Aim
We undertook an empirical study designed to improve our understanding of the development of severe pressure ulcers by constructing detailed retrospective accounts of the development of severe pressure ulcers in eight patients.
Methods
Design
The research design was substantially influenced by two arguments. The first stemmed from discussions at the start of the study. Although our principal objective concerned the effect of organisational context on the development of severe pressure ulcers, we realised that we could not simply assume that a relationship between the two existed and could be studied empirically. Indeed, the available empirical evidence is limited, but the literature offers three distinct explanations,97,98namely:
1. pressure ulcers develop following a mistake made by an individual clinician99,100 2. they develop as a result of a sequence of otherwise unconnected mistakes101–103
3. there are systemic weaknesses in the organisation and delivery of care, such that the regime is one in which pressure ulcers are more likely to develop.104–106
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We decided that it would be necessary to discriminate between these candidate explanations to establish whether, and how, the organisational context helped to explain the development of severe pressure ulcers or alternatively played no role. We should also include two other logical possibilities, in order to identify their role in explaining development or eliminate them from consideration, namely (1) the behaviour of clinicians had no effect on the development of a pressure ulcer, which would have developed whatever they had done, and (2) there was an alternative explanation, which had not previously been reported or hypothesised. The second argument flowed from the nature of the domain that we were studying. Severe pressure ulcers occur relatively rarely and can develop in a wide range of settings over periods of days or weeks. It is not currently possible to predict who will develop them and who will not; it is only possible to identify people who have already developed a severe pressure ulcer. A prospective study was therefore not feasible. We opted to identify patients who had developed severe pressure ulcers and to reconstruct what had happened to them. This led us to adopt a retrospective case study design. A process-tracing case study method was used to capture the experiences of eight individuals who had developed severe pressure ulcers.107Accounts of their experiences were developed, which were then compared and contrasted to identify common features and hence common explanations. The two arguments taken together led us to develop a novel research design.
Setting
Eight patients were recruited in six NHS trusts in Yorkshire, England. Four patients’accounts occurred wholly or mainly in acute hospitals, three mainly in their own homes and one in a combination of a community hospital and an acute hospital rehabilitation ward. The decision to recruit eight patients was pragmatic: each account took approximately 4 months from initial interview to completion of analysis and we were therefore able to complete eight accounts with the resources available to this study.
Eligibility
Inclusion criteria
The study method was piloted with the first patient, who presented with few comorbidities, on the basis that the patient’s problems would be less likely to be confounded with organisational factors.
Subsequent patients were recruited from participating acute and community trusts if they: l had a current or previous category 3 or 4 pressure ulcer
l were a hospital inpatient, hospital outpatient, intermediate care patient or community patient under the care of community nursing services.
Recruitment was designed to maximise the variation and presentation of severe (category 3 and 4) pressure ulcers, including anatomical site (e.g. heel, sacrum, buttocks).
Exclusion criteria Patients were excluded if:
l it was considered ethically inappropriate to approach them, for example those whose death was imminent
l they were unable to tell the story (narrative) of their experience.
Recruitment and consent
Participants were sampled partly to maximise the diversity of individuals and the contexts in which they developed severe pressure ulcers and partly purposively (seeAppendix 10). Eligible patients were identified by members of the local tissue viability nurse teams at one of the six study sites in Yorkshire, England, who informed them about the study and provided them with a study information leaflet and an‘agree to be contacted by the researcher’form (seeAppendix 11). Consent to participate was obtained from individuals and, when appropriate, also from their main carers (seeAppendix 12).
Data collection
Data were collected by a field researcher (LP) with a non-clinical background from five sources, namely interviews with individuals who had developed a severe pressure ulcer (and, when relevant, their main carers), interviews with clinical and other staff who had been involved in their care, clinical records, other documents relevant to the account such as critical incident reports, and relevant local policy documents (e.g. on the conduct of skin risk assessments) (Figure 10, stage 1). A parallel review of patient notes was undertaken by a tissue viability nurse at each study site.
Patients were interviewed first and invited to give their account of the reasons why, in their view, their severe pressure ulcer had developed. Interviews were semistructured and lasted between 30 and 90 minutes. They were digitally recorded and transcribed.
The patient interview was used to direct the next phase of data collection, which involved accessing and reviewing nursing, medical and therapist notes, clinical incident reports and other documents (e.g. staff rotas for key periods of time in the patients’accounts). An initial analysis of the documents was undertaken and, on the basis of the analysis and the patient account, an initial interview schedule was drawn up. The analysis was also used to identify members of staff who were likely to be able to provide useful information about the development of the severe pressure ulcer. After the initial interviews, the researcher discussed the emerging possible explanations with the site tissue viability nurse specialist and a list of further interviewees was agreed. It is worth noting that, for this and subsequent analyses, the focus was on understanding how severe pressure ulcers developed, but a range of contextual information was provided in interviewees’responses and in the documentation provided that could be used to discriminate between the explanations identified earlier.
