Wounds research for patient benefit: a 5-year programme of research

Sampling strategies

Most studies were surveys of health-care professionals who were asked to complete a questionnaire for each patient they encountered with an eligible wound. Of those employing a sampling strategy, a random sample was identified from the population of interest, whether that was patients with a particular condition (e.g. diabetes65), health-care professionals71 or the wider public/population (e.g. from census data45).

Method of data collection

The method of data collection was not reported in 21 of the studies. When information was provided, the most widely used method was paper-based questionnaires (including postal questionnaires; n = 16). Other methods of data collection included interviews (including telephone interviews with patients), electronic or web-based online questionnaires and questionnaires for which the method was unspecified.

Case validation

Fifteen studies3,26,36,37,41,42,45,53,55,57,58,60–62,72–74 undertook some method of case validation for positive reports of ulcers. The majority of these undertook clinical examination of either all people identified as having a wound or a random sample or convenience sample (e.g. those in hospital but not those in the community). One study cross-referenced self-reported wounds with community nursing services. 45 One study attempted to identify false negatives, conducting a clinical examination of a random sample of patients not reported as having a wound. 47

Validation of underlying pathology in cases

The majority of studies did not describe or report validation of the underlying wound pathology. Six studies39,40,56,59,63,71 accepted the differential diagnosis reported by the care provider.

Eight studies3,37,41,42,48,54,60,62 reported that the ankle–brachial pressure index (ABPI) had been measured to determine whether or not there was any ischaemia. Venous competence was assessed in fewer studies: vein status was assessed using ultrasound in one study;41 venous refilling was assessed by photoplethysmography in two studies;37,41 and popliteal reflux was assessed in a single study using Rheo Dopplex II and duplex scanning. 3

Denominator data

Over half of the studies (n = 27) used a defined geographical population (or representative sample of that population) for the denominator. 3,26–28,31,32,36–44,48–51,53,54,56–63,73,74 The choice of denominator for the remainder of the studies included the total current caseload29,30,64,69,75–78,82 of health-care professionals or the provider organisation, the sample surveyed (not clear if these were representative samples of geographical populations)45–47,55,62,65–68,70 and respondents to the survey. 72,79 Of the studies that used a defined geographical population, just over half (n = 15) reported that the source of the information was census data or some type of official national statistics. The source of information was not stated in the other 12 studies that used a geographical population. Fifteen of the 27 studies that used a geographical population also gave an indication of how contemporary the denominator was in relation to the date that the study was undertaken (they ranged from the same year to up to 6 years preceding the study). Twelve studies did not provide any information on the contemporaneous nature of the denominator.

Capture–recapture technique

The technique of capture–recapture was employed in one of the included studies, although not for a ‘hard-to-reach’ group. 50 Walker et al. 50 conducted a population-based, cross-sectional study in New Zealand in 1998 in which people with leg ulcers were identified by both health-care professionals and self-notification. The team used both traditional and capture–recapture methods to estimate the cumulative incidence and prevalence of leg ulcers. Their results indicated that actual leg ulcer prevalence was six to eight times higher than that observed in the traditional method, although in this study the prevalence estimate derived from traditional reporting methods was much lower than expected (even taking account of differences in methods, etc.).

Quality-of-life data

Two studies52,89 compared quality of life data from individuals with leg ulcers with data from matched control subjects.

Jull et al. 52 (a publication describing the Walker et al. 51 2002 study population) compared Short Form questionnaire-36 items (SF-36) scores of people with leg ulcers with those of a control group randomly selected from the electoral roll using a stratified sampling process and population norms. Cases reported significantly lower mean SF-36 scores than the control group (and the population norms), with an impact similar to that of conditions such as diabetes and arthritis (as reported in the Medical Outcomes Study90).

Using cases from their 2004 study of the prevalence of leg ulceration in a south-west London population,3 Moffatt et al. 89 matched these cases with control subjects from six general practice age/sex registers within the same catchment area. The authors reported that cases had a significantly worse quality of life status than control subjects for all domains on the Nottingham Health Profile.

Current estimates of the prevalence of complex wounds

Estimates of the prevalence of all chronic/complex wounds for individual studies are provided in Table 4 (in which cases are people not wounds). Prevalence estimates varied by wound type. Table 5 reports the range of prevalence estimates for people affected by each wound type.

Tables 6–9 summarise the point prevalence estimates from studies in the following wound categories: leg ulcers, leg and foot ulcers, diabetic foot ulcers and pressure ulcers. Data were taken directly from published studies with no pooling or weighting. Cases are people rather than wounds.

Health professionals providing care

Table 16 indicates both the professional background and the grade (Agenda for Change band) of those completing the questionnaires. Health professionals caring for people with complex wounds were mainly qualified nurses (accounting for around 66% of the individuals captured by the survey), with 5.9% being podiatrists. The nurses providing care and completing the survey questionnaires were mainly district nurses (reporting on 36.3% of people with complex wounds) followed by practice nurses (25.1%) and specialist nurses (4.7%). Just over 85% (247/289) of the ‘other’ category were also nurses. Thus, 88% of people with complex wounds were receiving nursing care from (and were reported into the survey by) a nurse. The majority (74.4%) were seen by band 5 and band 6 staff (46.1% and 28.4%, respectively).

Wound consultations

Services providing wound care are presented in Table 17. Individuals were mainly cared for by community NHS services (801/1103, 72.6%). Acute NHS services cared for 9.5% of individuals with complex wounds, and nursing homes and hospices provided services for 7.3% and 0.8% of individuals, respectively. Approximately one-quarter of patients were seen within more than one health-care setting.

The frequency of wound consultations per week was recorded for 1066 individuals and ranged between 1 and 14. The mean number of consultations per patient per week was 3.15 (SD 2.15) (median of two per week). The duration of the most recent consultation was recorded for 1083 individuals (98.2%) and the mean duration was 28 minutes (SD 43.6 minutes). If it is assumed that the maximum recorded consultation of 20 hours was a recording error, the mean duration was just below 27 minutes (SD 25.2 minutes).

Treatment objectives

The most frequent wound treatment objective was protection (66.5% of 1416 wounds). Encouraging granulation was the second most frequent objective (49.3%), whereas reducing ‘overgranulation’ was the least common treatment objective.

Wound dressings

A primary dressing was reported in 1326 (93.6%) of the 1416 wounds. The five most frequently reported primary dressings were non- and low-adherence wound contact dressings (26.3%), foam (15.9%), iodine-containing low-adherence wound contact dressings (12.4%), spun hydrocolloid/hydrofibre (8.4%) and soft polymers (7.7%). Collagen dressings, hyaluronic acid, silicone sheets or gels, silver-containing silicone sheets or gels and acrylic dressings were not reported as being used as the primary dressing for any wound. A secondary dressing was reported for 678 (47.9%) of the 1416 wounds. The five most frequently reported secondary dressings were non- and low-adherence wound contact (37.9%), foam (30.5%), soft polymer (12.4%), vapour permeable/film (4.3%) and odour absorbent/charcoal (3.1%).

The three most frequently reported dressings for each wound type are presented in Tables 18 and 19 for primary and secondary dressings, respectively.

A cavity wound dressing (either silver or non-silver containing) was used as the primary dressing for 35 wounds and was used most frequently in relation to ‘other’ surgical wounds and pilonidal sinuses.

Bandaging and hosiery

For all wound types, a non-compression bandage plus wadding was the most frequently reported bandaging (16.5%). Approximately one-quarter of the 455 leg ulcers in the sample was treated using a non-compression bandage (Table 20) and multilayer compression was used for just over one-fifth of these wounds (22.6%).

Hosiery was rarely used in wound treatment (53/1416 wounds, 3.7%). When used as a treatment, hosiery was most frequently used for venous leg ulcers (33/298, 11.1%) but was also used in the treatment of some traumatic wounds, diabetic and non-diabetic foot ulcers, ‘other’ wounds, burns and arterial/venous leg ulcers.

There were 218 individuals in the sample population with at least one venous leg ulcer. Of these, 176 (80.7%) were receiving at least one form of compression therapy, most frequently (34.4% of those with a venous leg ulcer) multilayer compression (Table 21). Compression bandaging was used more frequently than compression hosiery.

Equipment and footwear

Table 22 summarises all forms of equipment used. Equipment was mainly pressure-relieving equipment for people with, or at risk of, pressure ulceration. The static, air-filled mattress overlay (Repose^®, Frontier Medical Group, Blackwood, South Wales, UK) was the most frequently reported pressure-relieving mattress, used by 15.7% of the sample population. In addition, 8% of patients had a wheelchair and a few used crutches (0.8%). Of the 236 individuals with at least one pressure ulcer, 173 (73.3%) were using a pressure-relieving mattress, most commonly an alternating-pressure mattress replacement (41.6%). A minority of people were using more than two types of mattress (5.2% of 173 patients).

Use of orthotics is detailed in Table 23. Prescribed footwear was reported for 12.6% of people. Heel pressure relief, footwear adaptations and insoles were reported much less frequently (2.7%, 2.5% and 0.9%, respectively). Of the 95 individuals with at least one diabetic foot ulcer, 62 (65.3%) were using an orthotic device, whereas only 23 out of 71 (32.4%) people with a non-diabetic foot ulcer were using one.

Medication and other treatments

Topical steroids were being used in the care of 7.2% of people with complex wounds. In total, 19% of patients were taking analgesics and 13.8% were taking antibiotics related to wound infection. Only one patient (who had a venous leg ulcer) was taking pentoxifylline.

In terms of other treatments, a small number of people were reported to be having physiotherapy (4.3%, 47/1103), occupational therapy (2.8%, 31/1103) or hyperbaric oxygen therapy (0.3%, 3/1103).

Pressure ulcer categorisation

Nearly 95% of all pressure ulcers (272/287) had been given a European Pressure Ulcer Advisory Panel (EPUAP) severity classification (or had been classed as unstageable),83 in line with NICE guidelines. 13

Venous leg ulcers

We were able to compare the management of venous leg ulcers in Leeds with elements of the Royal College of Nursing93 and SIGN94 guidelines, specifically screening for arterial disease using Doppler-aided ABPI; use of compression therapy; use of low-adherence/low-cost dressings; and prescription of pentoxifylline. Overall, adherence to guideline recommendations was generally good. Nearly 70% of people recorded as having at least one venous leg ulcer had an ABPI assessment recorded in their notes (60% for people with at least one leg ulcer of any type). In total, 80% of people with a venous ulcer were receiving some form of compression; 56% of primary dressings and 67% of secondary dressings were non-/low-adherence wound contact dressings. The percentage of people recorded as having an ABPI assessment may be an underestimate if, for instance, patients’ notes were not available when the survey form was completed or the ABPI assessment was carried out by a specialist team (such as a vascular secondary care team) and the recommended treatment was carried out by another care provider who completed the survey form (with the ABPI assessment not necessarily recorded in the notes if carried out by another provider).

Figures for the use of compression therapy and ABPI assessment in patients with venous leg ulcers are very similar to those reported in previous studies in the UK and Ireland. In Bradford, Vowden and Vowden34 reported that a Doppler assessment had been performed in 66% of people with leg ulcers and 75% of people with venous leg ulcers received some sort of compression therapy. A survey of leg ulcer management in Ireland estimated that 75% of limbs with a venous leg ulcer had an ABPI recorded, 50% were receiving high levels of compression therapy and a further 15% were receiving lower levels of compression therapy. 40

Royal College of Nursing guidelines93 recommend that simple low-adherent, low-cost dressings that are acceptable to the patient are used in the management of venous leg ulcers. Similarly, SIGN guidelines94 also recommend the use of simple non-adherent dressings and, in addition, do not recommend the routine use of either honey or silver dressings in the management of venous leg ulcers. The high use of non-/low-adherence wound contact dressings in the management of venous leg ulcers in our survey is particularly encouraging. In contrast, the studies by Vowden and Vowden34 and Clarke-Moloney et al. 40 both reported that the most frequently used dressings for venous leg ulcers were antimicrobial products (Vowden and Vowden34 reported that 41% of primary dressings were antimicrobials and in the Irish survey40 silver-impregnated dressings were the most commonly used dressings). In our survey, antimicrobial dressings were used relatively rarely for venous ulcer management (52/276 cases, 19%) when a primary dressing was reported. Reducing the use of antimicrobial dressings has been a priority in Leeds Community Healthcare NHS Trust, with intensive efforts made to bring about change, and this strategy appears to have been successful.

