Psychosocial Impact of False-Positive Newborn Screening Results: A Scoping Review.

Psychosocial consequences of false-positive results following newborn bloodspot screening have been identified as a potential risk to this highly successful public health initiative. A scoping review was undertaken in October 2023 underpinned by the Arksey and O'Malley framework. Twenty-four papers were included in the review, many of which focused on cystic fibrosis. The results indicated that impact of false-positive results is variable; some studies suggest false-positive results have the potential to result in negative sequelae including increased stress and changes in parental perceptions of their child, while others suggest these impacts are transient and, in some instances, may even lead to positive outcomes. Further evidence is needed to ensure the representation of other conditions included in newborn bloodspot screening and to support strategies to overcome potential negative sequela.

International Perspectives of Extended Genetic Sequencing When Used as Part of Newborn Screening to Identify Cystic Fibrosis.

There is increasing interest in using extended genetic sequencing (EGS) in newborn screening (NBS) for cystic fibrosis (CF). How this is implemented will change the number of children being given an uncertain outcome of CRMS/CFSPID (cystic fibrosis transmembrane conductance regulator (CFTR)-related metabolic syndrome/CF Screen Positive Inconclusive Diagnosis), probable carrier results, and the number of missed CF diagnoses. An international survey of CF health professionals was used to gather views on two approaches to EGS-specific (may reduce detection of CRMS/CFSID but miss some CF cases) versus sensitive (may increase detection of CRMS/CFSPID but avoid missing more CF cases). Health professionals acknowledged the anxiety caused to parents (and health professionals) from the uncertainty surrounding the prognosis and management of CRMS/CFSPID. However, most preferred the sensitive approach, as overall, identifying more cases of CRMS/CFSPID was viewed as less physically and psychologically damaging than a missed case of CF. The importance of early diagnosis and treatment for CF to ensure better health outcomes and reducing diagnostic odysseys for parents were highlighted. A potential benefit to identifying more children with CRMS/CFSPID included increasing knowledge to obtain a better understanding of how these children should best be managed in the future.

Stakeholder Views of the Proposed Introduction of Next Generation Sequencing into the Cystic Fibrosis Screening Protocol in England.

The project aimed to gather, analyse, and compare the views of stakeholders about the proposed UK cystic fibrosis (CF) screening protocol incorporating next generation sequencing (NGS). The study design was based on principles of Q-methodology with a willingness-to-pay exercise. Participants were recruited from 12 CF centres in the UK. The study contained twenty-eight adults who have experience with CF (parents of children with CF (n = 21), including parents of children with CF transmembrane conductance regulator (CFTR)-related metabolic syndrome (CRMS)/CF screen positive-inconclusive diagnosis (CFSPID), an uncertain outcome (n = 3), and adults with CF (n = 4)), and nine health professionals involved in caring for children with CF. Parents and health professionals expressed a preference for a sensitive approach to NGS. This was influenced by the importance participants placed on not missing any children with CF via screening and the balance of harm between missing a case of CF compared to picking up more children with an uncertain outcome (CRMS/CFSPID). Given the preference for a sensitive approach, the need for adequate explanations about potential outcomes including uncertainty (CFSPID) at the time of screening was emphasized. More research is needed to inform definitive guidelines for managing children with an uncertain outcome following CF screening.

Patient experience of imaging reports: A systematic literature review.

Introduction: Written reports are often the sole form of communication from diagnostic imaging. Reports are increasingly being accessed by patients through electronic records. Experiencing medical terminology can be confusing and lead to miscommunication, a decrease in involvement and increased anxiety for patients. Methods: This systematic review was designed to include predefined study selection criteria and was registered prospectively on PROSPERO (CRD42020221734). MEDLINE, CINAHL, Academic Search Complete (EBSCOhost), EMBASE, Scopus and EThOS were searched to identify articles meeting the inclusion criteria. Studies were assessed against the Mixed-Methods Appraisal Tool version 2018 for quality. A segregated approach was used to synthesise data. A thematic synthesis of the qualitative data and a narrative review of the quantitative data were performed, and findings of both syntheses were then integrated. Findings: Twelve articles reporting 13 studies were included. This review found that patients' experiences of imaging reports included positive and negative aspects. The study identified two main themes encompassing both qualitative and quantitative findings. Patients reported their experiences regarding their understanding of reports and self-management. Discussion: Patient understanding of imaging reports is multi factorial including medical terminology, communication aids and errors. Self-management through direct access is important to patients. While receiving bad news is a concern, responsibility for accessing this is accepted. Conclusion: A patient-centred approach to writing imaging reports may help to improve the quality of service, patient experience and wider health outcomes.

