Autistic adults experience significant physical and mental health inequities yet remain underrepresented in clinical research, with few randomised controlled trials to guide care. Randomised controlled trials (RCTs) of selective serotonin reuptake inhibitors (SSRIs) are limited, underpowered, and rarely focused on anxiety. Anticipating recruitment challenges in a large RCT ("STRATA") evaluating sertraline for anxiety in autistic adults, we embedded qualitative research to support recruitment, retention, and monitoring trial acceptability. We organised our findings into the theoretical framework of acceptability (TFA) constructs to assess the acceptability of trial design and delivery for autistic adults. We conducted 64 interviews with autistic adults at different trial stages. Data were analysed thematically and mapped to the seven TFA constructs. Participants considered involvement in a blinded medication RCT acceptable across the TFA domains, which they weighed differently when reflecting on anticipated versus experienced aspects of participation. STRATA was a low-burden, ethically sound, and methodologically coherent study for most participants, who reported minimal trade-offs, potential benefits, and self-efficacy in managing anxiety and research participation. Acceptability of trial participation is dynamic and multidimensional, which can be enhanced by meaningful involvement of autistic people throughout the research cycle, accessible participant information design, and responsive ongoing engagement.Lay AbstractAutistic adults often experience poorer physical and mental health than the general population. Yet they are rarely included in clinical research. There have been very few high-quality studies (RCTs) testing medications for anxiety in this group. Most existing studies are small and focus on other outcomes. They don't provide clear guidance for care. To help address this gap, the STRATA trial tested whether the medication sertraline (an SSRI) can reduce anxiety in autistic adults. Recruiting participants for such trials can be challenging. We included a qualitative study to better understand what helps or hinders people from joining and staying in the trial. We aimed to explore what aspects of the STRATA trial made it easier or more appealing for autistic adults to take part. We used a framework called the theoretical framework of acceptability (TFA) to define acceptability in this context. We interviewed 64 autistic adults at different stages of the trial, including 2 who chose not to take part. Most participants found the trial acceptable when assessed against the seven aspects of the TFA (i.e., how someone feels about taking part, how much effort is needed, whether taking part fits with a person's values, how well someone understands the study, what someone may have to give up, whether the study is likely to help, and how confident someone feels about taking part). In summary, they felt positive about taking part. They thought the study was ethical and easy to understand and believed it could benefit them. Many also felt more confident in managing their anxiety and contributing to research. STRATA is one of the largest studies of its kind; 318 autistic adults took part across the United Kingdom and Australia. The trial had a very high retention rate. Ninety-two per cent of participants stayed until the main outcome point, and 87% completed the full 52 weeks. How acceptable clinical trials like STRATA are may change during their course, and researchers need to be responsive. To do this well, researchers should involve autistic people meaningfully throughout the research process and from an early stage. Researchers also need to respect individual communication needs and provide clear and accessible information. These approaches were central to STRATA and supported by other studies.

PURPOSE:The STRATA randomised-controlled trial (RCT) examined the antidepressant sertraline vs placebo for treating anxiety in autistic adults. Autistic people are often assumed to be reluctant to take part in RCTs due to intolerance of their inherent uncertainty. This study aimed to qualitatively examine autistic people's experiences of RCT participation, specifically regarding their random assignment to an antidepressant (sertraline) or placebo for their mental health, whilst blinded to treatment allocation. METHODS:Semi-structured interviews were undertaken with a purposive sample of 62 STRATA participants. The interviews examined why they chose to take part, why they continued in the trial and/or discontinued medication, and their overall experience of participation. Interviews took place either during participation, or at participants' final trial appointment at 52-weeks post randomisation ('exit interviews'). Data were analysed thematically through a collaborative process, with multiple researchers independently coding, discussing, and refining themes. RESULTS:Interviewees often discussed improved anxiety, attributing changes to believing they were taking sertraline, experiencing the placebo effect, or external factors. Post-analysis unblinding revealed that improved anxiety was discussed equally by participants in both the sertraline and placebo groups. Some participants, including those taking placebo, experienced side effects, which mirrored the types, frequency, and severity seen in the general population. Many were able to manage these and continue, but some discontinued medication as a result. CONCLUSION:Aspects of trial design and delivery facilitated continuation with the study medication, including frequent appointments, shared control over medication dose, and meaningfully involving autistic people in trial design. Such non-pharmacological factors may enhance therapeutic benefits, and may improve RCT design and therapeutic alliances with autistic people.

