A systematic review on the qualitative experiences of people living with lung cancer in rural areas.

PURPOSE: To synthesize the qualitative literature exploring the experiences of people living with lung cancer in rural areas. METHODS: Searches were performed in MEDLINE, CINAHL, and PsycINFO. Articles were screened independently by two reviewers against pre-determined eligibility criteria. Data were synthesized using Thomas and Harden's framework for the thematic synthesis of qualitative research. The CASP qualitative checklist was used for quality assessment and the review was reported in accordance with the ENTREQ and PRISMA checklists. RESULTS: Nine articles were included, from which five themes were identified: (1) diagnosis and treatment pathways, (2) travel and financial burden, (3) communication and information, (4) experiences of interacting with healthcare professionals, (5) symptoms and health-seeking behaviors. Lung cancer diagnosis was unexpected for some with several reporting treatment delays and long wait times regarding diagnosis and treatment. Accessing treatment was perceived as challenging and time-consuming due to distance and financial stress. Inadequate communication of information from healthcare professionals was a common concern expressed by rural people living with lung cancer who also conveyed dissatisfaction with their healthcare professionals. Some were reluctant to seek help due to geographical distance and sociocultural factors whilst others found it challenging to identify symptoms due to comorbidities. CONCLUSIONS: This review provides a deeper understanding of the challenges faced by people with lung cancer in rural settings, through which future researchers can begin to develop tailored support to address the existing disparities that affect this population.

Volunteering on Heritage at Risk sites and wellbeing: A qualitative interview study.

INTRODUCTION: We explored experiences of volunteering in Heritage at Risk (HAR) projects, intended to mitigate the deterioration to historic assets, and the relationship with wellbeing. We aimed to understand the value of HAR to volunteers' wellbeing and relationships between HAR programme characteristics such as location, asset type and type of activity. METHODS: We used a qualitative design with semi-structured interviews of a purposive sample of volunteers recruited via Historic England (HE), employing Systematic Grounded Theory involving open, axial and selective coding. FINDINGS: We interviewed 35 volunteers (18 male and 17 female) participating in 10 HAR projects. We identified six themes from the data analysis. (1) Purpose-was associated with volunteering motivations; there were some barriers to volunteering and many types of facilitators, including accessibility to local heritage sites. (2) Being-volunteers showed an appreciation and attachment to their place of residence. (3) Capacity-to learn heritage-specific skills and diversify experiences in learning new skills (life, technical and personal). (4) Sharing-community engagement, connectedness, and inclusivity captured diversity and inclusion within volunteers across age, ethnicity, ability, and gender. (5) Self-nurture-HAR volunteering created physical, psychological, and social benefits with limited risks and adverse outcomes. (6) Self-actualisation-described volunteers reflecting on their experiences. CONCLUSION: HAR volunteering was associated with positive physical, social and psychological wellbeing outcomes. The study provides an evidence base for specific wellbeing benefits of volunteering at Heritage at Risk sites, although we could not conclude that HAR project activity was the cause of increased wellbeing. PUBLIC CONTRIBUTION: Staff from HE were involved in designing the project brief. In selecting the HAR project sites, we took advice and recommendations from HE staff across all their six regional offices.

Adherence to swallowing recommendations during (chemo)radiotherapy in head and neck cancer survivors: a scoping review.

PURPOSE OF REVIEW: There is a paucity of knowledge regarding patient adherence to dysphagia recommendations. It is recognized that unique barriers and facilitators contribute to poor treatment adherence in head and neck cancer (HNC) survivors. This review aims to identify the key themes and knowledge gaps regarding adherence to swallowing recommendations in HNC survivors during (chemo)radiotherapy (C)RT. RECENT FINDINGS: Seven studies were identified. Six facilitators to adherence were extracted, namely pain relief, behavioural intervention, attendance at multidisciplinary clinic, individualised swallowing therapy, absence of prophylactic percutaneous endoscopic gastronomy (PEG) and positive social control from a spouse. Barriers to adherence included pain, depression and presence of prophylactic PEG. Adherence to swallowing recommendations positively impacted swallowing outcomes in one study. SUMMARY: Little is known about adherence to swallowing recommendations during (C)RT in HNC survivors. Capturing adherence is challenging. Several knowledge gaps were identified. Further research is needed to better understand the barriers and facilitators from the survivors' perspective. This will inform development of best practice regarding how swallowing recommendations are provided to promote adherence and improve outcomes.

