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Commentaries Observing Objective, Structure, Clinical Examinations (OSCE) Observing Objective, Structure, Clinical Examinations (OSCE) Objective, structure, clinical examinations (OSCE) are increasingly used to examine clinical skills in both undergraduate and postgraduate students in the UK (1). As suggested by their name, the OSCEs are intended to reduce subjectivity amongst examiners by having predefined marking. This objectivity of marking as well as the structure of the examination, where all students are asked to answer the same questions and perform the same procedures, is intended to make OSCEs 'fairer' than other types of clinical examinations, such as short and long cases (2). I have now taken part in six OSCEs - four as a clinical medical student and two as a 'sim', or simulated patient. My first experience on the other side of the couch was as a young woman who wanted to start taking the contraceptive pill. Fourth year medical students had to determine whether or not I was an appropriate candidate for the pill and explain to me how to take it and what to do if I missed one. More recently, third year dental students were asked to perform an extra- and intra oral examination on me. As a postgraduate student trying to get by on something similar to the minimum wage, the incentive of £9 an hour to do almost nothing is irresistible. Although it makes for a rather mind, or mouth, numbing morning, being a sim patient can have its interesting aspects. In terms of advice for students, I learned two key things. Firstly, remembering to introduce yourself can make the difference between passing and failing (3). In both exams, specific marks were allotted for introducing yourself and confirming the patient's identity. Secondly, communication skills (3). In the medical exam, there were three marks assigned to 'overall impression'. These weren't awarded for knowledge but for confidence, demeanor and ability to put the patient at ease and treat with respect. In addition, I also have a number of reflections on the whole process of OSCEs. To begin with, I feel a small sense of injustice that I never had the chance to take part in an OSCE as a sim patient before, rather than after, taking part as a student. Having the opportunity to observe a number of individuals perform exactly the same task gives you a very good sense of what works and what doesn't. Everyone has to develop a clinical style that they feel comfortable with. Being on the receiving end of a number of different approaches to the same problem is a great way of identifying just what aspects you might want to incorporate into your own style. OSCEs could, therefore, be used as a learning experience for one group of students at the same time as an examination procedure for another. Undergraduate, like postgraduate students, are a willing and constant source of labor. Disclosure of exam contents from student sim patients should be of no concern since (4) it is easy enough to find out what appeared in last year's OSCE by simply asking someone who took it. Next, there were one or two dental students who managed to hurt me. Not hurting the patient is a golden rule of exams, and clinical medicine in general. However, the OSCEs that I have taken part in had no way of assessing distress caused to patients. It would have taken minimal training and time to ask me to mark each student on their gentleness and include this at the bottom of the examiner's mark sheet. In fact, there are numerous examples in the literature, particularly from the USA, where sim patients are trained to do some or all of the marking at OSCE stations (5-7). This not only allows the patients to comment on 'how it was for them', but can also remove the need for a separate examiner altogether if sim patients are trained to perform all the marking. In turn, this can make OSCEs cheaper and easier to run, as fewer clinical staff are required. Lastly, the OSCEs that I have taken part in as a medical student have provided no real opportunity for feedback on my performance. Whilst one of the main aims of exams, particularly in the later stages of the course, is to confirm that students will make safe practitioners (8,9), failing to provide feedback beyond an overall mark is a wasted opportunity. The General Medical Council has recently emphasized the need for formative (where students are given feedback on their performance), as well as summative (where students are graded on their performance) assessments in medical education (10). One of the identified benefits of OSCEs are the opportunities they give for formative assessment and feedback (2). OSCEs are an opportunity for each individual student to be observed by experts in a number of different clinical encounters. It makes sense to make use of this unique opportunity to provide all students with an assessment of their performance that goes beyond pass or fail. Again, there are examples of this in the literature, particularly from the USA, where students are given feedback either after the exam or as part of each OSCE station (2,5). One possible way of providing individualized feedback would be to ask examiners to write, or dictate, a few sentences on each student between stations. These notes could then be transcribed, collated and returned to students with their marks. Such a procedure would not be particularly onerous and would allow students to learn from the experience of the OSCE, as well as the preparation beforehand. OSCEs were first trialed in 1975 (11) and despite varied responses from both staff and students (12-16), they look set to stay with us. Although they are undoubtedly an improvement on the old 'long cases' in terms of fairness (1), the current use of OSCEs in the UK seems to present a number of missed opportunities in terms of both education and efficiency. Jean Adams, BMedSci, MBBS Acknowledgements References
IRB Reform In North America: Challenges And Opportunities Clinical research is necessary to advance medical knowledge and to test new drugs or devices. It is therefore vital to society, and ethically imperative, that clinical studies be performed if patients are to have access to safe and effective treatments. However, clinical research by its very nature involves risk. Subjects who volunteer in clinical studies may receive no benefit; in fact, they may be seriously harmed or even die as a result of their participation. Indeed, research-related injuries and deaths, though relatively few in number (1), have become the subject of much controversy in recent years (2). Thus, protection of human research subjects must be given the highest priority by researchers, their institutions, and the government and regulatory bodies charged with overseeing the clinical research process. Central to this process is the institutional review board (IRB) in the United States (U.S.), or research ethics board as it is known in Canada. (For the purpose of this paper, the term "IRB" will be used to refer to both American and Canadian boards.) The IRB has frequently been referred to as the "first line of defense" in research subject protection (3), yet the specific roles and responsibilities of this board and its members are not clear (4). Defining these roles and responsibilities is more important now than ever before, for several reasons. The Issues IRBs in crisis First, biomedical science is advancing at an unprecedented rate, and the number of clinical studies is increasing exponentially (5). This situation can only add to the strain on already over-burdened IRBs (6). Numerous articles in recent literature have made reference to the "crisis" in American IRBs (7,8), being unable to cope with the sheer volume of protocols they are asked to review, and the "pressure-cooker atmosphere" (9) IRB members must contend with as they struggle to balance the interests of subjects with those of the researchers. A report commissioned by the Law Commission of Canada indicates that Canadian IRBs are not faring any better (10). The U.S. Office of Human Research Protection (OHRP; the agency responsible for oversight of IRBs in the U.S.) concluded in a 1998 report that