Intellectual Property Chapter in Part 18: Intellectual Property and Communications

This chapter addresses the areas more commonly found in everyday practice (NB circuit layouts and plant breeder's rights are not covered). Importantly, IP law has become very specialised, and as such one for which practitioners will need expertise or access to relevant experts in order to properly provide advice. The following therefore is an overview only of relevant issues.

Concordance of genetic risk across migraine subgroups: Impact on current and future genetic association studies

BACKGROUND There has been intensive debate whether migraine with aura (MA) and migraine without aura (MO) should be considered distinct subtypes or part of the same disease spectrum. There is also discussion to what extent migraine cases collected in specialised headache clinics differ from cases from population cohorts, and how female cases differ from male cases with respect to their migraine. To assess the genetic overlap between these migraine subgroups, we examined genome-wide association (GWA) results from analysis of 23,285 migraine cases and 95,425 population-matched controls. METHODS Detailed heterogeneity analysis of single-nucleotide polymorphism (SNP) effects (odds ratios) between migraine subgroups was performed for the 12 independent SNP loci significantly associated (p < 5 x 10(-8); thus surpassing the threshold for genome-wide significance) with migraine susceptibility. Overall genetic overlap was assessed using SNP effect concordance analysis (SECA) at over 23,000 independent SNPs. RESULTS: Significant heterogeneity of SNP effects (p het < 1.4 x 10(-3)) was observed between the MA and MO subgroups (for SNP rs9349379), and between the clinic- and population-based subgroups (for SNPs rs10915437, rs6790925 and rs6478241). However, for all 12 SNPs the risk-increasing allele was the same, and SECA found the majority of genome-wide SNP effects to be in the same direction across the subgroups. CONCLUSIONS Any differences in common genetic risk across these subgroups are outweighed by the similarities. Meta-analysis of additional migraine GWA datasets, regardless of their major subgroup composition, will identify new susceptibility loci for migraine.

Frequency of dressing changes for central venous access devices on catheter-related infections

Background People admitted to intensive care units and those with chronic health care problems often require long-term vascular access. Central venous access devices (CVADs) are used for administering intravenous medications and blood sampling. CVADs are covered with a dressing and secured with an adhesive or adhesive tape to protect them from infection and reduce movement. Dressings are changed when they become soiled with blood or start to come away from the skin. Repeated removal and application of dressings can cause damage to the skin. The skin is an important barrier that protects the body against infection. Less frequent dressing changes may reduce skin damage, but it is unclear whether this practice affects the frequency of catheter-related infections. Objectives To assess the effect of the frequency of CVAD dressing changes on the incidence of catheter-related infections and other outcomes including pain and skin damage. Search methods In June 2015 we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We also searched clinical trials registries for registered trials. There were no restrictions with respect to language, date of publication or study setting. Selection criteria All randomised controlled trials (RCTs) evaluating the effect of the frequency of CVAD dressing changes on the incidence of catheter-related infections on all patients in any healthcare setting. Data collection and analysis We used standard Cochrane review methodology. Two review authors independently assessed studies for inclusion, performed risk of bias assessment and data extraction. We undertook meta-analysis where appropriate or otherwise synthesised data descriptively when heterogeneous. Main results We included five RCTs (2277 participants) that compared different frequencies of CVAD dressing changes. The studies were all conducted in Europe and published between 1995 and 2009. Participants were recruited from the intensive care and cancer care departments of one children's and four adult hospitals. The studies used a variety of transparent dressings and compared a longer interval between dressing changes (5 to15 days; intervention) with a shorter interval between changes (2 to 5 days; control). In each study participants were followed up until the CVAD was removed or until discharge from ICU or hospital. - Confirmed catheter-related bloodstream infection (CRBSI) One trial randomised 995 people receiving central venous catheters to a longer or shorter interval between dressing changes and measured CRBSI. It is unclear whether there is a difference in the risk of CRBSI between people having long or short intervals between dressing changes (RR 1.42, 95% confidence interval (CI) 0.40 to 4.98) (low quality evidence). - Suspected catheter-related bloodstream infection Two trials randomised a total of 151 participants to longer or shorter dressing intervals and measured suspected CRBSI. It is unclear whether there is a difference in the risk of suspected CRBSI between people having long or short intervals between dressing changes (RR 0.70, 95% CI 0.23 to 2.10) (low quality evidence). - All cause mortality Three trials randomised a total of 896 participants to longer or shorter dressing intervals and measured all cause mortality. It is unclear whether there is a difference in the risk of death from any cause between people having long or short intervals between dressing changes (RR 1.06, 95% CI 0.90 to 1.25) (low quality evidence). - Catheter-site infection Two trials randomised a total of 371 participants to longer or shorter dressing intervals and measured catheter-site infection. It is unclear whether there is a difference in risk of catheter-site infection between people having long or short intervals between dressing changes (RR 1.07, 95% CI 0.71 to 1.63) (low quality evidence). - Skin damage One small trial (112 children) and three trials (1475 adults) measured skin damage. There was very low quality evidence for the effect of long intervals between dressing changes on skin damage compared with short intervals (children: RR of scoring ≥ 2 on the skin damage scale 0.33, 95% CI 0.16 to 0.68; data for adults not pooled). - Pain Two studies involving 193 participants measured pain. It is unclear if there is a difference between long and short interval dressing changes on pain during dressing removal (RR 0.80, 95% CI 0.46 to 1.38) (low quality evidence). Authors' conclusions The best available evidence is currently inconclusive regarding whether longer intervals between CVAD dressing changes are associated with more or less catheter-related infection, mortality or pain than shorter intervals.

