Health Catch-UP!: a realist evaluation of an innovative multi-disease screening and vaccination tool in UK primary care for at-risk migrant patients.

BACKGROUND: Migrants to the UK face disproportionate risk of infections, non-communicable diseases, and under-immunisation compounded by healthcare access barriers. Current UK migrant screening strategies are unstandardised with poor implementation and low uptake. Health Catch-UP! is a collaboratively produced digital clinical decision support system that applies current guidelines (UKHSA and NICE) to provide primary care professionals with individualised multi-disease screening (7 infectious diseases/blood-borne viruses, 3 chronic parasitic infections, 3 non-communicable disease or risk factors) and catch-up vaccination prompts for migrant patients. METHODS: We carried out a mixed-methods process evaluation of Health Catch-UP! in two urban primary healthcare practices to integrate Health Catch-UP! into the electronic health record system of primary care, using the Medical Research Council framework for complex intervention evaluation. We collected quantitative data (demographics, patients screened, disease detection and catch-up vaccination rates) and qualitative participant interviews to explore acceptability and feasibility. RESULTS: Ninety-nine migrants were assessed by Health Catch-UP! across two sites (S1, S2). 96.0% (n = 97) had complete demographics coding with Asia 31.3% (n = 31) and Africa 25.2% (n = 25), the most common continents of birth (S1 n = 92 [48.9% female (n = 44); mean age 60.6 years (SD 14.26)]; and S2 n = 7 [85.7% male (n = 6); mean age 39.4 years (SD16.97)]. 61.6% (n = 61) of participants were eligible for screening for at least one condition and uptake of screening was high 86.9% (n = 53). Twelve new conditions were identified (12.1% of study population) including hepatitis C (n = 1), hypercholesteraemia (n = 6), pre-diabetes (n = 4), and diabetes (n = 1). Health Catch-UP! identified that 100% (n = 99) of patients had no immunisations recorded; however, subsequent catch-up vaccination uptake was poor (2.0%, n = 1). Qualitative data supported acceptability and feasibility of Health Catch-UP! from staff and patient perspectives, and recommended Health Catch-UP! integration into routine care (e.g. NHS health checks) with an implementation package including staff and patient support materials, standardised care pathways (screening and catch-up vaccination, laboratory, and management), and financial incentivisation. CONCLUSIONS: Clinical Decision Support Systems like Health Catch-UP! can improve disease detection and implementation of screening guidance for migrant patients but require robust testing, resourcing, and an effective implementation package to support both patients and staff.

Driving delivery and uptake of catch-up vaccination among adolescent and adult migrants in UK general practice: a mixed methods pilot study.

BACKGROUND: Migrants in the UK and Europe face vulnerability to vaccine-preventable diseases (VPDs) due to missed childhood vaccines and doses and marginalisation from health systems. Ensuring migrants receive catch-up vaccinations, including MMR, Td/IPV, MenACWY, and HPV, is essential to align them with UK and European vaccination schedules and ultimately reduce morbidity and mortality. However, recent evidence highlights poor awareness and implementation of catch-up vaccination guidelines by UK primary care staff, requiring novel approaches to strengthen the primary care pathway. METHODS: The 'Vacc on Track' study (May 2021-September 2022) aimed to measure under-vaccination rates among migrants in UK primary care and establish new referral pathways for catch-up vaccination. Participants included migrants aged 16 or older, born outside of Western Europe, North America, Australia, or New Zealand, in two London boroughs. Quantitative data on vaccination history, referral, uptake, and sociodemographic factors were collected, with practice nurses prompted to deliver catch-up vaccinations following UK guidelines. Focus group discussions and in-depth interviews with staff and migrants explored views on delivering catch-up vaccination, including barriers, facilitators, and opportunities. Data were analysed using STATA12 and NVivo 12. RESULTS: Results from 57 migrants presenting to study sites from 18 countries (mean age 41 [SD 7.2] years; 62% female; mean 11.3 [SD 9.1] years in UK) over a minimum of 6 months of follow-up revealed significant catch-up vaccination needs, particularly for MMR (49 [86%] required catch-up vaccination) and Td/IPV (50 [88%]). Fifty-three (93%) participants were referred for any catch-up vaccination, but completion of courses was low (6 [12%] for Td/IPV and 33 [64%] for MMR), suggesting individual and systemic barriers. Qualitative in-depth interviews (n = 39) with adult migrants highlighted the lack of systems currently in place in the UK to offer catch-up vaccination to migrants on arrival and the need for health-care provider skills and knowledge of catch-up vaccination to be improved. Focus group discussions and interviews with practice staff (n = 32) identified limited appointment/follow-up time, staff knowledge gaps, inadequate engagement routes, and low incentivisation as challenges that will need to be addressed. However, they underscored the potential of staff champions, trust-building mechanisms, and community-based approaches to strengthen catch-up vaccination uptake among migrants. CONCLUSIONS: Given the significant catch-up vaccination needs of migrants in our sample, and the current barriers to driving uptake identified, our findings suggest it will be important to explore this public health issue further, potentially through a larger study or trial. Strengthening existing pathways, staff capacity and knowledge in primary care, alongside implementing new strategies centred on cultural competence and building trust with migrant communities will be important focus areas.

