Nested Process Evaluation Research Articles

Exploring critical intervention features and trial processes in the evaluation of sensory integration therapy for autistic children

BackgroundWe evaluated the clinical and cost-effectiveness of manualised sensory integration therapy (SIT) for autistic children with sensory processing difficulties in a two-arm randomised controlled trial. Trial processes and contextual factors which may have affected intervention outcomes were explored within a nested process evaluation. This paper details the process evaluation methods and results. We also discuss implications for evaluation of individual level, tailored interventions in similar populations.MethodsThe process evaluation was conducted in line with Medical Research Council guidance. Recruitment, demographics, retention, adherence, and adverse effects are reported using descriptive statistics. Fidelity of intervention delivery is reported according to the intervention scoring manual. Qualitative interviews with therapists and carers were undertaken to explore the acceptability of the intervention and trial processes. Qualitative interviews with carers explored potential contamination.ResultsRecruitment, reach and retention within the trial met expected thresholds. One hundred thirty-eight children and carers were recruited (92% of those screened and 53.5% of those who expressed an interest) with 77.5% retained at 6 months and 69.9% at 12 months post-randomisation. The intervention was delivered with structural and process fidelity with the majority (78.3%) receiving a ‘sufficient dose’ of intervention. However, there was considerable individual variability in the receipt of sessions. Carers and therapists reported that trial processes were generally acceptable though logistical challenges such as appointment times, travel and COVID restrictions were frequent barriers to receiving the intervention. No adverse effects were reported.ConclusionsThe process evaluation was highly valuable in identifying contextual factors that could impact the effectiveness of this individualised intervention. Rigorous evaluations of interventions for autistic children are important, especially given the limitations such as limited sample sizes and short-term follow-up as faced by previous research. One of the challenges lies in the variability of outcomes considered important by caregivers, as each autistic child faces unique challenges. It is crucial to consider the role of parents or other caregivers in facilitating access to these interventions and how this may impact effectiveness.Trial registrationThis trial is registered as ISRCTN14716440. August 11, 2016.

Is a novel digital system for arm and hand rehabilitation suitable for stroke survivors? A qualitative process evaluation of OnTrack

Objectives and designNational guidelines emphasise the need to enhance arm and hand recovery poststroke. OnTrack is a 12-week package aiming to address this need. Feasibility was evaluated in a single-arm...

Group music therapy with songwriting for adult patients with long-term depression (SYNCHRONY study): a feasibility and acceptability study of the intervention and parallel randomised controlled trial design with wait-list control and nested process evaluation

BackgroundDespite effective treatments, one fifth of patients develop chronic depression. Music therapy may offer a different approach. This study aimed to assess feasibility and acceptability of a music therapy intervention and trial methodology.MethodsA parallel two-arm randomised controlled trial with wait-list control, mixed feasibility/acceptability measures and nested process evaluation. Adults with long-term depression (symptom duration > 1 year) were recruited from community mental health services and computer randomised to 42 sessions of group music therapy with songwriting three times per week or wait-list control. Depression, social functioning, distress, quality of life, satisfaction and service use were assessed by blinded researchers at enrolment, 1 week and 3 and 6 months post-therapy. Outcomes were analysed descriptively, controlling for baseline covariates. Recruitment (number eligible, participation and retention rates) and intervention (fidelity, adherence) feasibility were assessed using pre-defined stop–go criteria. Attendance, adverse events, mood, relationship satisfaction and semi-structured interviews were analysed in a nested process evaluation.ResultsRecruitment processes were feasible with 421 eligible, 12.7% participation and 60% (18/30) retention. Thirty participants were randomised to intervention (N = 20) and control (N = 10). Session attendance was low (mean 10.5) with four withdrawals. Music therapist adherence was good but changes to session frequency were suggested. Outcomes were available for 10/20 treatment and 9/10 wait-list participants. Depression increased in both arms post-therapy. Treatment depression scores fell below baseline 3 and 6 months post-therapy indicating improvement. Wait-list depression scores increased from baseline 3 and 6 months post-therapy. At 3 months, the treatment arm improved from baseline on all measures except satisfaction and functioning. At 6 months, quality of life, distress and functioning improved with reduction in health service contacts. High-attending participants improved more than low-attending. Seven adverse events (one serious) were reported.LimitationsAs this was a feasibility study, clinical outcomes should be interpreted cautiously.ConclusionA randomised controlled trial of group music therapy using songwriting is feasible with inclusion criteria and session frequency modifications, but further intervention development is required.Trial registrationISRCTN18164037 on 26.09.2016.

