to make decisions is in question. Consent, testamentary capacity, powers of attorney, the Court of Protection, "living wills," and research on people with dementia are briefly considered.
Images
PMCID: PMC2351542  PMID: 8688779
19.  The Legal Aspects of Expedited Partner Therapy Practice: Do State Laws and Policies Really Matter? 
Sexually transmitted diseases  2013;40(8):657-662.
Background
Expedited partner therapy (EPT) is a potential partner treatment strategy. Significant efforts have been devoted to policies intended to facilitate its practice. However, few studies have attempted to evaluate these policies.
Methods
We used data on interviewed gonorrhea cases from 12 sites in the STD Surveillance Network (SSuN) in 2010 (n=3,404). Patients reported whether they had received EPT. We coded state laws relevant to EPT for gonorrhea using Westlaw legal research database, and the general legal status of EPT in SSuN sites from CDC’s website in 2010. We also coded policy statements by medical and other boards. We used chi-squares to compare receipt of EPT by legal/policy variables, patient characteristics and provider type. Variables significant at p<.10 in bivariate analyses were included in a logistic regression model.
Results
Overall, 9.5% of 2,564 interviewed gonorrhea patients reported receiving EPT for their partners. Receipt of EPT was significantly higher where laws and policies authorizing EPT existed. Where EPT laws for GC existed and EPT was permissible, 13.3% of patients reported receiving EPT as compared to 5.4% where there were no EPT laws and EPT was permissible, and 1.0% where there were no EPT laws and EPT was potentially allowable (p<.01). EPT was higher where professional boards had policy statements supporting EPT (p<.01). Receipt of EPT did not differ by most patient characteristics or provider type. Policy-related findings were similar in adjusted analyses.
Conclusions
EPT laws and policies were associated with higher reports of receipt of EPT among interviewed gonorrhea cases.
doi:10.1097/01.OLQ.0000431358.18959.d4
PMCID: PMC3927721  PMID: 23859917
20.  Does gender matter? Exploring mental health recovery court legal and health outcomes 
Health & justice  2014;2(1):12-.
Background
Based upon therapeutic justice principles, mental health courts use legal leverage to improve access and compliance to treatment for defendants who are mentally ill. Justice-involved women have a higher prevalence of mental illness than men, and it plays a greater role in their criminal behavior. Despite this, studies examining whether women respond differently than men to mental health courts are lacking. Study goals were to examine gender-related differences in mental health court participation, and in criminal justice, psychiatric and health-related outcomes.
Methods
This study utilized a quasi-experimental pre-posttest design without a control group. The data were abstracted from administrative records of Kalamazoo Community Mental Health and Substance Abuse agency, the county jail and both county hospitals, 2008 through 2011. Generalized estimating equation regression was used to assess gender-differences in pre-post program outcomes (jail days, psychiatric and medical hospitalization days, emergency department visits) for the 30 women and 63 men with a final mental health court disposition.
Results
Program-eligible females were more likely than males to become enrolled in mental health court. Otherwise they were similar on all measured program-participation characteristics: treatment compliance, WRAP participation and graduation rate.
All participants showed significant reductions in emergency department visits, but women-completers had significantly steeper drops than males: from 6.7 emergency department visits to 1.3 for women, and from 4.1 to 2.4 for men. A similar gender pattern emerged with medical-hospitalization-days: from 2.2 medical hospital days down to 0.1 for women, and from 0.9 days up to 1.8 for men. While women had fewer psychiatric hospitalization days than men regardless of program involvement (2.5 and 4.6, respectively), both genders experienced fewer days after MHRC compared to before. Women and men showed equal gains from successful program completion in reduced jail days.
Conclusions
Despite similar participation characteristics, findings point to greater health gains by female compared to male participants, and to lower overall psychiatric acuity. Mental-health-court participation was associated with decreased psychiatric hospitalization days and emergency department visits. Successful program completion correlated to fewer jail days for both women and men.
doi:10.1186/s40352-014-0012-0
PMCID: PMC4269165  PMID: 25530934
Mental health court; Gender and justice; Criminogenic factors; Healthcare utilization
21.  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
22.  Reasons for and consequences of missed appointments in general practice in the UK: questionnaire survey and prospective review of medical records 
BMC Family Practice  2005;6:47.
Background
Missed appointments are a common occurrence in primary care in the UK, yet little is known about the reasons for them, or the consequences of missing an appointment. This paper aims to determine the reasons for missed appointments and whether patients who miss an appointment subsequently consult their general practitioner (GP). Secondary aims are to compare psychological morbidity, and the previous appointments with GPs between subjects and a comparison group.
Methods
Postal questionnaire survey and prospective medical notes review of adult patients missing an appointment and the comparison group who attended appointments over a three week period in seven general practices in West Yorkshire.
Results
Of the 386 who missed appointments 122 (32%) responded. Of the 386 in the comparison group 223 (58%) responded, resulting in 23 case-control matched pairs with complete data collection. Over 40% of individuals who missed an appointment and participated said that they forgot the appointment and a quarter said that they tried very hard to cancel the appointment or that it was at an inconvenient time. A fifth reported family commitments or being too ill to attend. Over 90% of the patients who missed an appointment subsequently consulted within three months and of these nearly 60% consulted for the stated problem that was going to be presented in the missed consultation. The odds of missing an appointment decreased with increasing age and were greater among those who had missed at least one appointment in the previous 12 months. However, estimates for comparisons between those who missed appointments and the comparison group were imprecise due to the low response rate.
Conclusion
Patients who miss appointments tend to cite practice factors and their own forgetfulness as the main reasons for doing so, and most attend within three months of a missed appointment. This study highlights a number of implications for future research. More work needs to be done to engage people who miss appointments into research in a meaningful way.
doi:10.1186/1471-2296-6-47
PMCID: PMC1291364  PMID: 16274481
23.  End-of-Life Decisions: A Cross-National Study of Treatment Preference Discussions and Surrogate Decision-Maker Appointments 
PLoS ONE  2013;8(3):e57965.
Background
Making treatment decisions in anticipation of possible future incapacity is an important part of patient participation in end-of-life decision-making. This study estimates and compares the prevalence of GP-patient end-of-life treatment discussions and patients’ appointment of surrogate decision-makers in Italy, Spain, Belgium and the Netherlands and examines associated factors.
Methods
A cross-sectional, retrospective survey was conducted with representative GP networks in four countries. GPs recorded the health and care characteristics in the last three months of life of 4,396 patients who died non-suddenly. Prevalences were estimated and logistic regressions were used to examine between country differences and country-specific associated patient and care factors.
Results
GP-patient discussion of treatment preferences occurred for 10%, 7%, 25% and 47% of Italian, Spanish, Belgian and of Dutch patients respectively. Furthermore, 6%, 5%, 16% and 29% of Italian, Spanish, Belgian and Dutch patients had a surrogate decision-maker. Despite some country-specific differences, previous GP-patient discussion of primary diagnosis, more frequent GP contact, GP provision of palliative care, the importance of palliative care as a treatment aim and place of death were positively associated with preference discussions or surrogate appointments. A diagnosis of dementia was negatively associated with preference discussions and surrogate appointments.
Conclusions
The study revealed a higher prevalence of treatment preference discussions and surrogate appointments in the two northern compared to the two southern European countries. Factors associated with preference discussions and surrogate appointments suggest that delaying diagnosis discussions impedes anticipatory planning, whereas early preference discussions, particularly for dementia patients, and the provision of palliative care encourage participation.
doi:10.1371/journal.pone.0057965
PMCID: PMC3589464  PMID: 23472122
24.  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
25.  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

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