Development of an intervention for reducing infant bathing frequency.

BACKGROUND: Bathing babies less frequently and intensively in the first six months of life may prevent eczema, but this has not yet been definitively tested in a randomised controlled trial. Such a trial would require evidence-based support to help parents engage with a minimal bathing routine. The present study reports the development of this support. METHODS: We adopted a four-stage design process: (i) Pregnant women and their families (n = 31) were interviewed to ascertain key barriers and facilitators towards following the minimal bathing intervention. (ii) These barriers and facilitators were mapped to behaviour change techniques, focussing on the intervention types of education, persuasion and environmental restructuring, alongside appropriate modes of delivery, and prototype intervention materials were developed. (iii) We iteratively refined these materials in a workshop with multidisciplinary experts and Patient and Public Involvement and Engagement (PPIE) representatives (n = 13) and an (iv) intervention walkthrough with families (n = 5). The design process was informed by the Behaviour Change Wheel, Theoretical framework of acceptability and the Template for intervention description and replication. RESULTS: Social influences and motivational factors are likely to influence both uptake and adherence to the intervention. Anticipated emotional reward from participating in research for the benefit of others was indicated to be a strong facilitator for intervention uptake. Alternatives to bathing, having fun with the baby and the night-time routine, alongside family support, were notable facilitators suggested to aid adherence to the intervention. Barriers included hygiene concerns and anticipated negative social appraisal. Barriers and facilitators were mapped to thirty-six behaviour change techniques, focussing on the intervention types of education, persuasion and environmental restructuring, all of which were embedded into the package of support. The prototype intervention materials received positive feedback from the expert workshop and study walkthrough with families. The final package of support comprises printed and digital prompts and cues, a study booklet, video, and digital tool for self-monitoring. CONCLUSIONS: The intervention design process incorporated the 'real world' views and experiences of families, experts and PPIE representatives, alongside criteria for designing behavioural interventions. The effectiveness of the package of support will be tested in a feasibility trial and embedded process evaluation.

Identifying barriers and facilitators to increase fibre intakes in UK primary school children and exploring the acceptability of intervention components: a UK qualitative study.

OBJECTIVE: Within the UK, dietary fibre intakes are well below recommended intakes and associated with increased risk of obesity. This study aimed to explore the views of parents and children on barriers and facilitators to increasing fibre intakes and improving diets, alongside investigating the appropriateness of intervention components to overcome modifiable barriers. DESIGN: Qualitative study including semi-structured interviews and focus groups informed by the Theoretical Domains Framework (TDF) and the Capability-Opportunity-Motivation-Behaviour (COM-B) model. PARTICIPANTS: Year 5 children (aged 9-10-years) and parents, recruited through London primary schools. RESULTS: A total of twenty-four participants (eleven parents and thirteen children) took part. Five key themes were identified as barriers and facilitators, namely lack of (and improving) knowledge, social factors (including parent-child conflicts, limited time for food preparation, influence of peer and family members), current eating habits, influence of the school, community and home environment in shaping eating behaviours, and the importance of choice and variety in finding foods that are healthy and tasty. Parents strongly supported school-based dietary interventions to enable consistent messaging at home and school and help support dietary behaviour change. Practical sessions (such as workshops to strengthen knowledge, taste tests and food swap ideas) were supported by parents and children. CONCLUSIONS: By using a theory-driven approach to explore the barriers and facilitators to increasing fibre intake, this research identified important themes and modifiable barriers to behaviour change and identifies acceptable intervention components to overcome barriers and bring about sustained dietary behaviour change in primary school children.

Impact of the COVID-19 pandemic on total, sex- and age-specific all-cause mortality in 20 countries worldwide during 2020: results from the C-MOR project.

