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IntroductionIn Canada, most provinces have established administrative health data repositories to facilitate access to these data for research. Anecdotally, researchers have described delays and substantial inter-provincial variations in the timeliness of data access approvals and receipt of data. Currently, the reasons for these delays and variations in timeliness are not well understood. This paper provides a study protocol for (1) identifying the factors affecting access to administrative health data for research within select Canadian provinces, and (2) comparing factors across provinces to assess whether and how they contribute to inter-provincial variations in access to administrative health data for research. MethodsA qualitative, multiple-case study research design will be used. Three cases will be included, representing three different provinces. For each case, data will be collected from documents and interviews. Specifically, interviews will be carried out with (1) research stakeholders, and (2) regulatory stakeholders (10 individuals/group*,2 groups/province * 3 provinces =$ 60). During within-case analysis, interview data for each stakeholder group will be analyzed separately using constant comparative analysis. Document analysis will occur iteratively, and will inform interview guide adaptation, and supplement interview data. Cross-case analysis will involve systematic comparison of findings across cases. DiscussionThis study represents the first in-depth examination of access to administrative health data in Canada. The main outcome will be an overarching mid-range theory explaining inter-provincial variations in access to administrative health data in Canada. This theory will be strengthened by the inclusion of the perspectives of both researchers and those involved in the regulation of data access. The findings from this study may be used to improve equitable and timely access to administrative health data across provinces, and may be transferable to other jurisdictions where barriers to access to administrative health data have been reported.

Objective: Our aim was to examine histopathological changes in three chronic wounds, and to assess whether the application of negative pressure wound therapy (NPWT) changes the wound bed environment. Method: - Results: We recruited three patients were recruited who had a non-healing wounds in excess of eight weeks. Histopathological changes in the wound bed supported the evidence that NPWT changes the wound bed environment by reducing inflammatory damage and facilitating wound bed perfusion with angiogenesis. Conclusion: We suggest that NPWT is a valuable adjunct to aid chronic wound healing. In this case series, we observed histopathological changes and improvement in the wounds, following one week's treatment with NPWT. Further analysis should be done to demonstrate any interaction between the cells involved in the wound healing process is enhanced, growth factor performance is optimised and cell migration is achieved following NPWT, in order to facilitate the healing process.

Introduction It is increasingly recognised that patients with end stage renal failure can have needs similar to those with advanced cancer. This is particularly relevant in patients who have opted for conservative management or who wish to withdraw from renal replacement therapy (RRT) and in those patients who are deteriorating despite RRT. In Shropshire a renal palliative multidisciplinary team (MDT) has been formed and it is recognised that mutual education is important in delivering a good service to these patients. Methods Joint workshops were held to identify learning needs and a two day programme was then designed and delivered in June/July 2017. Day one covered aspects of mortality/morbidity of RRT in an ageing population, conservative care, psychological adaptations and symptom management. Day two delivered communication skills training specific to renal scenarios, using simulated patients. Results The course was well attended and positively evaluated. Overall delegates reported an improved confidence in approaching end of life issues in renal patients and a recognition of the importance and benefit of a collaborative approach, with effective information sharing and ongoing co-education. Recognised especially was the complexity of an ageing and increasing frail population of patients and a recognition of the psychological adaptations over time to renal failure. Evaluations for communication skills training revealed increased confidence in initiating and expanding conversations, especially around advance care planning and resuscitation. Conclusion A greater understanding of the population we support and mutual education has resulted in closer working relationships within the renal palliative MDT. Dialysis end of life link nurses have planned spin-off educational sessions with frontline dialysis staff. The education programme is to be repeated in 2018 using a similar format. Similar streams of education in heart failure are planned.