IRBs review "too much, too quickly, with too little expertise" (6), and that the entire system was "in jeopardy" (6). Though there is no equivalent to the OHRP in Canada, Canadian IRBs have not escaped criticism (11,12) or calls for reform (10,13). Clearly, IRBs in North America are overwhelmed under the current system. It is not reasonable to expect these same IRBs to handle double or triple their current workload without a significant reduction in the quality of their reviews. If IRBs are to continue to be relied upon as the primary safeguard of clinical trial volunteers, a clear mandate for their roles and responsibilities must be established. In defining these roles and responsibilities, it may be possible to lessen the current burden on IRBs by delegating certain responsibilities to other committees or regulatory bodies. Alternatively, recognition of the many obligations of the board and its members could result in provisions for increased support to give the members the resources they need to do their job properly. Liability and the IRB member The second reason for the impetus to define the IRB's specific roles and responsibilities is the alarming, albeit not new, threat of personal legal liability of IRB members. The U.S. National Commission for the Protection of Human Subjects Report and Recommendations: Institutional Review Boards, published in 1978, clearly states that IRB members may be held personally liable "for malpractice or negligence in discharging their IRB functions" (14). Angela Holder, a legal expert on human subject research, was quick to respond in her 1979 article "Liability and the IRB Member: The Legal Aspects", that such a thing would never actually happen (15). Times have changed. In 2001, a lawsuit filed on behalf of subjects who had participated in a study of a melanoma vaccine at the University of Oklahoma named twelve IRB members as defendants (16). The 130-page complaint contained many allegations, including inadequate procedures for the manufacturing and safety testing of the vaccine, failure to adhere to the protocol inclusion/exclusion criteria, incomplete informed consent documents, and a failure by the IRB to meet its federal regulatory obligations (16). The individual IRB members were accused of negligence in their duties (16). This precedent-setting case sent shockwaves through IRBs across North America. IRB members are, for the most part, volunteers who commit a tremendous
amount of time and energy to the onerous task of reviewing the hundreds
of protocols that pour into their institutions each year. Their work is
often not respected by researchers, who tend to view the ethics review
process as "a bureaucratic pain in the neck" (3). IRB members
face a great deal of pressure from researchers, sponsors, institutions,
and even the public to push through protocols at a rate that cannot possibly
be consistent with a meticulous and thoughtful consideration of all the
ethical issues at stake. Though the IRB has the power to require revisions
to protocols, "exercise of this power does not enhance a committee's
popularity within its institution" (17). In addition, IRB members
must make difficult decisions about increasingly complex protocols that
do not fall neatly under any guidelines currently in use (17). These decisions,
which often come down to judgment calls, require "a fair exercise
of intelligence and discretion on the part of IRB members" (18).
As one article describes it, "the quality of an IRB's work depends
to an inordinate degree on the conscience and commitment of its volunteer
members" (19). The idea that individual IRB members could be held
legally liable for these decisions is disturbing. This threat of legal
action may result in IRBs rejecting more protocols than they approve,
or reviews so painstakingly thorough that the review process effectively
grinds to a halt (20). It will undoubtedly serve as a deterrent to future
IRB members, at a time when it is already difficult to fill these positions
(20,21). However, no one would suggest that IRB members be exempt from
accountability. Certainly, even without a proper set of guidelines, one
would expect IRB members to carry out their duties in a conscientious
manner. But knowing precisely what they will be held accountable for,
and what protections are in place for them, will be essential if these
individuals are to be expected to continue this important work without
fear of litigation. Finally, for clinical trials to proceed and potentially life-saving treatments to reach patients who need them, researchers need the public's trust. Donors, funding agencies, government, and most importantly, clinical study volunteers and their families, all want assurance that a solid system of checks and balances is in place to protect research subjects. Without the public's trust, the system cannot function. Unfortunately, this trust has been eroded in recent years by high-profile incidents involving the tragic deaths of research subjects, and the allegations of misconduct that followed. As Dennis De Rosia, chairman of the Association of Clinical Research Professionals, said in an interview, "Each time you have one of these incidents, there's a rash of publicity, and it gets harder to recruit volunteers" (22). Most notable among these are the cases of 18 year-old Jesse Gelsinger, who died while participating in a gene therapy trial at the University of Pennsylvania (23), and 24 year-old Ellen Roche, a healthy volunteer who died after inhaling hexamethonium as part of an asthma study at Johns Hopkins (24). Both of these cases drew international attention when failures of the research subject protection system were uncovered. Since 1998, the OHRP has suspended or restricted research at over a dozen institutions due to IRB inadequacies, including such prestigious institutions as Duke (25) and Johns Hopkins (26). In both Canada and the U.S., research related deaths and injuries have landed IRBs or their sponsoring institutions in court (27,28). Subsequent investigations have often directed much of their criticism at the IRB involved (20). The reports themselves often reflect expectations of the IRB that are simply unwarranted. As an example, the report of the external review committee for the Johns Hopkins incident faults the IRB for not having a pharmacologist on their board (29). Yet none of the current guidelines for IRB membership contain any reference to a requirement for the presence of pharmacologist (30), nor is it obvious that "rigorous pharmacological review" (29) is the responsibility of the IRB (31). Discrepanciessuch as these serve as excellent examples to illustrate why the IRB and its members must be given a specific framework within which to act. The public's faith in the system is flagging (2,22); a clear set of responsibilities for the IRB would put an end to finger-pointing that further damages that faith. Coping Strategies And Solutions Commercial IRBs Several mechanisms have arisen over the past few years as means to cope with the over-burdening of local IRBs. As a result of the significant increase in industry funded research, commercial or "for-hire" IRBs were established. Commercial IRBs now exist in both Canada and the U.S., though official information on the number of these boards operating in either country is lacking (18). These IRBs primarily review research to take place at research centers affiliated with pharmaceutical companies, at contract research organizations, or in private clinics by medical professionals not associated with academic research institutions (32). Review through these IRBs is faster and arguably better and more consistent than that obtained through traditional IRBs, given the stipulations these boards may hold regarding the education and expertise of their members and the fact that there is less turnover in their membership. Using a commercial IRB for a multicenter trial may also save time and money by allowing researchers to forgo multiple, redundant reviews of the same protocol at each individual site (32). However, serious concerns have arisen regarding the inherent conflicts of interest that exist within commercial IRBs (18,32). Whether the