Model-based economic evaluation of the effectiveness of "'Hypos' can strike twice", a leaflet-based ambulance clinician referral intervention to prevent recurrent hypoglycaemia.

"'Hypos' can strike twice" (HS2) is a pragmatic, leaflet-based referral intervention designed for administration by clinicians of the emergency medical services (EMS) to people they have attended and successfully treated for hypoglycaemia. Its main purpose is to encourage the recipient to engage with their general practitioner or diabetic nurse in order that improvements in medical management of their diabetes may be made, thereby reducing their risk of recurrent hypoglycaemia. Herein we build a de novo economic model for purposes of incremental analyses to compare, in 2018-19 prices, HS2 against standard care for recurrent hypoglycaemia in the fortnight following the initial attack from the perspective of the UK National Health Service (NHS). We found that per patient NHS costs incurred by people receiving the HS2 intervention over the fortnight following an initial hypoglycaemia average £49.79, and under standard care costs average £40.50. Target patient benefit assessed over that same period finds the probability of no recurrence of hypoglycaemia averaging 42.4% under HS2 and 39.4% under standard care, a 7.6% reduction in relative risk. We find that implementing HS2 will cost the NHS an additional £309.36 per episode of recurrent hypoglycaemia avoided. Contrary to the favourable support offered in Botan et al., we conclude that in its current form the HS2 intervention is not a cost-effective use of NHS resources when compared to standard NHS care in reducing the risk of hypoglycaemia recurring within a fortnight of an initial attack that was resolved at-scene by EMS ambulance clinicians.

Examiner perceptions of the MRCGP recorded consultation assessment for general practice licensing during COVID-19: cross-sectional study.

BACKGROUND: The Recorded Consultation Assessment (RCA) was developed rapidly during the COVID-19 pandemic to replace the Clinical Skills Assessment (CSA) for UK general practice licensing. Our aim was to evaluate examiner perceptions of the RCA. METHODS: We employed a cross-sectional design using a questionnaire survey of RCA examiners with attitudinal (relating to examiners thoughts and perceptions of the RCA) and free text response options. We conducted statistical descriptive and factor analysis of quantitative data with qualitative thematic analysis of free text responses. RESULTS: Overall, 182 of 260 (70%) examiners completed the questionnaire. Responders felt that consultations submitted were representative of the work of a typical GP during the pandemic and provided a good sample across the curriculum. They were also generally positive about the logistic, advisory and other support provided as well as the digital platform. Despite responders generally agreeing there was sufficient information available in video or audio consultations to judge candidates' data gathering, clinical management, and interpersonal skills, they were less confident about their ability to make judgments of candidates' performance compared with the CSA. The qualitative analysis of free text responses detailed the problems of case selection and content, explained examiners' difficulties when making judgments, and detailed the generally positive views about support, training and information technology. Responders also provided helpful recommendations for improving the assessment. CONCLUSION: The RCA was considered by examiners to be feasible and broadly acceptable, although they experienced challenges from candidate case selection, case content and judgments leading to suggested areas for improvement.

Scaling-up a pharmacist-led information technology intervention (PINCER) to reduce hazardous prescribing in general practices: Multiple interrupted time series study.