Scottish Intercollegiate Guidelines Network guidelines94 recommend the use of pentoxifylline in the management of venous leg ulcers; however, we identified only one person who was reported to be receiving pentoxifylline. However, there has been no particular effort to promote the prescribing of pentoxifylline for people with venous leg ulcers in Leeds (or elsewhere as far as we are aware). In December 2012 NHS Leeds recategorised pentoxifylline as suitable for prescribing for people with hard-to-heal leg ulcers in primary care. The findings from our survey will provide a useful benchmark from which to monitor the use of pentoxifylline in the management of venous leg ulcers in Leeds.

Pressure ulcers

We were able to assess adherence to NICE guidelines13 in the management of pressure ulcers in a number of areas: ulcer categorisation, risk assessment, availability and suitability of pressure-relieving equipment and use of suitable wound dressings. Overall, adherence to guidelines was good but some areas for improvement were identified.

According to NICE guidelines, people with existing pressure ulcers should receive ongoing assessment, although there is little evidence to support any particular method of assessment. The Braden risk assessment tool95 is recommended for all Leeds NHS providers. Other care providers such as nursing homes do not necessarily use the Braden risk assessment tool, for example some use the Waterlow score. 96 The survey captured information about those people who had a Braden risk assessment reported in their notes in the last month. In people with at least one pressure ulcer, 57.2% (135/236) were reported as having had a Braden risk assessment completed in the last month, 30.5% (72/236) had not and 12.3% (29/236) of the data were missing. This percentage of those reported as having had a Braden risk assessment may potentially be an underestimate if, for example, a risk assessment had been completed but not monthly or patients’ notes were not available when the survey form was completed.

National Institute for Health and Care Excellence guidelines recommend that all pressure ulcers are categorised according to EPUAP recommendations. We identified that 94.8% (272/287) of pressure ulcers had been either categorised or classed as unstageable. It is encouraging that most pressure ulcers are assigned a category from which clinicians can assess improvement or deterioration of the ulcer.

National Institute for Health and Care Excellence guidelines also recommend that patients with pressure ulcers should have access to appropriate pressure-relieving support surfaces and strategies. In total, 77% of people were reported as being in receipt of one of the listed pieces of pressure-relieving equipment (high-specification foam replacement, static air-filled mattress overlay, foam overlay, alternating pressure overlay, alternating pressure mattress replacement). It was not possible to estimate the proportion of people who had declined pressure-relieving equipment and so the proportion of people having access to pressure relief could be > 77%.

Based on professional consensus (as opposed to research evidence), NICE clinical guidelines recommend the creation of an optimum wound healing environment using modern dressings, for example hydrocolloids, hydrogels, hydrofibres, foams, films, alginates and soft silicones. The dressings identified in this survey in the management of pressure ulcers were largely concordant with NICE guidelines (foam and soft polymer were the most frequently reported dressings for both primary and secondary dressings).

Inclusion criteria

Any paper reporting a chronic disease register was included. A chronic disease was defined as a long-lasting or recurrent condition. Registries relating to surgical procedures were excluded. A medical register was defined as a database that met the six characteristics that define a medical database register:97

1. mergeable data: data from many users and patients can be aggregated

2. standardised data set: same variables collected for all patients

3. rules for data collection: protocol-driven data collection

4. observations associated over time: follow-up data for individual patients linked

5. knowledge about patient outcomes: complete ascertainment of end points of patients in the register

6. inclusion principle: the clinical characteristic or diagnosis on which the register is focused and which all registrants share.

Search methods

A MEDLINE search was undertaken using OvidSP and the following search strategy:

1. exp Chronic Disease/ (182,090)

2. 2(chronic adj (illness$or disease$)).tw. (25,675)

3. 1 or 2 (199,178)

4. exp Registries/ (35,210)

5. (registr$or register$1).tw. (77,603)

6. 4 or 5 (92,049)

7. 6 and 3 (1409)

This searching was supplemented by less formal internet searching via the search engine Google (Google Inc., Mountain View, CA, USA). Similar terms to those used in the MEDLINE search were used.

Screening stage 1

All study titles and abstract (when available) were reviewed. Full papers were obtained when the title and/or abstract suggested that the paper reported:

1. a review of medical registers

2. a study in which a medical data register relating to a chronic condition was discussed or explicitly used as a source of data.

The selection process was carried out by two reviewers. Any disagreement was taken to a third, senior reviewer.

Screening stage 2

Full articles were then screened against the criteria of Drolet and Johnson97 and classified as medical data registers or not. When a paper provided very limited information, that is, a register was mentioned only briefly as a source of data without sufficient information to make an inclusion decision, we followed the methods of Drolet and Johnson97 and searched for further information on MEDLINE and the internet. We had also planned to contact authors if necessary. When no further useful information could be obtained the study was excluded with regard to further data extraction. Again, all phases were conducted by two reviewers.

Newton and Garner98

In their report, Newton and Garner98 draw a distinction between ‘disease register’ (or ‘case register’) and ‘clinical database’. They reserve the term ‘disease register’ for those databases that have a clearly identified denominator population. Clinical databases do not necessarily relate to a defined denominator population and usually include cases from a particular institution or group of institutions. According to this definition, registers can be used for epidemiological research and needs assessment as well as to improve clinical care and service quality and for health technology assessment (HTA). Clinical databases generally have the objectives of quality improvement and HTA and, although cases should be as representative as possible of those in the target population, these databases are not suitable for epidemiological research because of the lack of a clear denominator and they are potentially misleading as indicators of the need for care in the community.

Raftery et al.99

Raftery et al. 99 adopted the following key terms (or definitions) in their review:

• routine data – there is no unequivocal definition but important characteristics include regular/continuous/periodic collection, use of standard definitions, degree of obligation to collect data completely/regularly and collection at a national or regional level

• health technologies – all methods used by health professionals to promote health, prevent and treat disease, and improve rehabilitation and long-term care

• HTA – includes the assessment of:

  • efficacy (patient benefit/harm in experimental and closely monitored studies) and effectiveness (benefit/harm when applied in everyday practice)

  • equity (extent of use by different groups or particular health technologies in relation to some measure of clinical need or perceived fairness)

  • diffusion (factors influencing uptake of health technologies by place and time)

  • costing (cost efficacy, cost-effectiveness, cost of illness, cost–consequences and cost impact).

Raftery et al. 99 then developed a classification system for routine databases according to their potential use in HTA (to assess efficacy or effectiveness and, to a large extent, equity and diffusion):

• Group I databases. These capture information on both the HTA being used and outcomes. They offer the greatest potential for HTA and can be subdivided into three groups:

  1. Ia – clinical registries are clinically rich databases that contain data on both the interventions (health technology) and the outcomes (health states) at the patient level. These have frequently been designed for research purposes

  2. Ib – clinical administrative databases contain data on health technologies but only limited health state data at the patient level. They are typically designed for administration purposes, for example NHS Hospital Episode Statistics.

  3. Ic – population-oriented databases identify the health technology and health state at the population level, for example vaccination programmes.

• Group II databases. These contain information about health technologies in use but not the outcomes associated with these technologies, for example prescribing data that summarise drugs prescribed but not patient outcomes.

• Group III databases. These contain only health state information but no details of health technologies or interventions received. Group III databases are further subdivided into:

  • IIIa – adverse event reporting and confidential enquiries

  • IIIb – disease/disability-only registers

  • IIIc – health surveys.

When considering the use of databases to assess the costs of health technologies, Raftery et al. 99 suggest a classification system that distinguishes between the different ways that health technologies can be costed.

Drolet and Johnson97

Drolet and Johnson97 created a detailed definition for registries in health care and outlined a set of characteristics common to them all. Their framework [MDR-OK – mergeable data (M), data set standardized (D), rules for data collection (R), observations associated over time (O) and knowledge of outcomes (K)] includes six distinguishing features of registries, which were summarised in the methods section.

Newton and Garner98

Newton and Garner98 reported that the number of disease registers already in existence in England is large, possibly larger than is generally appreciated. Their review was not exhaustive but identified approximately 250 registers. They noted the heterogeneity in every aspect of these registers, reflecting the fragmentation of policy and lack of strategy in this area. Cancer registries were recognised as an exception because there is now a developing national framework and regional structures to support it.

Raftery et al.99

This report identified around 270 databases at the level of the UK, England and Wales or England (> 1000 including databases specific to Scotland, Wales and Northern Ireland). The lack of detail in the review by Newton and Garner98 meant that it was not possible to cross-reference the English registers identified in both reviews, but we assumed that a large number of the registers would have been identified by both reviews. Newton and Garner98 did list six national treatment and device registers by name and these were all also included in the review by Raftery et al. ,99 with Raftery et al. 99 also presenting a more extensive list of named registers from across the UK. Around 60 of the registers identified by Raftery et al. 99 had the potential for HTA and approximately half of these were group I registries. Eighteen clinical registries were identified as having the greatest potential although only two could be directly used in costing. Review of the potential capture of health technologies prioritised by the UK NIHR Health Technology Assessment programme showed that only 10% would be captured in these databases, mainly drugs prescribed in primary care (wound care, specifically for venous leg ulcers, would not be captured by any of the databases).

Newton and Garner98

Newton and Garner98 identified the following current uses of registers:

• Patient care (regular review and recall, structured care programmes, monitoring high-risk groups, managing demand and regulating access, communication and risk stratification).

• Public health (surveillance, planning the provision of health care, monitoring the impact of preventative measures).

• Health technology assessment. Databases and registries can make a useful contribution to evaluation if they conform to certain criteria (large numbers of patients defined in the same way, data collected in a standardised fashion, followed over long periods of time using precise definitions applied uniformly). As the authors indicate, although not as rigorous as RCTs for deriving comparative effect estimates, registries have the advantage of being based on more representative populations and often include far larger numbers of cases.

• Research (descriptive studies, improving the performance of other research designs, studies of processes, hypothesis testing).

Raftery et al.99

Raftery et al. 99 examined the most promising databases that they had identified for the extent to which they had actually been used for HTA. They concluded that:

• the use of databases for HTA has been limited

• clinical registers were mainly used for national comparative audits

• effectiveness assessment is more feasible when relevant outcomes can be readily included (most databases contain insufficient data on health states and lack the detail required for risk adjustment)

• accessibility is a major barrier to using clinical registers, with their use largely limited to those who ‘own’ them.

Newton and Garner98

Newton and Garner98 identified the following factors that seem to consistently predict success:

• Appropriate multidisciplinary team, including a computer scientist, a biostatistician and someone trained in the clinical domain of the register.

• Stability of funding – challenging as it may be years before the benefits of a database become apparent.

• Focused aims – a register should have initial aims that are clear and focused. Although there is often a temptation to collect a large number of data, this may be of marginal value and questionable quality and can interfere with the primary objectives.

• Data collection systems and a design that relate well to function.

• Leadership – there should be a clearly identified, senior professional in charge of a register plus a senior administrative officer who is responsible for the quality of all aspects of the register.

• Ideal physical location (an academic environment, expertise available, ‘neutral ground’, all potential users feel that they have equal access, all disciplines feel comfortable).

Newton and Garner98

Newton and Garner98 identified a number of steps that might be considered when setting up a population-based register:

• Establish an expert group who can ensure that a register has a sound financial and scientific basis and decide on initial data collection processes and data content.

• Establish a steering group to ensure that a register is run according to its stated aims and objectives and that the rights of patients are respected. This steering group should include patient/family representation.

• Notify the information commissioner.

• Obtain approval from a research ethics committee if the register is to be used for research.

• Establish arrangements for access to the data.

• Consider arrangements for data security, including physical security (secure room in a secure building), local security (encryption), technical security (passwords) and procedural security (staff training and written records of procedures).

• Establish appropriate arrangements for accountability.

• Publicise the register and its findings. It is essential to promote the register among those who contribute data. Some form of ‘corporate identity’ may be useful to reinforce the presence of the register. The maintenance of good will requires frequent communication with participants and appropriate reporting. It is very important to avoid the perception that data are collected for the sake of it.