commercial IRB is one set up by a pharmaceutical company to review research on its own products, or an independent review board on contract to review research taking place elsewhere, in both cases the IRB is a for-profit enterprise. Academic IRBs have also been criticized for conflicts of interest, as IRB members may be motivated by their desire for career advancement, future opportunities for collaboration, or even maintaining friendships with colleagues when reviewing protocols (33). However, because academic IRBs are non-profit institutions, these concerns - at least in terms of financial conflicts of interest - are less obvious. Further problems with commercial IRBs arise when a researcher who has a protocol rejected by one IRB simply takes it to another. The researcher has no obligation to inform an IRB of previous submissions of the same protocol, nor does an IRB have access to any other IRB's review. The problem of "IRB shopping" is a serious one, and one that did not exist when the traditional IRB was the only channel through which a researcher could have their protocols reviewed. Similarly, independent IRBs are not required to monitor the research they have approved, as is the case for traditional IRBs. Independent IRBs may also lack the familiarity with local research conditions and culture that traditional IRBs have. Thus, while the commercial IRB fills an important niche in the context of the current ethics review system, it is not without problems, nor is it a replacement for the traditional IRB. In fact, because there are no clear rules and regulations for IRB review, oversight and accountability, commercial IRBs are no better equipped than traditional IRBs to meet the challenges posed by the present system. Central IRBs A second development in recent years is the creation of the central IRB
(CIRB) for multi-center trials. This CIRB could perform a detailed review
of the science and experimental design of a protocol for multi-center
trials, eliminating the need for the IRB at each individual site to repeat
this process (34). The local IRBs could then expedite their review of
a protocol approved by the CIRB, focusing their attention on local issues
the protocol may present (such as institutional policies, or language
differences that may require changes to the consent form), rather than
needlessly duplicating the review of the scientific aspects of the protocol
(35). An added advantage of the CIRB would be in managing the ongoing
monitoring of these trials. Safety reports and annual study reports from
multicenter trials comprise a significant proportion of the workload of
local IRBs (7). A centralized approach to monitoring these trials would
not only free up more of the local IRBs time and resources to put toward
other responsibilities (such as review of local studies), but may in fact
result in more effective review of adverse events. The CIRB would be reviewing
reports of adverse events from all individual sites in the context of
the trial as a whole, a comprehensive view that most local IRBs do not
have. Furthermore, the CIRB would have access to reports by data and safety
monitoring boards (DSMBs) and information from the sponsor that is not
available to local IRBs, but which could be crucial in making decisions
with respect to monitoring. The CIRB approach is currently in the pilot
phase at the National Cancer Institute in the U.S. (34). This pilot model
was established in order to increase patient access to National Cancer
Institute-supported trials. With sixteen members, all cancer experts,
from both academic and community organizations across the U.S., the CIRB
initially served 22 local institutions (34). Results so far have been
promising, and plans are presently underway to expand to serve 100 (34).
However, challenges still remain in terms of the division of responsibilities,
both between the local and CIRB and between the CIRB and other bodies
(such as the DSMB). Another potential complication is that local IRBs
may also want to continue to conduct complete reviews of protocols even
after CIRB approval if they are concerned about being held accountable
for the decision to approve. This is another instance where defining responsibilities
for IRBs would facilitate quicker reviews and more effective collaboration
between partners in the review process. A third way in which the research ethics review system is attempting to deal with its ever-increasing workload is by rethinking how the IRB manages its many obligations. By most accounts, monitoring is the function that IRBs perform most poorly. Canadian (11) and American (36) reports indicate that few IRBs conduct any monitoring beyond reviewing annual study reports, the bare minimum requirement in both countries (14,37). Papers in recent literature have proposed that monitoring should be delegated to a separate body, particularly for multi-center trials (7,34). Both the Office of Human Research Protection and the Food and Drug Administration in the U.S. are encouraging greater use of DSMBs, and the National Institutes of Health now require an independent DSMB for all Phase III trials (1). Others suggest that certain aspects of monitoring, such as consent monitoring (determining whether research subjects understand the risks and benefits of the research they are being asked to participate in) be delegated to a subcommittee of the IRB, or an intermediary (38). While at present these proposals are just that - proposals - the idea of delegating some of the IRB's responsibilities is attractive. Many IRBs already assign some aspects of the review process, such as the review of contracts between clinical investigators and sponsors, or the assessment of statistical power of clinical trials, to individuals who are not members of the IRB. While the danger exists that adding several subcommittees or consulting bodies will increase the time and red tape involved in reviewing protocols, the reassurance that all the functions of the IRB are being fulfilled by persons with the expertise to perform them properly makes the additional layer of bureaucracy worthwhile. The IRB can then concentrate its time and efforts on thorough primary reviews and oversight of local studies. The Future In considering any changes to the current system, it must be kept in mind that the IRB's primary purpose is the protection of research subjects. This mandate cannot be achieved without a formal regulatory framework within which the IRB can operate. Such a system would need to establish standards harmonizing national and international laws and policies. A single set of clear guidelines is required with respect to conflicts of interest, division of duties, and accountability. The IRBs need greater support from government and their institutions, both in terms of funding and staff, as well as training and ongoing education for IRB members and clinical investigators. How close is this major overhaul to becoming a reality? It may be closer than it seems. Last fall, an Institute of Medicine committee delivered its recommendations for improving research subject protection in the U.S. (39). A central theme throughout the report is easing the strain on IRBs by reducing their workload and increasing their resources. Among the recommendations are calls for a national registry to track research participants, as well as the creation of a CIRB. The report also contains a plan to separate the IRB's functions into three committees: one to evaluate the scientific merit of a protocol, one to assess potential conflicts of interest, and a third to integrate all the information, consider other issues and make a decision. The Institute of Medicine plan also proposes a no-fault compensation system for subjects who are harmed as a result of their participation in research, thereby avoiding litigation. It remains to be seen whether these changes will be implemented, and whether Canada will adopt similar strategies. If our governments, granting agencies and institutions recognize the value of clinical research and the independent ethics review process that must accompany it to our society, then they must also recognize that this important issue needs to be addressed, and deserves our immediate attention. Marjorie Ellen Zettler, B.Sc. References