BACKGROUND: We previously reported on a randomised trial demonstrating the effectiveness and cost-effectiveness of a pharmacist-led information technology intervention (PINCER). We sought to investigate whether PINCER was effective in reducing hazardous prescribing when rolled out at scale in UK general practices. METHODS AND FINDINGS: We used a multiple interrupted time series design whereby successive groups of general practices received the PINCER intervention between September 2015 and April 2017. We used 11 prescribing safety indicators to identify potentially hazardous prescribing and collected data over a maximum of 16 quarterly time periods. The primary outcome was a composite of all the indicators; a composite for indicators associated with gastrointestinal (GI) bleeding was also reported, along with 11 individual indicators of hazardous prescribing. Data were analysed using logistic mixed models for the quarterly event numbers with the appropriate denominator, and calendar time included as a covariate. PINCER was implemented in 370 (94.1%) of 393 general practices covering a population of almost 3 million patients in the East Midlands region of England; data were successfully extracted from 343 (92.7%) of these practices. For the primary composite outcome, the PINCER intervention was associated with a decrease in the rate of hazardous prescribing of 16.7% (adjusted odds ratio (aOR) 0.83, 95% confidence interval (CI) 0.80 to 0.86) at 6 months and 15.3% (aOR 0.85, 95% CI 0.80 to 0.90) at 12 months postintervention. The unadjusted rate of hazardous prescribing reduced from 26.4% (22,503 patients in the numerator/853,631 patients in the denominator) to 20.1% (11,901 patients in the numerator/591,364 patients in the denominator) at 6 months and 19.1% (3,868 patients in the numerator/201,992 patients in the denominator). The greatest reduction in hazardous prescribing associated with the intervention was observed for the indicators associated with GI bleeding; for the GI composite indicator, there was a decrease of 23.9% at both 6 months (aOR 0.76, 95% CI 0.73 to 0.80) and 12 months (aOR 0.76, 95% CI 0.70 to 0.82) postintervention. The unadjusted rate of hazardous prescribing reduced from 31.4 (16,185 patients in the numerator/515,879 patients in the denominator) to 21.2% (7,607 patients in the numerator/358,349 patients in the denominator) at 6 months and 19.5% (2,369 patients in the numerator/121,534 patients in the denominator). We adjusted for calendar time and practice, but since this was an observational study, the findings may have been influenced by unknown confounding factors or behavioural changes unrelated to the PINCER intervention. Data were also not collected for all practices at 6 months and 12 months postintervention. CONCLUSIONS: The PINCER intervention, when rolled out at scale in routine clinical practice, was associated with a reduction in hazardous prescribing by 17% and 15% at 6 and 12 months postintervention. The greatest reductions in hazardous prescribing were for indicators associated with risk of GI bleeding. These findings support the wider national rollout of PINCER in England.

People with diabetes and ambulance staff perceptions of a booklet-based intervention for diabetic hypoglycaemia, "Hypos can strike twice": a mixed methods process evaluation.

BACKGROUND: Hypoglycaemia is a potentially serious condition, characterised by lower-than-normal blood glucose levels, common in people with diabetes (PWD). It can be prevented and self-managed if expert support, such as education on lifestyle and treatment, is provided. Our aim was to conduct a process evaluation to investigate how ambulance staff and PWD perceived the "Hypos can strike twice" booklet-based ambulance clinician intervention, including acceptability, understandability, usefulness, positive or negative effects, and facilitators or barriers to implementation. METHODS: We used an explanatory sequential design with a self-administered questionnaire study followed by interviews of people with diabetes and ambulance staff. We followed the Medical Research Council framework for process evaluations of complex interventions to guide data collection and analysis. Following descriptive analysis (PWD and staff surveys), exploratory factor analysis was conducted to identify staff questionnaire subscales and multiple regression models were fitted to identify demographic predictors of overall and subscale scores. RESULTS: 113 ambulance staff members and 46 PWD completed the survey. We conducted interviews with four ambulance staff members and five PWD who had been attended by an ambulance for a hypoglycaemic event. Based on surveys and interviews, there were positive attitudes to the intervention from both ambulance staff and PWD. Although the intervention was not always implemented, most staff members and PWD found the booklet informative, easy to read and to use or explain. PWD who completed the survey reported that receiving the booklet reminded and/or encouraged them to test their blood glucose more often, adjust their diet, and have a discussion/check up with their diabetes consultant. Interviewed PWD felt that the booklet intervention would be more valuable to less experienced patients or those who cannot manage their diabetes well. Overall, participants felt that the intervention could be beneficial, but were uncertain about whether it might help prevent a second hypoglycaemic event and/or reduce the number of repeat ambulance attendances. CONCLUSIONS: The 'Hypos may strike twice' intervention, which had demonstrable reductions in repeat attendances, was found to be feasible, acceptable to PWD and staff, prompting reported behaviour change and help-seeking from primary care. TRIAL REGISTRATION: Registered with ClinicalTrials.gov: NCT04243200 on 27 January 2020.