Newton and Garner98

Newton and Garner98 proposed the following:

• A clear case definition is fundamental to the success of any register.

• Methods used to ascertain cases need to be considered carefully. Diagnostic processes must be based on a formal protocol. If clinical assessment is the basis for a diagnosis, it is good practice to assess the reliability of the diagnostic protocol from the outset.

• Reliable identification of duplicates requires patient identifiers although this is not necessarily straightforward even when these are available.

• Future development of disease registers should relate to the evolving NHS information strategy,110 for example electronic patient records.

Newton and Garner98

Newton and Garner98 suggest the following as characteristics that can be used to assess the quality and value of registers:

• the public health importance of the topic

• the system used and its objectives

• the uses and other outputs of the register

• an evaluation of the system against a set of technical attributes (sensitivity, timeliness, representativeness, predictive value, accuracy and completeness of descriptive information, simplicity, flexibility and acceptability)

• the resources used to operate the system and a summary of whether or not the system is meeting its objectives and any modifications required.

Newton and Garner98 also describe methods for assessing the completeness and validity of register data:

• Completeness – the proportion of all cases in the population that appear in the register.

• Death certificate method – completeness is the proportion of cases not first identified from a death certificate.

• Independent case ascertainment – completeness assessed by means of an independent survey, for example a survey of part of the population covered by the register or capture–recapture techniques to compare two incomplete registers (for this method to be valid, the two registers must be assumed to have identified independent random samples of the population of true cases).

• Historic data methods – data from previous years or some other ‘known’ prevalence/incidence rate are used to predict an expected rate of identification.

• Validity – the extent to which the information on the register agrees with some external source that objectively measures the same variable.

• Diagnostic criteria method – register staff examine clinical records to assess the proportion of cases that satisfy strict diagnostic criteria.

• Re-abstracted record method – a sample of case data is re-abstracted from the original source records and compared with register records.

• Internal consistency method – a computer programme is used to check the register for illegitimate codes and logical inconsistencies.

Raftery et al.99

Raftery et al. 99 proposed criteria for assessing the validity of databases and then applied these criteria to those routine databases identified as having the most potential for HTA. They distinguished two broad dimensions for assessing validity: coverage and accuracy.

Coverage addresses the following concepts:

• extent of the data set, that is, the completeness of variables or content validity

• completeness of data collection by variable, that is, the frequency of missing data

• completeness of recruitment of units and their representativeness, that is, the characteristics of patients or delivery of the health technology may differ in selected units, giving different results, which could reduce the external validity of the findings on effectiveness, equity and diffusion

• completeness of recruitment of patients or technologies in each setting (there is a risk of selection bias).

Accuracy relates to:

• the use of explicit definitions of variables, including in the coding system

• checks on the reproducibility of coding

• the extent to which data are audited, both internally (internal consistency) and externally (by an external agency or by comparison with another database).

Raftery et al. 99 reported that, although internal consistency checks of databases were common, relatively few had any form of external audit. Issues around coverage and coding have, in general, received little attention.

Newton and Garner98

Newton and Garner98 addressed several issues relating to confidentiality and data protection. Patient consent should be obtained unless there is a good reason not to do so; however, there is empirical evidence that the obligation to express consent results in levels of bias that could invalidate epidemiological research. Registers can rarely be operated using fully anonymised data for four main reasons:

1. it is difficult to avoid or check for duplication of cases with anonymised data

2. construction of longitudinal records for linking exposure and outcome is harder with anonymised data

3. validation of a register against external data sets is more difficult

4. data linkage with other unrelated data sets is more difficult.

However, in the UK, the NHS number is beneficial because, being a unique identifier, it facilitates data linkage even with anonymised data.

Registers must comply with current legislation on data protection (e.g. Data Protection Act 1998111 and Human Rights Act 1998112) and take into account NHS policy on confidentiality. Newton and Garner98 noted that, at the time of writing, the legal position regarding the use of register data was contradictory and uncertain. However, since that time, legislation around confidentiality and data protection has been clarified and amended. Current legislation means that there are only two classes of disease register using identifiable data: those for which explicit consent of the patient is required and those for which it is impracticable to obtain consent and which are covered by regulations under Section 251 of the NHS Act 2006. 113

The important question for health researchers is whether or not registers should be used to support both clinical care and research. It is likely that few registers are capable of both addressing service needs and providing the basis for high-quality science. We were particularly interested in whether or not we could use a wounds register for HTA purposes, including to derive treatment effect estimates in the absence of RCT data. Registers have the advantage of greater external validity as there is likely to be less selection in operation than for recruitment of participants into RCTs. Registers are also likely to have greater sample sizes than many RCTs, particularly in wound care where our own work has shown a median sample size of 63. 114 Of course, the major disadvantage of using such observational data sets for estimating comparative effectiveness is the presence of selection bias and confounding. Furthermore, registers based on routine data may lack the detailed information on comorbidities necessary to adjust for important confounders.

Another question is whether or not the benefits of disease registers are worth the costs. There has been little published on the cost of establishing and running a register. Newton and Garner98 have detailed the costs that need to be considered including set-up costs (hardware, software, IT support and training), ongoing costs (cost of full-time administrator, cost of routine procedures associated with data collection and preparation), development costs (upgrading hardware and enhancements to data collection systems) and private costs (incurred by health professionals, patients and carers, mostly in terms of time but also travel, etc.). They suggest that a high-quality register generally requires a dedicated administrator and therefore has a minimum cost of around £30,000 per annum. 98 Most modest regional or district registers cost between £50,000 and £80,000 per year to perform the central functions of the register. Size, in terms of numbers of cases registered, partly determines cost, as does the desired quality of the data. Raftery et al. 99 also discussed the costs of those databases with the greatest potential for HTA. They reported that, in 2005, the total central cost of health databases was > £50M or around 0.1% of the NHS annual spend. Large variations exist in the annual estimated cost of each database, with the top four, which are clinical administrative databases (Prescription Pricing Authority database, Hospital Episode Statistics, Cancer Registers, General Practice Research Database), accounting for > 80% of the total cost. Most clinical registers claim very low costs per record (possibly because of uncosted, local-level inputs). Many clinical registers receive no formal Department of Health or NHS funding. It is not clear whose responsibility it is to fund registers and stability of funding is crucial. Lead times are often long and substantial costs accrue before useful outputs can be demonstrated. Newton and Garner98 recommend that registers used for research purposes should be developed within integrated research programmes to make the most use of them. They also suggest funding such registers as research infrastructure so that they are not competing for funding with research project proposals.

Routinely collected NHS data

This pilot study aimed to capture routine data from a variety of services. Because of differences in the method of routine data capture, as outlined in the previous section, the data collection process for services differed. For tissue viability and podiatry (whether clinic based or ‘mobile’), clinical information about the wound was input directly into SystmOne on the wound assessment form at each wound consultation and stored in the trust ‘databank’ (FRANK). District nurses and practice nurses continued to complete a paper version of the wound assessment form. Forms were printed specifically for the pilot study to include a ‘carbon copy’ (or multiple copies). The original form remained with the patient notes and at each wound consultation a carbon copy was returned to the data co-ordinator. Paper-based data from district nurses were then entered into SystmOne. Data from practice nurses were entered into a separate spreadsheet. Data were collected from participants for the duration of the study pilot or until wound healing or loss to follow-up.

The SystmOne and paper-based data collection processes are detailed in Figures 3 and 4, respectively.

FIGURE 3.

Electronic data collection process using SystmOne.

FIGURE 4.

Paper-based data collection process. DN, district nurse; PN, practice nurse; WAF, wound assessment form.

Self-reported health-state data

The EQ-5D form along with a covering letter were posted to the home address of register participants four times per year. A prepaid envelope was included for return of the completed form to the University of York.

Routinely collected NHS data

Table 26 details the NHS data variables that were used to populate the register (some variables are still under development as the wound assessment form continues to be developed for clinical use in SystmOne).

Self-reported health-state data

The EQ-5D is a standardised instrument that includes the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. 115–117 Each dimension has three levels: no problems, some problems and extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the five dimensions.

Third-party data sharing policy

Once patient data were provided to the University of York by Leeds Community Healthcare NHS Trust, the trust was the data controller and the university became the data processor. A third-party data sharing agreement was drafted to ensure safe and effective transfer of shared information.

As the owner of the wounds register, the university became a data controller. A third-party data sharing policy ensured that data were shared with only (1) those organisations that had a legitimate right to view and process that data, having signed up to a third-party data sharing agreement (i.e. Leeds Community Healthcare NHS Trust) or (2) the individuals to whom the data related.

Will patients consent to participate in a register of complex wounds and, if not, why not?

Patients with a complex wound were identified systematically by administrative staff and mailed information about the register. When patients declined to participate we attempted to establish reasons for non-consent; an opportunity to provide feedback on their reasons for non-consent was included on the consent form and the form could be returned to the data co-ordinator in a prepaid envelope. Alternatively, patients could telephone or e-mail the data co-ordinator with their feedback.

Can data from consenting patients be accurately identified within routinely collected data?

It was important that patients who consented to participate were correctly identified on the routine data system (SystmOne) to ensure that (1) their data could be ‘extracted’ from the NHS databank and (2) no patient who had ‘not consented’ was incorrectly identified as ‘consented’. The signed paper consent forms containing patient information were cross-referenced with information held in SystmOne and any discrepancies reported.

Are participants willing to provide additional self-reported health-state data and can these data be correctly linked with their routinely collected data?

We report the proportion (%) of register participants who returned the EQ-5D questionnaire at each time point. We also assessed the number of participants who could be correctly matched with the information from the databank.

Do health-care professionals collect the data that we need to populate a register? If they do not, what are the reasons for this?

To assess whether health-care professionals collect the data that we need to populate a register we estimated the number (%) of missing data for each register variable. We also investigated differences in the completion rate between the two methods of data collection (electronic data input into SystmOne and paper-based data collection). Feedback sessions were held with the different staff groups to ascertain the barriers and facilitators involved in collecting the data. The feedback sessions were facilitated by a member of the research team (KL, based in the NHS) using a series of semistructured questions. Responses were noted by the facilitator during the sessions. Topic headings were constructed (which were informed by the questions) and populated with themes that were identified from the responses.

How well do health-care professionals collect the data?

To assess the ‘accuracy’ of data, variables were checked for logical inconsistencies and inaccurate codes. For paper-based data, a random sample was selected and cross-referenced with case notes and discrepancies noted. Accuracy of data input from paper copy to register was also cross-referenced in a random sample and discrepancies noted.

Can data for the register be pulled out of the NHS databank and transferred safely to the University of York?

We assessed the feasibility of the trust IT department generating data files for register participants from their databank (FRANK). We also assessed the efficiency and safety of data transfer.

How much additional activity does the register generate?

We estimated the additional activities associated with running a prospective register, including both staff time and resources and materials (disposable) required, for example for printing paper copies of the wound assessment form.

What can we do with the data that we have collected?

We summarise the characteristics of the register population, their wounds and their care and investigate variation based on sex, postcode, etc. The potential for analyses that utilise the longitudinal nature of the data is considered. The rate of healing is explored and the potential to investigate the relative effectiveness of different treatments for healing through propensity scoring and instrumental variable methods is considered.

Do the data have value that could pay for the register in the future?

We originally intended to explore the potential for the register to become self-financing through revenue generated by data access, for example by the pharmaceutical industry. Unfortunately, we did not have sufficient time to complete this work.

Treatment outcomes most wanted by people with leg ulcers

Fifteen interviewees had leg ulcers. Six of these were men who regarded their leg ulcers as a consequence of intravenous drug use; these men were among the youngest people in the sample. Of those without intravenous drug use involvement, six were women in their 70s, 80s and 90s and three were men in their 50s, 60s and 70s with a range of comorbidities including arterial and venous disease, arthritis, Bowen’s disease, thyroid problems, gout, leukaemia and lymphoedema. Eight out of these nine interviewees said that what they most wanted from treatment was healing:

. . . get it healed up and dried up as quickly as possible.

LU1, female, 75 years

. . . to be cured . . . to be rid of the ulcer.

LU4, male, 66 years

. . . for them to get better.

