Key components influencing the sustainability of a multi-professional obstetric emergencies training programme in a middle-income setting: a qualitative study.

BACKGROUND: Multi-professional obstetric emergencies training is one promising strategy to improve maternity care. Sustaining training programmes following successful implementation remains a challenge. Understanding, and incorporating, key components within the implementation process can embed interventions within healthcare systems, thereby enhancing sustainability. This study aimed to identify key components influencing sustainability of PRactical Obstetric Multi-Professional Training (PROMPT) in the Philippines, a middle-income setting. METHODS: Three hospitals were purposively sampled to represent private, public and teaching hospital settings. Two focus groups, one comprising local trainers and one comprising training participants, were conducted in each hospital using a semi-structured topic guide. Focus groups were audio recorded. Data were analysed using thematic analysis. Three researchers independently coded transcripts to ensure interpretation consistency. RESULTS: Three themes influencing sustainability were identified; attributes of local champions, multi-level organisational involvement and addressing organisational challenges. CONCLUSIONS: These themes, including potential barriers to sustainability, should be considered when designing and implementing training programmes in middle-income settings. When 'scaling-up', local clinicians should be actively involved in selecting influential implementation champions to identify challenges and strategies specific to their organisation. Network meetings could enable shared learning and sustain enthusiasm amongst local training teams. Policy makers should be engaged early, to support funding and align training with national priorities.

Experiencing menopause in the UK: The interrelated narratives of normality, distress, and transformation.

We investigated the experience and perspectives of menopause among 48 UK mothers through qualitative in-depth interviews. Interviews were analyzed thematically then explored using social science theories. Three interdependent narratives emerged: menopause as a normal, biological process, distinct from self and social transitions; menopause as struggle, an "idiom of distress" expressing upset, identity loss, shame, and social upheaval; and menopause as transformative and liberating, arising from biopsychic and relational changes. Some women followed a predictable "rite of passage" trajectory with transformation emerging from distress, but not all: Menopause arises from a complex interplay of personal predicament, somatic change, and sociocultural context.

What do tests do for doctors? A qualitative study of blood testing in UK primary care.

Background: Rates of blood testing are rising with significant geographical variability. Most research into diagnostic testing focuses on the role of tests in diagnostic decision-making. Objective: The aim of this study was to explore the non-medical motives for blood testing by considering what tests do for doctors, through qualitative interviews with general practitioners (GPs). Methods: We undertook 23 in-depth semi-structured interviews with UK GPs. Reasons for performing recent inflammatory marker blood tests were explored by reviewing GPs pathology inboxes to ground discussions in real-life clinical practice. Interviews were transcribed verbatim and analysed using a grounded theory approach. Results: Blood tests offer doctors a tool to manage uncertainty; within a context of increased litigation, risk aversion and reduced continuity of care. Tests can also be offered as a 'gift' for patients, a way to be seen to be 'doing something'; in the social context of time pressures and perceived patient pressures. There was a tension however. On the one hand, doctors talked about using tests for reassurance and as a 'gift' offering 'truth'. Yet paradoxically, they also discussed the challenges of uncertainty and anxiety from inconclusive test results. Conclusion: Our study emphasises that defining 'unnecessary' blood testing may not be as simple as determining medical criteria for testing; psychosocial reasons may be equally valid and interlinked. Further research is needed to help GPs manage uncertainty within the context of a risk averse society, and to explore the congruence and dissonance between doctors' and patients' perceptions of testing.

Using qualitative research to inform development of a diagnostic algorithm for UTI in children.