Patient-reported symptoms and experience following Guillain-Barré syndrome and related conditions: Questionnaire development and validation.

BACKGROUND: Guillain-Barré syndrome (GBS) is a rare inflammatory peripheral nerve disorder with variable recovery. Evidence is lacking on experiences of people with GBS and measurement of these experiences. OBJECTIVE: We aimed to develop and validate an instrument to measure experiences of people with GBS. DESIGN: We used a cross-sectional design and online self-administered questionnaire survey. Question domains, based on a previous systematic review and qualitative study, covered experiences of GBS, symptom severity at each stage, healthcare and factors supporting or hindering recovery. Descriptive, exploratory factor and reliability analyses and multivariable regression analysis were used to investigate the relationships between variables of interest, explore questionnaire reliability and validity and identify factors predicting recovery. SETTING AND PARTICIPANTS: People with a previous diagnosis of GBS were recruited through a social media advert. RESULTS: A total of 291 responders, of different sexes, and marital statuses, were included, with most diagnosed between 2015 and 2019. Factor analysis showed four scales: symptoms, information provided, factors affecting recovery and care received. Positive social interactions, physical activity including physiotherapy and movement, changes made at home and immunoglobulin treatment were important for recovery. Multivariable models showed that immunoglobulin and/or plasma exchange were significant predictors of recovery. Employment and recovery factors (positive interactions, work support and changes at work or home, physical activity and therapy), though associated with recovery, did not reach statistical significance. CONCLUSION: The questionnaire demonstrated good internal reliability of scales and subscales and construct validity for people following GBS. PATIENT CONTRIBUTION: Patients were involved in developing and piloting the questionnaire.

Candidate perceptions of the UK Recorded Consultation Assessment: cross-sectional data linkage study.

The Recorded Consultation Assessment (RCA) was rapidly developed to replace the Clinical Skills Assessment (CSA) for UK general practice licencing during COVID-19. We aimed to evaluate candidate perceptions of the RCA and relationships with performance. We conducted a cross-sectional survey of RCA candidates with attitudinal, demographic, and free text response options, undertaking descriptive and factor analysis of quantitative data with qualitative thematic analysis of free text. Binomial regression was used to estimate associations between RCA pass, candidate characteristics and questionnaire responses.645 of 1551 (41.6%) candidates completed a questionnaire; 364 (56.4%) responders permitted linkage with performance and demographic data. Responders and non-responders were similar in exam performance, gender and declared disability but were significantly more likely to be UK graduates (UKG) or white compared with international medical (IMG) or ethnic minority graduates. Responders were positive about the digital platform and support resources. A small overall majority regarded the RCA as a fair assessment; a larger majority reported difficulty collecting, selecting, and submitting cases or felt rushed during recording.Logistic regression showed that ethnicity (white vs minority ethnic: odds ratio [OR] 2.99,95% confidence interval [CI] 1.23, 7.30, p = 0.016), training (UK vs IMG: OR 6.88, 95% CI 2.79, 16.95, p < 0.001), and English as first language (OR 5.11, 0% CI 2.08, 12.56, p < 0.001) were associated with exam success but questionnaire subscales, consultation type submitted, or extent of trainer review were not. The RCA was broadly acceptable but experiences were variable. Candidates experienced challenges and suggested areas for improvement.

