Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial (Preprint)

Background: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality in the world. Prevalence is estimated at around 100 million patients worldwide. There is evidence that antiplatelet agents and antihypertensive medication reduce the risk of new vascular events in this population, but treatment adherence is very low. Objective: We developed an intervention based on behavioral modification techniques delivered via mobile short message services (SMS) to increase the adherence to pharmacologic treatment on patients with prior history of ASCVD. Methods: We conducted a randomized controlled clinical trial for patients with a prior diagnosis of cardiovascular event such as acute myocardial infarction, unstable angina, cerebrovascular disease or peripheral artery disease in one centre in Colombia. Patients randomized to the intervention arm were assigned to receive SMS daily for the first 4 weeks, five SMS on week 5: three SMS per week from week 6, and one SMS from 8th week until 52nd week. Patients in the control arm received a monthly SMS reminding them of the next study appointment, requesting information about changes in phone number, thanking them for participating in the study and reminding them of the importance of the study. Primary endpoint was change in Low Density Lipoprotein-Cholesterol (LDL-C) and the secondary endpoints were change in thromboxane B2 levels, heart rate, systolic and diastolic blood pressure. Medication adherence was measured with the Medication Adherence Report Scale (MARS 5), mortality and new cardiac hospitalization were assessed at one year end point. A logistic regression analysis and bivariate testing was performed. Results: Nine hundred and thirty patients were randomized, 805 (87%) completed follow up, and were analyzed for the primary endpoint. There was no difference between arms in change of LDL-C at 12 months (P=.41). or for any of the secondary outcomes. No adverse events were reported. Conclusions: In our study we did not find evidence that a behavior modification intervention delivered by SMS improved LDL-C, blood pressure levels or adherence at 12 months. More research is needed to evaluate whether different SMS strategies including personalized messages and with different timing are effective; future studies should include mixed methods to understand better why, for whom and in which context (e.g. health system, social environment) SMS interventions work (or not) to improve adherence in patients with ASCVD. Clinical Trial: Clinicaltrial.gov NCT03098186. Date of registration: March 31st 201

‘Berrypicking’ in the formation of ideas about problem drinking amongst users of alcohol online support groups

Beliefs held by individuals about the illnesses or problems that affect them have been shown to impact upon the health and other outcomes that they achieve. Online support groups (OSGs) are one source of information used by those with health problems which may influence or determine what they think about their particular issue and how to resolve it. Problem drinking remains a major source of significant costs to society. This article explores whether the discussion forums of alcohol OSGs that do not follow the 12-step philosophy of Alcoholics Anonymous influence the formation of these beliefs, reporting on the outcome of thematic analysis of interviews with 25 users from five groups. It argues that Bates’ ‘Berrypicking’ model of information searching is helpful in illuminating group members’ information seeking activities. It looks at the four key aspects of berrypicking identified by Bates – the nature of the search query, the information ‘domains’ drawn on, the information retrieved and the search techniques used. The study finds that users are typically berrypickers, selecting information from different sources and forming their own interpretations

Polyethylene thickness is a risk factor for wear necessitating insert exchange

PURPOSE: The aim of this observational study was to investigate the optimal minimal polyethylene (PE) thickness in total knee arthroplasty (TKA) and identify other risk factors associated with revision of the insert due to wear. METHODS: A total of 84 TKA were followed for 11-16 years. All patients received the same prosthesis design (Interax; Howmedica/ Stryker) with halfbearings: separate PE-inserts medially and laterally. Statistical analysis comprised Cox-regression to correct for confounding. RESULTS: Eight knees (9.5%) had been revised due to thinning inserts and an additional patient is scheduled for revision. PE thickness, diagnosis, BMI and weight are risk factors for insert exchange. For each millimetre decrease in PE thickness, the risk of insert exchange increases 3.0 times, which remains after correction for age, gender, weight, diagnosis and femoral-tibial angle. Insert exchange was 4.73 times more likely in OA-patients compared to RA-patients. For every unit increase in BMI and weight the risk for insert exchange increases 1.40 times and 1.14 times, respectively. CONCLUSIONS: In conclusion we therefore advise against the use of thin PE inserts in modular TKA and recommend PE inserts with a minimal 8-mm thickness.Optimising joint reconstruction management in arthritis and bone tumour patient