BACKGROUND: Diagnostic and prognostic algorithms can help reduce clinical uncertainty. The selection of candidate symptoms and signs to be measured in case report forms (CRFs) for potential inclusion in diagnostic algorithms needs to be comprehensive, clearly formulated and relevant for end users. OBJECTIVE: To investigate whether qualitative methods could assist in designing CRFs in research developing diagnostic algorithms. Specifically, the study sought to establish whether qualitative methods could have assisted in designing the CRF for the Health Technology Association funded Diagnosis of Urinary Tract infection in Young children (DUTY) study, which will develop a diagnostic algorithm to improve recognition of urinary tract infection (UTI) in children aged <5 years presenting acutely unwell to primary care. METHODS: Qualitative methods were applied using semi-structured interviews of 30 UK doctors and nurses working with young children in primary care and a Children's Emergency Department. We elicited features that clinicians believed useful in diagnosing UTI and compared these for presence or absence and terminology with the DUTY CRF. RESULTS: Despite much agreement between clinicians' accounts and the DUTY CRFs, we identified a small number of potentially important symptoms and signs not included in the CRF and some included items that could have been reworded to improve understanding and final data analysis. CONCLUSIONS: This study uniquely demonstrates the role of qualitative methods in the design and content of CRFs used for developing diagnostic (and prognostic) algorithms. Research groups developing such algorithms should consider using qualitative methods to inform the selection and wording of candidate symptoms and signs.

Using qualitative research methods to improve recruitment to randomized controlled trials: the Quartet study.

OBJECTIVE: Randomized controlled trials (RCTs) are considered the optimum method for evaluating health care interventions, yet many fail to recruit sufficient participants in a timely manner. The ProtecT (Prostate testing for cancer and Treatment) study employed qualitative research methods as part of a complex intervention to improve recruitment to the RCT. The Quartet (Qualitative research to improve recruitment to trials) study was set up to evalute whether the ProtecT study's success in increasing randomization rates could be replicated in other trials experiencing recruitment difficulties. This paper reports on the issues that emerged from the attempts to apply qualitative research methods to improve recruitment rates in RCTs collaborating with the Quartet team. METHODS: The methods used were: investigation of RCT documents; semi-structured interviews and focus groups with RCT staff; audio-recording of recruitment appointments; and individual and group feedback sessions for RCT staff. Data were analysed using content and thematic analysis. RESULTS: Barriers arose when we attempted to establish collaborations with RCTs. Difficulties were encountered in securing the commitment of all relevant staff because of poor communication between lead investigators and other staff as well as RCT staff's concerns about having recruitment appointments audio-recorded. Recruitment processes were often more complex than anticipated. Governance procedures took considerable time and resources, limiting the time available for data collection and implementation of the intervention before recruitment closure. CONCLUSION: Straightforward replication of the ProtecT complex intervention was more complicated than expected. However, the study has increased understanding of RCT recruitment and identified ways to overcome barriers to collaboration. Such research is more easily undertaken in the feasibility stage of an RCT, and greater success will be achieved if the research is integrated into the everyday conduct of RCTs.

Evidence-based diagnosis.

Making an accurate diagnosis is essential to ensure that a patient receives appropriate treatment and correct information regarding their prognosis. Characteristics of diagnostic tests are quantified in test accuracy studies, but many such studies have methodological flaws. The HSRC evidence-based diagnosis programme has focused on methods for systematic reviews of test accuracy studies, and the wider context in which tests are ordered and interpreted. We carried out a range of projects relating to literature searching, quality assessment, meta-analysis, presentation of results, and interactions between doctors and patients during the diagnostic process. We have shown that systematic reviews of test accuracy studies should search a range of databases and that current diagnostic filters do not have sufficient accuracy to be used in test accuracy reviews. Summary quality scores should not be used in test accuracy reviews; the Quality Assessment of Studies of Diagnostic Accuracy included in Systematic Reviews (QUADAS) tool for assessing test accuracy studies is acceptable for quality assessment. We have shown that the hierarchical summary receiver operating characteristic (HSROC) and bivariate models for meta-analysis of test accuracy are statistically equivalent in many circumstances, and have developed an add-on module for the statistical software package Stata that enables these statistically rigorous models to be fitted by those without expert statistical knowledge. Three areas that would benefit from further research are literature searching, synthesis of results from individual patient data and presentation of results.

Guidance was developed on how to write a plain language summary for diagnostic test accuracy reviews.

OBJECTIVE: To develop guidance for authors of diagnostic test accuracy (DTA) reviews to help them write a plain language summary of the results of their review. STUDY DESIGN AND SETTING: We used a combination of focus groups, user testing, and a web-based survey. Participants included patient representatives, media representatives, and health professionals. RESULTS: We present step-by-step guidance for authors of DTA reviews for writing a plain language summary. This guidance is illustrated with examples of reader-tested sentences, explanations, and a figure. CONCLUSION: We hope this guidance will allow reviewers to present the findings of DTA reviews so that it is easier for readers to understand the results and conclusions. This will increase the accessibility of these reviews for various audiences.