BACKGROUND: To understand the impact of the COVID-19 pandemic on mortality, this study investigates overall, sex- and age-specific excess all-cause mortality in 20 countries, during 2020. METHODS: Total, sex- and age-specific weekly all-cause mortality for 2015-2020 was collected from national vital statistics databases. Excess mortality for 2020 was calculated by comparing weekly 2020 observed mortality against expected mortality, estimated from historical data (2015-2019) accounting for seasonality, long- and short-term trends. Crude and age-standardized rates were analysed for total and sex-specific mortality. RESULTS: Austria, Brazil, Cyprus, England and Wales, France, Georgia, Israel, Italy, Northern Ireland, Peru, Scotland, Slovenia, Sweden, and the USA displayed substantial excess age-standardized mortality of varying duration during 2020, while Australia, Denmark, Estonia, Mauritius, Norway, and Ukraine did not. In sex-specific analyses, excess mortality was higher in males than females, except for Slovenia (higher in females) and Cyprus (similar in both sexes). Lastly, for most countries substantial excess mortality was only detectable (Austria, Cyprus, Israel, and Slovenia) or was higher (Brazil, England and Wales, France, Georgia, Italy, Northern Ireland, Sweden, Peru and the USA) in the oldest age group investigated. Peru demonstrated substantial excess mortality even in the <45 age group. CONCLUSIONS: This study highlights that excess all-cause mortality during 2020 is context dependent, with specific countries, sex- and age-groups being most affected. As the pandemic continues, tracking excess mortality is important to accurately estimate the true toll of COVID-19, while at the same time investigating the effects of changing contexts, different variants, testing, quarantine, and vaccination strategies.

Nonpharmacological Interventions to Lengthen Sleep Duration in Healthy Children: A Systematic Review and Meta-analysis.

Importance: Adequate sleep duration is necessary for many aspects of child health, development, and well-being, yet sleep durations for children are declining, and effective strategies to increase sleep in healthy children remain to be elucidated. Objective: To determine whether nonpharmaceutical interventions to improve sleep duration in healthy children are effective and to identify the key components of these interventions. Data Sources: CENTRAL, MEDLINE, Embase, PsycINFO, Web of Science Core collection, ClinicalTrials.gov, and WHO trials databases were searched from inception to November 15, 2021. Study Selection: Randomized clinical trials of interventions to improve sleep duration in healthy children were independently screened by 2 researchers. A total of 28 478 studies were identified. Data Extraction and Synthesis: Data were processed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) reporting guideline. Random-effects meta-analytic models were used to estimate pooled effect sizes. Main Outcomes and Measures: Difference in sleep duration, measured in minutes. Results: A total of 13 539 child participants from 45 randomized clinical trials were included. Of these, 6897 (50.9%) were in the intervention group and 6642 (49.1%) in the control group, and the mean age ranged from 18 months to 19 years. Pooled results indicate that sleep interventions were associated with 10.5 minutes (95% CI, 5.6-15.4) longer nocturnal sleep duration. There was substantial variation between trials. Sources of variation that were not associated with the study effect size included age group, whether the population was identified as having a sleep problem or being at a socioeconomic disadvantage (eg, coming from a low-income family or area), method of assessment of sleep duration (objective vs subjective), location of intervention delivery (home vs school), whether interventions were delivered in person or used parental involvement, whether behavioral theory was used, environmental change, or had greater or lower intensity. Interventions that included earlier bedtimes were associated with a 47-minute sleep extension (95% CI, 18.9-75.0; 3 trials) compared with remaining studies (7.4 minutes; 95% CI, 2.9-11.8; 42 trials) (P = .006 for group difference). Trials of shorter duration (6 months or less) had larger effects. Conclusions and Relevance: Interventions focused on earlier bedtimes may offer a simple, pragmatic, effective way to meaningfully increase sleep duration that could have important benefits for child health.

COVID-19 vaccination uptake in 441 socially and ethnically diverse pregnant women.

