Factors Influencing the Participation of Older People in Clinical Trials : Data Analysis from the MAVIS Trial

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The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial

Introduction People with type 1 diabetes (T1DM) require insulin therapy to sustain life, and need optimal glycaemic control to prevent diabetic ketoacidosis and serious long-term complications. Insulin is generally administered using multiple daily injections but can also be delivered using an infusion pump (continuous subcutaneous insulin infusion), a more costly option with benefits for some patients. The UK National Institute for Health and Care Excellence (NICE) recommend the use of pumps for patients with the greatest need, citing insufficient evidence to approve extension to a wider population. Far fewer UK adults use pumps than in comparable countries. Previous trials of pump therapy have been small and of short duration and failed to control for training in insulin adjustment. This paper describes the protocol for a large randomised controlled trial comparing pump therapy with multiple daily injections, where both groups are provided with high-quality structured education. Methods and analysis A multicentre, parallel group, cluster randomised controlled trial among 280 adults with T1DM. All participants attended the week-long dose adjustment for normal eating (DAFNE) structured education course, and receive either multiple daily injections or pump therapy for 2 years. The trial incorporates a detailed mixed-methods psychosocial evaluation and cost-effectiveness analysis. The primary outcome will be the change in glycosylated haemoglobin (HbA1c) at 24 months in those participants whose baseline HbA1c is at or above 7.5% (58 mmol/mol). The key secondary outcome will be the proportion of participants reaching the NICE target of an HbA1c of 7.5% (58 mmol/mol) or less at 24 months. Ethics and dissemination The protocol was approved by the Research Ethics Committee North West, Liverpool East and received Medicines and Healthcare products Regulatory Agency (MHRA) clinical trials authorisation. Each participating centre gave National Health Service R&D approval. We shall disseminate study findings to study participants and through peer reviewed publications and conference presentations, including lay user groups. Trial registration number ISRCTN 61215213

The Men's Safer Sex (MenSS) trial: protocol for a pilot randomised controlled trial of an interactive digital intervention to increase condom use in men

Sexually transmitted infections (STI) are a major public health problem. Condoms provide effective protection but there are many barriers to use. Face-to-face health promotion interventions are resource-intensive and show mixed results. Interactive digital interventions may provide a suitable alternative, allowing private access to personally tailored behaviour change support. We have developed an interactive digital intervention (the Men's Safer Sex (MenSS) website) which aims to increase condom use in men. We describe the protocol for a pilot trial to assess the feasibility of a full-scale randomised controlled trial of the MenSS website in addition to usual sexual health clinical care

The Relationship between Diabetes Mellitus and Health-Related Quality of Life in Korean Adults: The Fourth Korea National Health and Nutrition Examination Survey (2007-2009)

BackgroundDiabetes is a major health problem in Korea. However, interest in the quality of life in patients with diabetes is low. We examined the effects of diabetes on health-related quality of life (HRQoL) and compared it with HRQoL in the general Korean population using the Fourth Korea National Health and Nutrition Examination Survey (KNHANES IV) (2007-2009).MethodsUsing KNHANES IV data, we compared EuroQol (EQ)-5D and EQ-visual analogue scale (VAS) scores after adjusting for sociodemographic and psychosocial factors as well as for comorbidities (hypertension, heart disease, stroke, arthritis, and chronic renal disease). Logistic regressions were used to explore determinants for the lowest quintile HRQoL scales in the diabetes group.ResultsThe mean age of the 14,441 enrolled subjects (6,129 men and 8,312 women) was 52.5±14.5 years. The mean EQ-5D and EQ-VAS scores were significantly lower in the diabetes group (EQ-5D. 0.87; EQ-VAS, 71.94) than in the non-diabetes group (EQ-5D, 0.94; EQ-VAS, 77.40) (P<0.001). Self-reported depressive symptom had a significant effect on lowering the EQ-VAS (odds ratio [OR], 1.7; 95% confidence interval [CI], 1.1 to 2.6) in the diabetes group. Stress level had a significant effect in lowering both the EQ-5D (OR, 2.0; 95% CI, 1.3 to 2.9) and the EQ-VAS (OR, 1.9; 95% CI, 1.3 to 2.9). HbA1c, diabetes duration, and treatment modalities had no significant effect on lowering HRQoL.ConclusionDiabetes was clearly associated with impaired HRQoL compared with the non-diabetic population regardless of comorbidities. Therapeutic approaches should focus much more on the subjective perception of health in patients with diabetes