The SEE-IT Trial: emergency medical services Streaming Enabled Evaluation In Trauma: study protocol for an interventional feasibility randomised controlled trial

IntroductionAccurate and timely dispatch of emergency medical services (EMS) is vital due to limited resources and patients’ risk of mortality and morbidity increasing with time. Currently, most UK emergency operations...

Refining and optimising a behavioural intervention to support endocrine therapy adherence (ROSETA) in UK women with breast cancer: protocol for a pilot fractional factorial trial

IntroductionWomen with breast cancer who do not adhere to adjuvant endocrine therapy (AET) have increased risks of mortality and recurrence. There are multiple barriers to AET adherence, including medication side-effects,...

Digital interventions for hypertension and asthma to support patient self-management in primary care: the DIPSS research programme including two RCTs

Digital interventions for hypertension and asthma to support patient self-management in primary care: the DIPSS research programme including two RCTs

Protocol for the Feasibility Randomised Controlled Trial of Being a Parent- Enjoying Family Life (BAP-EFL): A peer-led group intervention for parents and caregivers with significant emotional and interpersonal difficulties

Group-format parenting interventions are well-established at reducing challenging child behavior and risk for psychopathology. However, there is significantly less evidence about the performance of these interventions for parents with significant emotional and interpersonal difficulties, including personality disorder. This protocol presents the rationale and design of a two-arm parallel group feasibility Randomised Controlled Trial and nested process evaluation of Being a Parent (BaP)- Enjoying Family Life, a novel peer-led intervention. The trial compares BaP-Enjoying Family Life to the well-established Empowering Parents Empowering Communities-Being a Parent (EPEC-Being a Parent) in a sample of parents who experience significant emotional and interpersonal difficulties and who are concerned about their child's, aged 2–11 years, behavior. 72 parents will be recruited and randomised to receive either BaP-Enjoying Family Life or EPEC-Being a Parent group-format interventions. The primary aim of this study is to examine the feasibility and acceptability of BaP-Enjoying Family Life and the proposed trial methods. Secondary clinical outcomes include child behavioral difficulties, parenting, parental reflective function, parent wellbeing, satisfaction and self-efficacy. An observational assessment of parent and index child will also assess changes in the home environment. Outcome measures will be collected pre-intervention, post-intervention and at 6-month follow up. A parallel process evaluation will use qualitative data from interviews to assess parents' experience of the intervention delivery and trial methods. Findings will be evaluated against pre-determined feasibility criteria. The results will be used to determine the planning of a definitive clinical trial. The wider methodological and clinical implications are also discussed.

Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP): Protocol for a multicentre cluster randomised trial comparing a complex intervention for medication optimization against usual care.

