This study aimed to develop a core outcome set (COS) for trials evaluating the effects of complementary therapies in people with multiple sclerosis (pwMS). We sought to identify the outcomes most relevant to pwMS, their relatives and friends, healthcare professionals and researchers and to propose these for inclusion in future trials.

A participatory international research project using a mixed-method approach with qualitative and quantitative methods. The study included a scoping review and a national survey in Switzerland to identify candidate outcomes, followed by an international COS survey to rate the importance of these outcomes. The final phases involved two consensus meetings to refine and finalise the COS.

Data were sourced from the published literature and input from international stakeholders.

pwMS and other relevant stakeholders, including their relatives and friends, healthcare professionals and researchers.

A total of 770 individuals participated in the international COS survey of 39 candidate outcomes (662 pwMS, 27 relatives/friends, 58 healthcare professionals and 23 researchers). According to the survey results, 13 outcomes were added to the COS, 5 were excluded and 21 were classified as ‘no consensus’. 13 individuals (six pwMS, one pwMS’s friend, three healthcare professionals and three researchers) attended the first consensus meeting. Following the voting on the outcomes without consensus, seven outcomes were added to the COS, four were excluded and 10 outcomes were still classified as ‘no consensus’. The six members of the stakeholders advisory board (one pwMS, four healthcare professionals and two researchers) attended the second consensus meeting to define the final COS. Nine additional outcomes were included in the COS. Sexual problems, an outcome previously excluded, were also added. In total, 30 outcomes were included in the final COS.

We have developed the first COS for future trials of complementary therapies for pwMS. The use of this COS will promote that future research in complementary therapies is relevant for pwMS and other stakeholders involved in MS care. Future COS research should integrate diverse geographical regions, where perspectives and access to complementary therapies may vary.

https://osf.io/ys7xt/.

Older crime victims may be particularly vulnerable to psychological distress.

To compare the clinical effectiveness of a Victim Improvement Package (VIP) to treatment as usual (TAU) for reducing continued crime-associated distress.

A three-step parallel-group single-blind randomised controlled trial.

Police-reported victims of community crime aged 65 and over were recruited from 12 local authority areas in a major urban city in England, UK.

Selection criteria—inclusion: victims of community crime aged 65 years or more, with significant Generalised Anxiety Disorder (GAD-2) and Patient Health Questionnaire (PHQ-2) distress associated with the crime. Exclusion: type of crime, diagnosis, receipt of cognitive–behavioural therapy (CBT) in the last 6 months; an inability to participate in CBT; cognitive impairment. Participants were typical of our local authority population; 71% were female, 69% white, with the majority of crimes associated with burglary (35%) and theft (26%). 67% (88/131) of the randomised participants were included in the primary analysis.

TAU was compared with TAU plus up to 10 sessions of a cognitively-behaviourally informed VIP, delivered by a mental health charity over 12 weeks.

Timings are in relation to the crime; baseline (3 months), post-VIP intervention (6 months) and follow-up (9 months). The primary outcome was a composite of the Beck Anxiety and Beck Depression Inventories. The primary endpoint was 6 months.

24% (4255/17 611) of reported crime victims were screened, 35% (1505/4255) were distressed. Of 60% (877/1505) rescreened at 3 months, 49% (427/877) remained distressed. Out of our target of 226, 131 participants were randomised; 65 to VIP and 66 to TAU alone. 68% (89/131) completed the primary outcome (post-intervention). The VIP showed no overall benefit; mean VIP –0.41 (SD 0.89) vs mean TAU –0.19 (SD 1.11); standardised mean difference –0.039; 95% CI (–0.39, 0.31), although stratified analyses suggested an effect in burglary victims (n=27, standardised mean difference –0.61; 95% CI (–1.22, –0.002), p=0.049).

Community crime had long-lasting impacts. The police are ideally placed to screen for distress, present in 35% of victims, but only 58% of participants were recruited and the cognitive–behavioural therapy was not delivered competently. Further research on victim care and improving the delivery and quality of therapy is required.

All procedures were approved by the University College London (UCL) Research Ethics Committee on 17 March 2016 (6960/001). International Standard Randomised Controlled Trial Number is ISRCTN16929670: https://doi.org/10.1186/ISRCTN16929670.