LU6, female, 97 years

I just want them to heal.

LU7, female, 88 years

. . . not to have the sores.

LU8, female, 81 years

. . . not to have a hole in my leg. For it to heal up.

LU3, male, 53 years

. . . what do I want most? Give me a miracle cure! That would be very welcome. Find a cure, that’s what I want.

LU2, female, 80+ years

One of these interviewees with a leg ulcer for > 10 years was faced with the prospect of amputation but was still hoping that his wound might heal:

Not to have a hole in my leg. For it to heal up. Or, like they did, they said, it’s never going to heal, I think we’ll go down the amputation route . . . I just want it to heal up and that. And if it’s not going to heal up a decision has to be made whether I’m going to have to carry on dressing it forever, or what. But nobody seems to want to make that decision. Because it’s got smaller now . . . And the bloke who were going to chop me leg off went, ahhh you see, good job we didn’t cut your leg off now, isn’t it? And I thought, you were all for it at one bit. You were sat there with your meat cleaver and your sharpener.

LU3, male, 53 years

Another of these interviewees, a man in his early 70s with bilateral leg ulcers and diabetic foot ulcers for > 5 years, had refused amputation. What he most wanted was healing but he also acknowledged that once one wound healed another might break out and that he could have recurrent ulcers until he died:

[What I most want from treatment is] to get them cured, right. You see that one . . . that was about that long. That was painful, right. But it healed 100% up, right. But as that closes up, the other one opens out. So what the hell, you know . . . You talk about throwing your hankie in the sky and clapping hands, right. No . . . the same day as it healed, I got another one. This one I’ve got, nearly 6 years now . . . that can heal and another will break out . . . when’s it going to end? I don’t know. It will end when I die, probably. I mean, I’m 72 now, which I’ve probably lived a bit over time. I think to myself that I’ll take it with me.

LDFU5, male, 72 years

The exception was a woman aged 85 years who had had a leg ulcer for 6 months and had faced barriers in getting access to treatment:

I felt as though I’d hit a brick wall. That nobody were listening to me. Now, I’m 85, but I’m not senile and I’m not stupid.

LU5, female, 85 years

She said what she most wanted was to be listened to and to get it properly treated. Once it was being treated, she most wanted to get the bandages off and ‘not look like Nora Batty’:

Well what I wanted – I didn’t want to be pushed off to one side; people saying, oh come back on . . . And then, no you can’t come Wednesday because there won’t be a nurse here. And you had to fit in round them . . . them receptionists, well [laughter] . . . I wanted access. And I wanted somebody to do something about it. That’s all. I wasn’t asking for a miracle . . . But I just wanted somebody to get something started. [Now] I just want to get these bandages off . . . And not look like Norah Batty.

LU5, female, 85 years

All six men with leg ulcers who were or had been intravenous drug users said that what they most wanted from their treatment was healing:

I just want it to be better, you know, I just want it to get better.

IVLU1, male, 35 years

. . . to heal up.

IVLU3, male, 45 years

. . . just to get them healed up . . . just generally make it better.

IVLU4, male, 21 years

. . . to get it right . . . Get my health back.

IVLU2, male, 36 years

. . . just to get it healed up, and that’s it . . . I just want to get rid of it.

IVLU5, male, 33 years

I basically just want to get better.

IVLU6, male, 39 years

One of these interviewees with a leg ulcer for > 3 years wanted his ulcer to heal but talked about how attending appointments and waiting for it to heal was putting his life on hold:

I just want it to be better, you know, I just want it to get better . . . If that’s [healing] not going to happen, I’d rather have that knowledge now so I know where to take my life in what direction, you know, even if I have to just have it done once a week at least I could go back to some part-time work . . . All I want to do is go back to work. I don’t want to be on the dole . . . make sure it’s clean and doesn’t smell.

IVLU1, male, 35 years

He was coming to terms with possibly irreversible damage caused by intravenous drug use and wanted resolution of his chronic ulcer even if that meant amputation:

I thought I’d done everything right . . . with 5 years of being totally clean after I had the bust artery. Everything felt all right and then all of a sudden I got this just because I scratch my leg basically . . . I’ve even thought about having my leg chopped off and just saying, sod it, just get the leg chopped off and have it healed up as a stump rather than be like I am. I mean the worst I’ve been I’ve wanted that to happen.

IVLU1, male, 35 years

The interviewee with a groin wound had experienced barriers to accessing treatment. What he most wanted was to be listened to and get the treatment he needed:

They doubt your pain . . . Their attitude was that I were a smack head – a heroin addict – nobody says that, ‘a smack head’ . . . You’ve brought it on yourself, tough. Eventually I got what I wanted. I wanted it cut out [groin infection] and I got it cut out.

IVG1, male, 40 years (from contemporaneous notes)

Treatment outcomes most wanted by people with pressure ulcers

Seven interviewees had pressure ulcers. Three were men, all of whom used wheelchairs, two because of spinal cord injury and one because of spina bifida and hydrocephalous. Of the four female interviewees, one had MS and three had multiple comorbidities including cancer, cardiovascular conditions, chronic obstructive pulmonary disease, arthritis and asthma. All required a wheelchair or other mobility aids. Three of the interviews took place at the interviewee’s bedside. Six out of seven interviewees said that what they most wanted from treatment was for their pressure ulcer to heal:

For it [the treatment] to work! . . . [G]et it over and done with . . . I just want rid.

PU1, male, 40 years

I want it clearing up. I want the ulcer to go.

PU2, female, 77 years

I just wish it would hurry up and get better . . . get it right.

PU4, female, 72 years

Ideally get rid of it.

PU5, male, 57 years

To have it operated on . . . I just want it [surgery] to be done as quickly as possible and I want it to be successful and to be mobilised again as fast as I possibly can.

PU6, male, 53 years

To heal and be finished with.

PU7, female, 65 years

Healing and/or getting access to treatment was seen as the key to getting mobile and getting on with life, especially for those forced to live much of their lives in bed. For example:

I just wish it would hurry up and get better and then I can sit up all day . . . I want to go back to going to the day centre as well but I can’t see that happening before Christmas.

PU4, female, 72 years

One interviewee with previous experience of pressure ulcers was frustrated with the time that he had waited to receive surgical treatment:

It was quite obvious by Christmas time that it wasn’t going to heal. It was so deep . . . I would like to know, and I’m going to ask them when I go in, have they ever seen a sore this big, this deep that’s healed itself? I’ve a sneaky feeling the answer is no. So why don’t they operate in the first place because it’s wasting time, wasting money, wasting National Health effort, you know, nurses coming here . . . I just want it [surgery] to be done as quickly as possible and I want it to be successful and to be mobilised again as fast as I possibly can.

PU6, male, 53 years

Most interviewees talked about the difficulty of achieving healing and the fact that even if this wound did heal, they were at risk of developing new ulcers. For example:

I just want it over and done with and hopefully not get another pressure sore again. I know that’s not going to happen, I probably will get another pressure sore.

PU1, male, 40 years

I want the ulcer to go, you know, to not be there anymore. I suppose that’s wishful thinking.

PU2, female, 77 years

One interviewee with a current ulcer for 5 months, experience of previous ulcers and an ongoing risk of pressure ulcers because of spinal cord injury said:

Ideally get rid of it If that can’t happen, to manage it so it doesn’t interfere with your life . . . [What I most want is] the treatment that allows you to get on with living.

PU5, male, 57 years

The exception to the expressed desire for healing was one woman who spent most of her time in bed. She most wanted to keep the wound clean and dressed, fearing neglect, that is, that the nurses would no longer come and attend to it:

I’ll have it for the rest of my life, well what life I’ve got left. It won’t go away love . . . I wouldn’t like to go about without nothing on, a pad on, you know . . . I sometimes think to myself, oh they’ll stop coming soon, you know, they’ll stop coming. It’s got down to twice a week.

PU3, female, 90 years

Five of the seven interviewees with pressure ulcers linked their acquisition to medical interventions including hospitalisation, radiotherapy and an accident with a shoe horn while being fitted for special shoes by orthotics. Two interviewees expressed frustration at not being turned in hospital after being placed on surfaces on which they could not turn themselves. When asked whether he had any coping strategies or advice for others, one of these interviewees (PU1, male, 40 years), who had spina bifida and hydrocephalous, and therefore a lifetime of managing pressure ulcers, said, ‘stay out of hospital’. Although some interviewees were concerned that their ulcers may have been avoidable, one elder interviewee was resigned to acquiring pressure ulcers during hospitalisation: ‘it’s just one of them things that happened you know’ (PU3, female, 90). An interviewee who had heel pressure ulcers from tight leg bandaging while in hospital with pneumonia, acquired during respite care, focused the interview on another ulcer, which she blamed on her own tendency to scratch. Interviewees who were wheelchair users all talked about risk and the complexities of avoiding pressure ulcers while still being able to live a full life.

Treatment outcomes most wanted by people with diabetic foot ulcers

Four out of five interviewees with diabetic foot ulcers said that what they most wanted from treatment was healing:

I want it to get better . . . Just get it healed.

DFU2, female, 80 years

. . . what I most wanted is for them to heal up quickly, which they haven’t done . . . Get them healed fast and get home.

DFU3, male, 70 years

I’m hoping it’ll heal.

DFU4, female, 83 years

To get them cured.

LDU5, male, 72 years

One of these interviewees also said, ‘I want them to take the pain away’ and ‘to make me walk’ (DFU4, female, 83 years). One persisted with treatment rather than amputation despite the gradual loss of toes and a long experience of leg ulcer recurrence:

. . . and then again it’s knowing it’s not going to be a success . . . because it’s like cancer. Although many, many years and moons have gone by, they’re still struggling to find that cure, right, and they haven’t found it yet.

LDFU5, male, 72 years

The exception here was one man facing the prospect of amputation who said what he most wanted was to get mobile again. At the time of the interview he had his wound for 3 months. A severe foot infection resulting in surgery for the removal of toes had been the trigger to finding out that he also had diabetes and needed a coronary artery bypass operation:

. . . so within a week of finding an infection, half my foot’s gone . . . I want to get mobile again . . . I’ve been sat here for 3 month now and it’s doing my head in . . . If you said to me right now, I’m going to perform an operation this afternoon, I’d say take that foot off because I can’t walk on it far, so it might as well not be there, do you know what I mean? I don’t [won’t] class myself as a cripple, alright I’ve had an operation. I might be disabled, I might not be able to drive a wagon again but I’m not housebound and I need mobility, you know, that’s what I need.

DFU1, male, 55 years

He was left with doubts about whether or not the surgeon should have tried to save his foot in the first place:

He was the only doctor available [an accident and emergency rather than diabetes specialist] and they have said, he was thorough and did them a favour . . . [he] is what they call a conservationist, he likes to conserve stuff instead of chop off, get rid. But the amount of money that it must cost the health service to do this, all that time because the [negative pressure wound therapy] you had to pay for daily. The medication that I’m on, the attendance by the nurses, it’s all expenses.

DFU1, male, 55 years

Treatment outcomes that matter most to people with surgical wounds healing by secondary intention

All six of these interviewees wanted healing:

The flesh has merged and we just want that final closure of an epidermis to finish it off.

A1, male, 63 years

I need it to close. I just want it to close. I need to be comfortable. I need it to be quick.

A2, female, 42 years

I just want it over and done with . . . just get rid of it all . . . to heal where it’s going to heal for life and I don’t have to worry about it any more.

A3, female, 59 years

. . . you just want it to heal and, you know, get better.

A4, female, 57 years

. . . to see light at the end of the tunnel . . . a resolution to it . . . I can start doing all the things I used to do.

A5, male, 35 years

One of these interviewees, who was left with a small wound 12 months after treatment, weighed his concern about his wound healing against his cancer survival: ‘these other things [the wound and stoma] are really more secondary. The fact that you’re alive still is the number one consideration’ (A1, male, 63 years). However, he was also concerned about being left with bodily disfigurement:

[T]here wasn’t really a good successful outcome to the healing of my wound anyway because I was still going to be left sort of body dysmorphic at the end of it . . . So other than the healing aspect, I had to deal with the other issues of the muscles not being joined together and just having to accept that situation as being . . . [it’s] the least worst case scenario. I’ve not had a recurrence of cancer, so you’re thankful for that . . . there were six of us [in hospital at the same time] and there are only two of us that are still alive, so you know, it puts it all into perspective.

