Qualitative study of views and experiences of performance management for healthcare-associated infections.

BACKGROUND: Centrally led performance management regimes using standard setting, monitoring, and incentives have become a prominent feature of infection prevention and control (IPC) in health systems. AIM: To characterize views and experiences of regulation and performance management relating to IPC in English hospitals. METHODS: Two qualitative datasets containing 139 interviews with healthcare workers and managers were analysed. Data directly relevant to performance management and IPC were extracted. Data analysis was based on the constant comparative method. FINDINGS: Participants reported that performance management regimes had mobilized action around specific infections. The benefits of establishing organizational structures of accountability were seen in empirical evidence of decreasing infection rates. Performance management was not, however, experienced as wholly benign, and setting targets in one area was seen to involve risks of 'tunnel vision' and the marginalization of other potentially important issues. Financial sanctions were viewed especially negatively; performance management was associated with risks of creating a culture of fearfulness, suppressing learning and disrupting inter-professional relationships. CONCLUSION: Centrally led performance management may have some important roles in IPC, but identifying where it is appropriate and determining its limits is critical. Persisting with harsh regimes may affect relationships and increase resistance to continued improvement efforts, but leaving all improvement to local teams may also be a flawed strategy.

[Better Reporting of Interventions: Template for Intervention Description and Replication (TIDieR) Checklist and Guide]. / Die TIDieR Checkliste und Anleitung - ein Instrument für eine verbesserte Interventionsbeschreibung und Replikation.

Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face-to-face panel meeting. The resultant 12-item TIDieR checklist (brief name, why, what (materials), what (procedure), who intervened, how, where, when and how much, tailoring, modifications, how well (planned), how well (actually carried out)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with a detailed explanation of each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure the accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.

What do research ethics committees say about applications to conduct research involving children?

OBJECTIVE: To identify issues raised by research ethics committees (RECs) in letters about applications to conduct research involving children. METHODS: Analysis of 80 provisional and unfavourable opinion decision letters written by RECs in response to applications to conduct research involving child participants. RESULTS: RECs were most likely to be concerned about issues relating to consent, recruitment, care and protection of participants, scientific design and confidentiality. RECs focused on children's status as "vulnerable". They sought to ensure that children would be protected, that appropriate written language would be used to communicate with children and that an appropriate person would give consent for children to participate. IMPLICATIONS: Researchers should be attentive to issues of potential vulnerability when preparing applications. REC letters may be improved by giving clear and explicit reasons for their opinions.

How will it work? A qualitative study of strategic stakeholders' accounts of a patient safety initiative.

OBJECTIVES: Implementation of quality improvement programmes may suffer if the stakeholders involved do not share a common understanding of the theory of change or do not accept it as legitimate. We aimed to identify how strategic stakeholders understood and responded to the first phase of the Health Foundation's Safer Patients Initiative, a programme aimed at making hospitals safer for patients in the UK. METHODS: Semistructured telephone interviews were conducted with 60 strategic-level hospital stakeholders and with five stakeholders involved in commissioning, designing and introducing the initiative. Analysis was based on the constant comparative method. RESULTS: The aims of the initiative were seen as legitimate and sound by most hospital stakeholders, and the theory of change was generally understood and accepted, but seven hospital stakeholders were unable to describe it. Although participants had specific doubts, particularly relating to feasibility of implementation and scientific legitimacy of some elements of the initiative, overall there was a broadly shared vision and commitment to the principles and practices associated with the theory of change, and considerable enthusiasm and optimism. Contestations about the legitimacy and relevance of the initiative among front-line staff, local resistance to changes that went against established norms, and resource and structural issues were, however, seen as potentially threatening to implementation. CONCLUSIONS: It is possible to get strategic-level individuals, even when widely dispersed, to understand and agree upon a theory of change that can be used in their organisations. These individuals are also able to recognise the contexts of negotiation in which programmes of change are enacted.

Research involving storage and use of human tissue: how did the Human Tissue Act 2004 affect decisions by research ethics committees?