Paediatric eye and vision research participation experiences: a systematic review.

BACKGROUND: For children and young people with eye and vision conditions, research is essential to advancing evidence-based recommendations in diagnosis, prevention, treatments and cures. Patient 'experience' reflects a key measure of quality in health care (Department of Health. High Quality Care for All: NHS Next Stage Review Final Report: The Stationery Office (2008)); research participant 'experiences' are equally important. Therefore, in order to achieve child-centred, high-quality paediatric ophthalmic research, we need to understand participation experiences. We conducted a systematic review of existing literature; our primary outcome was to understand what children and young people, parents and research staff perceive to support or hinder positive paediatric eye and vision research experiences. Our secondary outcomes explored whether any adverse or positive effects were perceived to be related to participation experiences, and if any interventions to improve paediatric ophthalmic research experiences had previously been developed or used. METHODS: We searched (from inception to November 2018, updated July 2020) in MEDLINE, Embase, CINAHL, Web of Science, NICE evidence and The Cochrane Library (CDSR and CENTRAL), key journals (by hand), grey literature databases and Google Scholar; looking for evidence from the perspectives of children, young people, parents and staff with experience of paediatric ophthalmic research. The National Institute for Health Research (NIHR) Participant in Research Experience Survey (PRES) (National Institute for Health Research. Research Participant Experience Survey Report 2018-19 (2019); National Institute for Health Research. Optimising the Participant in Research Experience Checklist (2019)) identified 'five domains' pivotal to shaping positive research experiences; we used these domains as an 'a priori' framework to conduct a 'best fit' synthesis (Carroll et al., BMC Med Res Methodol. 11:29, 2011; Carroll et al., BMC Med Res Methodol. 13:37, 2013). RESULTS: Our search yielded 13,020 papers; two studies were eligible. These evaluated research experiences from the perspectives of parents and staff; the perspectives of children and young people themselves were not collected. No studies were identified addressing our secondary objectives. Synthesis confirmed the experiences of parents were shaped by staff characteristics, information provision, trial organisation and personal motivations, concurring with the 'PRES domains' (National Institute for Health Research. Optimising the Participant in Research Experience Checklist (2019)) and generating additional dimensions to participation motivations and the physical and emotional costs of study organisation. CONCLUSIONS: The evidence base is limited and importantly omits the voices of children and young people. Further research, involving children and young people, is necessary to better understand the research experiences of this population, and so inform quality improvements for paediatric ophthalmic research care and outcomes. TRIAL REGISTRATION: Review registered with PROSPERO, International prospective register of systematic reviews: CRD42018117984. Registered on 11 December 2018.

Co-designing Improved Communication of Newborn Bloodspot Screening Results to Parents: Mixed Methods Study.

BACKGROUND: Each year in England, almost 10,000 parents are informed of their child's positive newborn bloodspot screening (NBS) results. This occurs approximately 2 to 8 weeks after birth depending on the condition. Communication of positive NBS results is a subtle and skillful task, demanding thought, preparation, and evidence to minimize potentially harmful negative sequelae. Evidence of variability in the content and the way the result is currently communicated has the potential to lead to increased parental anxiety and distress. OBJECTIVE: This study focused on the development of co-designed interventions to improve the experiences of parents receiving positive NBS results for their children and enhance communication between health care professionals and parents. METHODS: An experience-based co-design approach was used to explore experiences and co-design solutions with 17 health professionals employed in 3 National Health Service Trusts in England and 21 parents (13/21, 62% mothers and 8/21, 38% fathers) of 14 children recruited from the same 3 National Health Service Trusts. Experiences with existing services were gathered via semistructured interviews with health professionals. Filmed narrative interviews with parents were developed into a composite film. The co-design process identified priorities for improving communication of positive NBS results through separate parent and health professional feedback events followed by joint feedback events. In total, 4 interventions were then co-designed between the participants through a web-based platform. RESULTS: Parents and health professionals provided positive feedback regarding the process of gathering experiences and identifying priorities. Themes identified from the parent interviews included impact of initial communication, parental reactions, attending the first clinic appointment, impact of health professionals' communication strategies and skills, impact of diagnosis on family and friends, improvements to the communication of positive NBS results, and parents' views on NBS. Themes identified from the health professional interviews included communication between health professionals, process of communicating with the family, parent- and family-centered care, and availability of resources and challenges to effective communication. In response to these themes, 4 interventions were co-designed: changes to the NBS card; standardized laboratory proformas; standardized communication checklists; and an email or letter for providing reliable, up-to-date, condition-specific information for parents following the communication of positive NBS results. CONCLUSIONS: Parents and health professionals were able to successfully work together to identify priorities and develop co-designed interventions to improve communication of positive NBS results to parents. The resulting co-designed interventions address communication at different stages of the communication pathway to improve the experiences of parents receiving positive NBS results for their children. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s40814-019-0487-5.