Emerging Patterns In The Resistance To The Medicalization Of Birth In North America Childbirth is one of the most ubiquitous experiences of human life. It is an integral ritual of the life cycle. Nevertheless, different cultures have evolved strikingly varied practices surrounding childbirth. As such, one might argue that in any society, "the way a woman gives birth and the kind of care given to her point as sharply as an arrowhead to the key values in the culture” (1). Within the last century, the process of childbirth has increasingly taken place within the realm of medicine: in a hospital, attended by a physician. This medicalization of childbirth is especially evident in Western societies with an established technomedical infrastructure such as in "non-Indigenous" North America and societies where the medicalization of birth has been imposed such as in Inuit communities. This paper will explore women's concerns regarding the medicalization of childbirth, as illustrated by the example of the Inuit women in Canada. In North America, the ritual of birth was once the dominion of women, but has since been incorporated into the practice of medicine, causing a shift of "authoritative knowledge" from older women and midwives to trained physicians. The increasing reliance of medicine on technology within North American society has permeated the realm of childbirth. In so doing, the framework of empirical science has been introduced into the birthing process, perpetuating the values of a technologically-oriented society. One might argue that "[b]y making the naturally transformative process of birth into a cultural rite of passage, a society can ensure that its basic values will be transmitted" (2). Many feel as though the process of childbirth is being "sterilized" and its cultural and emotional content diminished. Many "non-Indigenous" North American women feel as though they are being alienated from the birthing process and have lost control of their own bodies. As such, women are increasingly seeking alternatives to hospital deliveries (3). There has been a recent and marked resurgence of homebirths and reliance on midwives. Midwifery allows women to play a larger role in their deliveries, and returns the process of childbirth to the home: roughly half of all midwife-attended births are performed in the home (4). Until 1992, midwifery was illegal in Canada when Ontario became the first province to legalize midwifery. Since then, four other provinces including Quebec have followed suit and midwifery is becoming an increasingly accepted alternative to hospital childbirths (3). In 2000, 4% of Ontario births were attended by midwifes and by the year 2004, the percentage is estimated to rise to 10% (4). The experience of Inuit women in the last few decades provides an even more salient example of the institutionalization of childbirth and its separation from community life. In traditional Inuit culture, an expectant woman was followed throughout her pregnancy and assisted in childbirth by a midwife and several women helpers (5). Traditional midwives received no official training, but were taught how to deliver by older women. Hence, the skills associated with midwifery were passed on from generation to generation. The knowledge of midwives was considered indispensable and midwives were accorded much respect within the community. In fact, the ability to assist in childbirth endowed women with a sense of pride and empowerment in a predominantly patriarchal society (6). In addition to an honoured position within society, a special relationship existed between the children and the midwives who delivered them. An Inuit boy gave the midwife who delivered him his first catch, and a girl, the first item she sowed (5). For the Nuu-chah-nulth people of British Columbia, the term midwife translates as "she who can do everything." Hence, depriving these women of assisting in childbirth is tantamount to removing them from their influential and honoured position in society (7). In addition to the reliance on midwives and women helpers, several other aspects of traditional Inuit childbirth are worth mentioning. Unlike current Western practices, such as those outlined in the 2002 National Guidelines for the Childbearing Years (8), an expectant woman was to remain highly active throughout her pregnancy, performing all her daily chores until the advent of labour. It was thought that such activity would give the woman the strength needed to deliver (5). Women would give birth in rapidly constructed snow houses in either a squatting or kneeling position with the midwife behind them (6). The midwife would often enlist the help of the pregnant woman's husband and female relatives, thus involving the whole family in the process of childbirth (5). The traditional Inuit process of childbirth, as described above, was practiced without scrutiny until the 1960s. During the 1960s, so-called Nursing Stations were set up throughout the Canadian North and deliveries were relegated to officially-trained, licensed midwives within these stations. Although traditional Inuit midwives were legally excluded from these deliveries, these Nursing Stations nevertheless permitted women to deliver within their communities, surrounded by their families. Since the 1980s, however, due mostly to a shortage of professionally trained midwives, deliveries must be performed within hospitals in cities far removed from the Northern communities. Today, Inuit women are "evacuated" three weeks before their due date and sent to hospitals in cities, such as Winnipeg, where obstetricians perform their deliveries. Hence, within three generations, Inuit women have experienced a transition from birth performed by a traditional midwife in the context of the home and family, to birth performed by a professional midwife in a Nursing Station within their community and presently, to birth performed by a physician in a hospital far removed from their community (5,6). Since the practice of sending women to distant hospitals began, Inuit women have repeatedly expressed their dissatisfaction with the current system. In fact, since its inception in 1984, a primary concern of the Inuit Women's Association has been the issue of childbirth (5,9). The concerns about the system in place centre around five main issues: (1) the women sent to distant hospitals experience loneliness and alienation, (2) the family is removed from the process of childbirth, (3) the separation of the expectant woman from herhusband and children causes undue strain on their relationship, (4) the skills and knowledge of traditional Inuit midwives are being eradicated, and (5) Inuit children are receiving out-of-territory birth certificates. Inuit women feel as though their control over childbirth has been usurped by the government and that they have now become dependent on health care services. The status previously endowed by the knowledge of childbirth on midwives and women in general has been perturbed by the forced reliance on the expertise of faraway physicians. According to John O'Neil and Patricia A. Kaufert (6), the practice of sending Inuit women to distant hospitals is a manifestation of "internal colonialism." Although a discussion of Inuit childbirth as an extension of colonialism is beyond the scope of this paper, this idea serves to illustrate the clash of cultures at hand. The imposition of the Western culture's birthing practices on the Inuit community has left many Inuit feeling robbed of yet another aspect of their culture and heritage. The Western culture which tends to dissociate childbirth and illness, in general, from community life is in sharp contrast to the Inuit culture which views childbirth and illness as being integral and continuous aspects of community life (6). As the current situation remains unfavourable to the majority of Inuit women, a compromise of some sort must be reached. Such a compromise was articulated at a workshop held in the Inuit community of Keewatin in 1988 and relies on a cooperation between traditional midwives and obstetricians such that