INTRODUCTION:The COVID-19 pandemic impacted the operationalisation of non-COVID-19 clinical trials globally, particularly site and participant recruitment and trial success/stoppage. Trials which anticipate recruitment challenges may embed methods such as the QuinteT Recruitment Intervention (QRI) to help identify and understand the sources of challenges. Such interventions can help shed light on pandemic-related challenges. This paper reports our experience of the impact of the COVID-19 pandemic on conducting clinical trials with an embedded QRI, highlighting how the QRI aided in identifying challenges and potential solutions, particularly related to the site set-up and participant recruitment. MAIN BODY:We report on 13 UK clinical trials which included a QRI. Information is from QRI data and researchers' experience and reflections. In most trials, recruitment was lower than even the lowest anticipated rates. The flexibility of the QRI facilitated rapid data collection to understand and document, and in some instances respond to, operational challenges. Challenges were mostly logistical, pandemic-related and beyond the control of the site or central trial teams. Specifically: disrupted and variable site opening timelines -often due to local research and development (R&D) delays- shortages of staff to recruit patients; fewer eligible patients or limited access to patients; and intervention-related factors. Almost all trials were affected by pandemic-related staffing issues including redeployment, prioritisation of COVID-19 care and research, and COVID-19-related staff illness and absence. Trials of elective procedures were particularly impacted by the pandemic, which caused changes to care/recruitment pathways, deprioritisation of services, reduced clinical and surgical capacity and longer waiting lists. Attempted solutions included extra engagement with staff and R&D departments, trial protocol changes (primarily moving online) and seeking additional resourcing. CONCLUSION:We have highlighted wide-ranging, extensive and consistent pandemic-related challenges faced by UK clinical trials, which the QRI helped to identify and, in some cases, address. Many challenges were insurmountable at individual trials or trials unit level. This overview highlights the need to streamline trial regulatory processes, address staffing crises, improve recognition of NHS research staff and for clearer, more nuanced central guidance on the prioritisation of studies and how to deal with the backlog. Pre-emptively embedding qualitative work and stakeholder consultation into trials with anticipated difficulties, moving some processes online, and flexible trial protocols may improve the resilience of trials in the current challenging context.

Scalp acupuncture is a therapeutic procedure that involves inserting needles into the scalp to treat various medical conditions, including pain and neurological and psychological disorders. The inter-system variability of scalp acupuncture limits secondary analysis and evidence synthesis, delaying its inclusion into evidence-based healthcare policies and establishment as a treatment intervention recognized by Western medicine. This scoping review aimed to identify the range of scalp acupuncture systems, systematically collect and summarize information on their general, anatomical, and clinical characteristics, and build a framework for understanding scalp acupuncture systems. This review included all English-language publications on scalp acupuncture applied to treat any health condition in humans. Extensive searches were conducted across bibliographic databases, journals, trial registries, and supplementary sources. The detailed general, anatomical, and clinical application characteristics of 19 scalp acupuncture systems were extracted. Data were collected and analyzed using charting and image manipulation software. Framework synthesis was performed using the Standard International Acupuncture Nomenclature Scalp Acupuncture as an a priori framework. The review revealed that the heterogeneity related to scalp acupuncture methods can be attributed to the high variability among the theoretical bases of different systems, intersystem mismatch in anatomical locations of treatment points and areas on the scalp, and inconsistencies in the methods used for locating them. These discrepancies in anatomical and clinical features have limited the synthesis and development of a framework for scalp acupuncture. Discussion and agreement on the anatomical locations of scalp stimulation areas, identification of methods for precise positioning of acupuncture areas on the scalp, and further exploration of theoretical bases will aid in the standardization of scalp acupuncture and improve the quality of research in this area.