A1, male, 63 years

This interviewee and two others were also coming to terms with having a colostomy:

[There was] very little preparation beforehand regarding how mentally it would affect me having a colostomy. And the consequences you know of the cancer treatment as well . . . very little counselling other than the night before. Even then I was given some news, he said ‘you realise you could be impotent and lose all erectile function’. I mean these things were just thrown at one.

A1, male, 63 years

All of these interviewees had undergone abdominal surgery. Two interviewees had undergone surgery for a perforated bowel and were being investigated for possible Crohn’s disease or colitis. A woman with an open wound for 8 months was trying to reconcile herself to accepting that there was little that could be done to speed up healing:

It’s like, you know it’s there [the open wound] and you’re putting up with it but it’s very frustrating that it is there and that nobody is doing anything about it but in some ways they can’t. So you’d like somebody to magically do something. Stitch it up and get rid of it but they can’t do it. It’s impossible to do.

A3, female, 59 years

She and others reflected on how the wound had happened and whether or not it might have been prevented:

. . . maybe if they’d stapled it, it wouldn’t have popped. I don’t know. Maybe it would, maybe it wouldn’t, I don’t know. I’d perhaps like to think that it wouldn’t have done because when it’s been cut three times in the same place, to stick it with glue seems a bit – I don’t know. It just literally ‘pfff’ all the way down. Whereas when it was stapled before at least it had a bit of a chance.

A3, female, 59 years

Now I’ve read from doing research from other parties that do colorectal cancers that what is supposed to be a good thing is for you to have a series of antibiotics before you go down to theatre. Now that wasn’t offered to me and neither was it suggested . . . So I do think that if I’d had . . . It would have helped.

A1, male, 63 years

The nurses were a bit concerned because there was a small internal stitch that had been left inside the wound and they thought maybe that was why it wasn’t healing, that maybe this stitch needed taking out.

A4, female, 57 years

I just think to myself if I’d been operated on at the time when they’d seen me and they probably would have saved themselves so much money, so it’s not a complaint about how the treatment went or anything like that or the surgery that I’ve had, it’s just the waiting time that I had to wait to have the initial operation. If that waiting time had been decreased, I don’t think we would have had all the subsequent problems that we’ve had afterwards.

A5, male, 35 years

One woman suspected that a short-term determination to cut costs meant rationing of more-expensive dressings, which she assumed would help her to heal more quickly:

Like I say, a lot of it is down to money, you know, like wasting time with all different dressings and I think they started with the cheapest first and worked their way up to the most expensive. Whereas if somebody has got a reaction to a dressing, try the more expensive one and if that works, well that’s good. It means it’s going to heal quicker. I mean maybe if they’d have done that, put the more expensive one on me first, they might have been able to leave it, you know, a couple of days and it might have healed quicker, so they would have saved money in the long run because, I mean they’re buying dressings all the time.

A4, female, 57 years

Three interviewees developed their wounds after what they had anticipated to be relatively routine or minor operations: a hernia operation, removal of the appendix and a keyhole sterilisation procedure, which ‘failed, so they had to cut me open’ (A2, female, 42 years). There were lots of comments from these interviewees about how waiting for the wound to heal was putting their lives on hold – they had a feeling that they were in limbo and wanted to get back to being able to carry out their usual activities:

[I want] to see light at the end of the tunnel . . . my life has stood still for about 12 months and I’d like to think that there is a resolution to it . . . I can start looking for work again. I can start exercising again. I can start doing all the things I used to do. That’s what I’m looking for more than anything else.

A5, male, 35 years

I need it to be quick . . . and not painful . . . when it’s closed I can get my life back on track and go back to work properly and go back to my job, my friends and I can’t [becomes tearful].

A2, female, 42 years

[I want] speed [laugh]! Because you think, god, how long is it going to take?

A4, W, 57 years

One interviewee who self-referred to the study said that, although his wound was healed, it still caused him pain. He did not know why he had developed the wound in the first place and suspected it was implicated in other health issues currently affecting him:

They have to tell me what is going on . . . why still now I’ve got that [wound] and why my tissue is not healing. Everyone tells me something different . . . Only I want them to, you know, provide for me [answers] like why my wound has been – that pain because sometimes pain is killing me and, you know, I can’t eat and I can’t – so that most I want from them is the treatment . . . to treat my wound [2 years after closure of a wound that was open for 5 months].

A6, male, 41 years

Summary of key findings

When asked what they most want from treatment:

• Most people (29 out of 33) said that what they most wanted from treatment is healing.

• Two people who had experienced barriers to getting treatment said that what they most wanted was access to treatment, ‘to be listened to’ (LU5, female, 85 years; IVG1, male, 40 years).

• One man, who was deciding whether or not to have his foot amputated, said that what he most wanted from treatment was to become mobile again (DFU1, male, 55 years).

• One woman, who thought she would die with her pressure ulcer, wanted it to be managed and not neglected (PU3, female, 93 years).

When asked what bothered them most about the wound itself, six people said pain, five people said the social embarrassment of the smell, three people said the social embarrassment of leakage, two people said the boredom caused by confinement to the bed/house, two said itching, two said the threat of infection, one said the strangeness of not having pain (neuropathy), some gave more than one answer and some did not answer or said ‘everything’:

. . . how would you like to stand in front of a friend when you smell, it’s like you’ve got body odour or something like that. It’s not nice and then you’ve got the pain as well, so you’re always rubbing it or trying to do something to make yourself comfortable, it’s not right when you’re being out with people to be in that situation. So it’s left me at home, you know . . . For the last 5 years I haven’t had a girlfriend. I’ve just got one recently . . . She said to me that she can smell it but she’s not bothered about it because she knows it’s such and such. She said to me, got to get something sorted out about it. I said I want to do, I don’t want to be like this forever.

IVLU1, male, 35 years

When asked if they could change one thing about the wound what that would be, most people did not opt for incremental change. Instead, they said that they wanted:

To get rid of it.

LU2, female, 80+ years

Take it away. Completely.

LU4, male, 66 years

Just to heal.

LU5, female, 85 years

To heal properly, but to heal properly and to have your legs back.

LU7, female, 88 years

Not to have it full-stop. I don’t want it full-stop. I wouldn’t wish it on my worst enemy.

IVLU1, male, 35 years

Get rid of them.

IVLU2, male, 36 years

I’d make my legs better.

IVLU3, male, 45 years

A new leg. With that not there.

IVLU5, male, 33 years

I’d take it away.

IVLU6, male, 39 years

If I could change it? Just not have it.

DFU2, female, 80 years

Others said that they would speed up healing, pay for skin grafts or go back in time and prevent the triggering incident/injury that started the wound. One interviewee said ‘make me walk’ (DFU4, female, 83) and one said ‘change the pain’ (A6, male, 41 years).

In summary, interviewees wanted to have access to treatment, to be healed and to ‘get their life back’ as soon as possible. The one exception was an elderly woman with pressure ulcers who thought that she would have her ulcer until she died and she most wanted to ensure that the wound would continue to be managed and not neglected. The social consequences of the wound were as troubling to many participants as the physical pain and discomfort.

A shared desire for fast healing and a return to mobility was common among people with different wound types, along with a shared frustration that life had to be put on hold pending healing. Those facing amputation of a limb wanted to know when to give up their hope of healing. Some of those with wounds associated with intravenous drug use were coming to terms with the fact that the underlying damage to their venous system might not be reversible once they stopped injecting drugs. Those with pressure ulcers and a leg ulcer ‘ambassador’ spoke most about their desire for healing in the context of managing the ongoing risk of acquiring another wound once their current ulcer was healed. Many of those with pressure ulcers and surgical wounds were left with patient safety concerns about the cause of wounds that were acquired while in health and care services and whether or not these could have been prevented.

Ideal treatment outcomes

Most carer interviewees said that ideally what they most wanted from treatment was for the wounds of the person who they were caring for to heal and for things to go back to how they were, but they knew that this was unlikely to happen:

Well, the impossible – as was [things as they were]. But that will never be.

C8

Take them off [her] and put them on me!

C5

Well best of all I would like him to be walking again, but I don’t think that will ever happen now . . . sometimes it seems to bother him a bit and I’d just like it to heal for his sake.

C7

This is rather dwarfed into insignificance compared to the other problems . . . You’re still stuck with it . . . Like old friends who won’t be parted. But we would quite happily be parted . . . I should imagine we’re always going to have to be very careful of it. It’s going to need protecting with a lot of care. But let’s get there first . . . The target’s moving back a bit. It’s moved back hundreds of times, but nevertheless it still would be nice if something could be done [to heal it] . . . [It’s been] three and a quarter years!

C6

The following interviewee was the carer of someone with a pressure ulcer and said that he wanted these wounds to be prevented in the first place:

Yes, we think prevention. It’s a bit annoying that these things are happening so much in hospitals. They do need to be reducing them, because it’s costing the NHS so much . . . orthopaedic people and plastic surgeons. The cost is just ridiculous to be quite honest. I know money’s short but you could save on that if you could stop this sort of thing. But maybe that’s the Holy Grail, that’s easier said than done.

C6

Disagreements about treatment

There were points of conflict between carers and the people they cared for about some interventions. Two were concerned about the reluctance of the person cared for to seek help. One, who feared losing his independence, was reluctant to call the doctor in ‘in case they cart him off’ (C4). Another refused to leave the house for appointments to treat multiple underlying conditions:

I think he’s just given up . . . This is the trouble. This is the worst thing for me. Because I can’t get him to go out . . . every year he’s supposed to go to the eye clinic [because of diabetes] and they would provide an ambulance but he won’t go. And he won’t have his ears tested . . . that’s the thing that I find frustrating. Well you can’t get any further, can you?

C7

Carers also sometimes feared the consequences of the surgical interventions that the person being cared for hoped would help resolve problems with the wound:

And that is the fear. He [the surgeon] can’t control your healing process. You’re diabetic. You’re classed as obese in the sense that you are not the skinniest thing . . . [as a consequence of inactivity because of the wound] so even that is another additional risk problem. The fact that you’ve had all of this . . . if you are worrying about appearances . . . from my point it does not worry me at all. I am probably the only one that sees that and I’m not saying it to make you feel better. I’d rather have you here than take the risk of a cosmetic situation and that’s how I feel and I still feel like that.

C1

You just go from week to week waiting for another ulcer to appear and it dries up and then it comes back and to me, that will be it. That’ll be what his feet will be doing now.

Not when I’ve had my feet straightened.

I don’t know. I don’t know.

Well, hopefully, anyway.

That’s all you can say, but you don’t know, do you? But you see, when he’s [had the operation] – what is it, you’re about 6 weeks aren’t you with them pegs in? So it’s [going to be] even harder.

Some carers had gone through periods when they felt that they were drifting along and there was treatment activity but no real treatment plan. This carer wished he had pushed more to see a tissue viability nurse but he did not know about them at the time:

It just seemed to be a bit of a – not a losing battle, but we weren’t really getting anywhere. It would have been nicer if we could have a tissue nurse in, if there was such a thing . . . We just seemed to be plodding on and not getting anywhere. ‘Til that setback came [heel damage caused by orthotics] and the really prompt reaction – I’m not criticising anybody, but it’s just the way that it . . . We should have pushed more . . . The district nurses, one of them came one day and said . . . I think we’ll be coming in years to come unless we do something. I should have thought of that and pushed it myself earlier on. I didn’t know what to expect. I didn’t know anything about pressure sores at all. I didn’t know much about them other than they were a nuisance.

C6

Most interviewees praised the treatment that the person they cared for had received but some were ambivalent about the effectiveness of the interventions they had seen:

I think she’s always had fairly good treatment from the surgery and the doctors and nurses who have been to her. They’ve always given her – everything that’s new that’s come out, they’ve tried. So I mean, there’s not much else they can do really . . . They actually just heal themselves, I think. They use something that will heal up, and then the next time she gets one they’ll try it and it doesn’t work. So then they try other different things.

