Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures : vital D study

Background Randomised, placebo-controlled trials are needed to provide evidence demonstrating safe, effective interventions that reduce falls and fractures in the elderly. The quality of a clinical trial is dependent on successful recruitment of the target participant group. This paper documents the successes and failures of recruiting over 2,000 women aged at least 70 years and at higher risk of falls or fractures onto a placebo-controlled trial of six years duration. The characteristics of study participants at baseline are also described for this study.Methods The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapted from identified risk factors for hip fracture. Participants were randomised to orally receive either 500,000 IU vitamin D3 (cholecalciferol) or placebo every autumn for five consecutive years. A variety of recruitment strategies were employed to attract potential participants.Results Of the 2,317 participants randomised onto the study, 74% (n = 1716/2317) were consented onto the study in the last five months of recruiting. This was largely due to the success of a targeted mail-out. Prior to this only 541 women were consented in the 18 months of recruiting. A total of 70% of all participants were recruited as a result of targeted mail-out. The response rate from the letters increased from 2 to 7% following revision of the material by a public relations company. Participant demographic or risk factor profile did not differ between those recruited by targeted mail-outs compared with other methods.Conclusion The most successful recruitment strategy was the targeted mail-out and the response rate was no higher in the local region where the study had extensive exposure through other recruiting strategies. The strategies that were labour-intensive and did not result in successful recruitment include the activities directed towards the GP medical centres. Comprehensive recruitment programs employ overlapping strategies simultaneously with ongoing assessment of recruitment rates. In our experience, and others direct mail-outs work best although rights to privacy must be respected. <br /

Behandeling en stigmamanagement bij opzettelijke zelfverwonding: het smalle pad tussen te veel en te weinig interveniëren

Opzettelijke zelfverwonding wordt gedefinieerd als de intentionele directe beschadiging van het eigen lichaam, zonder bewuste suïcidale intentie. De behandeling varieert van gedwongen opname in een psychiatrische instelling (in het Britse Gemenebest), tot een permissieve aanpak zonder behandeling en uiteenlopende behandelingsmogelijkheden er tussenin. Eerst wordt de gepastheid van de mate van interveniëren besproken in functie van verschillende diagnosen. Het tweede gedeelte van het artikel bespreekt het advies dat door hulpverleners verstrekt wordt aangaande de omgang met wonden en littekens en aangaande de mogelijkheden voor een (gewezen) zelfverwonder om het stigma van een deviante identiteit te vermijden. Een rondvraag bij Belgische hulpverleners bracht aan het licht dat velen onder hen adviseren om littekens te verbergen, terwijl er anderzijds aanwijzingen zijn dat niet-verbergen een teken van herstel is. Aangezien verbergen en smoesjes verzinnen ook kunnen leiden tot de instandhouding van een deviante identiteit, wordt gewezen op meer gepaste vormen van stigmamanagement

The impact of a decision aid about heart disease prevention on patients' discussions with their doctor and their plans for prevention: a pilot randomized trial

BACKGROUND: Low utilization of effective coronary heart disease (CHD) prevention strategies may be due to many factors, but chief among them is the lack of patient involvement in prevention decisions. We undertook this study to test the effectiveness of an individually-tailored, computerized decision aid about CHD on patients' discussions with their doctor and their plans for CHD prevention. METHODS: We conducted a pilot randomized trial in a convenience sample of adults with no previous history of cardiovascular disease to test the effectiveness of an individually-tailored, computerized decision aid about CHD prevention against a risk factor list that patients could present to their doctor. RESULTS: We enrolled 75 adults. Mean age was 53. 59% were female, 73% white, and 23% African-American. 66% had some college education. 43% had a 10-year CHD risk of 0–5%, 25% a risk of 6–10%, 24% a risk of 11–20%, and 5% a risk of > 20%. 78% had at least one option to reduce their CHD risk, but only 45% accurately identified the strategies best supported by evidence. 41 patients received the decision aid, 34 received usual care. In unadjusted analysis, the decision aid increased the proportion of patients who discussed CHD risk reduction with their doctor from 24% to 40% (absolute difference 16%; 95% CI -4% to +37%) and increased the proportion who had a specific plan to reduce their risk from 24% to 37% (absolute difference 13%; 95% CI -7% to +34%). In pre-post testing, the decision aid also appeared to increase the proportion of patients with plans to intervene on their CHD risk (absolute increase ranging from 21% to 47% for planned medication use and 5% to 16% for planned behavioral interventions). CONCLUSION: Our study confirms patients' limited knowledge about their CHD risk and effective risk reduction options and provides preliminary evidence that an individually-tailored decision aid about CHD prevention might be expected to increase patients' discussions about CHD prevention with their doctor and their plans for CHD risk reduction. These findings should be replicated in studies with a larger sample size and patients at overall higher risk of CHD. Trial Registration: ClinicalTrials.gov NCT0031597

Beyond a single story: The importance of separating 'harm' from 'wrongfulness' and 'sexual innocence' from 'childhood' in contemporary narratives of childhood sexual abuse

This article draws on research exploring adult women’s engagement with narratives of childhood sexual abuse (CSA) and identifies implications for both child and adult victims. As this research showed, any single story cannot accommodate all experiences. When that single story becomes dominant those whose experiences are not acknowledged are at risk of being silenced and left without a narrative framework to make sense of their experiences, which in turn risk being unrecognised as abuse by others. The article looks at contemporary understandings of CSA and argues for the need to move beyond a single damage narrative in which victims are constructed as sexually innocent, weak and passive and seen to be inevitably damaged by their experiences. The article argues for the need to separate wrongfulness from harm and (sexual) innocence from childhood. This would enable us to recognise sexual abuse in all sexually abused children, including those who do not conform to sexual innocence, and to recognise that CSA is wrong irrespective of psychological damage. In doing so, it is argued, we would all be better equipped to recognise sexual abuse and victims would be better able to tell their own stories which may, but may not, include psychological damage