BACKGROUND: Little is known about the types of issues research ethics committees (RECs) raise in their letters about research involving the storage and use of human tissue. AIMS: To classify the issues that appear to trouble RECs and to identify how the implementation of the Human Tissue (HT) Act in September 2006 might have affected REC decisions. METHODS: 100 letters relating to applications about research use of human tissue were randomly selected from the National Research Ethics Service database, of which half were issued before the implementation of the HT Act and half post-implementation. Ethical issues raised by RECs were classified with a coding scheme developed using ethnographic content analysis. RESULTS: Many letters raised issues about informed consent, including specific concerns about the information to be provided to participants about the taking, using and storing of their tissue samples. However, RECs appeared to be less likely to raise concerns about informed consent to use or store tissue after the HT Act, and there was some evidence that RECs were more comfortable allowing archived tissue samples to be used without additional patient consent after the HT Act than before. CONCLUSIONS: In the wake of the HT Act, RECs do not appear to be more cautious about approving research to use or store tissue without consent when responding to applications for ethical approval. The HT Act has provided clarity and authority to RECs and may indeed facilitate the process of gaining ethical approval for tissue-based research.

Seeking consent to tissue banking: a survey of health professionals in childhood cancer.

To identify the views of health professionals working in childhood cancer on seeking consent to tissue banking from potential donors. Self-completion questionnaires sent to 553 UK paediatric oncology health professionals. The response rate was 60%. Respondents (100%) were in favour of using tissue samples from children with cancer for research. A substantial minority (30%) had concerns about the impact of the law on their professional role in relation to tissue banking. Almost all (90%) reported that both the parent(s) and the child, if able, should be asked for consent, though the UK Human Tissue Act provides that a competent child's consent is sufficient. Most (94%) supported 'generic' rather than 'specific' consent. Barriers to obtaining consent included: (1) timing of the approach to families; (2) availability of suitable staff; (3) sensitivity of the issues; (4) difficulties of managing the process; and (5) problems of maintaining a paper trail. Many would welcome training on seeking consent. Personal knowledge and relationships with families are often seen as important in guiding the proper approach to consent rather than formalized rules. There is widespread support among health professionals for tissue banking in childhood cancer. In sensitive situations, disciplined exercise of professional discretion might better deliver on aspirations for regulation than rigid procedures.

Research involving adults who lack capacity: how have research ethics committees interpreted the requirements?

Two separate regulatory regimes govern research with adults who lack capacity to consent in England and Wales: the Mental Capacity Act (MCA) 2005 and the Medicines for Human Use (Clinical Trials) Regulations 2004 ("the Regulations"). A service evaluation was conducted to investigate how research ethics committees (RECs) are interpreting the requirements. With the use of a coding scheme and qualitative software, a sample of REC decision letters where applicants indicated that their project involved adults who lacked mental capacity was analysed. The analysis focuses on 45 letters about projects covered by the MCA and 12 letters about projects covered by the Regulations. The legal requirements for involving incapacitated adults in research were not consistently interpreted correctly. Letters often lacked explicitness and clarity. Neither consent nor assent from third parties is a legally valid concept for purposes of the MCA, yet they were suggested or endorsed in 10 post-MCA letters, and there was evidence of confusion about the consultee processes. The correct terms were also not consistently used in relation to clinical trials. Inappropriate use of terms such as "relative" had the potential to exclude people eligible to be consulted. Unless the correct terms and legal concepts are used in research projects, there is potential for confusion and for exclusion of people who are eligible to be consulted about involvement of adults who lack capacity. Improved clarity, explicitness and accuracy are needed when submitting and reviewing applications for ethical review of research in this area.

Do research ethics committees identify process errors in applications for ethical approval?

We analysed research ethics committee (REC) letters. We found that RECs frequently identify process errors in applications from researchers that are not deemed "favourable" at first review. Errors include procedural violations (identified in 74% of all applications), missing information (68%), slip-ups (44%) and discrepancies (25%). Important questions arise about why the level of error identified by RECs is so high, and about how errors of different types should be handled.

An analysis of decision letters by research ethics committees: the ethics/scientific quality boundary examined.

OBJECTIVES: The performance of NHS research ethics committees (RECs) is of growing interest. It has been proposed that they confine themselves to "ethical" issues only and not concern themselves with the quality of the science. This study aimed to identify current practices of RECs in relation to scientific issues in research ethics applications. METHODS: Letters written by UK RECs expressing provisional or unfavourable opinions in response to submitted research applications were sampled from the research ethics database held by the Central Office for Research Ethics Committees. Ethnographic content analysis (ECA) was used to develop a coding framework. QSR N6 software was used to facilitate coding. RESULTS: "Scientific issues" were raised in 104 (74%) of the 141 letters in our sample. The present data suggest that RECs frequently considered scientific issues and that judgments of these often informed their decisions about approval of applications. Current processes of peer review seemed insufficient to reassure RECs about the scientific quality of applications they were asked to review. CONCLUSIONS: This study provides evidence that scientific issues are frequently raised in letters to researchers and are often considered a quality problem by RECs. In the discussion, the authors reflect on how far issues of science can and should be distinguished from those of ethics and the policy implications.