C5

Nevertheless, carers appreciated someone coming to ‘keep an eye on it’:

Well all she does, she looks at it, measures it sometimes and changes the plaster and puts cream on his legs. Because his skin’s very dry. But apart from that, nothing. I think more or less to keep an eye on it . . . I don’t know enough about it, really . . . I would have thought that if they cleaned whatever the debris is there it would perhaps heal better, but I don’t know. She did put a little pad on today, because it wasn’t healing, as well as the plaster. So, you know, they do try different things now and again . . . the advantage to them coming, you see, is they can keep an eye on it. Because I mean, I don’t know enough about them.

C7

Over the longer term some of the carers felt that there was a lack of interest in the outcome and that they were being left to get on with it:

But sometimes though because it’s so long and it’s so chronic and these wounds are chronic whether they’re ulcers or . . . you sometimes have to re-address them a little bit further on . . . and you can only re-address them if somebody bothers to ask or if somebody asks, ‘oh has he healed yet?’ or something like that. Nobody knows whether he’s healed or not. I’m sorry but this sounds terribly like moaning and it’s not moaning but how can you possibly know whether a patient has recovered from that unless you enquire to what the outcome is.

C1

The following carer cared for someone with a surgical wound healing by secondary intention. She said that at first there had been lots of people around, to the point when it sometimes felt that ‘your life is not your own’ (C1); however, over time she felt that she lacked the reassurance of nursing back-up or follow-up:

[At the start] you have a lot of support – I don’t know whether you have support but you have a lot of people around you, so you feel like you’ve got that support. Then it became obvious that once . . . in that respect, I think I felt let down . . . in the sense that you needed that kind of nursing support. We didn’t need the physicality, the fact of a nurse being able to do it. I’m perfectly able to do that [change dressings]. If somebody says to me, look let’s try this, do this, I’m perfectly able to do it . . . I wasn’t to start off with . . . I was looking through my fingers when I had to look at him, that’s how scared I was but it’s not a problem anymore. It’s become second nature but I just think maybe a phone call might have been to see how he’s getting along or whatever. I suppose they could feel that if you need them you’ll ring but sometimes that’s not what you want to do . . . Just somebody to pick the phone up and say, do you need anything and then I can say, ‘no I don’t’ or I can ask them, ‘what do you think?’ . . . I know everybody is stretched every which way with whatever and I know there is an older lady on her round that hasn’t got anybody to come in and has to take priority. No harm is going to befall [him].

C1

Some carers performed no physical wound care. This carer had been specifically told not to:

I’ve only changed the plaster once . . . occasionally the catheter leaks – it [the dressing] was wet and came off. So I stuck another one on. They told me off about it. They said, ‘oh you mustn’t do that. You must ring us’. Well, I mean, it doesn’t take a science degree to do that, does it? I thought I’d done quite well . . . I’m not supposed to touch them at all.

C7

Other carers had become used to applying dressings:

When it [pressure ulcer] first appeared it’s not normal for somebody to have a big hole, is it? It was a bit scary at first but obviously over time you get used to it . . . I wouldn’t say that I know too much about them . . . I know how to change his dressing and basically [he] relays it to me and I get all my information from [him].

C4

The following carer said that nurses would answer her questions if asked but, especially as she was involved in dressing the wound, she would like to be more actively included in discussions: ‘the key thing is [to feel] trust’ (C4). Some carers felt cautious about annoying health professionals and the person who they were caring for with their questions:

I think me mam’s one of these, she doesn’t tend to ask. It’s me who asks. Me mam’s more laid back than me. I want to know everything . . . I get worried over her and I’m asking all the time.

C2

We always get a list of questions, don’t we? They think, ‘oh, he’s one of them’.

C6

One couple spoke about the difficulty of having to watch their ‘p’s and q’s’ to not offend health professionals with questions and comments while also being worried about the consequences of disagreements and conflicting advice:

. . . one [surgeon] wanted to take it out and drain it and another one said, no we won’t and . . . and then he thought maybe it would heal on its own. Well it didn’t heal on its own because he had to come home and I had to empty the bag . . . with an abscess . . . oh the stench of that was bad.

C1

One carer felt that she was not very good at asking questions and that health professionals were mostly too busy to talk:

. . . an odd one will say something. Mostly they’re so busy they just come in and bang bang . . . There are some that are very good and talk, but mostly they . . . I mean, they are quite friendly, but they are so busy . . . I think most of them take the attitude that they don’t expect you to understand really. They just sort of get on with their job. An odd one will say something, but not really . . . I’m always interested. I mean, you learn things that way don’t you? . . . I’m not very good at asking questions.

C7

One carer was applying support stockings and compression bandages and felt that she needed more support to make sure she was doing the right thing:

I’m shown something, how to do it, then I can do it . . . I never know, with not being a professional, I’m doing it the right way; the correct way. But obviously, I have been doing it the correct way . . . he can’t bend . . . I mean [he] couldn’t do it himself. But I don’t mind doing it, you know, as long as, shall I say, we both get support . . . And quite frankly, I feel that . . . we’ve been let down by the district nurses. I feel as though, yes, there’s probably other people more important than we are, but for something as serious as [leg ulcers and] lymphoedema, you have to have proper bandaging done, and because, yes, I can do it, but am I doing it right? Am I doing it correctly? Do I know what I’m looking for once the bandages come off and [he] gets a shower and you know he showers his legs. Do I know what I’m looking for? Because I don’t. I don’t know if it’s good or bad. We’ve said this before, haven’t we? . . . And as regards feedback, the only feedback we did get is from [nurse] at the lymphoedema clinic. And she said, yes, they’re going on all right. And she automatically says, but your ulcer is not healing. Have you been to your GP [general practitioner]? . . . And what does the practice nurse do there? ‘Oh yes it’s okay, so don’t bother coming again’. So I mean, honestly, it seemed as though we were between a rock and a hard place.

C3

One carer said that what she would really have liked was a care plan:

. . . it would be wonderful if they could have . . . A care plan and we don’t have that because you do need it. You are scared. You think, what’s going to happen if . . . I mean basically you’re just waiting to see if something rears it head again and then you deal with it. There is none of that continuity there . . . There’s nobody to ask . . . your GP doesn’t know.

C1

There was a lot of sympathy for how busy nurses were and a sense that they were fulfilling physical care tasks but concerns that there was no clear treatment pathway for patients engaged with many different services and that no one was overseeing or managing cases:

I suppose you’re thinking that the district nurse should cover all of those things but sadly a district nurse really goes out to do wound care, this or that. They really can’t go beyond that. They don’t know anything about stomas . . . They certainly can’t deal with psychological issues or anything like that or feelings, so it is a tough one . . . because of the volume of patients that they have and they have to spread themselves thinly, [they] are literally going in . . . to deal with just wound care . . . They’re there to do that specific one task and we’ve had to find out different things even from all your sexual issues and urinating and all that and we had to branch out in all these different directions. Nobody could deal with it and it would have been lovely if somebody could have given us some pointers . . . There’s no one point where you can say, I’ll point you in that direction and I know it’s possible to do it . . . You have to find your own support network basically.

C1

Carers in the study were more likely than patients to express doubt that the interventions being applied to patients would lead to healing. Nevertheless, they wanted health professionals to ‘keep an eye’ on the wound. Patients and carers both felt that waiting for the wound to heal left them in limbo. Carers expressed frustration at a lack of overall case management of the wound and feelings of being abandoned by health professionals and being left to cope with the wound.

Treatment outcomes aimed for and considered most important by staff

Health professionals aimed to make a positive difference for patients although many of them rarely saw the final outcomes of their interventions. When asked what treatment outcomes they aim for, most health professionals said healing, but this was often qualified: ‘you find out that that’s not realistic’ (H3) and ‘there’s clearly going to be some chronic wounds where that’s not a realistic outcome’ (H5). Outcome aims then became ‘improvement’ (H3, H2, H5, H4), for the ‘patient to feel positive’ (H2) and (for tissue viability nurses) determining the cause of the wound and why it is not healing. There were two mentions of finding a treatment with which the patient is able to comply and one mention of the prevention of recurrence.

Methods described to determine the cause of wounds included assessment of circulation, nutrition, sources of pressure damage and levels of activity. Investigation was also said to involve checking that the treatment given is appropriate, advising on lifestyle changes to promote wound healing and referring patients on to appropriate sources of treatment and support including vascular surgeons, smoking cessation services and dieticians.

All health professionals aimed for symptom management outcomes that focused on the removal of slough and the reduction of pain, odour and exudate. If a wound was the result of pressure damage, health professionals ensured the provision of appropriate offloading and pressure-relieving devices and services. Infected wounds were treated with antibiotics.

Two podiatrists said that that the outcome that they aimed for was to find a treatment with which the patient was able to comply. One health professional in a predominantly preventative role (H1) described most of the healing that could be achieved as ‘fragile healing’ and identified the prevention of recurrence as an important treatment outcome.

One tissue viability nurse said that sometimes she thought goals for treatment outcomes were different for patients and health professionals:

I think sometimes our goals are different to their goals . . . Well our goal is we want to heal it but the patients might not be. They might just want . . . I’ve had a patient before in a wheelchair . . . They can’t feel half their body, so they’re really not that fussed. It doesn’t give them any pain but what they don’t want the wound to be, they don’t want to be wet through with exudate and they don’t want it smelling and as long as that’s contained, they can carry on doing what they’re doing and they’re happy.

H10

Most challenging aspects of wound care for staff

Many of the health professionals interviewed said that one of the most challenging things about working with patients with chronic wounds was not seeing or knowing if patients heal. For example, two tissue viability nurses and a podiatrist said that it was challenging not knowing whether or not their work made a difference because they did not find out the outcomes for patients who they had treated:

We don’t get to know what’s happened with them . . . what’s the outcome.

H2

Just finding out when they heal would be helpful . . . do patients that come under our umbrella have different outcomes to the patients that don’t? . . . We don’t know what our outcomes are really . . . we don’t have a service model that takes all patients with wounds [and] follows them through to healing and it’s not really right that we do in lots of ways because otherwise you just end up with a very de-skilled generic nursing population.

H12

. . . you want to see the end of the tale kind of thing.

H10

Most health professionals discussed how repetitive and time-consuming wound care could be and the difficulty of keeping themselves and their patients motivated over long periods of uncertainty about the outcome:

It can be a really slow moving thing . . . it’s having the patience.

H2

The longevity of the wound.

H11

It’s time-consuming [and] trying to keep motivated yourself that this is actually going to heal and hence motivate them.

H1

Most challenging thing is probably . . . Sometimes you feel like you’re going in day in and day out . . . even though you’ve got all the various people on board . . . you’re just going in there and it looks exactly the same and it’s not changing and it’s not getting any better and . . . it’s kind of out of my hands because there is vascular people involved, tissue viability nurses involved and I’m just going in there and just doing what the care plan says basically and you kind of think, it’s up to them isn’t it what they do at the top. I’m just going in bandaging and not seeing any improvement. There is nothing else that you can particularly do really.

H8

Most health professionals described the challenge of getting patients to comply with their advice:

Very challenging is when you can see that you are not going to heal this wound and that is challenging, especially if . . . it’s because they make unhealthy choices . . . this is his choice . . . But we cannot be effective, we cannot help this person, that’s challenging.

H1

. . . sometimes it’s hard to get patients on your side, you know, make them understand that you’re trying to help them . . . You have patients who don’t want to listen, don’t want to help themselves . . . you’ll find those are the ones who have chronic ulcers a lot longer than others.

H2

If they’re non-compliant with their diabetes, if they’re smoking and not looking after themselves or if they’re walking about barefoot and neuropathic, you’re sometimes up against it with people.

H6

In particular, they described the challenges they faced getting people to attend appointments and to comply with advice about managing blood glucose levels and weight, moisturising skin and wearing the right footwear. Nurses raised the challenge of getting leg ulcer patients to go to bed rather than ‘insisting on sitting in a chair’ (H10). Some interviewees acknowledged that it could be difficult for patients to comply with some of the advice they gave:

they’re human beings after all.

H1

One of my most frustrating things is weight management . . . because the [chronic wounds on the] legs are the main concern we tend to be the main person managing . . . care when [actually] . . . The legs are a knock-on effect. The diet and other support and psychological support need to be the main thing . . . it’s really frustrating . . . because they need not just dietary input, they need psychological input as well, support. I think they get a raw deal . . . They don’t get much here . . . just get a dietician visiting every month to 6 weeks when they need somebody going in every week going you’re doing really, really well. Like Weight Watchers at Home service, you know, somebody coming around and giving you loads of encouragement.