Polypharmacy is increasingly common, and associated with undesirable consequences. Polypharmacy management necessitates balancing therapeutic benefits and risks, and varying clinical and patient priorities. Current guidance for managing polypharmacy is not supported by high quality evidence. The aim of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial is to evaluate the effectiveness of an intervention to optimise medication use for patients with polypharmacy in a general practice setting. This trial will use a multicentre, open-label, cluster-randomised controlled approach, with two parallel groups. Practices will be randomised to a complex intervention comprising structured medication review (including interprofessional GP/pharmacist treatment planning and patient-facing review) supported by performance feedback, financial incentivisation, clinician training and clinical informatics (intervention), or usual care (control). Patients with polypharmacy and triggering potentially inappropriate prescribing (PIP) indicators will be recruited in each practice using a computerised search of health records. 37 practices will recruit 50 patients, and review them over a 26-week intervention delivery period. The primary outcome is the mean number of PIP indicators triggered per patient at 26 weeks follow-up, determined objectively from coded GP electronic health records. Secondary outcomes will include patient reported outcome measures, and health and care service use. The main intention-to-treat analysis will use linear mixed effects regression to compare number of PIP indicators triggered at 26 weeks post-review between groups, adjusted for baseline (pre-randomisation) values. A nested process evaluation will explore implementation of the intervention in primary care. The protocol and associated study materials have been approved by the Wales REC 6, NHS Research Ethics Committee (REC reference 19/WA/0090), host institution and Health Research Authority. Research outputs will be published in peer-reviewed journals and relevant conferences, and additionally disseminated to patients and the public, clinicians, commissioners and policy makers. 90146150 (28/03/2019).

A study of prisms and therapy in attention loss after stroke (SPATIAL): A feasibility randomised controlled trial

Objective Investigate feasibility and acceptability of prism adaptation training for people with inattention (spatial neglect), early after stroke, during usual care. Design Phase II feasibility randomised controlled trial with 3:1 stratified allocation to standard occupational therapy with or without intervention, and nested process evaluation. Setting Ten hospital sites providing in-patient stroke services. Participants Screened positive for inattention more than one-week post-stroke; informal carers. Occupational therapists participated in qualitative interviews. Intervention Adjunctive prism adaptation training at the start of standard occupational therapy sessions for three weeks. Main measures Feasibility measures included recruitment and retention rates, intervention fidelity and attrition. Outcomes collected at baseline, 3 weeks and 12 weeks tested measures including Nottingham Extended Activities of Daily Living Scale. Acceptability was explored through qualitative interviews and structured questions. Results Eighty (31%) patients were eligible, 57 (71%) consented, 54 randomised (40:13, +1 exclusion) and 39 (74%) completed 12-week outcomes. Treatment fidelity was good: participants received median eight intervention sessions (IQR: 5, 12) lasting 4.7 min (IQR: 4.1, 5.0). All six serious adverse events were unrelated. There was no signal that patients allocated to intervention did better than controls. Twenty five of 35 recruited carers provided outcomes with excellent data completeness. Therapists, patients and carers found prism adaptation training acceptable. Conclusions It is feasible and acceptable to conduct a high-quality definitive trial of prism adaptation training within occupational therapy early after stroke in usual care setting, but difficult to justify given no sign of benefit over standard occupational therapy. Clinical trial registration https://www.isrctn.com/ Ref ISRCTN88395268.

Barriers to the management of sexual dysfunction among people with psychosis: analysis of qualitative data from the REMEDY trial

BackgroundMore than half of people who use antipsychotic medication for psychosis report having sexual dysfunction. The REMEDY trial aimed to find out if switching antipsychotic medication provides an effective way to reduce sexual dysfunction among people with psychosis. We set out to recruit 216 participants over a two-year period, but recruitment was stopped after an extended 12-month pilot phase, during which we recruited only 10 participants. As part of a nested process evaluation, we conducted qualitative interviews with front-line clinicians to examine barriers to recruitment to the trial.MethodsWe developed a semi-structured interview schedule to explore staff views on factors that influenced whether they referred potential participants to the study. We interviewed a purposive sample of 51 staff from four National Health Service (NHS) Trusts in England, ensuring a range of different backgrounds, seniority, and levels of involvement in the trial. Audio recordings of interviews were transcribed for verbatim, and data were analysed using an inductive approach to thematic analysis.ResultsNine interconnected themes were generated. Six themes concerned barriers to recruitment; including; prioritising patients’ mental stability, mutual discomfort and embarrassment about discussing a “taboo” subject, and concerns about unintended consequences of asking people with psychosis about their sexual functioning. Three themes, including the quality of treatment relationships and strategies for opening dialogue suggested ways to improve recognition of these “hidden” side effects.ConclusionThe identification and management of sexual dysfunction among people with psychosis are not priorities for mental health services in England at this time. Many staff working in front-line services feel unprepared and uncomfortable asking people with psychosis about these problems. While greater use of screening tools may improve the identification of sexual dysfunction among people with psychosis, the evaluation and implementation of interventions to manage them will continue to be challenging unless NHS leaders and senior clinicians demonstrate greater commitment to changing current clinical practice.Trial registrationCurrent Controlled Trials ISRCTN12307891.