Access to and use of clinical services and disease-modifying therapies by people with progressive multiple sclerosis in the United Kingdom

Background: According to current UK guidelines everyone with progressive MS should have access to an MS Specialist but levels of access and use of clinical services is unknown. Our objective was to investigate access to MS Specialists, use of clinical services and disease-modifying therapies (DMTs) by people with progressive MS in the United Kingdom. Methods: A UK wide, online survey was conducted via the UK MS Register. Inclusion criteria: age over 18 years, primary or secondary progressive MS and a member of the UK MS Register. Participants were asked about access to MS Specialists; recent clinical service use; receipt of regular review and current and previous DMT use. Participant demographics; quality of life and disease impact measures were supplied from the UK MS Register. Results: In total 1298 participants responded: 5% were currently taking DMT; 23% had previously taken DMT; and 95% reported access to an MS Specialist. Most utilised services were: MS Doctor/Nurse (50%), General Practitioner (45%), and Physiotherapist (40%). Seventy-four percent received a regular review although 37% received theirs less than annually. Current DMT use was associated with better quality of life but past DMT use was associated with poorer quality of life and higher impact of disease. Conclusions: Access to, and use of, MS Specialists was high. However a gap in service provision was highlighted in both receiving and frequency of regular reviews

Reliability and validity of a self-administration version of DEMQOL-Proxy.

: This study aimed to investigate the reliability and validity of a self-administered version of DEMQOL-Proxy, a disease-specific instrument that measures health-related quality of life in people with dementia. : The sample consisted of 173 informal carers of people with dementia, aged 29 to 89 years old. Carers were mostly female, White/White British and closely related to the patient. They completed DEMQOL-Proxy (self-administered), EQ-5D-3L (proxy reported about the person with dementia), EQ-5D-3L (self-reported about their own health) and the Zarit Burden Interview. Using well-established methods from classical test theory, we evaluated scale level acceptability, reliability and convergent, discriminant and known-groups validity of DEMQOL-Proxy. : DEMQOL-Proxy (self-administered) showed high acceptability (3.5% missing data and 0% scores at floor or ceiling), high internal consistency reliability (α = 0.93) and good convergent and discriminant validity. Amongst others, we found a moderately high correlation with EQ-5D-3L proxy reported (r = 0.52) and low to essentially zero correlations with EQ-5D-3L self-reported (r = 0.20) and carer and patient background variables (r ≤ 0.20). As predicted, DEMQOL-Proxy (self-administered) showed a modest correlation with DEMQOL (r = 0.32). Known-groups differences on health-related quality of life (comparing people with versus people without cognitive impairment) were of moderate effect size (d = 0.38) and in the expected direction. : DEMQOL-Proxy (self-administered) has comparable acceptability, reliability and validity with DEMQOL-Proxy (interviewer administered). DEMQOL-Proxy (self-administered) can be used in a wider variety of contexts than its interviewer-administered version, including routine use in busy clinics. Copyright © 2016 John Wiley &amp; Sons, Ltd.<br/

Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in acute lung injury to reduce pulmonary dysfunction (HARP-2) trial : study protocol for a randomized controlled trial

Acute lung injury (ALI) is a common devastating clinical syndrome characterized by life-threatening respiratory failure requiring mechanical ventilation and multiple organ failure. There are in vitro, animal studies and pre-clinical data suggesting that statins may be beneficial in ALI. The Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2) trial is a multicenter, prospective, randomized, allocation concealed, double-blind, placebo-controlled clinical trial which aims to test the hypothesis that treatment with simvastatin will improve clinical outcomes in patients with ALI