Towards a new era of tissue-based diagnosis and research.

Molecular investigation of tissue obtained from patients with many chronic illnesses is becoming increasingly important. Using the example of childhood cancer, we show how such investigations contribute in important ways to understanding the underlying pathophysiological basis of disease, determining optimal patient management, and identifying targets for potential new novel therapeutic approaches. Tissue banks are now recognized as an important resource for biomedical research in this area. Challenges for the future of tissue-banking include formalization of technical matters, including the generation of standard operating procedures and quality-control methods. More complex challenges attend the legal and ethical issues in tissue banking. Notwithstanding recent UK legislation, there are many legal uncertainties. Use of excised tissue in research is often claimed to raise a range of ethical issues, but it is not at all clear that public confidence and support for tissue-based research is as negative as some accounts in the socio-anthropological and ethical literature would suggest. Nonetheless, ensuring confidence and trust in tissue-banking will remain an important objective, and the possibilities of novel governance structures should be explored.

Consistency in decision making by research ethics committees: a controlled comparison.

There has been longstanding interest in the consistency of decisions made by research ethics committees (RECs) in the UK, but most of the evidence has come from single studies submitted to multiple committees. A systematic comparison was carried out of the decisions made on 18 purposively selected applications, each of which was reviewed independently by three different RECs in a single strategic health authority. Decisions on 11 applications were consistent, but disparities were found among RECs on decisions on seven applications. An analysis of the agreement between decisions of RECs yielded an overall measure of agreement of kappa = 0.286 (95% confidence interval -0.06 to 0.73), indicating a level of agreement that, although probably better than chance, may be described as "slight". The small sample size limits the robustness of these findings. Further research on reasons for inconsistencies in decision making between RECs, and on the importance of such inconsistencies for a range of arguments, is needed.

Referral and attendance at a specialist antenatal clinic: qualitative study of women's views.

OBJECTIVE: To explore women's views on being referred to and attending a specialist antenatal hypertension clinic. DESIGN: Qualitative interview study. SETTING: A pregnancy hypertension clinic in a large teaching hospital in the East Midlands. POPULATION: Twenty-one women (aged 18 years and above) attending the pregnancy hypertension clinic for the first time during their current pregnancy. METHODS: Women who had been referred to and attended a specialist antenatal clinic participated in semi-structured interviews. Data analysis was based on the constant comparative method. MAIN OUTCOME MEASURES: Women's experiences and perceptions of being referred to and attending a specialist antenatal clinic. RESULTS: Being referred to the clinic conferred an 'at risk' status on women. Some women welcomed the referral but others experienced it as unsettling. Many were unclear about why they had been identified as being at risk or had difficulties in accepting the legitimacy of the reason for referral. Women were often inadequately informed about why they were referred to the clinic, what they could expect and the benefits of attending the clinic over management in the community. Although attendance at the clinic was cited as a source of reassurance, the reassurance was often made necessary by concern raised by the initial referral. CONCLUSIONS: Women's accounts suggest that the interface between community and secondary antenatal services needs improvement to minimise possible adverse effects from identifying women as being 'at risk' during pregnancy.

Getting women to hospital is not enough: a qualitative study of access to emergency obstetric care in Bangladesh.

OBJECTIVE: To explore what happened to poor women in Bangladesh once they reached a hospital providing comprehensive emergency obstetric care (EmOC) and to identify support mechanisms. DESIGN: Mixed methods qualitative study. SETTING: Large government medical college hospital in Bangladesh. SAMPLE: Providers and users of EmOC. METHODS: Ethnographic observation in obstetrics unit including interviews with staff and women using the unit and their carers. RESULTS: Women had to mobilise significant financial and social resources to fund out of pocket expenses. Poorer women faced greater challenges in receiving treatment as relatives were less able to raise the necessary cash. The official financial support mechanism was bureaucratic and largely unsuitable in emergency situations. Doctors operated a less formal "poor fund" system to help the poorest women. There was no formal assessment of poverty; rather, doctors made "adjudications" of women's need for support based on severity of condition and presence of friends and relatives. Limited resources led to a "wait and see" policy that meant women's condition could deteriorate before help was provided. CONCLUSIONS: Greater consideration must be given to what happens at health facilities to ensure that (1) using EmOC does not further impoverish families; and (2) the ability to pay does not influence treatment. Developing alternative finance mechanisms to reduce the burden of out of pocket expenses is crucial but challenging. Increased investment in EmOC must be accompanied by an increased focus on equity.