Evidence-Based Mental Health Programs in Schools: Barriers and Facilitators of Successful Implementation

Although schools can improve children’s access to mental health services, not all school-based providers are able to successfully deliver evidence-based practices. Indeed, even when school clinicians are trained in evidence-based practices (EBP), the training does not necessarily result in the implementation of those practices. This study explores factors that influence implementation of a particular EBP, Cognitive Behavioral Intervention for Trauma in Schools (CBITS). Semi-structured telephone interviews with 35 site administrators and clinicians from across the United States were conducted 6–18 months after receiving CBITS training to discuss implementation experiences. The implementation experiences of participants differed, but all reported similar barriers to implementation. Sites that successfully overcame such barriers differed from their unsuccessful counterparts by having greater organizational structure for delivering school services, a social network of other clinicians implementing CBITS, and administrative support for implementation. This study suggests that EBP implementation can be facilitated by having the necessary support from school leadership and peers

Reactions to treatment debriefing among the participants of a placebo controlled trial

BACKGROUND: A significant proportion of trial participants respond to placebos for a variety of conditions. Despite the common conduct of these trials and the strong emphasis placed on informed consent, very little is known about informing participants about their individual treatment allocation at trial closure. This study aims to address this gap in the literature by exploring treatment beliefs and reactions to feedback about treatment allocation in the participants of a placebo-controlled randomized clinical trial (RCT). METHODS: Survey of trial participants using a semi-structured questionnaire including close and open-ended questions administered as telephone interviews and postal questionnaires. Trial participants were enrolled in a double-blind placebo-controlled RCT evaluating the effectiveness of corticosteroid for heel pain (ISRCTN36539116). The trial had closed and participants remained blind to treatment allocation. We assessed treatment expectations, the percentage of participants who wanted to be informed about their treatment allocation, their ability to guess and reactions to debriefing. RESULTS: Forty-six (73%) contactable participants responded to our survey. Forty-two were eligible (four participants with bilateral disease were excluded as they had received both treatments). Most (79%) participants did not have any expectations prior to receiving treatment, but many 'hoped' that something would help. Reasons for not having high expectations included the experimental nature of their care and possibility that they may get a placebo. Participants were hopeful because their pain was so severe and because they trusted the staff and services. Most (83%) wanted to be informed about their treatment allocation and study results. Over half (55%) said they could not guess which treatment they had been randomized to, and many of those who attempted a guess were incorrect. Reactions to treatment debriefing were generally positive, including in placebo responders. CONCLUSION: Our study suggests that most trial participants want to be informed about their treatment allocation and trial results. Further research is required to develop measure of hope and expectancy and to rigorously evaluate the effects of debriefing prospectively

Skin-impedance in Fabry Disease: A prospective, controlled, non-randomized clinical study

<p>Abstract</p> <p>Background</p> <p>We previously demonstrated improved sweating after enzyme replacement therapy (ERT) in Fabry disease using the thermo-regularity sweat and quantitative sudomotor axon reflex tests. Skin-impedance, a measure skin-moisture (sweating), has been used in the clinical evaluation of burns and pressure ulcers using the portable dynamic dermal impedance monitor (DDIM) system.</p> <p>Methods</p> <p>We compared skin impedance measurements in hemizygous patients with Fabry disease (22 post 3-years of bi-weekly ERT and 5 ERT naive) and 22 healthy controls. Force compensated skin-moisture values were used for statistical analysis. Outcome measures included 1) moisture reading of the 100^threpetitive reading, 2) rate of change, 3) average of 60–110^threading and 4) overall average of all readings.</p> <p>Results</p> <p>All outcome measures showed a significant difference in skin-moisture between Fabry patients and control subjects (p < 0.0001). There was no difference between Fabry patients on ERT and patients naïve to ERT. Increased skin-impedance values for the four skin-impedance outcome measures were found in a small number of dermatome test-sites two days post-enzyme infusions.</p> <p>Conclusion</p> <p>The instrument portability, ease of its use, a relatively short time required for the assessment, and the fact that DDIM system was able to detect the difference in skin-moisture renders the instrument a useful clinical tool.</p