Delivering Positive Newborn Screening Results: Cost Analysis of Existing Practice versus Innovative, Co-Designed Strategies from the ReSPoND Study.

Although the communication pathways of Newborn Bloodspot Screening (NBS) are a delicate task, these pathways vary across different conditions and are often not evidence-based. The ReSPoND interventions were co-designed by healthcare professionals alongside parents who had received a positive NBS result for their child. To calculate the cost of these co-designed strategies and the existing communication pathways, we interviewed 71 members of the clinical and laboratory staff of the 13 English NBS laboratories in the English National Health Service. Therefore, a scenario analysis was used to compare the cost of the existing communication pathways to the co-designed strategies delivered by (i) home-visits and (ii) telecommunications. On average, the existing communication pathway cost £447.08 per infant (range: £237.12 to £628.51) or £234,872.75 (£3635.99 to £1,932,986.23) nationally. Implementing the new interventions relying on home-visits exclusively would cost on average £521.62 (£312.84 to £646.39) per infant and £297,816.03 (£4506.37 to £2,550,284.64) nationally, or £447.19 (£235.79 to £552.03) and £231,342.40 (£3923.7 to £1,922,192.22) if implemented via teleconsultations, respectively. The new strategies delivered are not likely to require additional resources compared with current practice. Further research is needed to investigate whether this investment represents good value for money for the NHS budget.

International Approaches to Management of CFTR-Related Metabolic Syndrome/Cystic Fibrosis Screen Positive, Inconclusive Diagnosis.

The main aim of the present study was to explore health professionals' reported experiences and approaches to managing children who receive a designation of cystic fibrosis transmembrane conductance regulator-related metabolic syndrome/cystic fibrosis screen positive inconclusive diagnosis following a positive NBS result for cystic fibrosis. An online questionnaire was distributed via Qualtrics Survey Software and circulated to a purposive, international sample of health professionals involved in managing children with this designation. In total, 101 clinicians completed the online survey: 39 from the US, six from Canada, and 56 from Europe (including the UK). Results indicated that while respondents reported minor deviations in practice, they were cognizant of recommendations in the updated guidance and for the most part, attempted to implement these into practice consistently internationally. Where variation was reported, the purpose of this appeared to be to enable clinicians to respond to either clinical assessments or parental anxiety in order to improve outcomes for the child and family. Further research is needed to determine if these findings are reflective of both a wider audience of clinicians and actual (rather than reported) practice.

Processing of Positive Newborn Screening Results for Congenital Hypothyroidism: A Qualitative Exploration of Current Practice in England.

The objective of this research was to explore current communication practices for positive newborn bloodspot screening results for congenital hypothyroidism from the newborn bloodspot screening laboratory to clinicians and then families, in order to (i) understand how the pathway is implemented in practice, (ii) highlight regional differences and (iii) identify barriers and facilitators. A qualitative exploratory design was employed using semi-structured interviews across 13 newborn bloodspot screening laboratories in England. Participants included 35 clinicians and 17 NBS laboratory staff across the 13 laboratories and 18 members of relevant clinical teams. Findings illuminated variations in how positive newborn bloodspot screening results for congenital hypothyroidism are communicated in practice. This included regional variations due to historical arrangements and local resources. Contacting the appropriate person could be challenging and obtaining feedback from clinical teams to the laboratory after the child has been seen could be time consuming for those involved. Standardised communication model(s) for positive newborn bloodspot screening results for congenital hypothyroidism, which include named contact individuals, defined pathways of care and processes for feeding back to laboratories, may help to ensure the process is less labour intensive, particularly from a laboratory perspective.

Process evaluation of co-designed interventions to improve communication of positive newborn bloodspot screening results.