OBJECTIVE:Current Head and Neck cancer (HNC) follow-up models are considered sub-optimal at detecting recurrences. We describe the development of a patient-initiated follow up (PIFU) trial intervention support package, to support HNC patients to engage in PIFU self-care behaviors. METHODS:An intervention mapping approach, informed by evidence synthesis, theory and stakeholder consultation, guided intervention development. Data sources included a patient survey (n = 144), patient interviews (n = 30), 7 workshops with patients (n = 25) and caregivers (n = 3) and 5 workshops with health professionals (n = 21). RESULTS:The intervention ('ACT now & check-it-out') comprises an education and support session with a health professional and an app and/or a booklet for patients. The main targets for change in patient self-care behaviors were: assessing what is normal for them; regularly checking for symptom changes; prompt help-seeking for persistent/new symptoms; self-management of fear of recurrence; engaging with the intervention over time. CONCLUSIONS:We have developed an evidence, person and theory-based intervention to support PIFU self-care behaviors in HNC patients. PRACTICE IMPLICATIONS:A trial is underway to assess the effectiveness and cost-effectiveness of the intervention. If successful, this intervention could be adapted for patients with other cancers or diseases, which is important given the recent shift towards PIFU pathways.

Background: Current follow-up models in cancer are seen to be unsustainable and inflexible, and there is growing interest in alternative models, such as patient-initiated follow-up (PIFU). It is therefore important to understand whether PIFU is acceptable to patients and healthcare professionals (HCPs).Methods: Standard systematic review methodology aimed at limiting bias was used for study identification (to January 2022), selection and data extraction. Thematic synthesis was undertaken for qualitative data, and survey findings were tabulated and described.Results: Nine qualitative studies and 22 surveys were included, mainly in breast and endometrial cancer. Women treated for breast or endometrial cancer and HCPs were mostly supportive of PIFU. Facilitators for PIFU included convenience, control over own health and avoidance of anxiety-inducing clinic appointments. Barriers included loss of reassurance from scheduled visits and lack of confidence in self-management. HCPs were supportive of PIFU but concerned about resistance to change, unsuitability of PIFU for some patients and costs.Conclusion: PIFU is viewed mostly positively by women treated for breast or endometrial cancer, and by HCPs, but further evidence is needed from a wider range of cancers, men, and more representative samples.A protocol was registered with PROSPERO (CRD42020181412).

Y Aims: Current follow-up for head and neck cancer (HNC) is ineffective, expensive and fails to address patients' needs. The PETNECK2 trial will compare a new model of patient-initiated follow-up (PIFU) with routine scheduled follow-up. This article reports UK clinicians' views about HNC follow-up and PIFU, to inform the trial design. Materials and methods: Online focus groups with surgeons (ear, nose and throat/maxillofacial), oncologists, clinical nurse specialists and allied health professionals. Clinicians were recruited from professional bodies, mailing lists and personal contacts. Focus groups explored views on current follow-up and acceptability of the proposed PIFU intervention and randomised controlled trial design (presented by the study co-chief investigator), preferences, margins of equipoise, potential organisational barriers and thoughts about the content and format of PIFU. Data were interpreted using inductive thematic analysis. Results: Eight focus groups with 34 clinicians were conducted. Clinicians highlighted already known limitations with HNC follow-up - lack of flexibility to address the wide-ranging needs of HNC patients, expense and lack of evidence e and agreed that follow-up needs to change. They were enthusiastic about the PETNECK2 trial to develop and evaluate PIFU but had concerns that PIFU may not suit disengaged patients and may aggravate patient anxiety/fear of recurrence and delay detection of recurrence. Anticipated issues with implementation included ensuring a reliable route back to clinic and workload burden on nurses and allied health professionals. Conclusions: Clinicians supported the evaluation of PIFU but voiced concerns about barriers to help-seeking. An emphasis on patient engagement, psychosocial issues, symptom reporting and reliable, quick routes back to clinic will be important. Certain patient groups may be less suited to PIFU, which will be evaluated in the trial. Early, meaningful, ongoing engagement with clinical teams and managers around the trial rationale and recruitment process will be important to discourage selective recruitment and address risk-averse behaviour and potential workload burden. (C) 2021 The Authors. Published by Elsevier Ltd on behalf of The Royal College of Radiologists.