Chitosan, a natural polysaccharide derivate from chitin, offers a promising alternative biomaterial for use in wound dressings. In this work, the safety and efficacy of a next-generation KA01 chitosan wound dressing in facilitating the healing of nonhealing chronic wounds was studied. This open multicenter comparative prospective randomized clinical study was conducted at three medical centers in China. A total of 90 patients (45 in test group and 45 in control group) with unhealed chronic wounds including pressure ulcers, vascular ulcers, diabetic foot ulcers, and wounds with minor infections, or at risk of infection, were treated with the next generation chitosan wound dressing as the test article or traditional vaseline gauze as a control. Baseline assessments were undertaken with the primary end point being wound area reduction. The secondary end points included pain reduction (using the NRS11 pain scale) at dressing change, wound exudate levels, wound depth and duration of the treatment. After 4 weeks treatment, the wound area reduction was significantly greater in the test group (65.97 ± 4.48%) than the control group (39.95 ± 4.48%). The average pain level in the test group was 1.12 ± 0.23 and 2.30 ± 0.23 in the control group. The wound depth was also lower in the test group 0.30 ± 0.48 cm than the control group 0.54 ± 0.86 cm. The level of exudate fell and the dressing could be removed integrally in both the test and control groups. The mean duration of the test group was 27.31 ± 5.37 days and control group 27.09 ± 6.44 days. No adverse events were reported in either group. In conclusion this open multicenter comparative prospective randomized clinical study has provided compelling evidence that the next generation chitosan wound dressing can enhance wound progression towards healing by facilitating wound reepithelialization and reducing the patients pain level. Furthermore the dressing was shown to be clinically safe and effective in the management of chronic wounds.

Introduction: Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy. Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction. Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually. Results: Fourteen sites (47%) required individual patient consent for the study to proceed as proposed. Three (10%) indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites (38%) did not require consent. Two (7%) suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites (60%) required full committee review. Sixteen (53%) allowed an external research assistant to abstract information from the health record. Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions.

The tort system is roundly indicted for its inadequacies in providing compensation in response to injury. More egregious is its response to injuries incurred due to negligence in the provision of healthcare services specifically. Despite numerous calls for reform, tort-based compensation has persisted as the norm to date. However, recent developments regarding physician malpractice lead to consideration of the possibility of a move to “no-fault” compensation for healthcare-related injuries. In this paper, I explore these developments, examine programs in various foreign jurisdictions which have adopted no-fault compensation for medical injury, and discuss the wisdom and feasibility of adopting an administratively-based compensation system for healthcare-related injury in Canada.A number of jurisdictions around the world have created administrative bodies whose role is to assess and allocate appropriate compensation in response to healthcare-related injuries. The primary motivation has been either to accomplish greater justice or to deal with burgeoning costs of the medical malpractice system (often accompanied by threatened collapse of the major insurer). The administrative scheme adopted may replace tort completely vis-a-vis claims within its purview, or it may permit the claimant to select either to pursue the administrative route or to launch a civil lawsuit. The scheme may be comprehensive, i.e., attempting to cover all healthcare-related injury, or may be limited to a particular type or extent of injury. For example, three jurisdictions have adopted programs exclusively focused on serious neurological injury surrounding birth trauma.Under these administrative schemes, an injured claimant must establish that the claimant fits within the program criteria, and therefore is entitled to compensation. The claimant is aided in the process by program administrative staff, and often by the complainant’s health care provider. Thus, the adversarial relationship between plaintiff and defendant is replaced by a system wherein the care provider may provide assistance to the injured person in seeking compensation.Numerous prominent individuals have argued in favour of reform of the Canadian tort-based medical malpractice, but governments have not been highly motivated to take action. However, the Canadian Medical Protective Association has recently sharply hiked the premiums paid for the defence of physicians and residents, in some cases an increase of close to 100 percent from 2014-15 to 2015-16. The lion’s share of these premiums is funded by provincial governments, whose budgets are straining as a result. The question to be addressed in this paper is: Are events now such that governments will indeed be motivated to take on reform, perhaps radical reform? These recent price increases, combined with an enhanced focus on patient safety, may provide the stimulus for revision of our system’s response to healthcare-related injury.

This non-comparative study explored the benefits of a natural gelling fibre dressing in 10 children with epidermolysis bullosa (EB). The clinical challenge in managing these children is that they often present with recalcitrant wounds that are perpetuated by critical colonisation, presence of biofilms and infection. KytoCel® (Aspen Medical) is a highly absorbent dressing composed of natural, biodegradable acylated chitosan. These fibres bond with wound exudate to form a clear gel that locks in fluid absorbs pathogens and is conformable to the wound bed. It also has haemostatic properties. ( Dutta PK et al, 2004 ; Lee et al, 2009 ; Stephen Haynes et al, 2014 ). Factors considered were whether the dressing could aid healing, reduce bleeding, reduce bioburden, be atraumatic and comfortable during wear time and removal.