OBJECTIVE: To implement and evaluate co-designed interventions to improve communication of positive newborn bloodspot screening results and make recommendations for future research and practice. DESIGN: A process evaluation underpinned by Normalisation Process Theory. SETTING: Three National Health Service provider organisations in England. PARTICIPANTS: Twenty-four healthcare professionals (7 newborn screening laboratory staff and 24 clinicians) and 18 parents were interviewed. INTERVENTIONS: Three co-designed interventions were implemented in practice: standardised laboratory proformas, communication checklists and an email/letter template. PRIMARY OUTCOME MEASURES: Acceptability and feasibility of the co-designed interventions. RESULTS: Auditing the implementation of these interventions revealed between 58%-76% of the items on the laboratory proforma and 43%-80% of items on the communication checklists were completed. Interviews with healthcare professionals who had used the interventions in practice provided positive feedback in relation to the purpose of the interventions and the ease of completion both of which were viewed as enhancing communication of positive newborn bloodspot screening results. Interviews with parents highlighted the perceived benefit of the co-designed interventions in terms of consistency, pacing and tailoring of information as well as providing reliable information to families following communication of the positive newborn bloodspot screening result. The process evaluation illuminated organisational and contextual barriers during implementation of the co-designed interventions in practice. CONCLUSION: Variations in communication practices for positive newborn bloodspot screening results continue to exist. The co-designed interventions could help to standardise communication of positive newborn screening results from laboratories to clinicians and from clinicians to parents which in turn could improve parents' experience of receiving a positive newborn bloodspot screening result. Implementation highlighted some organisational and contextual barriers to effective adoption of the co-designed interventions in practice. TRIAL REGISTRATION NUMBER: ISRCTN15330120.

Congenital heart disease: factors influencing parents' knowledge of their child's condition.

The extent of parental knowledge is an important factor in the care of children with congenital heart disease (CHD), with research recommending that to achieve optimal care, parents should be appropriately educated in the condition. This literature review aimed to identify the factors that influence parents' knowledge of their child's CHD. Relevant databases were searched for literature using appropriate search terms. Thematic analysis identified four common themes in six articles: the educational technique used, the parents' educational background, effective communication and the source of information. The findings identified a need for improved delivery and communication of parental education.

Survey with content analysis to explore nurses' satisfaction with opportunities to undertake continuing professional education in relation to aseptic technique.

BACKGROUND: Aseptic technique is a key skill undertaken every day by large numbers of nurses. However, there is relatively little empirical evidence to underpin practice. Furthermore, it is not clear to what extent it should be considered a single task or a set of principles to be applied differentially depending upon the situation and how individual nurses make this decision. OBJECTIVE: This study explored nurses' experiences of continuing professional education (CPE) in relation to aseptic technique. DESIGN: A national survey was undertaken throughout the United Kingdom. Responses were subjected to inductive quantitative content analysis. PARTICIPANTS: Participants were recruited via an electronic link placed on the website of a major nursing organisation. RESULTS: 941 nurses responded. 253 (26.9%) were satisfied with arrangements for continuing professional education. Satisfaction was associated with a perception of good support from employers, sound preparation before qualifying and practising aseptic technique regularly. 311 (33%) were dissatisfied. Reasons included witnessing unwarranted variations in practice (n = 55, 5.8%), witnessing suboptimal practice requiring correction (65, 6.9%), a perception that standards had fallen through a decline in pre-registration preparation (n = 109, 11.6%) and opportunities for updating (n = 124, 13.2%). Some employers had introduced training in conjunction with organisation-wide change in practice. In other cases participants reported receiving updates when required to perform a new procedure, when moving between clinical specialities or changing employer. Train-the-trainer (cascade) teaching was used in formal and informal arrangements for updating. CONCLUSION: This study provides a springboard for exploring arrangements for updating and assessing nurses' competence to undertake aseptic technique. Health providers need to evaluate what is currently provided and address gaps in provision. There is clear evidence that the current system does not meet the needs of many nurses.

Practice nurses' perceptions of their immunization role and strategies used to promote measles, mumps, and rubella vaccine uptake in 2014 - 2018: A qualitative study.