Abstract Objective The objective of this work was to explore head and neck cancer (HNC) patients' and their family members' views on acceptability and feasibility of patient‐initiated follow‐up (PIFU), including concerns and anticipated benefits. Methods Patients were recruited from UK HNC clinics, support groups and advocacy groups. They completed a survey (n = 144) and/or qualitative interview (n = 30), three with a family member. Qualitative data were analysed thematically, quantitative data using descriptive statistics. Results Preference for follow‐up care in HNC was complex and individual. Many patients thought PIFU could beneficially reallocate health care resources and encourage self‐management. Patients' main concerns with PIFU were losing the reassurance of regular clinic appointments and addressing mental well‐being needs within PIFU, possibly using peer support. Patients were concerned about their ability to detect recurrence due to lack of expertise and information. They emphasised the importance of a reliable, direct and easy urgent appointment service and of feeling supported and heard by clinicians. Patients believed family and friends need support. Conclusion PIFU may be feasible and acceptable for certain HNC patients, providing it addresses support for mental well‐being, provides quick, reliable and direct clinician access and information on “red flag” symptoms, and ensures patients and their caregivers feel supported.

A key challenge for qualitative methods in applied health research is the fast pace that can characterize the public health and health and care service landscape, where there is a need for research informed by immediate pragmatic questions and relevant findings are required quickly to inform decision-making. The COVID-19 pandemic accelerated the pace at which evidence was needed to inform urgent public health and healthcare decision-making. This required qualitative researchers to step up to the challenge of conducting research at speed whilst maintaining rigor and ensuring the findings are credible. This article illustrates how working with multidisciplinary, collaborative teams and the tailoring of qualitative methods to be more pragmatic and efficient can provide timely and credible results. Using time-limited case studies of applied qualitative health research drawn from the work of the Behavioral and Qualitative Science Team from the National Institute for Health and Care Research Applied Research Collaboration West (NIHR ARC West), we illustrate our collaborative and intensive pragmatic qualitative (CLIP-Q) approach. CLIP-Q involves (i) collaboration at all stages of the design, conduct and implementation of projects and, where possible, co-production with people with lived experience, (ii) an intensive team-based approach to data collection and analysis at pace, and (iii) pragmatic study design and efficient strategies at each stage of the research process. The case studies include projects conducted pre COVID-19 and during the first wave of the pandemic, where urgent evidence was required in weeks rather than months to inform rapid public health and healthcare decision making.

Background Unity Sexual Health in Bristol UK, re-designed its service to improve access and delivery of care. This includes a Panther (Hologic Inc) system at the point of care to provide rapid STI tests, allowing Nucleic acid amplification testing results for STIs including gonorrhoea and chlamydia to be available within four hours. Previously patients waited over a week for results. Methods A qualitative evaluation running alongside the implementation of the new service, to understand experiences, and inform its iterative development. A total of 21 members of staff and 26 patients were interviewed, and 40 hours of observations conducted of the service in operation, were analysed thematically. Results The new service implementation required co-ordinated changes in practice across multiple staff teams. Patients also needed to make changes to how they accessed the service. Multiple small ‘pilots’ of process changes were necessary to find workable options. This responsive model created challenges for delivering comprehensive training/communication in advance to all staff. However, staff worked together to adjust and improve the new service, and morale was buoyed through observing positive impacts on patient care. Patients valued faster results and avoiding unnecessary treatment. They were willing to drop off samples and return for a follow-up appointment the same/next day, enabling infection-specific treatment in accordance with test results thus improving antimicrobial stewardship. Conclusions Implementation of service changes to improve access and delivery of care in the context of stretched resources can pose challenges for staff at all levels. Early evaluation of pilots of process change, provide opportunities for prompt feedback enabling adjustment, is valued. Visibility to staff of positive impacts on patient care is important in maintaining morale. The service was acceptable to patients.