Participating in a trial in a critical situation: a qualitative study in pregnancy.

BACKGROUND: Randomised controlled trials of interventions in critical situations are necessary to establish safety and evaluate outcomes. Pregnant women have been identified as a potentially vulnerable population. OBJECTIVE: To explore women's experiences of being recruited to ORACLE, a randomised controlled trial of antibiotics in pre-term labour. METHODS: Twenty qualitative interviews were conducted with women who had participated in ORACLE. Analysis was based on the constant comparative method. RESULTS: Women gave prominence to the socioemotional aspects of their interactions with healthcare professionals in making decisions on trial participation. Comments on the quality of written and spoken information were generally favourable, but women's accounts suggest that the stressful nature of the situation affected their ability to absorb the information. Women generally had poor understanding of trial design and practices. The main motivation for trial participation was the possibility of an improved outcome for the baby. The second and less prominent motivation was the opportunity to help others, but this was conditional on there being no risks associated with trial participation. In judging the risks of participation, women seemed to draw on "common sense" understandings including a perception that antibiotics were risk free. DISCUSSION: Recruitment to trials in critical situations raises important questions. Future studies should explore how rigorous governance arrangements for trials, particularly in critical situations, can protect participants rather than relying on ideals of informed consent that may be impossible to achieve. Future research should include a focus on interactions between research candidates and professionals involved in recruitment.

Practices and views on fetal heart monitoring: a structured observation and interview study.

OBJECTIVE: To assess and explain deviations from recommended practice in National Institute for Clinical Excellence (NICE) guidelines in relation to fetal heart monitoring. DESIGN: Qualitative study. SETTING: Large teaching hospital in the UK. SAMPLE: Sixty-six hours of observation of 25 labours and interviews with 20 midwives of varying grades. METHODS: Structured observations of labour and semistructured interviews with midwives. Interviews were undertaken using a prompt guide, audiotaped, and transcribed verbatim. Analysis was based on the constant comparative method, assisted by QSR N5 software. MAIN OUTCOME MEASURES: Deviations from recommended practice in relation to fetal monitoring and insights into why these occur. RESULTS: All babies involved in the study were safely delivered, but 243 deviations from recommended practice in relation to NICE guidelines on fetal monitoring were identified, with the majority (80%) of these occurring in relation to documentation. Other deviations from recommended practice included indications for use of electronic fetal heart monitoring and conduct of fetal heart monitoring. There is evidence of difficulties with availability and maintenance of equipment, and some deficits in staff knowledge and skill. Differing orientations towards fetal monitoring were reported by midwives, which were likely to have impacts on practice. The initiation, management, and interpretation of fetal heart monitoring is complex and distributed across time, space, and professional boundaries, and practices in relation to fetal heart monitoring need to be understood within an organisational and social context. CONCLUSION: Some deviations from best practice guidelines may be rectified through straightforward interventions including improved systems for managing equipment and training. Other deviations from recommended practice need to be understood as the outcomes of complex processes that are likely to defy easy resolution.

Why is compliance with occlusion therapy for amblyopia so hard? A qualitative study.

OBJECTIVE: To explore parents' perceptions and experiences of occlusion (patching) therapy for treatment of amblyopia in children. METHODS: Qualitative study involving semistructured interviews with 25 families of a child with amblyopia being treated at a specialist clinic. Interviews were tape recorded and transcribed verbatim. Data analysis was based on the constant comparative method, assisted by qualitative analysis software. RESULTS: Parents of children prescribed patching treatment found themselves obliged to manage the treatment. This involved dilemmas and tensions, with many parents describing children's distress, particularly in the early stages of patching treatment. Parents were highly sensitive to the credibility of the treatment, but were sometimes confused by information given in the clinic or did not see clinic staff as authoritative. There was evidence that parents were likely to abandon or modify treatment if no improvement could be detected or if the child continued to suffer socially or educationally. Parents described a range of strategies for facilitating patching, including explanation; normalisation; rewards; customising the patch; establishing a routine; and enlisting the help of others. Whatever their practices in relation to patching, parents were keen to defend their behaviour as that of a "good parent". CONCLUSIONS: Interventions that aim to improve compliance should take account of the difficulties and tensions experienced by parents, rather than simply treating non-compliance as resulting from information deficits. Practical support that builds on strategies described by parents is likely to be of benefit.