Worth their while?: Pursuing a rape complaint through the criminal justice system

If the criminal justice system were to advertise itself to victims of sexual violence, would its tag line be L'Oreal's 'Because you're worth it'? Or would the Foundry Premium Cider comment on the building of a pyramid: 'Twelve years in the making and it still doesn't taste very good' be more apposite? Certainly, a lack of faith in, or fear of, legal processes, is one of the reasons why eight out of nine women who are raped do not report the matter to the police.1 This article explores the extent to which victims' lack of faith in legal processes is warranted and asks if laying a complaint is worth the effort

Medico-Legal Findings, Legal Case Progression, and Outcomes in South African Rape Cases: Retrospective Review

Rachel Jewkes and colleagues examine the processing of rape cases by South African police and courts and show an association between documentation of ano-genital injuries, trials commencing, and convictions in rape cases

Maintenance lenalidomide in newly diagnosed transplant eligible and non-eligible myeloma patients; profiling second primary malignancies in 4358 patients treated in the Myeloma XI Trial

\ua9 2023 The AuthorsBackground: Early trials of long-term lenalidomide use reported an increased incidence of second primary malignancy (SPM), including acute myeloid leukaemia and myelodysplastic syndrome. Later, meta-analysis suggested the link to be secondary to lenalidomide in combination with melphalan. Methods: Myeloma XI is a large, phase III randomised trial in-which lenalidomide was used at induction and maintenance, in transplant eligible (TE) and non-eligible (TNE) newly diagnosed patients (NCT01554852). Here we present an analysis of SPM incidence and profile the SPM type to determine the impact of autologous stem cell transplantation (ASCT) and lenalidomide exposure in 4358 patients treated on study. Data collection took place from the start of the trial in May 2010, to May 2019, as per the protocol timeline. The Median follow-up following maintenance randomisation was 54.5 and 46.1 months for TE and TNE patients, respectively. Findings: In the TE pathway, the overall SPM incidence was 7.7% in lenalidomide maintenance patients compared to 3.2% in those being observed (p = 0.006). Although the TNE lenalidomide maintenance patients had the greatest SPM incidence (15.4%), this was not statistically significant when compared to the observed patients (10%, p = 0.10). The SPM incidence was higher in patients who received lenalidomide at induction and maintenance (double exposure), when compared to those treated with lenalidomide at one time point (single exposure). Again, this was most marked in TNE patients where the overall SPM incidence was 16.9% in double exposed patients, compared to 11.7% in single exposed patients, and 11.2% in patients who did not receive lenalidomide (p = 0.04). This is likely an effect of treatment duration, with the median number of cycles being 27 in the TNE double exposed patients, vs 6 in the single exposure patients. Haematological SPMs were uncommon, diagnosed in 50 patients (incidence 1.1%). The majority of cases were diagnosed in TE patients treated with lenalidomide maintenance (n = 25, incidence 2.8%), suggesting a possible link with melphalan. Non-melanoma skin cancer incidence was highest in patients receiving lenalidomide maintenance, particularly in TNE patients, where squamous cell carcinoma and basal cell carcinoma were diagnosed in 5.5% and 2.6% of patients, respectively. The incidence of most solid tumour types was higher in lenalidomide maintenance patients. Mortality due to progressive myeloma was reduced in patients receiving lenalidomide maintenance, noted to be 16.6% compared 22.6% in those observed in TE patients and 32.7% compared to 41.5% in TNE patients. SPM related mortality was low, 1.8% and 6.1% in TE and TNE lenalidomide maintenance patients, respectively, compared to 0.4% and 2.8% in those being observed. Interpretation: This provides reassurance that long-term lenalidomide treatment is safe and associated with improved outcomes in TE and TNE populations, although monitoring for SPM development should be incorporated into clinic review processes. Funding: Primary financial support was from Cancer Research UK [ C1298/A10410]

Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial

Background Results of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects. Methods FOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at 6 months. Patients, carers, health-care staff, and the trial team were masked to treatment allocation. Functional status was assessed at 6 months and 12 months after randomisation. Patients were analysed according to their treatment allocation. This trial is registered with the ISRCTN registry, number ISRCTN83290762. Findings Between Sept 10, 2012, and March 31, 2017, 3127 patients were recruited. 1564 patients were allocated fluoxetine and 1563 allocated placebo. mRS data at 6 months were available for 1553 (99·3%) patients in each treatment group. The distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups (common odds ratio adjusted for minimisation variables 0·951 [95% CI 0·839–1·079]; p=0·439). Patients allocated fluoxetine were less likely than those allocated placebo to develop new depression by 6 months (210 [13·43%] patients vs 269 [17·21%]; difference 3·78% [95% CI 1·26–6·30]; p=0·0033), but they had more bone fractures (45 [2·88%] vs 23 [1·47%]; difference 1·41% [95% CI 0·38–2·43]; p=0·0070). There were no significant differences in any other event at 6 or 12 months. Interpretation Fluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. Although the treatment reduced the occurrence of depression, it increased the frequency of bone fractures. These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function. Funding UK Stroke Association and NIHR Health Technology Assessment Programme

Barriers to evidence-based practice.

