Unblinded and Blinded N-of-1 Trials Versus Usual Care: A Randomized Controlled Trial to Increase Statin Uptake in Primary Care.

BACKGROUND: The aim was to assess whether an intervention incorporating a practicable open-label n-of-1 trial would lead to greater uptake of statin than usual care and comparable uptake to a closed-label gold-standard n-of-1 trial. METHODS: We enrolled patients who had stopped or declined statins into a 3-arm trial (usual care, unblinded, and blinded n-of-1 intervention arms). Physicians advised participants randomized to usual care to take statin therapy to prevent cardiovascular disease. In both intervention arms, physicians delivered a theoretically informed informed intervention endorsing the value of experimenting with medication in n-of-1 trials to assess whether it caused side-effects. In these trials, participants alternated between 4 weeks of medication and no medication (unblinded arm) or randomly sorted active and placebo (blinded arm) and recorded symptoms and symptom attributions for 6 months. Thereafter, physicians discussed participants' symptom reports during active/inactive treatment periods and asked participants to resume statins if appropriate. RESULTS: Seventy-three were randomized to the intervention arms and 20 to the control group. Fifty-six of 73 (77%) attempted the n-of-1 experiment; 28/36 (78%) in the unblinded arm; and 28/37 (76%) in the blinded arm. Forty-three of 56 (77%) completed the 6-month experiment and received feedback from the physician; 20/28 (71%) in the unblinded arm and 23/28 (82%) in the blinded arm. Thirty-three of 76 (45%) people restarted statins in the n-of-1 arms compared with 4/20 (20%) in the control arm, difference 24% (95% CI, 5%-43%; P=0.041). There was no evidence this differed between blinded and unblinded arms, difference 2% (95% CI, -20% to 24%; P=0.86). Adverse events occurred at a similar rate on and off statin. CONCLUSIONS: In patients refusing or intolerant of statin, supporting experimentation with n-of-1 trials increases medication uptake compared with usual care. Alternating on-off medication in unblinded n-of-1 experiments appears as effective as a blinded experiment. REGISTRATION: URL: https://doi.org/10.1186/ISRCTN11142694; Unique identifier: ISRCTN11142694.

Use of a novel silicone-acrylic drape with negative pressure wound therapy in anatomically challenging wounds.

Negative pressure wound therapy (NPWT) utilises a polyurethane drape with acrylic adhesive over foam dressings to create a seal. In anatomically challenging areas, ancillary products are frequently used. Additionally, health care providers are unable to reposition the drape once placed. A novel hybrid drape consisting of polyurethane film with acrylic adhesive and silicone perforated layer has been developed to allow for repositioning after initial placement and easy removal. This six-patient case series evaluates the use of NPWT with hybrid drape over anatomically challenging wounds. Three males and three females were treated. Dressing changes occurred every 2 to 3 days. Drape application, repositioning, and ability to maintain a seal were evaluated. During application, the drape was repositioned 1 to 2 times without periwound skin irritation in 4/6 wounds. Prior to initial application, ancillary products were applied to help create a seal. However, by the second or third application, ancillary products were no longer used in 4/6 wounds. None of the dressing applications resulted in negative pressure seal leaks. In these patients, health care providers could reposition the hybrid drape after initial placement without periwound skin irritation and successfully create a negative pressure seal without ancillary products in anatomically challenging wound locations.

Tackling statin intolerance with n-of-1 trials (TaSINI) in primary care: protocol for a feasibility randomised trial to increase statin adherence.

INTRODUCTION: Statins reduce the incidence of cardiovascular disease (CVD) and cause few adverse effects. Half of patients prescribed statins discontinue treatment due to perceived intolerance. Placebo-controlled (blinded) n-of-1 trials have shown people with perceived intolerance that the statin does not cause adverse events and most resume treatment. However, blinded n-of-1 trials are impractical to deliver in routine practice. Tackling Statin Intolerance using n-of-1 trials (TaSINI) will test the feasibility of a general practitioner (GP)-delivered behavioural intervention endorsing an unblinded n-of-1 trial to increase adherence to statins relative to usual care. METHODS AND ANALYSIS: TaSINI is a feasibility randomised controlled trial with a nested qualitative substudy. Ninety primary care patients who have discontinued statins due to intolerance or refused treatment will be randomised to an unblinded n-of-1 trial, a blinded n-of-1 trial (positive control) or usual care (negative control). Participants randomised to usual care will be advised to take statin therapy to prevent CVD. In both n-of-1 trial arms, GPs will deliver a behaviourally informed intervention that accessibly explains the benefits of statins, the prevalence of adverse effects and endorse the benefit of experimenting with medication. Participants will alternate between 4 weeks of medication and no medication (unblinded arm) or randomly sorted active and placebo (blinded arm) and will record adherence, symptoms and symptom attributions throughout. After 6 months, GPs will feedback symptom data during active/inactive treatment periods. All participants will be asked if they would like to initiate statin treatment. Measures of feasibility will be met if 4% of invited patients enrol, 50% of participants randomised to n-of-1 trials engage with the experiment and 25% more participants initiate statin in the unblinded n-of-1 arm than in usual care. ETHICS AND DISSEMINATION: This study has been granted ethical approval by North of Scotland Research Ethics Service. The results will be written up for publication and show whether to progress to an effectiveness trial where the primary outcome would be differences in low-density lipoprotein concentration.

Video Interaction Guidance: a practitioner's perspective.

School nurses are being encouraged to consider a more preventative agenda, and Video Interaction Guidance (VIG) is a tool to enhance communication between people that can be used effectively within community nursing. VIG involves a short piece of film taken by the professional--the guider--that is edited to highlight the participant's strengths and fed back in discussion between the guider and participant. This article describes the theoretical background and practical use of VIG by a school nurse seconded to a Children's Fund project, in a county where this method is being used across a number of agencies. The implications for ethical working are also considered.

Alcohol abuse and traumatic brain injury: quantitative magnetic resonance imaging and neuropsychological outcome.

Prior or concurrent alcohol use at the time of traumatic brain injury (TBI) was examined in terms of post-injury atrophic changes measured by quantitative analysis of magnetic resonance imaging (MRI) and neuropsychological outcome. Two groups of TBI subjects were examined: those with a clinically significant blood alcohol level (BAL) present at the time of injury (TBI + BAL) and those without a significant BAL (TBI-only). To explore the potential impact of both acute and chronic alcohol use, subjects in both groups were further clustered into one of four subgroups (NONE, MILD, MODERATE or HEAVY) based upon available information regarding their pre-injury alcohol use. One-way analysis of covariance (ANCOVA) and multiple analysis of covariance (MANCOVA) were used with subject grouping as the main factor. Age, injury severity as measured by Glasgow Coma Scale (GCS) score, years of education, total intracranial volume (TICV), and the number of days post-injury were included as covariates where appropriate. Increased general atrophy was observed in patients with (a) a positive BAL and/or (b) a history of moderate to heavy pre-injury alcohol use. In addition, performance on neuropsychological outcome variables (WAIS-R and WMS-R Index scores) was generally worse in the subgroups of patients with positive BAL and a history of preinjury alcohol use, as compared to the other TBI groups though not statistically significant. Implications of alcohol use, at the time of brain injury, are discussed.