Perceptions of Painful Diabetic Peripheral Neuropathy in South-East Asia: Results from Patient and Physician Surveys

Abstract

There are no data on physician–patient communication in painful diabetic peripheral neuropathy (pDPN) in the Asia–Pacific region. The objective of this study was to examine patient and physician perceptions of pDPN and clinical practice behaviors in five countries in South-East Asia. Primary care physicians and practitioners, endocrinologists, diabetologists, and patients with pDPN completed separate surveys on pDPN diagnosis, impact, management, and physician–patient interactions in Hong Kong, Malaysia, the Philippines, Taiwan, and Thailand. Data were obtained from 100 physicians and 100 patients in each country. The majority of physicians (range across countries, 30–85%) were primary care physicians and practitioners. Patients were mostly aged 18–55 years and had been diagnosed with diabetes for >5 years. Physicians believed pDPN had a greater impact on quality of life than did patients (ranges 83–92% and 39–72%, respectively), but patients believed pDPN had a greater impact on items such as sleep, anxiety, depression, and work than physicians. Physicians considered the diagnosis and treatment of pDPN a low priority, which may be reflected in the generally low incidence of screening (range 12–65%) and a lack of awareness of pDPN. Barriers to treatment included patients' lack of awareness of pDPN. Both physicians and patients agreed that pain scales and local language descriptions were the most useful tools in helping to describe patients' pain. Most patients were monitored upon diagnosis of pDPN (range 55–97%), but patients reported a shorter duration of monitoring compared with physicians. Both physicians and patients agreed that it was patients who initiated conversations on pDPN. Physicians most commonly referred to guidelines from the American Diabetes Association or local guidelines for the management of pDPN. This study highlights important differences between physician and patient perceptions of pDPN, which may impact on its diagnosis and treatment. For a chronic and debilitating complication like pDPN, the physician–patient dialogue is central to maximizing patient outcomes. Strategies, including education of both groups, need to be developed to improve communication.

Funding

Pfizer.

http://ift.tt/2rcvzc7

Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence

Abstract

Introduction

The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit–risk balance.

Methods

This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan. Long-term IOP and safety data were collected.

Results

Of the 4502 patients registered from 553 medical institutions, 4265 patients were analyzed. The majority of patients had normal-tension glaucoma (44.4%) and primary open-angle glaucoma (37.8%), and patients with ocular hypertension constituted 7.0%. Treatment patterns with tafluprost during the study period were as follows: naïve monotherapy (48.1%), switching monotherapy (18.4%), and concomitant therapy (33.5%). In all patients analyzed, mean IOP was significantly reduced from 18.6 ± 5.9 mmHg (month 0) to 15 mmHg or below throughout the 2-year observation period after initiation of tafluprost. Significant IOP-lowering effects were shown in various treatment patterns and disease types. Adverse reactions were observed in 795 patients (18.64%). Major adverse reactions included eyelid pigmentation, ocular hyperemia, eyelash changes, eyelid hypertrichosis, and iris hyperpigmentation. Kaplan–Meier curves showed that 84.6% and 76.1% of patients were persistent on tafluprost for 1 and 2 years, respectively, when discontinuation due to insufficient efficacy or adverse events was defined as a treatment failure event. Furthermore, among treatment-naïve patients (n = 2304), the persistency rates on tafluprost monotherapy were 77.0% for 1 year and 67.0% for 2 years.

Conclusion

Tafluprost showed significant long-term IOP-lowering effects regardless of treatment patterns or diagnosis, with minimum safety concerns in the actual clinical practice. The observed treatment persistence suggests that tafluprost can be used long term owing to its benefit–risk profile.

Funding

Santen Pharmaceutical Co., Ltd., Osaka, Japan.

http://ift.tt/2qdS0QQ

Protocol for the development of a Core Outcome Set (COS) for hemorrhoidal disease: an international Delphi study

Abstract

Purpose

Over the last decade, many studies were performed regarding treatment options for hemorrhoidal disease. Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes. However, the reported outcome measures are numerous and diverse. The heterogeneity of outcome definition in clinical trials limits transparency and paves the way for bias. The development of a core outcome set (COS) helps minimizing this problem. A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease. The aim of this project is to generate a COS regarding the outcome of treatment after hemorrhoidal disease.

Methods

A Delphi study will be performed by an international steering group healthcare professionals and patients with the intention to create a standard outcome set for future clinical trials for the treatment of hemorrhoidal disease. First, a literature review will be conducted to establish which outcomes are used in clinical trials for hemorrhoidal disease. Secondly, both healthcare professionals and patients will participate in several consecutive rounds of online questionnaires and a face-to-face meeting to refine the content of the COS.

Discussion

Development of a COS for hemorrhoidal disease defines a minimum outcome-reporting standard and will improve the quality of research in the future.

http://ift.tt/2rcLxCM

Sociodemographic predictors of participation in colorectal cancer screening

Abstract

Purpose

Colorectal cancer screening by inviting citizens to complete a test for blood in faeces was initiated in Denmark in 2014. We have examined sociodemographic predictors that influence participation to identify factors that could be targeted to increase compliance.

Methods

National registers were used to link data on invitations for colorectal cancer screening in Denmark from 2014 to 2015. Region of residence, age, gender, immigration status, income, educational level and marital status were identified. Logistic regression analysis was used to estimate the risk of non-participation for invited citizens while adjusting for all other sociodemographic variables.