INTRODUCTION when we speak of law we are referring to a set of rules. The formal construct of evidence-based (EB) decision making in clinical practice is a relatively new phenomenon, developed in the early 1990s by epidemiologists at McMaster University in Hamilton, Ontario in the context of evidence-based medicine (EBM). It was proclaimed by the New York Times Magazine in 2001 as one of the most influential ideas of the year. Discussion of its explicit application in the field of dentistry is very recent, with the first articles on the topic appearing in the late 1990s. In contrast, the use of evidence in law has a lengthy history; indeed, one might say it is as old as the law itself. What happens when the two (EB decision making in dental practice and evidence in law) are married? And are fears of a burgeoning likelihood of liability accurate, or do they constitute fear mongering? This article examines the role of evidence in law in the context of dental malpractice. It hones in on the concept of the standard of care in a dental malpractice lawsuit and on the derivation of an appropriate standard of care by judges and juries. Clinical practice guidelines are placed under the microscope in terms of their potential use in helping to set the standard of care in malpractice law. The article then reviews both positive and negative aspects of the move to reliance on clinical practice guidelines in dentistry. It concludes by arguing for the development of reliable, high quality guidelines as the best protection for dentists vis-a-vis the courts.

In September 2010, The Society of Obstetricians and Gynaecologists of Canada (SOGC) and The Association of Professors of Obstetrics and Gynaecology of Canada (APOG) issued an updated policy statement on pelvic examinations and consent.[1][1] The updated document contains a number of meaningful

Chitosan, a natural polysaccharide derivate from chitin, offers a promising alternative biomaterial for use in wound dressings. In this work, the safety and efficacy of a next-generation KA01 chitosan wound dressing in facilitating the healing of nonhealing chronic wounds was studied. This open multicenter comparative prospective randomized clinical study was conducted at three medical centers in China. A total of 90 patients (45 in test group and 45 in control group) with unhealed chronic wounds including pressure ulcers, vascular ulcers, diabetic foot ulcers, and wounds with minor infections, or at risk of infection, were treated with the next generation chitosan wound dressing as the test article or traditional vaseline gauze as a control. Baseline assessments were undertaken with the primary end point being wound area reduction. The secondary end points included pain reduction (using the NRS11 pain scale) at dressing change, wound exudate levels, wound depth and duration of the treatment. After 4 weeks treatment, the wound area reduction was significantly greater in the test group (65.97 ± 4.48%) than the control group (39.95 ± 4.48%). The average pain level in the test group was 1.12 ± 0.23 and 2.30 ± 0.23 in the control group. The wound depth was also lower in the test group 0.30 ± 0.48 cm than the control group 0.54 ± 0.86 cm. The level of exudate fell and the dressing could be removed integrally in both the test and control groups. The mean duration of the test group was 27.31 ± 5.37 days and control group 27.09 ± 6.44 days. No adverse events were reported in either group. In conclusion this open multicenter comparative prospective randomized clinical study has provided compelling evidence that the next generation chitosan wound dressing can enhance wound progression towards healing by facilitating wound reepithelialization and reducing the patients pain level. Furthermore the dressing was shown to be clinically safe and effective in the management of chronic wounds.

This study investigates the effect of a new short-stretch two-layer compression system in eight patients with common chronic lower-limb conditions in three locations in the UK. Chronic leg ulcers are the most common type of lower-limb ulceration with 70% caused by chronic venous hypertension. An appropriate level of compression is proven to heal chronic venous leg ulcers. The study was only a small sample of patients; however, the underlying conditions included chronic venous eczema, diabetes, sarcoma, cellulitis and mixed-aetiology ulcers. During the study, the UK experienced some of the hottest temperatures in the last 30 years. This had an impact on five patients, who noted an increase in malodour associated with their leg ulcers. CoFlex TLC (Aspen Medical Europe Ltd) foam comfort layer is impregnated with cyclodextrin—a naturally based oligosaccharide known to reduce malodour. The zinc-impregnated foam bandages in this study were viewed very favourably by both patients and staff, particularly those who had chronic venous eczema.

Canada was the last developed country in the world to remove thalidomide from the market, and doing so required an Act of Parliament. At the request of Health Canada’s then Food and Drug Directorate, thalidomide’s two manufacturers voluntarily withdrew the drug from the market on Mar. 2, 1962.[1

In “A Defense of Unqualified Medical Confidentiality,” Kenneth Kipnis (2006) makes the bold, even audacious, assertion that the professional obligation to prevent harm to third parties does not ope...

