Factors affecting access to administrative health data for research in Canada: a study protocol.

INTRODUCTION: In 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. METHODS: A 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. DISCUSSION: This 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.

A histological analysis of chronic wounds treated with negative pressure wound therapy to aid healing: a case series.

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.

An open multicenter comparative randomized clinical study on chitosan.

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.

Use of fibre dressings in children with severe epidermolysis bullosa.

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.

Incorporating novel solutions to lower-limb problems into compression formularies.

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.

Performance and ease of use evaluation of a new surgical post-operative foam island dressing in 14 patients undergoing elective gynaecological surgery.

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.

Who's minding the shop? The role of Canadian research ethics boards in the creation and uses of registries and biobanks.

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.

Chronic wound audit: evaluation of a tissue viability service.

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.

Back to work: vocational issues and strategies for Canadians living with HIV/AIDS.

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.