Patient, carer, and staff perceptions of robotics in motor rehabilitation: a systematic review and qualitative meta-synthesis.

BACKGROUND: In recent years, robotic rehabilitation devices have often been used for motor training. However, to date, no systematic reviews of qualitative studies exploring the end-user experiences of robotic devices in motor rehabilitation have been published. The aim of this study was to review end-users' (patients, carers and healthcare professionals) experiences with robotic devices in motor rehabilitation, by conducting a systematic review and thematic meta-synthesis of qualitative studies concerning the users' experiences with such robotic devices. METHODS: Qualitative studies and mixed-methods studies with a qualitative element were eligible for inclusion. Nine electronic databases were searched from inception to August 2020, supplemented with internet searches and forward and backward citation tracking from the included studies and review articles. Data were synthesised thematically following the Thomas and Harden approach. The CASP Qualitative Checklist was used to assess the quality of the included studies of this review. RESULTS: The search strategy identified a total of 13,556 citations and after removing duplicates and excluding citations based on title and abstract, and full text screening, 30 studies were included. All studies were considered of acceptable quality. We developed six analytical themes: logistic barriers; technological challenges; appeal and engagement; supportive interactions and relationships; benefits for physical, psychological, and social function(ing); and expanding and sustaining therapeutic options. CONCLUSIONS: Despite experiencing technological and logistic challenges, participants found robotic devices acceptable, useful and beneficial (physically, psychologically, and socially), as well as fun and interesting. Having supportive relationships with significant others and positive therapeutic relationships with healthcare staff were considered the foundation for successful rehabilitation and recovery.

Perceptions and experiences of residents and relatives of emergencies in care homes: a systematic review and metasynthesis of qualitative research.

BACKGROUND: the perceptions and experiences of care home residents and their families are important for understanding and improving the quality of emergency care. METHODS: we conducted a systematic review and metasynthesis to understand the perceptions and experiences of care home residents and their family members who experienced medical emergencies in a care home setting. The review protocol was registered in PROSPERO (CRD42020167018). We searched five electronic databases, MEDLINE, CINAHL, PubMed, Cochrane Library and PsycINFO, supplemented with internet searches and forward and backward citation tracking from included studies and review articles. Data were synthesised thematically following the Thomas and Harden approach. The Critical Appraisal Skills Programme qualitative checklist was used to assess the quality of studies included in this review. RESULTS: of the 6,140 references retrieved, 10 studies from four countries (Australia, Canada, UK and USA) were included in the review and metasynthesis. All the included studies were assessed as being of good quality. Through an iterative approach, we developed six analytical themes: (i) infrastructure and process requirements in care homes to prevent and address emergencies; (ii) the decision to transfer to hospital; (iii) experiences of transfer and hospitalisation for older patients; (iv) good communication is vital for desirable outcomes; (v) legal, regulatory and ethical concerns and (vi) trusting relationships enabled residents to feel safe. CONCLUSIONS: the emergency care experience for care home residents can be enhanced by ensuring resources, staff capacity and processes for high quality care and trusting relationships between staff, patients and relatives, underpinned by good communication and attention to ethical practice.

The effects of a leaflet-based intervention, 'Hypos can strike twice', on recurrent hypoglycaemic attendances by ambulance services: A non-randomised stepped wedge study.