Stage 1
Initial analysis Document review
Stage 2
Stage 3
Comparison Edit account
Stage 4 Subgroup review
Stage 5 Reviews by chief investigator and independent
organisational psychologist Data collection Initial patient- informed account Specialist nurse report Revised account
Revised account and summative nursing
judgement
Final ‘true and fair’ account and summative
judgements
FIGURE 10 Analysis and review of individual accounts.
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Interviewees for hospital-based accounts included matrons, ward nurses, health-care assistants, ward clerks, ward managers, physiotherapists and consultants. In community settings, interviewees included district nurses, home care assistants and therapists (Table 25). At least seven interviews were conducted for each account except for the eighth account, in which an individual developed a severe pressure ulcer in her own home after a fall and few health professionals had useful information about her circumstances. Few professionals were directly involved in identification of and response to her ulcer, and comprehensive notes were available about her assessment and treatment only once she came into contact with health services. In total, 70 interviews were conducted across the eight accounts. Judgements were made about the time period that each account needed to cover and the extent of the documentation that was needed. In some instances, both were extended when it became clear that the histories were longer or more complicated than at first appeared.
Analysis
Transcripts of patients’interviews were reviewed and key passages that set out their accounts of events were included verbatim at the start of each account. This was done partly because the patient (and in some cases also the carer) was the only person who had been present throughout and partly to guard against losing sight of the‘patient’s voice’in subsequent analysis. A Microsoft Access®2010 database (Microsoft Corporation, Redmond, WA, USA) was then created for each account and used to organise key decisions and actions into a chronological sequence. Patient- and carer-derived data were recorded in one column, clinician interview data in a second and clinical record and other documentary sources in a third (seeFigure 10, stage 2). The presentation of data in parallel columns made it possible to develop a chronological account of events, identify consistencies and inconsistencies between different data sources and assess the‘strength’of evidence available about key events, reflected in the number and quality of sources. These data were used as the basis of a single, provisional timeline of events.
The site principal investigator, who in each case was a nurse with a specialist interest in tissue viability, undertook a parallel review, based solely on available patient records and on other available documentation, including local guidelines and critical incident reports. The review followed the guidance for reviews of critical incidents in the NHS.94The investigator wrote a report, identifying key decisions and actions in chronological order, including departures from local guidelines. The field researcher and site principal investigator then met and compared their accounts, identifying consistencies and inconsistencies (e.g. actions that the nurse judged as important that were not included in the researcher’s account). The timeline in each initial account was revised in light of additional facts or insights generated (seeFigure 10, stage 3).
Refinement of the accounts
The initial summaries of each account, supported by transcripts of all of the interviews conducted, were reviewed by a subgroup of nursing members of the research team, one independent hospital-based and one independent community-based tissue viability nurse specialist and one of the co-chief investigators (JN) (seeFigure 10, stage 4). The subgroups met and reviewed the summaries and transcripts, identifying points where, in their professional opinion, there was a departure from‘good usual care’(e.g. category 2
pressure ulcer was recorded in the nursing notes but no additional action to treat the ulcer or prevent deterioration was reported). The meetings were recorded and transcribed.
The subgroups were asked to make summative judgements about the best explanation for the
development of a severe pressure ulcer for each account. The method for this stage of the study drew on Yin’s108strategy for eliminating hypotheses in case study research. The subgroups were invited to select one or more of the following five explanations for the development of a severe pressure ulcer:
1. it could not have been avoided 2. there was a single precipitating event 3. there was a sequence of precipitating events
4. the organisational context made development more likely 5. there was another explanation, not covered by the first four.
TABLE 25 Numbers of people interviewed by account Account Individual Carer TVN District nurse Staff nurse HCA Consultant Junior doctor Physiotherapist Occupational therapist Ward clerk Liaison nurse Ward manager Quality assurance manager
Total 11 1 2 2 2 1 1 1 1 1 1 1 4 21 1 2 3 1 1 1 1 1 1 2 31 1 2 1 1 1 7 41 1 1 1 1 1 1 7 51 1 2 2 3 1 11 1 2 61 1 2 1 1 17 71 1 1 1 2 2 8 81 1 1 3 HCA, health-care assistant; TVN, tissue viability nurse.
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The second, third and fourth explanations were derived pragmatically from the literature on patient safety, with each representing a major class of explanation for adverse events.109,110The other two–the first and fifth explanations–were logical alternatives to the first three (i.e. the organisation of care played no role and there was an explanation that was not predicted by any of the three theories). We did not define key terms such as‘precipitating event’and‘organisational context’on the basis that subgroup members were expected to articulate the reasons why they opted for different explanations and in so doing would provide their own definitions in each account.
Viewed in the context of patient safety studies, this approach is novel, taking the study away from a narrow focus on root causes (i.e. only allowing causal explanations of events to be considered) and
towards the broader classes of explanations in the safety literature. There is a technical point here, which is that the explanations are not based on causal relationships but on identifying the‘best fit’between the available data and one of the explanations.