high-risk deliveries would be performed by obstetricians and low-risk deliveries by traditional midwives. Although the death of a newborn was traditionally viewed as "meant to be," Inuit women overwhelmingly approve of seeking the expertise of an obstetrician for high-risk deliveries, but wish to be given the choice to have their births performed by traditional midwives in the case of low-risk deliveries. A spokeswoman for the Inuit Women's Association spoke of a system that will "look into the past to find the elements that can be adapted to contemporary conditions to ensure that the knowledge and experience of the elder midwives is retained as part of Inuit heritage” (5). Others, however, are proponents of a more confrontational approach. Women in the community of Puvirnituq have returned to performing traditional-style births and have reclaimed their dominion over the childbirth process (10). These women are doing so illegally. When Quebec legalized midwifery in 1999, Quebec law failed to recognize training programmes other than the one offered at the Université du Québec in Trois-Rivières. The women training at the Innuulitsivik Health Centre in Puvirnituq are unable to apply for a midwifery license. Negotiations are under way between the provincial Ministry of Health and the Inuit community, and offer promise that the traditional apprenticeship model of training midwives will be officially recognized (7). It is likely that in the years to come, the trend towards the deinstitutionalization of childbirth will be amplified, though technology's value in reducing infant and maternal mortality will undoubtedly ensure that it remains an integral component of childbirth. However, "[t]he issue is not whether technology is good or bad in and of itself, but under what circumstances should it be used, when does it augment the quality of life of those who use it, when does it detract from that quality, and, perhaps, most importantly, who has the power to decide what is appropriate use” (11). A better understanding of these issues and a discussion of the needs and concerns of those involved will likely enhance the quality, safety and diversity of tomorrow's childbirth practices. Gillian Morantz-Ornstein, B. Sc. References Doctors and patients have come to expect a cure for most every illness and condition. Unfortunately for both groups, this is not always possible. When faced with the prospect of the imminent death of a patient, doctors may exhibit curative attitudes and perform interventions which may not be in the best interest of the patient. Referral to palliative care may become the only appropriate avenue of treatment, yet it may never be offered. Nowhere is this seen more clearly than in the treatment of a dying child. The lack of healing services provided to terminally ill children is alarming. This dearth of pediatric palliative care stems from the history of palliative care, societal attitudes about dying children, the current standard of medical education, the limited experience of pediatricians with death, and the issues of required parental consent. These factors cumulatively affect the interactions between doctors, parents and children faced with a terminal illness. The World Health Organization has defined pediatric palliative care as "the active total care of patients whose disease is not responsive to curative treatment. Control of pain, of other symptoms and of psychological, social and spiritual problems is paramount. The goal of palliative care is achievement of the best quality of life for patients and families (1)." Contemporary society is obsessed with curative treatment. The last one hundred years have seen a dramatic increase in medical technology. Many once-fatal diseases are now mere inconveniences and science has given doctors incredible tools to eradicate illness and death. With respect to children, world mortality rates have been declining steadily. The chance of a newborn dying before its fifth birthday is seven percent, down from 25 percent in 1950 (2). This decrease is due largely to advances like pre-natal care, antibiotics, immunizations, and surgical repair of anomalies. Before the many scientific advances, a physician's role was fundamentally different. Without the many curative measures that we have today, death was much more common and different skills were in demand. Because of their inability to cure, doctors used a palliative approach to comfort and ease the burden of death on patients and their families. Today the curing role has superceded this healing role because science has given us the opportunity to do so. The ability to cure has changed the focus of medicine. With all the life-saving measures that exist, it is difficult for many to believe that nothing curative can be done. While the ability to prolong life may be possible, it is questionable whether or not it is advisable. In medicine, curing has been associated with life while palliative care has been linked with death. One reason why these associations exist: it seems to be easier for physicians and family to accept that a person died because heroic measures failed. This direct association of palliative care with death makes its implementation an uncomfortable decision when children are concerned. Dying children defy the natural order (3). While elderly individuals and their families may be more open to palliative care, parents and doctors of children seem to be reluctant to implement it. Those who have lived a long life are more apt to accept its final, inevitable, conclusion. Since they hold out no hope for a permanent cure, palliative care can be a desirable option for terminally ill adults. The Institute of Medicine states that a "decent or good death is: free from avoidable distress and suffering for patients, families, and caregivers; in general accord with patients' and families' wishes; and is reasonably consistent with clinical, cultural, and ethical standards (4)." Achieving this is the main goal of palliative care. However, this goal of palliative care is not envisioned in pediatric situations. One reason is lack of pediatric palliative care training and education. Training programs in the United States, like those offered by the American Academy for Hospice and Palliative Care, focus primarily on adults. There are no established national standards for pediatric palliative care curriculum (5). As a result, only 10 percent of pediatric oncologists have had formal courses and only 2.2 percent have undergone a clinical rotation in palliative care (6). In addition, undergraduate medical education in the United States has focused predominantly on palliative care for adult and geriatric patients (7). Therefore, the established adult model of seeking a cure, then palliating until death, is being applied to children. This model does not necessarily fit the situation experienced by caregivers of children. In what has been called the Persephone syndrome, a course of disease that is fraught with rebound-relapse episodes may lead family and other care providers to be more persistent in pursuing aggressive therapy for prolonged periods of time in hope of yet another astonishing recovery (8). Because the adult model is cure or palliate, these children never receive palliative treatment. They are perceived as being perpetually in the cure stage, despite terminal illness. The logical conclusion would indicate to use both curative and palliative treatments, but, because of current educational practices, the combination of potentially curative and palliative medicine currently escapes us (9). Even the World Health Organization's definition of pediatric palliative care as quoted earlier in this paper seems to artificially separate curative and palliative efforts. Further complicating the issue, pediatricians are relatively inexperienced with death. On average, a general pediatrician will come into contact with 3 children per year who will die (10). This limited exposure has two major effects: first, pediatricians lack experience dealing with the complex emotions related to death; and second, they report feeling a sense of guilt about their inability to cure. As a result, a common reaction