Aim The aim of this evaluation was to investigate ease of use and clinical performance of a new post-operative foam island dressing in female patients undergoing elective gynaecological surgery. Women undergoing surgery have genuine concerns regarding the risk of a hospital acquired infection. Methodology The new post-operative dressing was evaluated on 14 patients undergoing elective gynaecological surgery during two weeks in March 2011. Evaluators rated packaging and dressing ease of use, wear time, shower proof ability, skin blistering and ease of removal. Patients rated comfort of the dressing during wear time and removal. Results Nurses and Midwives rated blister prevention 100% (good), shower proof capabilities 86% (good) and ease of removal 79% (good). Patients rated comfort during wear time, skin integrity, and the importance of bathing (shower proof). No wound infections, peri wound maceration or adverse events were recorded. Conclusion Ensuring best patient outcomes and meeting individual needs remains the cornerstone of nursing practice. Reducing the risk of surgical site infections (SSI) remains a focus for NHS Trust throughout the UK particularly as Gynaelogical procedures require mandatory surveillance by the Health Protection Agency 1(The importance of patient comfort and ability to tend to hygiene needs is fundamental). The evaluated dressing has a flexible island pad allowing further tensile stretch and conformability when in situ. This was demonstrated in this study by both clinicians and patients in blister prevention, conformability, and patient comfort outcomes of this evaluation.

In October 2009, the academic health research community and the pharmaceutical industry were brought closer together with the appointment of Dr. Bernard Prigent, vice-president of Pfizer Canada, to the Governing Council of the Canadian Institutes of Health Research (CIHR). This bridging of the two

Background The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks. Methods Chairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank. Results There was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied. Conclusion Participants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation.

From virtually anywhere that an electronic signal can be received, a world of information is at our fingertips and hours of research can be reduced to minutes just by keying a few well-chosen words into a web portal. It is difficult to control the quantity of the information received, and the quality can range from wholly accurate and reliable to grossly misleading and even dangerous. In our homes it is up to us to judge what is useful and safe and what is not. When public institutions like libraries provide patrons with internet access, it may behove them to exercise some control over what sites are accessible as the potential for harm exists — particularly for those searching for health information.

A chronic wound audit was carried out at the Conquest Hospital, East Sussex, to establish the prevalence of chronic wounds within the Trust, in light of evaluation of the tissue viability service. At the time of audit the Trust employed two specialist nurses on a part time basis (3 days a week) with 2 days clinical work on the wards. A total of 372 patients were included in the audit, 56 patients had a total of 82 chronic wounds. These wounds were subdivided into wound types. The highest numbers of chronic wounds were pressure ulcers grade 1–4, including the new category of moisture lesions totalling 47.5%. Surgical wounds followed at 20.7%. There was a marked reduction in grade 3–4 pressure ulcers consistent with the pressure ulcer prevalence report from August 2006 that saw an overall reduction of hospital acquired pressure ulcers of 3.9%. This was attributed to the purchase of pressure relieving equipment, the development of a pressure ulcer help line and focused education on pressure ulcer prevention throughout the wards. The mean bed stay for both medical and surgical patients was 28.5 bed days but with surgical patients alone median bed stay was a staggering 45.5 days.

Much has been written since the first appearance of HIV/AIDS in 1981 about its effects on the Canadian health care and social services systems. However, researchers have given limited attention to issues of entry or re-entry to the competitive job market for HIV positive individuals. The emergence of highly active antiretroviral therapies (HAART) has allowed a significant number of persons who are HIV positive to experience a major recovery in health and energy. This increase in physical health has in turn led to a re-examination of the possibility of returning to former types and levels of activity, including the prospect of going back to work or entering the competitive workforce for the first time. The purpose of this paper is to outline some of the issues and concerns that impact HIV positive individuals' attempts to return to or enter the competitive workforce, particularly those relating to disability policies and public insurance. Data from in-depth interviews with a sample of people living with HIV/AIDS (PHAs) are used to help illustrate the disconnect between these policies and the lived experiences of PHAs. Also discussed are the opportunities for Canadian policies and practices to employ a functional definition of disability and a philosophy of early intervention in vocational rehabilitation.