A review identifies and classifies reasons for ordering diagnostic tests.

OBJECTIVE: To consider the reasons and context for test ordering by doctors when faced with an undiagnosed complaint in primary or secondary care. STUDY DESIGN AND SETTING: We reviewed any study of any design that discussed factors that may affect a doctor's decision to order a test. Articles were located through searches of electronic databases, authors' files on diagnostic methodology, and reference lists of relevant studies. We extracted data on: study design, type of analysis, setting, topic area, and any factors reported to influence test ordering. RESULTS: We included 37 studies. We carried out a thematic analysis to synthesize data. Five key groupings arose from this process: diagnostic factors, therapeutic and prognostic factors, patient-related factors, doctor-related factors, and policy and organization-related factors. To illustrate how the various factors identified may influence test ordering we considered the symptom low back pain and the diagnosis multiple sclerosis as examples. CONCLUSIONS: A wide variety of factors influence a doctor's decision to order a test. These are integral to understanding diagnosis in clinical practice. Traditional diagnostic accuracy studies should be supplemented with research into the broader context in which doctors perform their work.

Erratum to: Methods for evaluating medical tests and biomarkers.

[This corrects the article DOI: 10.1186/s41512-016-0001-y.].

'I'm fishing really'--inflammatory marker testing in primary care: a qualitative study.

BACKGROUND: Inflammatory markers can be helpful as part of the diagnostic workup for specific diseases or for monitoring disease activity. A third use is as a screening and/or triage tool to differentiate between the presence or absence of disease. Most research into inflammatory markers looks at diagnosis of specific diseases and comes from secondary care. Qualitative studies to explore when and why clinicians use these tests in primary care are lacking. AIM: To identify clinicians' approaches to inflammatory marker testing in primary care. DESIGN AND SETTING: Qualitative study with 26 GPs and nurse practitioners. METHOD: Interviews were conducted using a semi-structured topic guide. Clinicians reviewed recent cases of inflammatory marker testing in their pathology inbox. Interviews were audiorecorded and transcribed. Qualitative analysis was conducted by two of the authors. RESULTS: Clinicians are uncertain about the appropriate use of inflammatory markers and differ in their approach to testing patients with undifferentiated symptoms. Normal or significantly elevated inflammatory markers are seen as helpful, but mildly raised inflammatory markers in the context of non-specific symptoms are difficult to interpret. Clinicians describe a tension between not wanting to 'miss anything' and, on the other hand, being wary of picking up borderline abnormalities that can lead to cascades of further tests. Diagnostic uncertainty is a common reason for inflammatory marker testing, with the aim to reassure; however, paradoxically, inconclusive results can generate a cycle of uncertainty and anxiety. CONCLUSION: Further research is needed to define when inflammatory marker testing is useful in primary care and how to interpret results.

Better the donor you know? A qualitative study of renal patients' views on 'altruistic' live-donor kidney transplantation.

BACKGROUND: In the UK there is a short-fall between individuals requiring a renal transplant and kidneys available for transplantation. Non-directed 'altruistic' living kidney donation has emerged as a strategy for bridging this gap between supply and demand, with the number increasing each year. OBJECTIVE: This study aimed to explore the views of potential recipients towards non-directed 'altruistic' live-donor kidney transplantation. METHODS: Semi-structured interviews with 32 UK deceased-donor kidney transplant recipients were performed. Interviews explored willingness to consider directed and non-directed live-donor kidney transplants (LDKTs). Interviews were recorded, transcribed verbatim and transcripts were analysed using the constant comparison method described in Grounded Theory. RESULTS: For those not willing to accept a non-directed 'altruistic' LDKT, the following themes were identified: i) Prioritising other recipients above self; ii) Fear of acquiring an unknown donor's characteristics, and iii) Concern for the donor - unnecessary risk. For those willing to accept a non-directed 'altruistic' LDKT the following themes were identified: iv) Prioritising known above unknown persons, v) Belief that they are as deserving as other potential recipients, and vi) Advantages of a LDKT. CONCLUSIONS: Drawing on 'gift exchange theory', this study contributes to our understanding of the experience of the intended recipient of a gift. The anonymity of the donor-recipient appears to be seen as a benefit of non-directed 'altruistic' live-donor transplants, freeing recipients from the obligations of the gift. However, those who feel unworthy of the 'gifted transplant' are concerned about the donor and by the lack of opportunity for direct reciprocity. Highlighting the 'reciprocal benefits' reported by donors may allow individuals whose preference is a live-donor transplant to accept one if offered. These insights provide the transplant community with targets for intervention, through which the concerns of potential recipients might be addressed.

Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials.

BACKGROUND: Recruitment of sufficient participants in an efficient manner is still widely acknowledged to be a major challenge to the mounting and completion of randomised controlled trials (RCTs). Few recruitment interventions have involved staff undertaking recruitment. This study aimed i) to understand the recruitment process from the perspective of recruiters actively recruiting RCT participants in six pragmatic RCTs, and ii) to identify opportunities for interventions to improve recruitment. METHODS: Interviews were undertaken with 72 individuals (32 doctors or RCT Chief investigators (CIs); 40 nurses/other health professionals) who were actively recruiting participants in six RCTs to explore their experiences of recruitment. The RCTs varied in scale, duration, and clinical contexts. Interviews were fully transcribed and analysed using qualitative content and thematic analytic methods derived from grounded theory. For this analysis, data were systematically extracted from each RCT and synthesised across all six RCTs to produce a detailed and nuanced understanding of the recruitment process from the perspectives of the recruiters. RESULTS: Recruiters readily identified organisational difficulties, fewer than expected eligible patients, and patients' treatment preferences as the key barriers to recruitment. As they described their experiences of recruitment, several previously hidden issues related to their roles as researchers and clinicians emerged, imbued with discomfort and emotion. The synthesis across the RCTs showed that doctors were uncomfortable about aspects of patient eligibility and the effectiveness of interventions, whereas nurses were anxious about approaching potential RCT participants and conflicts between the research and their clinical responsibilities. Recruiters seemed unaware that their views contributed to recruitment difficulties. Their views were not known to RCT CIs. Training and support needs were identified for both groups of staff. CONCLUSIONS: The synthesis showed that recruitment to these RCTs was a complex and fragile process. Clear obstacles were identified but hidden challenges related to recruiters' roles undermined recruitment, unbeknown to RCT CIs. Qualitative research can elicit and identify the hidden challenges. Training and support are then needed for recruiters to become more comfortable with the design and principles of RCTs, so that they can engage more openly with potentially eligible participants and create a more resilient recruitment process.

The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials.

OBJECTIVE: The aim of the study was to investigate how doctors considered and experienced the concept of equipoise while recruiting patients to randomized controlled trials (RCTs). STUDY DESIGN AND SETTING: In-depth interviews with 32 doctors in six publicly funded pragmatic RCTs explored their perceptions of equipoise as they undertook RCT recruitment. The RCTs varied in size, duration, type of complex intervention, and clinical specialties. Interview data were analyzed using qualitative content and thematic analytical methods derived from grounded theory and synthesized across six RCTs. RESULTS: All six RCTs suffered from poor recruitment. Doctors wanted to gather robust evidence but experienced considerable discomfort and emotion in relation to their clinical instincts and concerns about patient eligibility and safety. Although they relied on a sense of community equipoise to justify participation, most acknowledged having "hunches" about particular treatments and patients, some of which undermined recruitment. Surgeons experienced these issues most intensely. Training and support promoted greater confidence in equipoise and improved engagement and recruitment. CONCLUSION: Recruitment to RCTs is a fragile process and difficult for doctors intellectually and emotionally. Training and support can enable most doctors to become comfortable with key RCT concepts including equipoise, uncertainty, patient eligibility, and randomization, promoting a more resilient recruitment process in partnership with patients.

Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness.