Prescribing and using vitiligo treatments: lessons from a nested process evaluation within the HI-Light vitiligo randomized controlled trial.

BackgroundThe HI‐Light Trial demonstrated that for active, limited vitiligo, combination treatment with potent topical corticosteroid (TCS) and handheld narrowband ultraviolet B offers a better treatment response than potent TCS alone. However, it is unclear how to implement these findings.AimWe sought to answer three questions: (i) Can combination treatment be used safely and effectively by people with vitiligo?; (ii) Should combination treatment be made available as routine clinical care?; and (iii) Can combination treatment be integrated within current healthcare provision?MethodsThis was a mixed‐methods process evaluation, including semi‐structured interviews with a purposive sample of trial participants, structured interviews with commissioners, and an online survey and focus groups with trial staff. Transcripts were coded by framework analysis, with thematic development by multiple researchers.ResultsParticipants found individual treatments easy to use, but the combination treatment was complicated and required nurse support. Both participants and site investigators felt that combination treatment should be made available, although commissioners were less certain. There was support for the development of services offering combination treatment, although this might not be prioritized above treatment for other conditions. A ‘mixed economy’ model was suggested, involving patients purchasing their own devices, although concerns regarding the safe use of treatments mean that training, monitoring and ongoing support are essential. The need for medical physics support may mean that a regional service is more practical.ConclusionCombination treatment should be made available for people seeking treatment for vitiligo, but services require partnership with medical physics and ongoing training and support for patients.

The feasibility of delivering the ADVANCE digital intervention to reduce intimate partner abuse by men receiving substance use treatment: protocol for a non-randomised multi-centre feasibility study and embedded process evaluation

BackgroundCompared to men in the general population, men in substance use treatment are more likely to perpetrate intimate partner abuse (IPA). The ADVANCE group intervention for men in substance use treatment is tailored to address substance use and IPA in an integrated way. In a feasibility trial pre-COVID, men who received the ADVANCE intervention via face-to-face group delivery showed reductions in IPA perpetration. Due to COVID-19, ADVANCE was adapted for remote digital delivery.Methods/designThis mixed-methods non-randomised feasibility study, with a nested process evaluation, will explore the feasibility and acceptability of delivering the ADVANCE digital intervention to men in substance use treatment who have perpetrated IPA towards a female partner in the past year. Sixty men will be recruited from seven substance use treatment services in Great Britain. The ADVANCE digital intervention comprises a preparatory one-to-one session with a facilitator to set goals, develop a personal safety plan, and increase motivation and a preparatory online group to prepare men for taking part in the intervention. The core intervention comprises six fortnightly online group sessions and 12 weekly self-directed website sessions to recap and practise skills learned in the online group sessions. Each website session is followed by a one-to-one video/phone coaching session with a facilitator. Men will also receive their usual substance use treatment. Men’s female (ex) partners will be invited to provide outcome data and offered support from integrated safety services (ISS). Outcome measures for men and women will be sought post intervention (approximately 4 months post male baseline interview). Feasibility parameters to be estimated include eligibility, suitability, consent, recruitment, attendance, retention and follow-up rates. In-depth interviews or focus groups will explore the intervention’s acceptability to participants, facilitators and ISS workers. A secondary focus of the study will estimate pre-post-differences in outcome measures covering substance use, IPA, mental health, self-management, health and social care service use, criminal justice contacts and quality of life.DiscussionFindings will inform the design of a multicentre randomised controlled trial evaluating the efficacy and cost-effectiveness of the ADVANCE digital intervention for reducing IPA.Trial registrationThe feasibility study was prospectively registered: ISRCTN66619273.