is to separate themselves emotionally and physically from the dying children and their families (11). Although adults involved in the medical care of family members want dying parents not to suffer, they expect their children to outlive them. When families are faced with the terminal illness of a child, they are presented with many challenges, some of which the medical system imposes upon them. They receive an overwhelming amount of technically complicated information from which they must make difficult decisions about the fate of their child. They may feel that an incorrect choice will cause undue suffering or death. As a result, families in these situations prefer to be guided by their practitioners (12). Unfortunately, this creates a situation where pediatricians may influence parental attitudes and behavior. The feeling that the inability to cure a child is a personal failure, combined with a lack of education in pediatric palliative care, makes pediatricians reluctant to provide palliative care as an option. Even those pediatricians that do receive adult palliative care training are reluctant to turn care over to another clinician because of their strong relationship with the patient and his or her family (13). This makes the family see only one course: cure or nothing. This is unfortunate, because the decision of when to provide end-of-life care is paramount. Delay causes difficulties in tailoring treatment and exacerbates feelings of vulnerability and helplessness in the family and patient (14). Because of the paradoxical issues previously discussed, doctors are waiting for the family to decide to stop the curing process while the family is expecting the doctor to inform them when curative treatments should be abandoned. As a result, neither party actively initiates the discussion of terminal care. This can lead to prolonged suffering. "The need to do everything is a powerful force. This is relevant when interventions focused on cure are no longer reasonable and may well be harmful” (15). In a Wisconsin study of dying children whose parents had received a palliative care consultation, they found a significant decrease in the administration of blood tests, central lines, feeding tubes, gastrostomy tubes, endotracheal tubes, x-rays, and paralytic medications compared to children whose parents had not (16). This study suggests that once palliative care is introduced as an option, invasive medical procedures with limited benefit are refused. Misconceptions about children needing protection from pain, assumptions about their ability to understand, or the thought that they are too young to be affected continue today (17). In one study of dying hospitalized children in Edmonton between January 1996 and June 1998, only one child among 77 was documented as being specifically told that they were dying (18). Though legally unable to give informed consent, the "assent" of sick children may be weighed heavily by parents and doctors in deciding a course of treatment. When children are not informed that they are dying, they cannot make any direct contributions to their care. Because the parents and the child are not both directly included, they have no opportunity to work together in deciding the best course of action (19). Therefore the patient's best interests may not be met. The combination of these factors contribute to the lack of palliative care options offered for pediatric cases. Parents are dependent on the pediatrician to help make choices about end of life care. The pediatrician is not trained in offering such options, and the child is essentially uninvolved in the process. Since parents are not presented with the option to provide palliative care, they see stopping curative treatment as stopping all treatment for their child. There is some academic work being done in the area. Some schools, like The Johns Hopkins Children's center, offer a one-day seminar to residents (20). Several articles have been written recently (21,22,23) which show that awareness of the problem is growing. The issues at hand are: does medical intervention really lead to an improved quality of life for children? Are the necessary facilities and training available to residents and students to assist them in this aspect? Can doctors make better use of facilities and training that already exist? These are issues that must remain in the spotlight. Only by focusing on them will palliative services for children become more utilized in the future. Garrett Reed Bird, B.Sc. References
A More Objective Approach For Selecting The Journal To Which One Submits A Manuscript Introduction There is considerable variability in the methods authors use to identify journals for manuscript submission, and this process may be difficult for some junior (and even some more senior) investigators. Given the wide range of potential journal-candidates for any article being submitted, we believed that a grid-instrument might help authors explicitly set journal selection priorities that reflect realities, hopes, and expectations. Our model is based on five main steps for authors. Step one: authors identify individualized criteria for submission. We produced a research- and pragmatically-based model list of criteria and subcriteria, and subjected it to a modified Delphi process with participants that ranged from junior investigators to seasoned editors. Our proposed list for authors' initial consideration includes: journal prestige, likelihood of manuscript acceptance, quality of review, rapidity of turnaround, and intangibles. Step two: authors weight criteria by importance/priority for that particular author for that particular manuscript. Step three: select potential candidate journals. Step four: score each criterion on a grid for each candidate journal. Step five: calculate scores, and rank journals. All five steps are explained in greater detail in our full model description, and examples of model grid implementation are provided. This method is rapid and can be engaging, and could make the submission process more efficient and effective. It should be particularly useful for those authors with little experience or external guidance, and for more senior authors who wish to make their journal selection process more explicit. A five-step analytic model
Authors' motives and methods for choosing a goal journal for manuscript submission vary.(1) Such decisions are probably typically made implicitly and informally, with a view to achieving the highest possible prestige, commensurate to the quality of the proposed manuscript.(1) Manuscript submission is accompanied by much uncertainty on how the material will be judged (2). Considering the vast array of existing journals, and hence the wide range of potential journals (and editorial reactions) for any article being submitted, it might be beneficial to identify a methodological instrument that helps authors explicitly and parsimoniously set journal selection priorities, in keeping with their own expectations. Such quantitative priority setting would enable authors to both structure and refine their thinking about this often subjective topic. The model is based on five main steps (Figure 1) that are outlined below. Step 1: Identifying the main priority-setting criteria The first step is to select which criteria to consider in deciding where to submit an article. Our model is outlined below, but authors should modify this model with their own procedures and considerations. To create our list, we produced a provisional list of criteria and subcriteria taken from prior work (1) and guided pragmatically. The list was submitted to 16 colleagues from various nationalities (Italy, Australia, USA, Russia, UK) and healthcare domains, who had in common experience as authors in national and international peer-reviewed journals. Many of these individuals had also served as reviewers and editors, and some were the junior faculty who are potential users of this method. Using the received observations, we constructed a final list, and propose including the following five criteria (Table 1): "Prestige", "Likelihood of acceptance", "Quality of review", "Rapidity of turnaround" and "Intangibles".