Development, reliability and validity of the queensland evaluation of wheelchair skills (QEWS)

- Objectives To develop and test a valid and reliable assessment of wheelchair skills for individuals with spinal cord injuries (SCI); the Queensland Evaluation of Wheelchair Skills (QEWS). - Setting Hospital, Australia. - Methods Phase 1: Four Delphi panel rounds with clinical experts were used to develop the QEWS. Phase 2: Intra-rater and inter-rater reliability of the QEWS items were examined in 100 people with SCI. Phase 3a: Concurrent validity was investigated by examining the association between QEWS total scores and physiotherapists’ global ratings of wheelchair skill performance. Phase 3b: Construct validity was tested in 20 people with recent SCI by examining change in QEWS total scores between when they first mobilised in a wheelchair and scores obtained 10 weeks later. - Results Phase 1: The QEWS was developed. Phase 2: The intra-class correlation coefficients reflecting the intra-rater reliability and the inter-rater reliability for the QEWS total score were 1.00 and 0.98, with scores being within one point of each other 96 and 91% of the time, respectively. Phase 3a: The QEWS total scores were comparable with the global rating of wheelchair skill performance (r2=0.93). Phase 3b: The QEWS scores changed by a median (interquartile range (IQR)) of 4 (1 to 6) points over the 10-week period following first wheelchair mobilisation. - Conclusion The QEWS is a valid and reliable tool for measuring wheelchair skills in individuals with SCI. The QEWS is efficient and practical to administer and does not require specialised equipment.

Heparin versus 0.9% sodium chloride intermittent flushing for the prevention of occlusion in long term central venous catheters in infants and children: A systematic review

Background Around the world, guidelines and clinical practice for the prevention of complications associated with central venous catheters (CVC) vary greatly. To prevent occlusion, most institutions recommend the use of heparin when the CVC is not in use. However, there is debate regarding the need for heparin and evidence to suggest normal saline may be as effective. The use of heparin is not without risk, may be unnecessary and is also associated with increased costs. Objectives To assess the clinical effects (benefits and harms) of heparin versus normal saline to prevent occlusion in long-term central venous catheters in infants, children and adolescents. Design A Cochrane systematic review of randomised controlled trials was undertaken. - Data sources: The Cochrane Vascular Group Specialised Register (including MEDLINE, CINAHL, EMBASE and AMED) and the Cochrane Register of Studies were searched. Hand searching of relevant journals and reference lists of retrieved articles was also undertaken. - Review Methods: Data were extracted and appraisal undertaken. We included studies that compared the efficacy of normal saline with heparin to prevent occlusion. We excluded temporary CVCs and peripherally inserted central catheters. Rate ratios per 1000 catheter days were calculated for two outcomes, occlusion of the CVC, and CVC-associated blood stream infection. Results Three trials with a total of 245 participants were included in this review. The three trials directly compared the use of normal saline and heparin. However, between studies, all used different protocols with various concentrations of heparin and frequency of flushes. The quality of the evidence ranged from low to very low. The estimated rate ratio for CVC occlusion per 1000 catheter days between the normal saline and heparin group was 0.75 (95% CI 0.10 to 5.51, two studies, 229 participants, very low quality evidence). The estimated rate ratio for CVC-associated blood stream infection was 1.48 (95% CI 0.24 to 9.37, two studies, 231 participants; low quality evidence). Conclusions It remains unclear whether heparin is necessary for CVC maintenance. More well-designed studies are required to understand this relatively simple, but clinically important question. Ultimately, if this evidence were available, the development of evidenced-based clinical practice guidelines and consistency of practice would be facilitated.