BACKGROUND:Due to rising numbers of STI diagnosis and increasing prevalence of antimicrobial resistance, we explored trends in STI testing frequency and diagnoses, alongside sexual decision making and attitudes concerning condom use and HIV pre-exposure prophylaxis (PrEP) at a large urban UK sexual health clinic. METHODS:We examined 66 528 electronic patient records covering 40 321 attendees between 2016 and 2019, 3977 of whom were men who have sex with men or trans persons who have sex with men (MSM/TPSM). We also explored responses from MSM/TPSM attendees sent an electronic questionnaire between November 2018 and 2019 (n=1975) examining behaviours/attitudes towards PrEP. We measured trends in STI diagnoses and sexual behaviours including condomless anal intercourse (CAI), using linear and logistic regression analyses. RESULTS:Tests resulting in gonorrhoea, chlamydia or syphilis diagnoses increased among MSM/TPSM from 13.5% to 18.5% between 2016 and 2019 (p<0.001). The average MSM/TPSM STI testing frequency increased from 1.5/person/year to 2.1/person/year (p=0.017). Gay MSM/TPSM had the highest proportions of attendances resulting in diagnoses, increasing from 15.1% to 19.6% between 2016 and 2019 (p<0.001) compared with bisexual/other MSM/TPSM increasing from 6.9% to 14.5% (p<0.001), alongside smaller but significant increases in non-MSM/TPSM from 5.9% to 7.7% (p<0.001).The proportion of MSM/TPSM clinic attendees reporting CAI in the previous 3 months prior to at least one appointment in a given year increased significantly from 40.6% to 45.5% between 2016 and 2019 (p<0.0001) and average number of partners from 3.8 to 4.5 (p=0.002). Of 617 eligible questionnaire responses, 339/578 (58.7%) HIV-negative and 29/39 (74.4%) HIV-positive MSM/TPSM indicated they would be more likely to have CAI with someone on PrEP versus not on PrEP. 358/578 (61.9%) HIV-negative respondents said that PrEP use would make them more likely to have CAI with HIV-negative partners. CONCLUSION:Rising numbers of STI diagnoses among MSM/TPSM are not attributable to increased testing alone. Increased CAI and number of partners may be attributable to evolving sexual decision making among PrEP users and their partners. Proportionally, bisexual/other MSM/TPSM have the steepest increase in STI diagnoses.

Objectives To investigate experiences of implementing a new rapid sexual health testing, diagnosis and treatment service. Design A theory-based qualitative evaluation with a focused ethnographic approach using non-participant observations and interviews with patient and clinic staff. Normalisation process theory was used to structure interview questions and thematic analysis. Setting A sexual health centre in Bristol, UK. Participants 26 patients and 21 staff involved in the rapid sexually transmitted infection (STI) service were interviewed. Purposive sampling was aimed for a range of views and experiences and sociodemographics and STI results for patients, job grades and roles for staff. 40 hours of observations were conducted. Results Implementation of the new service required co-ordinated changes in practice across multiple staff teams. Patients also needed to make changes to how they accessed the service. Multiple small ‘pilots’ of process changes were necessary to find workable options. For example, the service was introduced in phases beginning with male patients. This responsive operating mode created challenges for delivering comprehensive training and communication in advance to all staff. However, staff worked together to adjust and improve the new service, and morale was buoyed through observing positive impacts on patient care. Patients valued faster results and avoiding unnecessary treatment. Patients reported that they were willing to drop-off self-samples and return for a follow-up appointment, enabling infection-specific treatment in accordance with test results, thus improving antimicrobial stewardship. Conclusions The new service was acceptable to staff and patients. Implementation of service changes to improve access and delivery of care in the context of stretched resources can pose challenges for staff at all levels. Early evaluation of pilots of process changes played an important role in the success of the service by rapidly feeding back issues for adjustment. Visibility to staff of positive impacts on patient care is important in maintaining morale.