OBJECTIVE: To explore COVID-19 vaccination uptake, facilitators and barriers in ethnically-diverse pregnant women. DESIGN AND SETTING: An anonymous quality improvement questionnaire survey exploring COVID-19 vaccination uptake, causes of vaccine hesitancy and trusted sources of information among pregnant women in two acute district general hospitals in England (Berkshire and Surrey) between 1.9.21 and 28.2.22. POPULATION: 441 pregnant women attending routine antenatal clinic appointments. METHODS: Consented pregnant women completed the survey either electronically using a QR code or on paper. Descriptive data were summarised and free text responses were thematically analysed. RESULTS: 441 pregnant women, mean age 32 years (range 17-44), completed the survey. Twenty-six percent were from ethnic minority groups, and 31% had a co-morbid health condition. Most respondents (66.2%) had been vaccinated against COVID-19 with at least one dose (White British 71.9%, Asian 67.9%, White-other 63.6%, Black 33%). The most common reasons for not being vaccinated were concerns about effects on the unborn baby and future pregnancies, anxiety about possible adverse impact on the mother, not enough known about the vaccine, and lack of trust in vaccines. Comments included: "I'd rather not risk injecting the unknown into my body", and "I don't trust it." Although 23% used social media for information on COVID-19 vaccination, the most trusted sources were the patient's GP and midwife (43%) and official health-related websites such as NHS (39%). CONCLUSIONS: A third of these pregnant women had not been vaccinated against COVID-19. Trusted health professionals like midwives and GPs could have a crucial role in increasing vaccination uptake.

Short-stay crisis units for mental health patients on crisis care pathways: systematic review and meta-analysis.

BACKGROUND: Internationally, an increasing proportion of emergency department visits are mental health related. Concurrently, psychiatric wards are often occupied above capacity. Healthcare providers have introduced short-stay, hospital-based crisis units offering a therapeutic space for stabilisation, assessment and appropriate referral. Research lags behind roll-out, and a review of the evidence is urgently needed to inform policy and further introduction of similar units. AIMS: This systematic review aims to evaluate the effectiveness of short-stay, hospital-based mental health crisis units. METHOD: We searched EMBASE, Medline, CINAHL and PsycINFO up to March 2021. All designs incorporating a control or comparison group were eligible for inclusion, and all effect estimates with a comparison group were extracted and combined meta-analytically where appropriate. We assessed study risk of bias with Risk of Bias in Non-Randomized Studies - of Interventions and Risk of Bias in Randomized Trials. RESULTS: Data from twelve studies across six countries (Australia, Belgium, Canada, The Netherlands, UK and USA) and 67 505 participants were included. Data indicated that units delivered benefits on many outcomes. Units could reduce psychiatric holds (42% after intervention compared with 49.8% before intervention; difference = 7.8%; P < 0.0001) and increase out-patient follow-up care (χ2 = 37.42, d.f. = 1; P < 0.001). Meta-analysis indicated a significant reduction in length of emergency department stay (by 164.24 min; 95% CI -261.24 to -67.23 min; P < 0.001) and number of in-patient admissions (odds ratio 0.55, 95% CI 0.43-0.68; P < 0.001). CONCLUSIONS: Short-stay mental health crisis units are effective for reducing emergency department wait times and in-patient admissions. Further research should investigate the impact of units on patient experience, and clinical and social outcomes.

The impact of working as a peer worker in mental health services: a longitudinal mixed methods study.

BACKGROUND: Peer workers are increasingly employed in mental health services to use their own experiences of mental distress in supporting others with similar experiences. While evidence is emerging of the benefits of peer support for people using services, the impact on peer workers is less clear. There is a lack of research that takes a longitudinal approach to exploring impact on both employment outcomes for peer workers, and their experiences of working in the peer worker role. METHODS: In a longitudinal mixed methods study, 32 peer workers providing peer support for discharge from inpatient to community mental health care - as part of a randomised controlled trial - undertook in-depth qualitative interviews conducted by service user researchers, and completed measures of wellbeing, burnout, job satisfaction and multi-disciplinary team working after completing training, and four and 12 months into the role. Questionnaire data were summarised and compared to outcomes for relevant population norms, and changes in outcomes were analysed using paired t-tests. Thematic analysis and interpretive workshops involving service user researchers were used to analysis interview transcripts. A critical interpretive synthesis approach was used to synthesise analyses of both datasets. RESULTS: For the duration of the study, all questionnaire outcomes were comparable with population norms for health professionals or for the general population. There were small-to-medium decreases in wellbeing and aspects of job satisfaction, and increase in burnout after 4 months, but these changes were largely not maintained at 12 months. Peer workers felt valued, empowered and connected in the role, but could find it challenging to adjust to the demands of the job after initial optimism. Supervision and being part of a standalone peer worker team was supportive, although communication with clinical teams could be improved. CONCLUSIONS: Peer workers seem no more likely to experience negative impacts of working than other healthcare professionals but should be well supported as they settle into post, provided with in-work training and support around job insecurity. Research is needed to optimise working arrangements for peer workers alongside clinical teams.