H10

Some of the interviewees discussed the challenging issue of ‘ownership’ of the wound and whether or not their services were creating a culture of dependency rather than encouraging behaviour change:

I think as nurses we own patients’ problems, we own their wounds, you know, it’s like if things aren’t improving, you hear district nurses saying all the time, ‘oh well I’ve tried everything, I don’t know what else we can do, I’m really sorry this hasn’t worked, oh let’s try this new dressing’ and yet . . . standing back from it, kind of observing this situation that the patient sat at the side of an ashtray spurring forth tab ends or . . . they’re still grossly obese . . . yet nothing is said about the bit that the patient can do. But you also haven’t done your bit and I think patients do need to do their bit because there is only so much we can influence and control.

H12

Sometimes they don’t think it’s about them, it’s what are people doing for them.

H6

It’s difficult because some patients will come in . . . and you can tell they’re . . . really aggravated with this ulcer and they have, I’d probably say a poor attitude, they just don’t care. Just let you get on with it and they don’t say anything to you and it’s really hard because you want to know what’s going on . . . and especially how they’re dealing with it at home because . . . we find that a lot of patients self-neglect . . . I think it’s denial a lot of it and then some patients will come in and just be like, I really need your help.

H2

. . . we sometimes say the leg belongs to them and not to us because I think over the years and months nurses go in and take over this bandaging and the elderly frail lady at home that doesn’t get any visitors . . . thinks very much the nurses keep coming . . . I think we take over where . . . the leg belongs to the patient and not us . . . we forget to step back . . . you get into this routine.

H4

I think all they think of is, ‘oh well the dressing they’re going to put on there is going to cure it’. Well it’s not, it’s actually . . . them . . . kind of taking control of their treatment in a way, helping themselves and a lot of patients you find really don’t do that. They don’t really help themselves that way.

H8

The challenge of dealing with patient expectations for healing came up in many of the interviews:

Just dealing with their expectations, you know, with them thinking, ‘oh I should be healed by now and it isn’t healing’. I think it’s important that you’ve got to remember that, that ulcer is their ulcer . . . It’s not just what everybody else can do for them.

H6

. . . you go in and you know they’ll go, ‘is it getting any better?’ and it clearly isn’t. Whereas the district nurses might go, ‘oh yeah, yeah’, you know, just to keep them [happy] . . . [the patient] chose to listen to the ones who said it was getting better.

H11

Their expectation I think is quite challenging . . . you can’t dash people’s hopes . . . sometimes they get really frustrated if you keep changing the treatment but if you don’t change it . . . it might end up being a chronic wound that you’re managing forever but when new treatments come out and you try it, you know, that can be quite challenging. You’ve got to really draw on change management techniques haven’t you to change people’s attitudes. If they’ve been having four-layer bandaging forever and we actually turn round and say, oh that’s no good now, I think we’re going to change the dressing – I think that’s probably frustrating.

H9

Many of the responses reflected the difficulties of what one interviewee described as ‘more pressure for delivering complex care in the community at both policy and demographic level’ (H5). The professional motivation of being able ‘to make a difference’ or ‘see people heal’ was particularly challenging when working with some groups of patients:

. . . pressure ulcer patients definitely are, your immobile pressure patients with lots of different comorbidities are sort of heart sink and your grossly obese patients as well like with their swollen wet legs are heart sink because even if you get them to recognise they need to lose weight that’s not something that happens overnight and therefore you’re going to manage the problem in the interim period.

H12

Nurses discussed the challenges of working with people exhibiting signs of self-neglect, for example ‘bad hygiene and [a] house . . . you can’t go into’ (H7), and also issues of safeguarding and the challenges of dealing with particularly unpleasant surgical wounds in a patient’s own home:

So we actually had to go in and open it up like a sandwich and fill it . . . with a filler, fasten it back up, pull it over and tape it on with Hypafix to keep it together, it was disgusting. It wasn’t nice. That was quite difficult for some members of staff because as soon as you take the Hypafix off it just went ‘phew’ . . . there are lots of wounds like that . . . [and] the possibility of safeguarding or, you know, it’s an unstageable wound that we’ve found. Could we have done anything about that? There’s a lot of reflection around wound cause analysis, you know.

H9

Some health professionals described the challenge of delivering a good service within current resources and sometimes the difficulty of understanding the reasoning behind the treatment decisions colleagues were making:

. . . in terms of nurses having enough time and . . . [their] knowledge base . . . are they assessing and picking up what they really need to pick up and then if it starts to deteriorate do they act on it? Or why do people take the decisions that they have taken?

H4

A key consideration in choosing treatments was to minimise the number of visits to patients or appointments at a clinic. Two reasons were given for this: one was to reduce patient disruption and the other was to minimise clinical costs. Health professionals therefore sought ‘products that are going to have the biggest impact on improvement as quickly as possible’ (H5). Some interviewees found it particularly challenging to select the correct treatment choice and to apply their knowledge of the evidence base to patients eager to see healing:

. . . making sure you get the right dressing and the most appropriate for that patient.

H7

. . . for me the challenging one is knowing sometimes what the evidence might say and therefore how do we follow that because . . . you can’t just immediately put the compression on because you need to do pain first and you need to manage the exudate but I need compression but I can’t do that because the patient is in too much pain. What’s causing that pain and how do we unpick that or maybe they’ve got arterial problems, a mixed leg ulcer arterial and venous and how do I balance both or am I waiting for them to go to vascular? But in the meantime a good patient that’s desperate that they’re wanting to move things on.

H4

Sometimes it’s very obvious what needs to be done, you know . . . you’ve got very sort of tangible outcomes . . . Other times it’s not at all easy because there isn’t the armament. You don’t have the armaments available to manage the problem or the things that you’ve got available to you have been rejected by the patient and they’re not interested in pursuing that kind of treatment because they’ve had a bad experience with it previously or they’re quite nervous. So then, you know, you’ve got to do quite a lot of investing time to try and explain the rationale and the research evidence behind things and how you know [that] it’s worked before with other patients and how it’s probably worth a try even though they’ve had an unsuccessful attempt previously.

H12

Some tissue viability nurses expressed frustration at expectations from colleagues who expected them to have a ‘magic dressing’ to cure a chronic wound:

Because we’re the experts, we’ve got the magic dressing haven’t we in our bags! We’ll get tissue viability in, they’ll sort it, there’s the magic dressing. There isn’t one, you know, and they still say that now even when you’re doing the study days. ‘We want to know what dressings to put on’? ‘What dressing for what type of wound’?

H11

. . . when you do training, they often come with this idea that you’re going to tell them what dressing to put on everything and they come with that expectation and when they leave without that information, they’re always desperately disappointed. So we’ve started almost saying, you will not leave today knowing what dressing to put on what wound for every patient because it isn’t about the dressing, it’s about the assessment of the patient and identifying what needs to be sorted out in order to enable healing and the dressing is like your last consideration in a way. It’s just the best plug for the hole.

H12

One interviewee felt that access to dressings was restricted and found this frustrating. She had previous experience at a trust that allowed direct access to a wider range of dressings. These dressings were thought to be effective based on her previous experience of using them:

. . . sometimes it can get quite frustrating when you’re putting on the same dressing all the time and you know that this is really not doing anything and something else would really benefit this patient, but we’re not allowed to access that because those specific dressings and resources are only for specific people in specific teams. I find that really frustrating because . . . I suppose you’ve got to look at cost and all the rest of it . . . [but] I’ve seen something work elsewhere . . . [they] had a cupboard full of all these fantastic dressings, not necessarily expensive but just really good and I saw that first hand that those worked. So I think coming here, it was hard . . . we only have three types of dressings . . . that’s really difficult when you know that these [other] dressings really work on patients . . . when I refer people on, I do make suggestions and say, look I know this works, perhaps try that.

H2

There was a sense from tissue viability nurses that patients shared the idea that there was a ‘magic dressing’ and that this was reinforced by dressing manufacturers and some health-care professionals:

. . . as my colleague . . . says, ‘you wear your glasses to create vision and you’re wearing your bandages to create your circulation’. If you take them off, your circulation will just go back to where it was because [patients] they’ll come to us and say, ‘oh is there not a cream I can put on it or a dressing’ and you’re like, nothing is going to fix it from the outside and it’s the same with pressure if you’re going to sit on your bottom all day, it’s going to be there. No plaster can fix that. There is not a wonder dressing out there that’s going to make that better.

H10

I mean I suppose they [patients] expect a solution and if they’ve got a wound, I suppose they expect some part of that solution is going to be whatever covers the hole. But I think the myth the patients [have] is just reinforced by staff . . . all the adverts that you see, you know, these beautiful bodies that have got dressings on, you know, that just got better magically . . . Nobody ever has the kind of bottom that I have to put dressings on [laugh]. Not on any advert that I’ve ever seen. So it’s just marketing isn’t it and it’s pedalled by industry that the dressing is the solution. Wound care solutions, you know, that’s often what the mantras are of the various companies. They provide wound care solutions.

H12

What most bothers patients (from the staff perspective)

When asked which aspects of having a chronic wound they thought most bothered their patients, the health professionals all identified pain, smell and exudate. Much of the pain and discomfort discussed was associated with compression bandaging and dressing changes. Most also identified restrictions in mobility caused by the wound and by their treatment interventions. Restricted mobility was associated with social isolation, a lack of independence and disengagement from society as a consequence of, for example, being unable to work, being advised to stay in bed or fear that the wound (signified by having to wear potentially leaky and smelly, bulky, pink or brown bandaging, not being able to wear ‘normal’ shoes or carrying a portable negative pressure wound therapy machine) might be negatively perceived by others.

Some health professionals identified patients as being most bothered by feeling fed up and frustrated with waiting for the wound to heal. One tissue viability nurse described some patients enduring ‘an endless rollercoaster of optimism and despair’ (H12). She attributed this to:

. . . new products . . . being prescribed and applied and then that not working and then another product being prescribed, recommended and applied and the optimism raises and then drops again . . . I think because we’re not able to say who won’t heal.

H12

In addition, some nurses identified restrictions on showering and bathing because of the need to keep dressings and bandages dry, the chore of having to ensure the correct dressing supplies were available in the house and occasional discomfort caused by wrongly applied dressings. A podiatrist identified the fear of losing a limb.

Some interviewees identified patients as being most bothered by feelings of intrusion from lots of appointments with different health professionals: ‘I would be very frustrated if I had a lot of different clinicians coming in with perhaps different levels of competency’ (H5). Some said that intrusion into the private space of the home or ‘living at the clinic’ (H1) could leave patients feeling that ‘their life is not their own’ (H1), although others said that they thought some patients particularly welcomed home visits. One community nurse thought that constant appointments could lead to patients ‘feeling old’ and as if they are ‘sponging off the system’ (H8).

Good outcomes from interventions

Health professionals described the personal satisfaction that they felt when patients were ‘pleased with the outcome’, ‘valued your intervention’ and have ‘had a positive outcome as a direct result of your intervention’ (H12). A speedy outcome was particularly welcome:

. . . anything within a reasonable time, if you can get some success and improve their comfort, then that’s what it’s all about really . . . improving people’s lives.

H6

. . . any patients whose wounds have healed are a success story. I mean the quicker the better!

H7

There was a particular sense of satisfaction if the professional’s own intervention was perceived as the one that made a direct difference, resulting in a positive outcome for a patient previously treated unsuccessfully for some time. Examples included:

• Getting leg ulcer patients into compression who had previously been treated only with dressings: ‘eventually [they] get referred and . . . you get them in[to] compression and then you heal them really quickly’ (H12).

• Choosing a key dressing or topical treatment: ‘They may have had lots of antibiotics but actually it wasn’t cellulitis it was wet eczema . . . prescribe some topical steroid and come back a week or 2 weeks later and you can clearly see that the patient is a completely different person and their leg is completely different and you go away and say, job well done’ (H4); ‘I packed it with iodine . . . I packed it from the inside and it just healed in no time’ (H2). The subsequent reoccurrence of this wound did not diminish a sense of achievement.