A qualitative process analysis of daily contact testing as an alternative to self-isolation following close contact with a confirmed carrier of SARS-CoV-2

BackgroundIn July 2021, a randomised controlled trial was conducted to compare the effect on SARS-CoV-2 transmission of seven days of Daily Contact Testing (DCT) using Lateral Flow Test (LFT) and two Polymerase Chain Reaction (PCR) tests as an alternative to 10 days of standard self-isolation with one PCR, following close contact with a SARS-CoV-2 carrier. In this qualitative study, we used a nested process evaluation to aid interpretation of the trial and provide insight into factors influencing use of tests, understanding of test results, and how tests were used to inform behavioural decisions.MethodsInterviews were conducted with 60 participants (42 randomised to DCT and 18 randomised to self-isolation) who had been in close contact with a confirmed SARS-CoV-2 carrier and had consented to take part in the trial.ResultsData were organised into three overarching themes: (1) assessing the risks and benefits of DCT (2) use of testing during the study period and (3) future use of testing. Attitudes toward DCT as an alternative to self-isolation and behaviour during the testing period appeared to be informed by an assessment of the associated risks and benefits. Participants reported how important it was for them to avoid isolation, how necessary self-isolation was considered to be, and the ability of LFTs to detect infection. Behaviour during the testing period was modified to reduce risks and harms as much as possible. Testing was considered a potential compromise, reducing both risk of transmission and the negative impact of self-isolation, and was regarded as a way to return to normal.ConclusionParticipants in this study viewed DCT as a sensible, feasible, and welcome means of avoiding unnecessary self-isolation. Although negative LFTs provided reassurance, most people still restricted their activity as recommended. DCT was also highly valued by those in vulnerable households as a means of providing reassurance of the absence of infection and as an important means of detecting infection and prompting self-isolation when necessary.

Antibiotic prescribing rate after optimal near-patient C-reactive protein testing in acutely ill children presenting to ambulatory care (ARON project): protocol for a cluster-randomized pragmatic trial

IntroductionChildren become ill quite often, mainly because of infections, most of which can be managed in the community. Many children are prescribed antibiotics which contributes to antimicrobial resistance and reinforces...

Action leveraging evidence to reduce perinatal mortality and morbidity (ALERT): study protocol for a stepped-wedge cluster-randomised trial in Benin, Malawi, Tanzania and Uganda

BackgroundInsufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a deterrence to achieving the Sustainable Development Goal 3. The majority of deaths occur during the intrapartum and immediate postnatal period. Overcoming the knowledge-do-gap to ensure implementation of known evidence-based interventions during this period has the potential to avert at least 2.5 million deaths in mothers and their offspring annually. This paper describes a study protocol for implementing and evaluating a multi-faceted health care system intervention to strengthen the implementation of evidence-based interventions and responsive care during this crucial period.MethodsThis is a cluster randomised stepped-wedge trial with a nested realist process evaluation across 16 hospitals in Benin, Malawi, Tanzania and Uganda. The ALERT intervention will include four main components: i) end-user participation through narratives of women, families and midwifery providers to ensure co-design of the intervention; ii) competency-based training; iii) quality improvement supported by data from a clinical perinatal e-registry and iv) empowerment and leadership mentoring of maternity unit leaders complemented by district based bi-annual coordination and accountability meetings. The trial’s primary outcome is in-facility perinatal (stillbirths and early neonatal) mortality, in which we expect a 25% reduction. A perinatal e-registry will be implemented to monitor the trial. Our nested realist process evaluation will help to understand what works, for whom, and under which conditions. We will apply a gender lens to explore constraints to the provision of evidence-based care by health workers providing maternity services. An economic evaluation will assess the scalability and cost-effectiveness of ALERT intervention.DiscussionThere is evidence that each of the ALERT intervention components improves health providers’ practices and has modest to moderate effects. We aim to test if the innovative packaging, including addressing specific health systems constraints in these settings, will have a synergistic effect and produce more considerable perinatal mortality reductions.Trial registrationPan African Clinical Trial Registry (www.pactr.org): PACTR202006793783148. Registered on 17th June 2020.