Immunisation status of UK-bound refugees between January, 2018, and October, 2019: a retrospective, population-based cross-sectional study.

BACKGROUND: WHO's new Immunization Agenda 2030 places a focus on ensuring migrants and other marginalised groups are offered catch-up vaccinations across the life-course. Yet, it is not known to what extent specific groups, such as refugees, are immunised according to host country schedules, and the implications for policy and practice. We aimed to assess the immunisation coverage of UK-bound refugees undergoing International Organization for Migration (IOM) health assessments through UK resettlement schemes, and calculate risk factors for under-immunisation. METHODS: We undertook a retrospective cross-sectional study of all refugees (children <10 years, adolescents aged 10-19 years, and adults >19 years) in the UK resettlement programme who had at least one migration health assessment conducted by IOM between Jan 1, 2018 and Oct 31, 2019, across 18 countries. Individuals' recorded vaccine coverage was calculated and compared with the UK immunisation schedule and the UK Refugee Technical Instructions. We carried out multivariate logistic regression analyses to assess factors associated with varying immunisation coverage. FINDINGS: Our study included 12 526 refugees of 36 nationalities (median age 17 years [IQR 7-33]; 6147 [49·1%] female; 7955 [63·5%] Syrian nationals). 26 118 vaccine doses were administered by the IOM (most commonly measles, mumps, and rubella [8741 doses]). During the study, 6870 refugees departed for the UK, of whom 5556 (80·9%) had at least one recorded dose of measles-containing vaccine and 5798 (84·4%) had at least one dose of polio vaccine, as per the UK Refugee Technical Instructions, and 1315 (19·1%) had at least one recorded dose of diphtheria-containing vaccine or tetanus-containing vaccine. 764 (11·1%) of refugees were fully aligned with the UK schedule for polio, compared with 2338 (34·0%) for measles and 380 (5·5%) for diphtheria and tetanus. Adults were significantly less likely than children to be in line with the UK immunisation schedule for polio (odds ratio 0·0013, 95% CI 0·0001-0·0052) and measles (0·29, 0·25-0·32). INTERPRETATION: On arrival to the UK, refugees' recorded vaccination coverage is suboptimal and varies by age, nationality, country of health assessment, and by disease, with particularly low coverage reported for diphtheria and tetanus, and among adult refugees. These findings have important implications for the delivery of refugee pre-entry health assessments and catch-up vaccination policy and delivery targeting child, adolescent, and adults migrants in the UK, and other refugee-receiving countries. This research highlights the need for improved data sharing and clearer definition of where responsibilities lie between host countries and health assessment providers. FUNDING: UK National Institute for Health Research (NIHR300072) and Medical Research Council (MR/N013638/1).

Defining the determinants of vaccine uptake and undervaccination in migrant populations in Europe to improve routine and COVID-19 vaccine uptake: a systematic review.

Understanding why some migrants in Europe are at risk of underimmunisation and show lower vaccination uptake for routine and COVID-19 vaccines is critical if we are to address vaccination inequities and meet the goals of WHO's new Immunisation Agenda 2030. We did a systematic review (PROSPERO: CRD42020219214) exploring barriers and facilitators of vaccine uptake (categorised using the 5As taxonomy: access, awareness, affordability, acceptance, activation) and sociodemographic determinants of undervaccination among migrants in the EU and European Economic Area, the UK, and Switzerland. We searched MEDLINE, CINAHL, and PsycINFO from 2000 to 2021 for primary research, with no restrictions on language. 5259 data sources were screened, with 67 studies included from 16 countries, representing 366 529 migrants. We identified multiple access barriers-including language, literacy, and communication barriers, practical and legal barriers to accessing and delivering vaccination services, and service barriers such as lack of specific guidelines and knowledge of health-care professionals-for key vaccines including measles-mumps-rubella, diphtheria-pertussis-tetanus, human papillomavirus, influenza, polio, and COVID-19 vaccines. Acceptance barriers were mostly reported in eastern European and Muslim migrants for human papillomavirus, measles, and influenza vaccines. We identified 23 significant determinants of undervaccination in migrants (p<0·05), including African origin, recent migration, and being a refugee or asylum seeker. We did not identify a strong overall association with gender or age. Tailored vaccination messaging, community outreach, and behavioural nudges facilitated uptake. Migrants' barriers to accessing health care are already well documented, and this Review confirms their role in limiting vaccine uptake. These findings hold immediate relevance to strengthening vaccination programmes in high-income countries, including for COVID-19, and suggest that tailored, culturally sensitive, and evidence-informed strategies, unambiguous public health messaging, and health system strengthening are needed to address access and acceptance barriers to vaccination in migrants and create opportunities and pathways for offering catch-up vaccinations to migrants.