Inpatient experience of anorexia nervosa

Anorexia nervosa (AN) is an extremely serious mental illness, with a high mortality rate and many debilitating physical and psychological symptoms. While hospitalisation is sometimes required for patients with AN there remains no evidence base for “best practice’ inpatient treatment. With patients’ views recognised as critical to improving efficiency and outcomes, calls have been made for more qualitative research into inpatients’ experiences. In light of this the current paper utilised thematic analysis to examine 16 semi-structured interviews with inpatients diagnosed with AN, at a specialised eating disorders hospital unit. The study found an overarching theme of relationship ambivalence in connection with sub-themes of patients’ eating disorders, eating disorder co-patients, staff and treatment. Participants’ goals in relationship to their eating disorder and engagement in treatment shaped and were shaped by interactions with other inpatients with AN and staff. Clinical implications for this study and future research directions are discussed.

Intensive versus conventional glycaemic control for treating diabetic foot ulcers

Background The estimated likelihood of lower limb amputation is 10 to 30 times higher amongst people with diabetes compared to those without diabetes. Of all non-traumatic amputations in people with diabetes, 85% are preceded by a foot ulcer. Foot ulceration associated with diabetes (diabetic foot ulcers) is caused by the interplay of several factors, most notably diabetic peripheral neuropathy (DPN), peripheral arterial disease (PAD) and changes in foot structure. These factors have been linked to chronic hyperglycaemia (high levels of glucose in the blood) and the altered metabolic state of diabetes. Control of hyperglycaemia may be important in the healing of ulcers. Objectives To assess the effects of intensive glycaemic control compared to conventional control on the outcome of foot ulcers in people with type 1 and type 2 diabetes. Search methods In December 2015 we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; EBSCO CINAHL; Elsevier SCOPUS; ISI Web of Knowledge Web of Science; BioMed Central and LILACS. We also searched clinical trial databases, pharmaceutical trial databases and current international and national clinical guidelines on diabetes foot management for relevant published, non-published, ongoing and terminated clinical trials. There were no restrictions based on language or date of publication or study setting. Selection criteria Published, unpublished and ongoing randomised controlled trials (RCTs) were considered for inclusion where they investigated the effects of intensive glycaemic control on the outcome of active foot ulcers in people with diabetes. Non randomised and quasi-randomised trials were excluded. In order to be included the trial had to have: 1) attempted to maintain or control blood glucose levels and measured changes in markers of glycaemic control (HbA1c or fasting, random, mean, home capillary or urine glucose), and 2) documented the effect of these interventions on active foot ulcer outcomes. Glycaemic interventions included subcutaneous insulin administration, continuous insulin infusion, oral anti-diabetes agents, lifestyle interventions or a combination of these interventions. The definition of the interventional (intensive) group was that it should have a lower glycaemic target than the comparison (conventional) group. Data collection and analysis All review authors independently evaluated the papers identified by the search strategy against the inclusion criteria. Two review authors then independently reviewed all potential full-text articles and trials registry results for inclusion. Main results We only identified one trial that met the inclusion criteria but this trial did not have any results so we could not perform the planned subgroup and sensitivity analyses in the absence of data. Two ongoing trials were identified which may provide data for analyses in a later version of this review. The completion date of these trials is currently unknown. Authors' conclusions The current review failed to find any completed randomised clinical trials with results. Therefore we are unable to conclude whether intensive glycaemic control when compared to conventional glycaemic control has a positive or detrimental effect on the treatment of foot ulcers in people with diabetes. Previous evidence has however highlighted a reduction in risk of limb amputation (from various causes) in people with type 2 diabetes with intensive glycaemic control. Whether this applies to people with foot ulcers in particular is unknown. The exact role that intensive glycaemic control has in treating foot ulcers in multidisciplinary care (alongside other interventions targeted at treating foot ulcers) requires further investigation.

Editorial: Special Issue on Performing Arts

This special issue of the journal Performance Enhancement and Health has been produced to both showcase and further contribute to the growing literature on the unique and specialised field of the performing arts. Over the past two decades, the application of sports-based approaches to performance enhancement and health has grown exponentially in its application to the performing arts sector; however, whilst these two fields share many similarities including individuals working both physically and mentally for many years to be able to perform at their best in their chosen discipline (e.g., dance, music), significant differences exist...