[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.

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.

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.

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.

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.

Women's accounts of consenting to surgery: is consent a quality problem?

BACKGROUND: Consent has been placed at the centre of doctor-patient relationships. Attempts to improve the consent process in medicine have drawn on bioethical and legal traditions. Current approaches to consent emphasise the provision of information and have, in the UK, resulted in a single standardised format and process for both elective and emergency situations. Investigation of patients' perceptions and priorities are important in understanding the quality of the consent process. METHODS: In this qualitative study, semi-structured interviews were conducted with 25 women. Eleven had elective and 14 had emergency operations in obstetrics and gynaecology. All interviews were recorded and transcribed verbatim. Data analysis was based on the constant comparative method. RESULTS: Participants' perceptions of surgery strongly influenced the meanings they gave to consent. Some, particularly those undergoing elective operations, wanted surgery. Others were uncertain of their desire for surgery or felt that it was imposed on them. Consenting was interpreted as a ritualistic legal procedure. There was an overwhelming tendency to view consent as not primarily serving patients' needs, although some advantages of the consent process were identified. Accounts made no reference to ethics. CONCLUSION: Countering paternalism will remain difficult to achieve if issues surrounding consent continue to be debated between professionals without due effort to reflect patients' own views and values and to appreciate the circumstances under which consent is sought.

The problem of appraising qualitative research.

Qualitative research can make a valuable contribution to the study of quality and safety in health care. Sound ways of appraising qualitative research are needed, but currently there are many different proposals with few signs of an emerging consensus. One problem has been the tendency to treat qualitative research as a unified field. We distinguish universal features of quality from those specific to methodology and offer a set of minimally prescriptive prompts to assist with the assessment of generic features of qualitative research. In using these, account will need to be taken of the particular method of data collection and methodological approach being used. There may be a need for appraisal criteria suited to the different methods of qualitative data collection and to different methodological approaches. These more specific criteria would help to distinguish fatal flaws from more minor errors in the design, conduct, and reporting of qualitative research. There will be difficulties in doing this because some aspects of qualitative research, particularly those relating to quality of insight and interpretation, will remain difficult to appraise and will rely largely on subjective judgement.

Writing wrongs? An analysis of published discourses about the use of patient information leaflets.

Much has been written about how to communicate with patients, but there has been little critical scrutiny of this literature. This paper presents an analysis of publications about the use of patient information leaflets. It suggests that two discourses can be distinguished in this literature. The first of these is the larger of the two. It reflects traditional biomedical concerns and it invokes a mechanistic model of communication in which patients are characterised as passive and open to manipulation in the interests of a biomedical agenda. The persistence of the biomedical model in this discourse is contrasted with the second discourse, which is smaller and more recent in origin. This second discourse draws on a political agenda of patient empowerment, and reflects this in its choice of outcomes of interest, its concern with the use of leaflets as a means of democratisation, and its orientation towards patients. It is suggested that the two discourses, though distinct, are not entirely discrete, and may begin to draw closer as they begin to draw on a wider set of resources, including sociological research and theory, to develop a rigorous theoretically grounded approach to patient information leaflets.

Including qualitative research in systematic reviews: opportunities and problems.

Qualitative research has been increasingly recognized in recent years as having a distinctive and important contribution to make to health care research. It is capable of being used as a methodologically sufficient approach in its own right, as a precursor to quantitative studies, during or after trials to explain processes and outcomes, and as a means of enhancing the link between evidence and practice. However, qualitative research has been little used as an evidence resource for systematic reviews. We argue that formal synthesis of both qualitative and quantitative forms of research is essential, and we discuss some of the problems that need to be overcome in carrying out such syntheses. These include methodological prejudice, problems in searching for qualitative evidence, and issues in synthesizing qualitative data. We call for progress to be made on the science and methods of including qualitative research in the evidence base of medicine.

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.