AIMS: We aimed to investigate the effect of an intervention in which ambulance personnel provided advice supported by a booklet-'Hypos can strike twice'-issued following a hypoglycaemic event to prevent future ambulance attendances. METHODS: We used a non-randomised stepped wedge-controlled design. The intervention was introduced at different times (steps) in different areas (clusters) of operation within East Midlands Ambulance Service NHS Trust (EMAS). During the first step (T0), no clusters were exposed to the intervention, and during the last step (T3), all clusters were exposed. Data were analysed using a general linear mixed model (GLMM) and an interrupted-time series analysis (ITSA). RESULTS: The study included 4825 patients (mean age 65.42 years, SD 19.42; 2,166 females) experiencing hypoglycaemic events attended by EMAS. GLMM indicated a reduction in the number of unsuccessful attendances (i.e., attendance followed by a repeat attendance) in the final step of the intervention when compared to the first (odds ratio OR: 0.50, 95%CI: 0.33-0.76, p = 0.001). ITSA indicated a significant decrease in repeat ambulance attendances for hypoglycaemia-relative to the pre-intervention trend (p = 0.008). Furthermore, the hypoglycaemia care bundle was delivered in 66% of attendances during the intervention period, demonstrating a significant level of practice change (p < 0.001). CONCLUSION: The 'Hypos can strike twice' intervention had a positive effect on reducing numbers of repeat attendances for hypoglycaemia and in achieving the care bundle. The study supports the use of information booklets by ambulance clinicians to prevent future attendances for recurrent hypoglycaemic events.

Patients' experiences and perceptions of Guillain-Barré syndrome: A systematic review and meta-synthesis of qualitative research.

BACKGROUND: Guillain-Barré syndrome (GBS) is an immune-mediated polyradiculoneuropathy, with an incidence of 1-2/100,000 per year. Its severity is variable, ranging from very mild cases with brief weakness to severe paralysis, leading to inability to breathe independently, or even death. Currently there is limited evidence exploring the experiences of GBS patients. The aim of this study was to review patients' experiences and perceptions of GBS and its variants at diagnosis, discharge and during recovery, by conducting a systematic review and thematic meta-synthesis of qualitative studies of patients' experiences of GBS (and its variants). METHODS: We searched twelve electronic databases, supplemented with internet searches and forward and backward citation tracking from the included studies and review articles. Data were synthesised thematically following the Thomas and Harden approach. The CASP Qualitative Checklist was used to assess the quality of the included studies of this review. RESULTS: Our search strategy identified a total of 5,282 citations and after removing duplicates and excluding citations based on title and abstract, and full-text screening, five studies were included in the review and meta-synthesis; all included studies were considered of acceptable quality. Through constant discussions and an iterative approach, we developed six analytical themes following a patient's journey from suspecting that they had a health problem, through to being hospitalised, experiencing ongoing difficulties, slowly recovering from GBS, adjusting to their new circumstances, and re-evaluating their lives. CONCLUSIONS: Despite the variety of experiences, it was evident from all included studies that being diagnosed with and surviving GBS was a life-changing experience for all participants. TRIAL REGISTRATION: Protocol was registered (CRD42019122199) on the International Prospective Register of Systematic Reviews (http://www.crd.york.ac.uk/PROSPERO).

Effects of cognitive behavioural therapy on insomnia in adults with tinnitus: Systematic review and meta-analysis of randomised controlled trials.

Insomnia is common in patients with tinnitus and negatively affects tinnitus symptoms and quality of life. This systematic review aimed to synthesise evidence of the effectiveness of cognitive behavioural therapy (CBT) based interventions on insomnia in adults with tinnitus. We conducted a comprehensive database search (MEDLINE, CINAHL, Web of Science, CENTRAL, ClinicalTrials.gov and PROSPERO) for published, unpublished and ongoing randomised controlled trials of CBT in adults with tinnitus. Five trials met the inclusion criteria for the systematic review, with four of these providing data for the meta-analysis. This demonstrated a statistically significant reduction in Insomnia Severity Index (a standard diagnostic questionnaire of insomnia used in clinical settings) following CBT (-3.28, 95% CI -4.51, -2.05, P=<0.001). There was no evidence of statistical heterogeneity (I2 = 0%). Risk of bias was considered low in all categories except blinding of participants, personnel, and/or the assessment of outcomes. Here, for the first time, we demonstrate that CBT-based interventions can significantly improve sleep in adults with tinnitus.