Case reports in medicine are fundamentally individual patient stories generally describing unique or unexpected findings in terms of disease or treatment. Anecdotally based, they are considered to be less rigorous an evidentiary base than other types of research. As described by Jenicek (1), although case reports rank low on the scale of types of evidence to be relied on, they are highly important in their frequent role as the “first line of evidence”. Historically, case reports were published without consent of the patient. However, standards have been evolving in law and ethics such that consent should now be viewed as mandatory. The remainder of the present commentary provides justification for this assertion. The interests at stake include, on the one hand, confidentiality and autonomy and, on the other hand, the need for scientific advancement, described by Levine and Stagno (2) as “pedagogical freedom”. Since at least Hippocrates’ era, patients have been seen to be entitled to respect for the confidentiality of their personal health information (3). The elemental value of confidentiality is rooted in the need for absolute trust by patients that revelations of personal matters to health care providers will not be indiscriminately broadcasted. Furthermore, the right of the individual to choose among treatment options has been enshrined in the concept of ‘informed consent.’ Its roots may be found in the right to respect for autonomy, and the right to determine the course of treatment may be extended to the right to determine what may be done with personal information that is garnered along the way. There is also, however, great interest in scientific advancement, which has led to some reluctance to seek patient consent to publication of case reports for fear that a negative decision would result in a lack of opportunity to publicize new information that has been gained by a particular case. Psychiatrists, in particular, have voiced concern that patients may not consent due to the nature of their illness – Munchausen’s syndrome being emblematic of this concern (2,4). Thus, there are legitimate interests on both sides of this issue. However, arguably, confidentiality and autonomy are taking precedence in ethics and in law. Confidentiality is protected through federal and provincial legislation regarding information generally and health information specifically (57-7). Such legislation would require, at the least, that case reports not contain any identifiable information about a patient without the patient’s consent. Likewise, a number of medical journals have enshrined the protection of confidentiality into their guidelines for publication. The International Committee of Medical Journal Editors (8) requires informed consent for publication if identifiable information is to be used, but does not refer specifically to case reports. This is similar to the approach of the Paediatrics & Child Health journal (9). Following legal advice, the British Journal of Psychiatry (10) has adopted a guideline saying that consent must be obtained if an individual patient is described; if consent cannot be obtained, “the report can be published only if all details that would enable any reader (including the individual or anyone else) to identify the person are omitted”. It is important to note that, particularly for case reports in our digital age, the bar may actually be quite high under these laws and guidelines. Case reports often deal with a rare disease or constellation of characteristics and, therefore, a person may be identifiable even if no direct identifiers are mentioned. Furthermore, the prospect of identifiability has increased due to broader access to the case reports themselves, both by professionals and by the public more generally, through medical journals that previously had a circumscribed distribution range, but are now available online. This, combined with the fact that patients are being urged to access health information both online and through libraries, increases the likelihood that case reports will be viewed and individuals may be identified. Confidentiality is the obligation of third parties to guard the secrecy of personal information; informational privacy refers to the person or group’s entitlement to make decisions regarding uses of the information. Even if there is no reasonable prospect that the individual patient would be identified, autonomy and privacy interests are at stake. As stated above, autonomy is the underpinning for the doctrine of informed consent. The Supreme Court of Canada signalled a dramatic shift in the ‘doctor knows best’ phenomenon when it ruled that patients are entitled to make their own decisions (11). Privacy, with its concomitant right to make decisions regarding the use of one’s information, engages the autonomy interest even if identifiability is not of concern (12). There is a consensus in Canadian law that personal health information is “fundamentally one’s own” (13), and that individuals should, in most circumstances, be the ones deciding how the information should be used. It might be argued, therefore, that case reports, even without any identifiable information, cannot be published without consent (but it must be noted that this has not been addressed by any Canadian court). Indeed, this is the position taken by the Journal of Medical Case Reports (14), which has adopted a blanket requirement of informed consent before publication. In the case of immature minors and those unable to provide consent, consent is required from the parents or guardians. No case report is to be published in the absence of consent. It is notable that this Journal, which exclusively deals with case reports, has taken this strong stance in favour of informed consent. This takes us to the bottom line. Consent is certainly required under a confidentiality analysis for the publication of case reports that contain any identifiable information. Consent is arguably required under an autonomy analysis for all case reports.