Step 2: Weighting the criteria In addition to selecting criteria, weighting the value of each assigned criterion also drives the outcome. In using our proposed method, authors would need to attentively assess the quality of their work, the rapidity with which they desire publication versus their need for prestigious publications, etc., in accordance with the criteria and subcriteria listed in step 1. The author should weight each criterion on a scale of 0 to 10, conforming with the above considerations. The criterion deemed most important by the author is assigned a value of 10 and the other criteria are rated accordingly. The scale is a rational scale, and the importance of the various criteria are represented proportionally, i.e. a value of 4 corresponds to an importance rating half the value of 8 and twice the value of 2. Decimal fractions of the points on the scale can also be used. A weight of 0 signifies that zero importance is attributed to that particular criterion for that particular manuscript. If there is more than one author, scoring could be conducted via a simplified two-round delphi method in which authors iteratively discuss (either electronically or through other media) and achieve consensus on their reasons for assigning particular weights. Scoring likely should be independent in the first round, but each author may revise his/her ratings on being informed (perhaps in aggregate, anonymous form) of the other authors' scores. A final determination could be made in a second round, with a decision created using consensus, a mean of authors' ratings, or other criteria. Step 3: Selecting the candidate journals The choice of candidate journals chiefly depends on an assessment of the manuscript and its prospects, the authors' personal objectives, and the objectives of the institutions for which the researchers work. The task is to reduce the extensive array of journals published throughout the world to a list of desirable candidates for subsequent ranking. A list may be generated from the authors' familiarity (keeping files on experiences with journals may help), colleagues' knowledge, a physical search in a local library, or via the Internet. One easily accessible source, for instance, is that of the journals listed by the main databases (3) or leading Impact Factor (IF) calculating companies (4), which often provide a service online and/or the option of receiving a free sample issue. Step 4: Rating each criterion GENERAL CONSIDERATIONS Most criteria proposed in this article require substantial subjective assessment, with only rapidity of turnaround and prestige (through using a journal's IF or Immediacy Index or readership composition) being more heavily based on objective elements. Each criterion's score should be represented on a scale of 0 to 10, identifying for each criterion the highest-ranking journal and giving it a rating of 10. Other journals will then be given a score directly or inversely proportional to that of the best journal. For example, if three journals (a,b,c) typically present a turnaround of 2 (a), 4 (b) and 10 weeks (c), the score given to the "Turnaround rapidity" criterion will be 10 for journal (a), which has the greatest rapidity. The score for journal b will be calculated by solving for x: a score of x is to a score of 10 as the inverse of 4 weeks is to the inverse of 2 weeks (i.e. x:10=1/4:1/2; or x=5) and the score for journal c bythe formula x:10=1/10:1/2 (i.e. 2). Some readers may find it easier to consider score calculation in the following way, solving for x: for journal b, a score of x (for journal b) is to a score of 10 (for journal a) as (using the inverse proportion, since a higher number of weeks is a worse outcome) 2 weeks is to 4 weeks (i.e. x/10=2/4; or x=5) and the score for journal c by the formula x/10=2/10 (i.e. 2). Where there is more than one author, the delphi methodology described in step 2 may be used. CRITERION 1: PRESTIGE Definition: The importance attributed to a particular journal. Specific considerations: A journal's prestige generally depends on reputation, reliability, circulation size, availability, and news coverage. There are somewhat objective methods for the measurement of prestige that rely mainly on citations in scientific journals; while these have been challenged and require critical, cautious adoption, they form a useful guide. The main methods of this kind are the Impact Factor (IF), measuring the frequency with which the "average article" in a journal has been cited in a particular year after publication, and the Immediacy Index, which considers citations made during the publication year of the quoted items. Another objective subcriterion is journal circulation, which can be measured by number of copies and readership estimates. The author may also be interested in impact via mass media and hence the level of attention paid to journals by the main press agencies. And prestige must be set in the context of specialty, particular objectives, and geography. For example, a laboratorian may prefer to publish a certain work in a journal from his/her own field rather than in a general medicine journal, even if the latter has a higher IF. Similarly, a European author might prefer to publish a work in a good national peer-reviewed journal than in a more renowned international one, bearing in mind the English-language barriers experienced in some countries and the author's desire for use/recognition of the work in their home country. In sum, the "prestige" criteria consider the relationship between perceived journal quality and appeal, and the ensuing personal and/or institutional benefits. Instructions: A subjective assessment must be made for each journal on a scale of 0 to 10 that considers such factors as reputation, reliability, circulation, availability, media coverage, and IF. The journal considered to be most prestigious should be assigned a score of 10, and the other journals proportionally lower scores. Where consideration is limited to just the IF, we are faced with an objective criterion. In this case, the journal with the highest IF will be given a score of 10 and the other journals a proportionally lower score in relation to their respective IFs. Let's suppose, for example, that there are three candidate journals: BMJ, Annals of Internal Medicine and New England Journal of Medicine, for which the IFs in 2000 were 5.331, 9.833 and 29.512, respectively. In this case, the New England Journal of Medicine will be assigned a criterion score of 10, BMJ a score of 2 (by approximation), derived by calculating the proportion 29.512:10=5.331:x, and the Annals of Internal Medicine a score of 3 (by approximation), derived by calculating the proportion 29.512:10=9.833:x. Data sources: IF values are published annually by the Journal of Citation Reports (JCR) of the Institute for Scientific Information (ISI). The report may be purchased from the ISI, or may be consulted at many medical libraries. As for subjective assessment, subcriteria might include prestige assigned to a journal by (a) colleagues at one's institution, (b) colleagues outsideone's institution in one's field, (c) other colleagues outside one's discipline, (d) one's Chair, (e) the promotions committee at one's institution, or (f) lay people to whom one will talk about one's work. CRITERION 2: LIKELIHOOD OF ACCEPTANCE Definition: Perception of the probability of a certain article being published in a certain journal Specific considerations: This crucial point requires both an impartial
view of one's paper (a skilled task) and a very good and current knowledge
of the rejection rate, how the target journal is managed, its mission,
and the sequence of publications on the same topic. Considerations should
include appropriateness of style/manuscript type and content, ability
to apply results to the journal's audience, a past record with the target
journal, and personal acquaintance with the Editor. Generally speaking,
the difficulty in being accepted increases as a journal's prestige increases.