An early intervention for adolescent depression targeting emotional mental images and memory specificity: a process evaluation

We have evaluated a novel early intervention for adolescent depression (age 16–18) in a feasibility randomised controlled trial. This nested process evaluation aimed to understand how this complex intervention worked. We sought to understand participants’ views and experiences of receiving and interacting with the intervention to evaluate whether the underpinning theoretical basis of the intervention is justified and whether it contributes to valued outcomes for participants. Twelve participants were invited to take part in semi-structured interviews. Framework analysis was employed to identify important aspects of adolescents’ experiences. The active ingredients identified by participants were consistent with and extended our understanding of the theoretical basis of the intervention. Four principle themes were identified: understanding how memory works and being able to remember memories in more detail; processing negative experiences and letting go; imagining positive future events; and understanding and being kinder to myself. The outcomes of the intervention were valued by participants. Six principle themes were identified: improving mood and well-being; reducing impact of negative memories; motivation and goal-directed behaviour; overcoming avoidance and rumination; relationships, communication and being open; and self-understanding and acceptance. A simplified logic model is also proposed to connect the intervention components, active ingredients, and valued outcomes. The findings provide an in-depth understanding of how participants interacted with the intervention and what they derived from it. For example, the findings establish processing negative experiences as a core intervention component, extend it to include letting go of these memories, and highlight that reducing the impact of negative memories is valued by participants. This richer understanding guides further intervention development and future implementation.

PD07: Prescribing and using vitiligo treatments for limited active vitiligo: lessons from a nested process evaluation within the HI‐Light Vitiligo randomized controlled trial

PD07: Prescribing and using vitiligo treatments for limited active vitiligo: lessons from a nested process evaluation within the HI‐Light Vitiligo randomized controlled trial

Effect of collaborative quality improvement on stillbirths, neonatal mortality and newborn care practices in hospitals of Telangana and Andhra Pradesh, India: evidence from a quasi-experimental mixed-methods study

BackgroundImproving quality of care is a key priority to reduce neonatal mortality and stillbirths. The Safe Care, Saving Lives programme aimed to improve care in newborn care units and labour wards of 60 public and private hospitals in Telangana and Andhra Pradesh, India, using a collaborative quality improvement approach. Our external evaluation of this programme aimed to evaluate programme effects on implementation of maternal and newborn care practices, and impact on stillbirths, 7- and 28-day neonatal mortality rate in labour wards and neonatal care units. We also aimed to evaluate programme implementation and mechanisms of change.MethodsWe used a quasi-experimental plausibility design with a nested process evaluation. We evaluated effects on stillbirths, mortality and secondary outcomes relating to adherence to 20 evidence-based intrapartum and newborn care practices, comparing survey data from 29 hospitals receiving the intervention to 31 hospitals expected to receive the intervention later, using a difference-in-difference analysis. We analysed programme implementation data and conducted 42 semi-structured interviews in four case studies to describe implementation and address four theory-driven questions to explain the quantitative results.ResultsOnly 7 of the 29 intervention hospitals were engaged in the intervention for its entire duration. There was no evidence of an effect of the intervention on stillbirths [DiD − 1.3 percentage points, 95% CI − 2.6–0.1], on neonatal mortality at age 7 days [DiD − 1.6, 95% CI − 9–6.2] or 28 days [DiD − 3.0, 95% CI − 12.9—6.9] or on adherence to target evidence-based intrapartum and newborn care practices. The process evaluation identified challenges in engaging leaders; challenges in developing capacity for quality improvement; and challenges in activating mechanisms of change at the unit level, rather than for a few individuals, and in sustaining these through the creation of new social norms.ConclusionDespite careful planning and substantial resources, the intervention was not feasible for implementation on a large scale. Greater focus is required on strategies to engage leadership. Quality improvement may need to be accompanied by clinical training. Further research is also needed on quality improvement using a health systems perspective.