Excess all-cause mortality and COVID-19-related mortality: a temporal analysis in 22 countries, from January until August 2020.

BACKGROUND: This study aimed to investigate overall and sex-specific excess all-cause mortality since the inception of the COVID-19 pandemic until August 2020 among 22 countries. METHODS: Countries reported weekly or monthly all-cause mortality from January 2015 until the end of June or August 2020. Weekly or monthly COVID-19 deaths were reported for 2020. Excess mortality for 2020 was calculated by comparing weekly or monthly 2020 mortality (observed deaths) against a baseline mortality obtained from 2015-2019 data for the same week or month using two methods: (i) difference in observed mortality rates between 2020 and the 2015-2019 average and (ii) difference between observed and expected 2020 deaths. RESULTS: Brazil, France, Italy, Spain, Sweden, the UK (England, Wales, Northern Ireland and Scotland) and the USA demonstrated excess all-cause mortality, whereas Australia, Denmark and Georgia experienced a decrease in all-cause mortality. Israel, Ukraine and Ireland demonstrated sex-specific changes in all-cause mortality. CONCLUSIONS: All-cause mortality up to August 2020 was higher than in previous years in some, but not all, participating countries. Geographical location and seasonality of each country, as well as the prompt application of high-stringency control measures, may explain the observed variability in mortality changes.

The psychiatric decision unit as an emerging model in mental health crisis care: a national survey in England.

Psychiatric decision units have been developed in many countries internationally to address the pressure on inpatient services and dissatisfactory, long waits people in mental health crisis can experience in emergency departments. Research into these units lags behind their development, as they are implemented by healthcare providers to address these problems. This is the first-ever national survey to identify their prevalence, structure, activities, and contextual setting within health services, in order to provide a robust basis for future research. The response rate was high (94%), and six PDUs in England were identified. The results indicated that PDUs open 24/7, accept only voluntary patients, provide recliner chairs for sleeping rather than beds, and limit stays to 12-72 hours. PDUs are predominantly staffed by senior, qualified mental health nurses and healthcare assistants, with psychiatry input. Staff:patient ratios are high (1:2.1 during the day shift). Differences in PDU structure and activities (including referral pathway, length of stay, and staff:patient ratios) were identified, suggesting the optimal configuration for PDUs has not yet been established. Further research into the efficacy of this innovation is needed; PDUs potentially have a role in an integrated crisis care pathway which provides a variety of care options to service users.

Correction: Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome.

[This corrects the article DOI: 10.1371/journal.pone.0144623.].

Correction: Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome.

[This corrects the article DOI: 10.1371/journal.pone.0144623.].

Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome.

UNLABELLED: Few studies have examined therapist effects and therapeutic alliance (TA) in treatments for chronic fatigue syndrome (CFS). Therapist effects are the differences in outcomes achieved by different therapists. TA is the quality of the bond and level of agreement regarding the goals and tasks of therapy. Prior research suffers the methodological problem that the allocation of therapist was not randomized, meaning therapist effects may be confounded with selection effects. We used data from a randomized controlled treatment trial of 296 people with CFS. The trial compared pragmatic rehabilitation (PR), a nurse led, home based self-help treatment, a counselling-based treatment called supportive listening (SL), with general practitioner treatment as usual. Therapist allocation was randomized. Primary outcome measures, fatigue and physical functioning were assessed blind to treatment allocation. TA was measured in the PR and SL arms. Regression models allowing for interactions were used to examine relationships between (i) therapist and therapeutic alliance, and (ii) therapist and average treatment effect (the difference in mean outcomes between different treatment conditions). We found no therapist effects. We found no relationship between TA and the average treatment effect of a therapist. One therapist formed stronger alliances when delivering PR compared to when delivering SL (effect size 0.76, SE 0.33, 95% CI 0.11 to 1.41). In these therapies for CFS, TA does not influence symptomatic outcome. The lack of significant therapist effects on outcome may result from the trial's rigorous quality control, or random therapist allocation, eliminating selection effects. Further research is needed. TRIAL REGISTRATION: ISRCTN74156610.