Exploring the experiences of having Guillain-Barré Syndrome: A qualitative interview study.

BACKGROUND: Guillain-Barré syndrome (GBS) is a rare inflammatory disorder affecting the peripheral nerves. Although typically there is full neurological recovery, some people continue to experience residual physical, psychological or social problems longer term. Evidence describing the experiences of people with GBS is limited. OBJECTIVE: We aimed to explore the experiences of people with GBS in the UK. DESIGN: We used qualitative (face-to-face and telephone) interviews to explore experiences of people with GBS. Audio-recorded data were transcribed verbatim and analysed using the Framework Method supported by NVivo 11. SETTING AND PARTICIPANTS: We purposively recruited a sample of 16 volunteers with a prior diagnosis of GBS of varying age, sex, ethnicity, location, marital status, time since diagnosis and length of hospital stay to maximize differences in experience. Interviewees were required to have been discharged from hospital, able to give informed consent, able to speak and understand English and currently resident in the United Kingdom. RESULTS: The key themes arising from the analysis were as follows: the importance of early diagnosis; the experiences of inpatient care; the importance of active support for recovery; the need for communication throughout the course of the illness; the need for greater awareness, knowledge and provision of information by health-care staff; and path to achieving function. CONCLUSION: This is the first qualitative study exploring experiences of people with GBS in the UK through their whole illness journey from onset to recovery. The findings contribute to our understanding of the experiences and support needs of people recovering from GBS.

Effectiveness of non-pharmacological interventions for insomnia in children with Autism Spectrum Disorder: A systematic review and meta-analysis.

BACKGROUND: Autism spectrum disorders (ASD) are a set of neurodevelopmental disorders characterised by behavioural, communication and social impairments. The prevalence of sleep disturbances in children with ASD is 40-80%, with significant effects on quality of life for the children and carers. This systematic review aimed to synthesise evidence of the effects of behavioural interventions to improve sleep among children with ASD. METHODS: Databases (MEDLINE, PsycINFO, CINAHL, ScienceDirect, Autism Data, CENTRAL, ClinicalTrials.gov and Current Controlled Trials) were searched for published, unpublished and ongoing randomised controlled trials evaluating the effect of non-pharmacological interventions for insomnia in children with autism spectrum conditions. RESULTS: Three studies met the inclusion criteria, one provided actigraphy data, one Children's Sleep Habits Questionnaire (CSHQ) data, and one both actigraphy and CSHQ data for use in meta-analyses. There were significant differences between the behavioural intervention and comparison groups (actigraphy data) for total sleep time (24.41 minutes, 95% CI 5.71, 43.11, P = 0.01), sleep latency (-18.31 minutes, 95% CI -30.84, -5.77, P = 0.004) and sleep efficiency (5.59%, 95% CI 0.87, 10.31, P = 0.02). There was also a favourable intervention effect evident for the subjective CSHQ data (-4.71, 95% CI -6.70, -2.73, P<0.00001). Risk of bias was low across several key domains (randomisation, allocation concealment and reporting), with some studies being unclear due to poor reporting. CONCLUSIONS: There are very few high quality randomised controlled trials in this area. Here we provide initial synthesised quantitative evidence of the effectiveness of behavioural interventions for treating sleep problems in children with ASD. TRIAL REGISTRATION: Protocol was registered (CRD42017081784) on the International Prospective Register of Systematic Reviews (http://www.crd.york.ac.uk/PROSPERO).

Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review.

BACKGROUND: We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. METHODS: A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. RESULTS: In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. CONCLUSIONS: Consent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent). Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.