ObjectiveTo investigate student, parent/carer and secondary school staff attitudes towards school COVID-19 mitigation measures.MethodsRecruitment used school communication, community organisations and snowball sampling in South West England. Audio recorded online or phone individual/group semi-structured interviews were conducted in July–Septtember 2020 and lasted 30–60 min. Interviews focused on views towards social distancing, hand hygiene and testing. Framework analysis was performed on interview notes/transcripts.ResultsParticipants were 15 staff, 20 parents and 17 students (11–16 years) from 14 diverse schools. Concerns about COVID-19 risk at school, especially to vulnerable individuals, were outweighed by perceived risks of missed learning. Some staff felt guilt around being a potential ‘spreader’ by teaching multiple classes. Findings highlighted a wide variety of school COVID-19 mitigation measures being deployed due to ambiguous government guidance. Participants generally saw mitigation measures as an acceptable and pragmatic solution to the perceived impossibility of social distancing in crowded schools, although anticipated challenges changing habitual behaviour. Participants supported school COVID-19 testing but identified the need to consider data security and stigma around COVID-19 diagnosis. Staff were concerned about unintended consequences of risk-reduction strategies on student behaviour, learning and pastoral care, particularly for those with Special Educational Needs or mental health issues who may find the measures especially challenging, and resultant widening inequalities.ConclusionFamilies and staff supported COVID-19 mitigation measures in schools and would welcome the roll out school COVID-19 testing. Clear messaging and engendering collective responsibility are important for compliance and success of COVID-19 mitigation measures. However, schools and policy-makers should consider unintended consequences of measures, providing extra support for vulnerable students and those with additional needs, and consider ways to avoid widening educational and health inequalities. Findings demonstrate the acceptability of school COVID-19 infection control measures is likely to be influenced by the balance of risks and benefits to students.

Background Human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) has helped reduce new HIV infections. However, bacterial sexually transmitted infections (STIs) have increased among PrEP users. We examined PrEP knowledge, access, and risk perceptions in an age of antimicrobial resistance (AMR). Methods An online anonymous survey was distributed to all cisgender men/transpersons who have sex with men attending a sexual health clinic in Bristol, United Kingdom (October 2018 to November 2019). Interviews with a sample identified at increased risk of HIV were analyzed thematically and integrated with survey data. Results Five hundred and seventy-eight (95%) of 617 cisgender men/transpersons who have sex with men survey respondents were HIV-negative/unknown, of these, 202 (34.9%) had ever used PrEP. Interviewees (n = 24) reported widespread awareness of and enthusiasm for PrEP. Among nonusers, 39% (146/376) were unaware how to access PrEP, and 27% (103/376) could not access PrEP through the national “impact” trial of whom 79% (81/103) were eligible. The PrEP was described as “life-changing,” but expense was the main barrier to use. Sixty-two percent (358/578) of HIV-negative/unknown respondents on PrEP were more likely to have condomless anal intercourse with someone they thought was HIV-negative. Interviewees used PrEP with other risk-reduction strategies. Sexually transmitted infections were seen as “curable” and AMR rarely influenced risk perception or sexual decision making. Conclusions The PrEP awareness was high, but purchase cost limited access. PrEP may increase condomless anal intercourse, but interviewees used PrEP as one of many risk-reduction tools. Reduced fear of HIV transmission and testing was highly valued. Sexually transmitted infection AMR was not seen as an immediate threat and did not influence risk perception or sexual decision making.

Purpose To collate evidence of changes in body composition following treatment of leukaemia in children, teenagers and young adults (CTYA, 0–24 years) with allogeneic haematopoietic stem cell transplant and total body irradiation (HSCT+TBI). Methods Papers were identified by searching Medline and Google Scholar, reference lists/citations and contacting key authors, with no date or language restrictions. Inclusion criteria were as follows: leukaemia, HSCT+TBI, aged ≤ 24 years at HSCT and changes in body composition (total fat, central adiposity, adipose tissue function, muscle mass, muscle function). Quality was assessed using a brief Newcastle–Ottawa scale. Results Of 900 papers, 20 were included: seven controlled, five uncontrolled studies and eight case reports. Study quality appeared good. There was little evidence of differences in total fat/weight for HSCT + TBI groups (compared to healthy controls/population norms/short stature controls). There was some evidence of significantly higher central adiposity and differences in adipose tissue function (compared to leukaemic/non-leukaemic controls). Muscle mass was significantly lower (compared to healthy/obese controls). Muscle function results were inconclusive but suggested impairment. Case reports confirmed a lipodystrophic phenotype. Conclusions Early remodelling of adipose tissue and loss of skeletal muscle are evident following HSCT + TBI for CTYA leukaemia, with extreme phenotype of overt lipodystrophy. There is some evidence for reduced muscle effectiveness. Implications for Cancer Survivors Body composition changes in patients after HSCT + TBI are apparent by early adult life and link with the risk of excess cardiometabolic morbidity seen in adult survivors. Interventions to improve muscle and/or adipose function, perhaps utilizing nutritional manipulation and/or targeted activity, should be investigated.