Objectives: This paper reports the findings of a study which aimed to identify the barriers to evidence-based practice in an acute National Health Service (NHS) trust. The study was carried out as part of an action research project designed to promote evidence-based practice. Design: A rapid organizational appraisal design was used. this involved formal and informal interviews, focus groups, and observation of staff interactions at meetings and in clinical practice in an acute hospital NHS trust. Interviews were undertaken with key stakeholders within the organization and focus groups held with nurse managers, audit staff, staff nurses, and junior medical staff. Observation took place in meetings and in clinical areas. Results: At an organizational level, the main issues identified were: (1) evidence-based practice was a low management priority, (2) problems with dissemination, (3) inadequate systems for personal and professional development, (4) difficulties in the management of innovations, (5) accessing evidence and resource constraints. At the individual practice level, the main issues were motivation, a lack of clarity about roles and practice, and a culture of practice which emphasizes ‘routine’ patient care. Conclusions: The results of this study demonstrate that structures and cultures within organizations can be important barriers to evidence-based practice. Factors which are external to individual trusts are also important. Existing hierarchical structures both in the NHS and within and between the different professional groups, are manifest in the existence of a largely deferential culture which emphasizes the routine in practice decision making. Given this reality, organizations will have to adopt multiple strategies to facilitate and promote the use of evidence in practice decision making

What we know- and what we don't: Single and multiple perpetrator rape in South Africa

This article offers an analysis of 1 886 rape dockets opened at 70 police stations in Gauteng Province in 2003. Multiple perpetrator rape (‘gang rape’) constituted 16% of all cases. Most of these incidents started when the victim was outdoors, either alone or accompanied, and occurred in the open or in a public space. In contrast, single perpetrator rape mostly occurs in a home. A key finding was that fewer than 40% of victims of either single or multiple perpetrator rape indicated that they had verbally or physically resisted the attacker. Yet in most cases perpetrators were not armed. Further, an analysis of J88 forms showed many victims had no injuries other than genital or anal injury. Injuries to other parts of the body were only found in 27% of single and 35% of multiple perpetrator rape victims. Although most victims reported to the police within 72 hours of the rape, the arrest rate was low, particularly for multiple perpetrator rapes (39%). The study showed that there are very important differences between single perpetrator and multiple perpetrator rape. It also points to a mismatch between perpetrators’ accounts and police case reports, suggesting differences in under-reporting between these two types of rapes. Improvement of DNA testing and rape case arrests of multiple perpetrator rapes are matters of urgency, and reasons for differences in low arrest rates should be the next step in the examination of multiple rape cases

Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK

Background Eligibility criteria are a fundamental element of clinical trial design, defining who can and who should not participate in a trial. Problems with the design or application of criteria are known to occur and pose risks to participants’ safety and trial integrity, sometimes also negatively impacting on trial recruitment and generalisability. We conducted a short, exploratory survey to gather evidence on UK recruiters’ experiences interpreting and applying eligibility criteria and their views on how criteria are communicated and developed. Methods Our survey included topics informed by a wider programme of work at the Clinical Trials Research Unit, University of Leeds, on assuring eligibility criteria quality. Respondents were asked to answer based on all their trial experience, not only on experiences with our trials. The survey was disseminated to recruiters collaborating on trials run at our trials unit, and via other mailing lists and social media. The quantitative responses were descriptively analysed, with inductive analysis of free-text responses to identify themes. Results A total of 823 eligible respondents participated. In total, 79% of respondents reported finding problems with eligibility criteria in some trials, and 9% in most trials. The main themes in the types of problems experienced were criteria clarity (67% of comments), feasibility (34%), and suitability (14%). In total, 27% of those reporting some level of problem said these problems had led to patients being incorrectly included in trials; 40% said they had led to incorrect exclusions. Most respondents (56%) reported accessing eligibility criteria mainly in the trial protocol. Most respondents (74%) supported the idea of recruiter review of eligibility criteria earlier in the protocol development process. Conclusions Our survey corroborates other evidence about the existence of suboptimal trial eligibility criteria. Problems with clarity were the most often reported, but the number of comments on feasibility and suitability suggest some recruiters feel eligibility criteria and associated assessments can hinder recruitment to trials. Our proposal for more recruiter involvement in protocol development has strong support and some potential benefits, but questions remain about how best to implement this. We invite other trialists to consider our other suggestions for how to assure quality in trial eligibility criteria