AIM: The aim of this study was to explore which aspects of their role practice nurses perceive to be most influential and the strategies they employ to promote the MMR vaccine. DESIGN: Qualitative study employing in depth interviews. METHOD: Fifteen London based practice nurses, nine in 2014 and six in 2018, took part in semi-structured interviews that were audio recorded and transcribed verbatim. Qualitative content analysis was used to systematically manage, analyse, and identify themes. RESULTS: Analysis of data identified aspects of their role practice nurses perceived to be most influential (the themes) including: promoting vaccination, assisting parents' to make informed decisions, and provided insight into how they used specific strategies to achieve these in practice. These themes were consistent over both phases of the study. CONCLUSION: The findings provide an understanding of: (i) the practice nurses perceptions of the most important aspects of their role when promoting the measles, mumps, and rubella vaccine; and (ii) the strategies they implemented in practice to achieve these. The latter included assisting parents in their immunization decisions and was facilitated by practice nurses engaging with parents to provide relevant evidence to address parent queries, dispel misconceptions and tailor strategies to promote the measles, mumps, and rubella vaccine. IMPACT: This study addresses the paucity of literature available that specifically explores practice nurses' perceptions of their role concerning the measles, mumps, and rubella vaccine. The findings reveal how practice nurses promote the measles, mumps, and rubella vaccine by identifying strategies to enable parents to make informed decisions. At a time of an increasing incidence of measles, practice nurses have an important public health role in achieving herd immunity levels for measles, mumps, and rubella.

Processing of positive newborn screening results: a qualitative exploration of current practice in England.

OBJECTIVE: To explore current communication practices for positive newborn screening results from the newborn bloodspot screening (NBS) laboratory to clinicians to highlight differences, understand how the pathways are implemented in practice, identify barriers and facilitators and make recommendations for future practice and research. DESIGN: A qualitative exploratory design was employed using semi-structured interviews. SETTING: Thirteen NBS laboratories in England. PARTICIPANTS: Seventy-one clinicians; 22 NBS laboratory staff across 13 laboratories and 49 members of relevant clinical teams were interviewed. RESULTS: Assurance of quality and consistency was a priority for all NBS laboratories. Findings indicated variation in approaches to communicating positive NBS results from laboratories to clinical teams. This was particularly evident for congenital hypothyroidism and was largely influenced by local arrangements, resources and the fact individual laboratories had detailed standard operating procedures for how they work. Obtaining feedback from clinical teams to the laboratory after the child had been seen could be challenging and time-consuming for those involved. Pathways for communicating carrier results for cystic fibrosis and sickle cell disease could be ambiguous and inconsistent which in turn could hamper the laboratories efforts to obtain timely feedback regarding whether or not the result had been communicated to the family. Communication pathways for positive NBS results between laboratories and clinical teams could therefore be time-consuming and resource-intensive. CONCLUSION: The importance placed on ensuring positive NBS results were communicated effectively and in a timely fashion from the laboratory to the clinical team was evident from all participants. However, variation existed in terms of the processes used to report positive NBS results to clinical teams and the people involved. Variant practice identified may reflect local needs, but more often reflected local resources and a more consistent 'best practice' approach is required, not just in the UK but perhaps globally. TRIAL REGISTRATION NUMBER: ISRCTN15330120.

Qualitative exploration of health professionals' experiences of communicating positive newborn bloodspot screening results for nine conditions in England.

OBJECTIVE: To explore health professionals' experiences of communicating positive newborn bloodspot screening (NBS) results, highlight differences, share good practice and make recommendations for future research. DESIGN: Qualitative exploratory design was employed using semi-structured interviews SETTING: Three National Health Service provider organisations in England PARTICIPANTS: Seventeen health professionals involved in communicating positive newborn bloodspot screening results to parents for all nine conditions currently included in the newborn bloodspot screening programme in England. RESULTS: Findings indicated variation in approaches to communicating positive newborn bloodspot screening results to parents, largely influenced by resources available and the lack of clear guidance. Health professionals emphasised the importance of communicating results to families in a way that is sensitive to their needs. However, many challenges hindered communication including logistical considerations; difficulty contacting the family and other health professionals; language barriers; parental reactions; resource considerations; lack of training; and insufficient time. CONCLUSION: Health professionals invest a lot of time and energy trying to ensure communication of positive newborn bloodspot screening results to families is done well. However, there continues to be great variation in the way these results are communicated to parents and this is largely influenced by resources available but also the lack of concrete guidance. How best to support health professionals undertaking this challenging and emotive task requires further exploration. We recommend evaluation of a more cohesive approach that meets the needs of parents and staff while being sensitive to the subtleties of each condition. TRIAL REGISTRATION NUMBER: ISRCTN15330120.

Processing Newborn Bloodspot Screening Results for CF.