Results

A total of 854,237 individuals were included in the analysis. The national participation proportion was 65.33%, with significant differences between sociodemographic groups. Participation proportions were the lowest in non-Western immigrants (53.00%), individuals without a partner (54.05%) and those in the lowest income quartile (54.65%), with subgroup participation as low as 40.56%. The highest participation proportion was seen in individuals in the highest income quartile (71.56%). Region of residence, age, gender, educational level, income quartile, marital status and immigration status all had statistically significant independent differences in risk of non-participation after full model adjustment.

Conclusion

Participation in colorectal cancer screening was high in Denmark in 2014 and 2015. Large differences in participation were seen between sociodemographic subgroups, potentially resulting in social inequality in the benefits from screening. Future efforts to increase participation should focus on the low compliance subgroups, such as singles, non-Western immigrants and people from the lowest socioeconomic groups.

http://ift.tt/2qdVsuR

An in vitro evaluation of sagittal alignment in the cervical spine after insertion of supraphysiologic lordotic implants

Abstract

Purpose

Cervical spine malalignment can develop as a consequence of degenerative disc disease or following spinal surgery. When normal sagittal alignment of the spine is disrupted, further degeneration may occur adjacent to the deformity. The purpose of this study was to investigate changes in lordosis and sagittal alignment in the cervical spine after insertion of supraphysiologic lordotic implants.

Methods

Eight cadaveric cervical spines (Occiput-T1) were tested. The occiput was free to translate horizontally and vertically but constrained from angular rotation. The T1 vertebra was rigidly fixed with a T1 tilt of 23°. Implants with varying degrees of lordosis were inserted starting with single-level constructs (C5–C6), followed by two (C5–C7), and three-level (C4–C7) constructs. Changes in sagittal alignment, Occ-C2 angle, cervical lordosis (C2–7), and segmental lordosis were measured.

Results

Increasing cage lordosis led to global increases in cervical lordosis. As implanted segmental lordosis increased, the axial levels compensated by decreasing in lordosis to maintain horizontal gaze. An increase in cage lordosis also corresponded with larger changes in SVA.

Conclusion

Reciprocal compensation was observed in the axial and sub-axial cervical spine, with the Occ-C2 segment undergoing the largest compensation. Adding more implant lordosis led to larger reciprocal changes and changes in SVA. Implants with supraphysiologic lordosis may allow for additional capabilities in correcting cervical sagittal plane deformity, following further clinical evaluation.

http://ift.tt/2pwlNF3

A case of arteriovenous fistula of the cauda equina fed by the proximal radicular artery: anatomical features and treatment precautions

Abstract

Purpose

Arteriovenous fistula (AVF) of the cauda equina (CE) fed by the proximal radicular artery (PRA) is very rare, and the differentiation from that of the filum terminale (FT) is important to avoid treatment-related injury to the CE when endovascular treatment is selected. The authors describe a case of AVF of the CE fed by the PRA, demonstrate the anatomical features and discuss the treatment precautions.

Methods

A 69-year-old man presented with a transient weakness of lower limbs. Spinal angiography and magnetic resonance (MR) imaging revealed AVF, of which the feeding artery arose from the anterior spinal artery (ASA), forming the fistula at L2 level to be drained into the longitudinal venous trunk. Under a tentative diagnosis of AVF of the FT, endovascular treatment was attempted but failed due to impossible catheterization into the ASA. Therefore, surgery was performed.

Results

Intraoperative finding revealed that the feeding artery and draining vein were not on the FT but on the CE, resulting in the proper diagnosis of AVF of the CE. Surgical clips were applied to the draining vein closest to the fistula, and postoperatively the symptom improved gradually. Although we thoroughly reevaluated spinal angiography and MR images postoperatively, AVF of the CE fed by the PRA and that of the FT were not distinguishable.

Conclusions

The authors described a case of AVF of the CE fed by the PRA and demonstrated the difficulty of the differentiation from that of the FT. The utmost precautions are necessary when endovascular treatment is selected.

http://ift.tt/2qgWAf0

Cytokine gene polymorphism associations with congenital cytomegalovirus infection and sensorineural hearing loss

Abstract

Cytomegalovirus (CMV) is the most common viral agent of congenital infections and a leading nongenetic cause of sensorineural hearing loss (SNHL). The host immunologic factors that render a developing foetus prone to intrauterine CMV infection and development of hearing loss are unknown. The aim of this study was to assess the potential associations between the polymorphisms within cytokine and cytokine receptors genes, and the risk of congenital CMV infection, and the hearing outcome. A panel of 11 candidate single nucleotide polymorphisms (SNPs): TNF rs1799964, TNF rs1800629, TNFRSF1A rs4149570, IL1B rs16944, IL1B rs1143634, IL10 rs1800896, IL10RA rs4252279, IL12B rs3212227, CCL2 rs1024611, CCL2 rs13900, CCR5 rs333 was genotyped in 470 infants (72 with confirmed intrauterine CMV infection and 398 uninfected controls), and related to congenital CMV infection, and the outcome. In multivariate analysis, the IL1B rs16944 TT and TNF rs1799964 TC genotypes were significantly associated with intrauterine CMV infection (aOR = 2.32; 95% CI, 1.11–4.89; p = 0.032, and aOR = 2.17, 95% CI, 1.25–3.77; p = 0.007, respectively). Twenty-two out of 72 congenitally infected newborns had confirmed SNHL. Carriers of CT or TT genotype of CCL2 rs13900 had increased risk of hearing loss at birth and at 6 months of age (aOR = 3.59; p = 0.028 and aOR = 4.10; p = 0.039, respectively). This is the first study to report an association between SNPs in IL1B, TNF, and CCL2, and susceptibility to congenital CMV infection (IL1B and TNF) and SNHL (CCL2).

http://ift.tt/2qdJBN8