Achievement of personal objectives thus demands careful weighting of all
criteria. Data sources: This is a criterion with many subjective and even unknowable aspects, but it is helpful to know the aims, target and rejection rate of potential journals; these can often be gleaned from the instructions for authors, which are usually available on the Web. CRITERION 3: QUALITY OF REVIEW Definition: Perception of the quality of the review process and that, whatever the outcome, there will be a benefit in terms of useful suggestions. Specific considerations: The helpfulness of the suggestions contained in the reviewed manuscript is linked to the ability of the editorial staff and pool of referees used by the journal, and concerns both the text and statistics/tables. Quality revisions make for good working relations, opportunities for professional growth, and improved articles. This criterion may warrant higher esteem than some authors might accord it, particularly for first submissions. Instructions: As with the prior criteria, a subjective assessment must be made for each journal on a scale of 0 to 10 that takes account of factors such as those described above, and the journal considered to be most advantageous should be assigned a score of 10 and the other journals proportionally lower scores. Data sources: This is a subjective criterion chiefly based on one's own, or one's colleagues' experiences, perceptions, and expectations. CRITERION 4: RAPIDITY OF TURNAROUND Definition: Speed with which the editor of a journal passes judgement on an article.
Specific considerations: Another critical parameter is the speed with which the journal reviews manuscripts and gives authors decisions. Many journals seem to give increasing attention to this factor, thereby shortening response times, in some cases taking advantage of communication by fax or entirely electronic communications. Some hard copy and on-line journals offer the interesting opportunity of following the revision process via Internet. Waiting times of 6 months and over, which still unfortunately occur, are becoming even less acceptable, with the result that many authors are becoming more able to act on a preference for journals that provide rapid reviews and decisions. Instructions: Whenever possible, an objective assessment must be made for each journal on a scale of 0 to 10. The journal considered to be most rapid must be assigned a score of 10 and the other journals proportionally lower scores. If data are not available, this criterion cannot be applied. Data sources: The rapidity of turnaround is sometimes indicated by the journal in the section of the Information for Authors that outlines their peer review process. In other cases, this information is based on one's own experience or that of colleagues, and can occasionally be inferred from acknowledgement letters. CRITERION 5: INTANGIBLES Definition: Perception of other mainly subjective advantages, such as an aesthetic preference for a certain journal, acquaintance with an editor, etc. Specific considerations: Lastly, there are less concrete factors that explicitly consider personal taste. These elements include personal preference for a certain journal, its editorial and graphical style, a liking for the editor or a member of the editorial board, or the desire to diversify the journals in which one publishes. Instructions: A subjective assessment must be made for each journal on a scale of 0 to 10 that takes account of factors such as those above described. The journal considered to be most advantageous must be assigned a score of 10, and the other journals proportionally lower scores. Data sources: It is a subjective criterion. Step 5: Calculating priorities The final choice of journal is made at the end of the process, using a simple mathematical priority-calculating formula. After weighting and rating the criteria, the total score can be calculated for each journal included in the author's list of candidates. Practically speaking, each criterion score is adjusted by the weight given to each criterion. Let us consider a finite number of candidate journals (a, b, c, ...) based on a finite number of criteria (1,2,3,4,5) which are given criterion weights (W1, W2, W3, W4, W5); these criteria and their weights are the same for all the candidate journals. Each journal also receives criterion scores (S1, S2, S3, S4, S5) which are calculated for each criterion for each alternative journal. The formula to calculate the priority score for journal (a) would therefore be as follows: Priority score forjournal (a) = [(criterion weight of criterion 1) x (criterion score attributed to journal a for criterion 1)] + [(criterion weight of criterion 2) x (criterion score attributed to journal a for criterion 2)] + [(criterion weight of criterion 3) x (criterion score attributed to journal a for criterion 3)] + [(criterion weight of criterion 4) x (criterion score attributed to journal a for criterion 4)] + [(criterion weight of criterion 5) x (criterion score attributed to journal a for criterion 5)] = [W1 x S(1a)] + [W2 x S(2a)] + [W3 x S(3a)] + [W4 x S(4a)] + [W5 x S(5a)]. Each of the 5 criteria receives a score based on its merits vs. those of the other candidate journals (see Table 2). Let's suppose for journal (a) that the maximum criterion score is given to "Prestige" (i.e. a score of 10), a score of 5 to "Likelihood of acceptance", a score of 5 to "Intangibles", a score of 9 to "Quality of review", and a score of 10 to "Rapidity of turnaround". Each of these scores is multiplied by the weight previously attributed to each criterion (for this example, let's assign: "Prestige"=10; "Likelihood of acceptance"=7, "Intangibles"=2; "Quality of review"=4; "Rapidity of turnaround"=5). Hence, the total score for journal (a) becomes: WS=(10x10) + (7x5) + (2x5) + (4x9) + (5x10) = 100+35+10+36+50 = 231. Priority scores are then calculated for the other candidate journals in the list (b, c, d, and e), which are then ranked, and the journal with the highest score gets priority of submission. Given this high score, an author may choose to first submit the paper
to journal (a). If the paper is rejected by journal (a), the author, preferably
after revision based on reviews, may submit the article to journal (b),
which presents the score immediately below. In the event of rejection
by (b), the author may behave in two ways. S/he may decide to submit the
manuscript to journal (c) or, since journal (c)'s ranking is well below
that of journal (a) (231) and (b) (206), may opt to repeat the assessment
process with additional candidate journals. These candidate journals for
reassessment (c, d, e) must be considered according to the first-time
assessment procedure, as described above. The proposed method is drawn in part from the Donaldson & Sox model for priority setting for the Office of Health Technology Assessment of the Agency for Healthcare Research and Quality, designed to determine which of the countless available health care technologies should be subject to systematic yearly assessment (5). Our model considerably simplifies theirs, particularly mathematically, and is (to the best of our knowledge) the only published method for objective determination of journal selection methodology. This novel approach to journal selection is a quantitative model. It is suggested because of its explicitness, and its ability to bring together different concepts and units of measurement in the same scale. It clarifies selection criteria, acknowledging their definitions, main characteristics, importance, and subjectivity. Subjective criteria may still prevail; while this method does not provide objective standards, it begins to pragmatically and explicitly outline the subjective and objective criteria for choosing the journal to which one submits a manuscript for publication. While some might find it rigid, time consuming, or overly quantitative, the method could be useful both for experienced authors who wish to make more explicit the criteria they use for deciding manuscript destinations, and for more junior authors whose lack of experience might benefit from a rational guide.
Mariotto, Aldo, M.D. Frank, Erica, M.D., M.P.H. References |
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