Every newborn bloodspot screening (NBS) result for cystic fibrosis (CF) consists of two parts: a screening part in the laboratory and a clinical part in a CF centre. When introducing an NBS programme, more attention is usually paid to the laboratory part, especially which algorithm is most suitable for the region or the country. However, the clinical part, how a positive screening result is processed, is often underestimated and can have great consequences for the affected child and their parents. A clear algorithm for the diagnostic part in CF centres is also important and influences the performance of a CF NBS programme. The processing of a positive screening result includes the initial information given to the parents, the invitation to the sweat test, what to do if a sweat test fails, information about the results of the sweat test, the inconclusive diagnosis and the carrier status, which is handled differently from country to country. The time until the definitive diagnosis and adequate information is given, is considered by the parents and the CF team as the most important factor. The communication of a positive NBS result is crucial. It is not a singular event but rather a process that includes ensuring the appropriate clinicians are aware of the result and that families are informed in the most efficient and effective manner to facilitate consistent and timely follow-up.

Psychological Impact of NBS for CF.

Newborn screening for cystic fibrosis has resulted in diagnosis often before symptoms are recognised, leading to benefits including reduced disease severity, decreased burden of care, and lower costs. The psychological impact of this often unsought diagnosis on the parents of seemingly well children is less well understood. The time during which the screening result is communicated to families but before the confirmatory test results are available is recognised as a period of uncertainty and it is this uncertainty that can impact most on parents. Evidence suggests this may be mitigated against by ensuring the time between communication and confirmatory testing is minimized and health professionals involved in communicating positive newborn screening results and diagnostic results for cystic fibrosis to families are knowledgeable and able to provide appropriate reassurance. This is particularly important in the case of false positive results or when the child is given a Cystic Fibrosis Screen Positive, Inconclusive Diagnosis designation. However, to date, there are no formal mechanisms in place to support health professionals undertaking this challenging role, which would enable them to meet the expectations set out in specific guidance.

Impact of isolation on hospitalised patients who are infectious: systematic review with meta-analysis.

OBJECTIVE: To systematically review the literature exploring the impact of isolation on hospitalised patients who are infectious: psychological and non-psychological outcomes. DESIGN: Systematic review with meta-analysis. DATA SOURCES: Embase, Medline and PsycINFO were searched from inception until December 2018. Reference lists and Google Scholar were also handsearched. RESULTS: Twenty-six papers published from database inception to December 2018 were reviewed. A wide range of psychological and non-psychological outcomes were reported. There was a marked trend for isolated patients to exhibit higher levels of depression, the pooled standardised mean difference being 1.28 (95% CI 0.47 to 2.09) and anxiety 1.45 (95% CI 0.56 to 2.34), although both had high levels of heterogeneity, and worse outcomes for a range of care-related factors but with significant variation. CONCLUSION: The review indicates that isolation to contain the risk of infection has negative consequences for segregated patients. Although strength of the evidence is weak, comprising primarily single-centre convenience samples, consistency of the effects may strengthen this conclusion. More research needs to be undertaken to examine this relationship and develop and test interventions to reduce the negative effects of isolation.

Applying thematic synthesis to interpretation and commentary in epidemiological studies: identifying what contributes to successful interventions to promote hand hygiene in patient care.

OBJECTIVES: Hand hygiene is considered the most important preventive measure for healthcare-associated infections, but adherence is suboptimal. We previously undertook a Cochrane Review that demonstrated that interventions to improve adherence are moderately effective. Impact varied between organisations and sites with the same intervention and implementation approaches. This study seeks to explore these differences. METHODS: A thematic synthesis was applied to the original authors' interpretation and commentary that offered explanations of how hand hygiene interventions exerted their effects and suggested reasons why success varied. The synthesis used a published Cochrane Review followed by three-stage synthesis. RESULTS: Twenty-one papers were reviewed: 11 randomised, 1 non-randomised and 9 interrupted time series studies. Thirteen descriptive themes were identified. They reflected a range of factors perceived to influence effectiveness. Descriptive themes were synthesised into three analytical themes: methodological explanations for failure or success (eg, Hawthorne effect) and two related themes that address issues with implementing hand hygiene interventions: successful implementation needs leadership and cooperation throughout the organisation (eg, visible managerial support) and understanding the context and aligning the intervention with it drives implementation (eg, embedding the intervention into wider patient safety initiatives). CONCLUSIONS: The analytical themes help to explain the original authors' perceptions of the degree to which interventions were effective and suggested new directions for research: exploring ways to avoid the Hawthorne effect; exploring the impact of components of multimodal interventions; the use of theoretical frameworks for behaviour change; potential to embed interventions into wider patient safety initiatives; adaptations to demonstrate sustainability; and the development of systematic approaches to implementation. Our findings corroborate studies exploring the success or failure of other clinical interventions: context and leadership are important.