The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation

BackgroundProcess evaluations have become a valued component, alongside clinical trials, of the wider evaluation of complex health interventions. They support understanding of implementation, and fidelity, related to the intervention and provide valuable insights into what is effective in a practical setting by examining the context in which interventions are implemented. The TOPSY study consists of a large multi-centre randomised controlled trial comparing the effectiveness of pessary self-management with clinic-based care in improving women’s condition-specific quality of life, and a nested process evaluation. The process evaluation aims to examine and maximise recruitment to the trial, describe intervention fidelity and explore participants’ and healthcare professionals’ experiences.MethodsThe trial will recruit 330 women from approximately 17 UK centres. The process evaluation uses a mixed-methods approach. Semi-structured interviews will be conducted with randomised women (18 per randomised group/n = 36), women who declined trial participation but agreed to interview (non-randomised women) (n = 20) and healthcare professionals recruiting to the trial (n ~ 17) and delivering self-management and clinic-based care (n ~ 17). The six internal pilot centres will be asked to record two to three recruitment discussions each (total n = 12–18). All participating centres will be asked to record one or two self-management teaching appointments (n = 30) and self-management 2-week follow-up telephone calls (n = 30). Process data (quantitative and qualitative) will be gathered in participant completed trial questionnaires. Interviews will be analysed thematically and recordings using an analytic grid to identify fidelity to the intervention. Quantitative analysis will be predefined within the process evaluation analysis plan.DiscussionThe wide variety of pessary care delivered across the UK for women with pelvic organ prolapse presents specific localised contexts in which the TOPSY interventions will be implemented. Understanding this contextual variance is central to understanding how and in what circumstances pessary self-management can be implemented (should it be effective). The inclusion of non-randomised women provides an innovative way of collecting indispensable information about eligible women who decline trial participation, allowing broader contextualisation and considerations of generalisability of trial findings. Methodological insights from examination of recruitment processes and mechanisms have the potential to inform recruitment mechanisms and future recruitment strategies and study designs.Trial registrationISRCTN62510577. Registered on 6 October 2017.

Randomized controlled trial of multi‐modular motion‐assisted memory desensitization and reconsolidation (3MDR) for male military veterans with treatment‐resistant post‐traumatic stress disorder

To explore the potential efficacy of multi-modular motion-assisted memory desensitization and reprocessing (3MDR) in British military veterans with treatment-resistant service-related PTSD. Exploratory single-blind, randomized, parallel arm, cross-over controlled trial with nested process evaluation to assess fidelity, adherence and factors that influence outcome. A total of 42 participants (all male) were randomized with 83% retention at 12weeks and 86% at 26weeks. The difference in mean Clinician-Administered PTSD Scale for DSM-5 scores between the immediate and delayed 3MDR arms was -9.38 (95% CI -17.33 to -1.44, P=0.021) at 12weeks and -3.59 (-14.39 to 7.20, P=0.513) at 26weeks when both groups had received 3MDR. The likely effect size of 3MDR was found to be 0.65. Improvements were maintained at 26-week follow-up. 3MDR was found to be acceptable to most, but not all, participants. Several factors that may impact efficacy and acceptability of 3MDR were identified. 3MDR is a promising new intervention for treatment-resistant PTSD with emerging evidence of effect.