The discussion leading up to the summative judgements, and the judgements themselves, were included in the revised accounts. The accounts at this stage therefore had three discrete sections, namely the patient’s account, the interpreted timeline and nurses’summative judgement. The subgroups sometimes made queries about details of the accounts. After each meeting the queries were checked by going back to primary data sources and accounts were amended as appropriate.
The last two stages of the analysis were reviews of the individual accounts by a non-clinical co-chief investigator (JK) and then by an organisational psychologist (MP) who had not been involved in the earlier stages (seeFigure 10, stage 5). The reviews focused on the coherence of each account (i.e. the extent to which the patient’s explanation and/or the nurses’judgements made sense of the available evidence). In the final step in the analysis, the accounts were compared with one another to identify themes that were common across the accounts, even though the details of the individuals, their pressure ulcers and the care settings varied widely. The themes were analysed inductively to develop a mid-range theory of the reasons why patients develop severe pressure ulcers.109
Results
The study demonstrates that it is possible to develop detailed retrospective accounts of events and to use them to judge which of five possible explanations best fits the available evidence. The large volumes of data collected and included in the timeline appear to have minimised problems that might have arisen as a result of‘missing data’. However, as we note in the discussion, the results may still be subject to a number of biases.
The eight accounts
The eight patients were selected, in part, to maximise diversity (Table 26). Unsurprisingly, then, there were marked differences in the details of their treatment and care and different explanations were offered by those interviewed for the development of severe pressure ulcers.
Seven of the eight–the exception being number 8–exhibited widely recognised risk factors and had complex treatment and care needs. In a number of accounts some staff who were interviewed blamed the patients, on the basis that they had not complied with advice on managing their risks (e.g. shifting position regularly). But patients themselves, in the same accounts, generally pointed to specific actions or omissions, such as the failure to be turned regularly overnight, to be provided with a specialised mattress or to act on patients’comments about their own risks.
Participants approached interviews in very different ways. Some patients and carers were very clear in their own minds about what had gone wrong whereas others were very reluctant to criticise any aspect of their care. Similarly, some accounts involved individuals moving between wards, or an account developed against a background of a major ward reorganisation. The significance attributed to these moves varied, including, for example, the failure to transfer notes with patients, which placed receiving staff at a disadvantage, and staff feeling harassed because they were working in an unfamiliar environment during a reorganisation.
Elimination of hypotheses
The diverse group of individuals all had the same outcome: a severe pressure ulcer. In one account (number 8), the review teams judged that the development of the pressure ulcer was unavoidable, because the individual concerned developed a severe pressure ulcer in her own home, before any health professional saw her. In another account (number 3) there was a single precipitating event and in three other accounts (numbers 2, 4 and 6) there was a sequence of events. But the clinical subgroup and subsequent reviewers all judged that the organisational context made development more likely in seven of the eight accounts (Table 27). It is possible that the organisational context made the‘key events’in accounts 2–4 and 6 more likely, although we cannot make causal inferences with any confidence on the basis of our evidence. The evidence suggests that the term‘organisational context’covers two distinct concepts. The first concerns the prevailing cultures in the settings where severe pressure ulcers developed (seeCross-patient themes). The second relates to what one might term the functional characteristics of those settings, particularly nursing staff shortages, staff who (justifiably or not) did not believe that they had enough time for proper treatment and care and wider organisational issues, including contemporaneous reconfigurations of services in four of the accounts.
TABLE 26 Individuals and settings
Account Individual Setting
1 38-year-old woman with paraplegia Acute hospital, surgical ward
2 65-year-old woman with a long-term chronic neurological condition and undiagnosed infection
Acute hospital, medical ward 3 75-year-old man with multiple chronic health problems and acute infection Community hospital,
rehabilitation ward 4 37-year-old woman with a long-term degenerative congenital neurological
condition
At home 5 90-year-old man with multiple chronic health problems and undiagnosed
acute illness
Acute hospital, surgical ward
6 39-year-old woman in hospital for acute undiagnosed postoperative surgical complications
Acute hospital, surgical ward
7 65-year-old man with quadriplegia At home, respite care and acute
hospital
8 89-year-old woman who fell at home At home
TABLE 27 Summative judgements by account
Account Unavoidable
Single/isolated event
Sequence of events
Environment made development more likely Other explanation 1 ✓ 2 ✓ ✓ 3 ✓ ✓ 4 ✓ ✓ 5 ✓ 6 ✓ ✓ 7 ✓ 8 ✓
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Cross-patient themes
The process of eliminating hypotheses, and the analysis of common themes across the eight individuals, led to the identification of three broad themes. First, the‘voices’of those who developed severe pressure ulcers, and of their carers when they were involved, were not heard by staff. As noted earlier, the
individuals themselves behaved differently and had different relationships with clinical staff, but failures to heed information were evident in several accounts. There were examples of patients making repeated appeals for pain and discomfort to be addressed and expressing concerns about their own well-being that were not heeded over periods of hours or even days. In some instances, these appeals seem to have been dismissed by staff, that is, they were heard but were not taken seriously. Patients were also blamed for the development of their pressure ulcers on the basis that they did not comply with instructions that they were