BACKGROUND: Under-recruitment to randomised controlled trials (RCTs) is often problematic and there may be particular difficulties in recruiting patients with severe mental illness. AIM: To evaluate reasons for under-recruitment in an RCT of patients with severe mental illness METHODS: Qualitative study during the recruitment phase of an RCT of supported employment. Trial staff and recruiting clinicians were interviewed. Data were analyzed thematically using constant comparative techniques. RESULTS: Recruitment rates were low. Five main reasons for recruitment difficulties were found. These included: (i) misconceptions about trials, (ii) lack of equipoise, (iii) misunderstanding of the trial arms, (iv) variable interpretations of eligibility criteria, (v) paternalism. CONCLUSION: Reasons for recruitment difficulties in trials involving patients with severe mental illness include issues that occur in trials in general, but others are more specific to these patients. Clinician and patient involvement in the study design may improve recruitment in future similar trials.

A review of reporting of participant recruitment and retention in RCTs in six major journals.

BACKGROUND: Poor recruitment and retention of participants in randomised controlled trials (RCTs) is problematic but common. Clear and detailed reporting of participant flow is essential to assess the generalisability and comparability of RCTs. Despite improved reporting since the implementation of the CONSORT statement, important problems remain. This paper aims: (i) to update and extend previous reviews evaluating reporting of participant recruitment and retention in RCTs; (ii) to quantify the level of participation throughout RCTs. METHODS: We reviewed all reports of RCTs of health care interventions and/or processes with individual randomisation, published July-December 2004 in six major journals. Short, secondary or interim reports, and Phase I/II trials were excluded. Data recorded were: general RCT details; inclusion of flow diagram; participant flow throughout trial; reasons for non-participation/withdrawal; target sample sizes. RESULTS: 133 reports were reviewed. Overall, 79% included a flow diagram, but over a third were incomplete. The majority reported the flow of participants at each stage of the trial after randomisation. However, 40% failed to report the numbers assessed for eligibility. Percentages of participants retained at each stage were high: for example, 90% of eligible individuals were randomised, and 93% of those randomised were outcome assessed. On average, trials met their sample size targets. However, there were some substantial shortfalls: for example 21% of trials reporting a sample size calculation failed to achieve adequate numbers at randomisation, and 48% at outcome assessment. Reporting of losses to follow up was variable and difficult to interpret. CONCLUSION: The majority of RCTs reported the flow of participants well after randomisation, although only two-thirds included a complete flow chart and there was great variability over the definition of "lost to follow up". Reporting of participant eligibility was poor, making assessments of recruitment practice and external validity difficult. Reporting of participant flow throughout RCTs could be improved by small changes to the CONSORT chart.

Qualitative research to improve RCT recruitment: issues arising in establishing research collaborations.

INTRODUCTION: Strategies to improve recruitment to RCTs (randomised controlled trials) are limited. The ProtecT (Prostate testing for cancer and Treatment) study successfully developed a complex intervention based on qualitative research methods to increase recruitment rates. The Quartet study (Qualitative Research to Improve Recruitment to RCTs) was established to evaluate whether the ProtecT qualitative methods could be transferred into other RCTs. This paper reports on the barriers and facilitators in setting up these collaborations. METHODS: The Quartet study collaborated with five RCTs. Qualitative methods used were: interviews and focus groups with RCT staff; audio-recording recruitment interactions; and feedback sessions for RCT staff based on qualitative findings. Data were audio-recorded, transcribed and analysed using content and thematic analyses. Issues arising during establishment of collaborations were recorded and analysed. RESULTS: Establishing collaborations proved challenging and not always surmountable. Difficulties were encountered in gaining agreement of RCT staff to participate because of central RCT staff's lack of authority over recruitment staff, poor communication within RCTs and recruiters' reluctance to have their practice scrutinised. The complexity of the recruitment process also hindered translation of ProtecT methods. Although Quartet enabled significant recruitment issues to surface, the bureaucratic tasks involved in securing governance approval delayed onset of collaborations, reducing the time to address issues and evaluate Quartet's impact. DISCUSSION: The Quartet study established collaborations with a range of RCTs and gained valuable insights for future collaborations between qualitative researchers and RCTs. Qualitative research methods need to be included at the feasibility stage of a RCT or fully integrated into the RCT, as in the ProtecT study, with routine audio-recording for monitoring and training purposes. Quartet-like collaborations could then be established without delay, and recruitment processes of RCTs could become transparent, monitored and improved.