• Dexterity with dressings: ‘It was such a complicated dressing to get a seal on [negative pressure wound therapy to anus and perineum] . . . It was only me who could ever do it or that’s what they’ve told me!’ (H9).

• Getting patients with foot ulcers into the right footwear and offloading damaging pressure.

A sense of satisfaction at a good outcome also came from effectively liaising with other health-care services, ‘put[ting] all the things in place’ (H8) and getting agreement to progress a treatment plan. Some health professionals reported satisfaction from identifying the root cause of the problem and from increasing the mobility of patients who are not going to heal: ‘it was never going to heal but she did manage for quite a while and she managed to get out again’ (H9). A health professional who said that the people she saw heal were ‘few and far between’ regarded patients changing some aspects of their damaging lifestyle as a good outcome, for example:

We’ve got one guy . . . he’s been coming to us for about, 6, 7 years . . . and he’s had this chronic leg ulcer and it has actually got smaller and smaller and it’s almost healed and that’s largely because he’s changed his lifestyle. He’s stopped injecting and he’s eating healthier and actually he’s put on an immense amount of weight. He’s trying to reduce his smoking at the moment and he’s actually taken it a bit further, he’s getting quite involved and quite vocal in some of the groups that are going on . . . I consider him a success really if we can just get this last bit of wound healed then I would consider him a success.

H3

Concerns about negative outcomes from interventions

Table 40 summarises the range of concerns that staff raised about the potential negative outcomes for patients associated with particular wound care interventions used.

All of the health professionals dealing with people with leg ulcers recognised four-layer compression bandaging as the evidence-based gold standard treatment for achieving healing as an outcome in venous leg ulceration. However, compression bandaging was contraindicated in some cases because of arterial disease or the risk of deep-vein thrombosis, and many interviewees reported examples of patients not being tolerant of it because of discomfort or because they were not able to wear their shoes. This impacted on their mobility and desire to go out:

. . . unless you . . . prescribe special footwear then you’re actually perhaps consigning the person to be stuck in their own home . . . you wouldn’t necessarily need to be house bound if you didn’t have four-layer bandaging. I think some of the things that we do prescribe can really challenge somebody’s lifestyle and sense of independence.

H5

As noted previously, there was also concern about the quest for the ‘magic dressing’ and the potentially disruptive impact of ongoing interventions on patients in terms of being able to get on and live their lives. There was also a concern that the ‘emotional roller coaster . . . cycle of optimism and despair’ may have a negative impact on healing outcomes:

. . . and we don’t have any concept of what the impact of despair has on healing and kind of feeling that everything that everyone has tried is useless and that they’re in a hopeless situation. We haven’t really got an understanding of how that affects us metabolically, physiologically but I think that’s ultimately what we put our patients through a lot of the time.

H12

Identifying agreements and disagreements in survey results

The rankings from the prioritisation survey were integrated to provide a picture of the most highly rated kinds of questions that had been identified by all three groups. The shortlist for final deliberation was based on the most highly ranked questions raised and ranked by all three groups. There were 10 topics that were identified and agreed as being very important by all three groups.

1. Repositioning for prevention and healing.

   • How effective is repositioning in the prevention of pressure ulcers?

     • for those in bed – turning self, being turned and changing position (sleep disruption)

     • for wheelchair users repositioning self or being repositioned in chair

     • for people with contracted limbs.

Ranking health professionals 1; patients/service users 3, 4, 6 and 9; carers 2 and 16.

• Does regular turning of patients in bed promote healing of pressure ulcers? How often is it best to turn people? For people who require a carer to help them move what is the most effective means of repositioning? For people with limited memory as well as limited mobility would a ‘prompt of routine’ tool that reminds people to reposition themselves help to heal pressure ulcers?

Ranking health professionals 2; patients/service users 6; carers 10.5 and 18.

1. Support surfaces for prevention and healing.

   • What is the relative effectiveness of the different types of pressure-relieving beds, mattresses, overlays and cushions (including cushions for electric and self-propelling wheelchairs) in preventing pressure ulcers? Do they meet the needs of the full range of patients at risk?

     • compared with conventional and other specialist surfaces

     • for those who share a mattress with a partner, people with MS

     • for those with contracted limbs.

Ranking health professionals 6, 8 and 9; patients/service users 2, 8, 10 and 15; carers 1, 3 and 14.

• Do pressure-reliving support surfaces, particularly mattresses, help ulcers heal? Are they appropriate and effective for treating the frail and elderly and those with MS?

Ranking health professionals 5 and 8; patients/service users 7; carers 1 and 13.

1. Involvement for prevention.

   • How effective at preventing pressure ulcers is involving (informing/educating/motivating) patients/family/lay carers in patient care?

Ranking health professionals 2, 16 and 18; patients/service users 1, 5, 7 and 18; carers 6.5 and 8.

1. Eating and drinking (nutrition/hydration) for prevention and healing.

   • Does improving diet (nutrition) and hydration promote pressure ulcer healing?

Ranking health professionals 1; patients/service users 2; carers 5.

• Does improved diet (nutrition) and hydration promote the prevention of pressure ulcers?

  • for people with MS, spina bifida and spinal injury

  • including effectiveness of high-protein diet, micronutrients and effects of weight loss and gain.

Ranking health professionals 7; patients/service users 13 and 21; carers 4.

1. Staff training/education for prevention.

   • Does the education of health and social care staff on prevention lead to a reduction in the incidence of pressure ulcers? If so, which are the most effective education programmes (at organisational and health/social care level)?

Ranking health professionals 3; patients/service users 12; carers 6.5.

1. Service models and healing outcomes.

   • What are the best service models (and are they sufficiently accessible) to ensure that patients with pressure ulcers receive the best treatment outcomes, for example awareness of and access to tissue viability nurses, and do people with specialist conditions (e.g. spinal injury) receive the best pressure ulcer treatment at specialist centres rather than at generalist services?

Ranking health professionals 9; patients/service users 4; carers 3.

1. Surgery for healing.

   • How effective are surgical operations to close pressure ulcers? What is the most appropriate surgical referral for people with MS and ulcers that will not heal?

Ranking health professionals 14; patients/service users 1; carers 14 (note highest for patients).

1. Bed rest for healing.

   • For wheelchair users sitting on a pressure ulcer, how effective is bed rest in promoting pressure ulcer healing? Is it safe for those with MS who have been advised to keep moving? Is it detrimental to mental health? How does its effectiveness compare with sitting on a pressure-relieving cushion? Is sitting for a small time (e.g. to eat a meal) likely to substantially increase pressure ulcer healing time?

Ranking health professionals 3 and 12; patients/service users 13, 17 and 18; carers 19.

1. Debridement for healing.

   • Does (surgical and non-surgical) debridement promote healing in patients with pressure ulcers? What is the most effective debridement strategy?

Ranking health professionals 11; patients/service users 14; carers 2 and 10.5.

1. Dressings for healing.

   • How effective are wound dressings in the promotion of pressure ulcer healing, including honey dressings? What is the optimal number of times that dressings should be changed to promote pressure ulcer healing?

Ranking health professionals 10 and 13; patients/service users 11; carers 7 and 8.

The following three topics were raised by all three groups but were ranked lower:

1. Dressings and zero friction products for prevention.

   • How effective are dressings and zero-friction fabric products in preventing pressure ulcers?

Ranking health professionals 26; patients/service users 16; carers 16.

1. Heel protectors for prevention.

   • How effective are heel protectors in preventing pressure ulcers?

Ranking health professionals 15; patients/service users 20; carers 9.

1. Topical products and skincare regimes for prevention.

   • How effective are topical skincare products at preventing pressure ulcers, for example the application of barrier creams or sprays [Sudocrem^® (Allergan plc) and Cavilon^TM (3M)], methylated spirits and moisturisers? Does the use of skincare regimes diminish the likelihood of pressure ulcer occurrence, for example, for patients confined to bed, does treating with washing, surgical spirit and/or talcum powder at all pressure areas prevent the occurrence of pressure ulcers?

Ranking health professionals 24; patients/service users 25, 26 and 27; carers 12 and 17.

Nine topics were raised by just two groups and were lower ranked:

1. Exercise for prevention.

   • For people with limited mobility, does exercise coaching help in the prevention of pressure ulcers? Do community physiotherapy interventions change the incidence of pressure ulcers?

Ranking patients/service users 14; carers 10 and 15.

1. Risk assessment scale/tool.

   • Is using a pressure ulcer risk rating scale/tool better than clinical judgement in preventing pressure ulcers and is there a best scale?

Ranking health professionals 23; patients/service users 19.

1. Service models for prevention.

   • What impact do different service models have on the incidence of pressure ulcers? For people with MS or spinal injury, is working with specialist clinicians more effective for prevention than working with generalists? Does access to a specialist wound prevention service improve pressure ulcer prevention?

Ranking health professionals 15 and 22; patients/service users 11.

1. Incontinence products for prevention.

   • How effective are incontinence devices in the prevention of pressure ulcers? Do cheap incontinence pads cause more irritation than expensive pads?

Ranking health professionals 19.5; carers 13.

1. Involvement and healing outcomes.

   • Does getting people with pressure ulcers and their carers more involved in their own pressure ulcer management improve ulcer healing? If so, what are the most effective models of engagement, for example what is the most effective way for family carers to be involved to help ulcer healing and how effective is education for lay carers in promoting pressure ulcer healing including understanding and concordance to recommendations (like turning regimes, diet, fluids)?

Ranking health professionals 6 and 7; carers 6 (note patients raise this in terms of prevention not treatment).

1. Continuity of care and healing outcomes.

   • How does continuity of care impact on treatment of pressure ulcers?

Ranking patients/service users 8; carers 4.

1. Pain relief.

   • For people with pressure ulcers (including people with MS), which analgesics are effective and safe for the treatment of pressure ulcer-related pain?

Ranking patients/service users 3; carers 15.

1. Topical agents for healing.

   • What is the value of topical agents in promoting pressure ulcer healing (including honey-based treatments and the application of sugar)?

Ranking patients/service users 15 and 19; carers 16.

1. Negative pressure wound therapy for healing.

   • How effective is negative pressure wound therapy as a treatment for pressure ulcers?

Ranking patients/service users 16; carers 20.

These topics indicated shared levels of agreement between stakeholders. In addition, there were a number of uncertainties that had been identified and ranked by one group only.

In a voting sheet exercise (see Appendix 5) conducted at events on Worldwide STOP Pressure Ulcer Day, 60 stakeholders ranked the three most important prevention and three most important treatment uncertainties that had been submitted by one stakeholder group only. The events attracted more health professionals than patients or carers, with 50 votes cast by health professionals, six by patients and four by carers.

The most highly ranked uncertainties raised by one group but agreed by all three groups were:

• Do staffing levels have an impact on the incidence of pressure ulcers (originally raised by health professionals and ranked joint 4th)?

• Is staff training effective in improving pressure ulcer healing (originally raised by patients and ranked 5th)?

• What is the most effective way of keeping clean (personal hygiene) to aid pressure ulcer healing (originally raised by patients and ranked 9th)?

• For people in hospital at risk of developing pressure ulcers, is the current organisation of nursing care effective as best practice in the prevention of pressure ulcers (originally raised by patients and ranked 24th)?

• How effective are pressure ulcer grading systems in determining the amount of skin damage and does the use of such scales improve ulcer healing (originally raised by health professionals and ranked joint 4th)?

There was no clear agreement across groups on the following uncertainty but it gained a high number of votes:

• How does continuity of care impact on the prevention of pressure ulcers (originally raised by carers and ranked 5th)?

Eight members of PURSUN UK took part in a workshop at Leeds Centre for Independent Living to hear about the process so far, identify any gaps and rank the three most important prevention and three most important treatment uncertainties that had been submitted by only one stakeholder group. The most highly ranked treatment uncertainties were:

• How effective are pressure ulcer grading systems in determining the amount of skin damage and does the use of such scales improve ulcer healing (originally raised by health professionals and ranked joint 4th)?

• Is staff training effective in improving pressure ulcer healing (originally raised by patients and ranked 5th)?

• What is the most effective way of keeping clean (personal hygiene) to aid pressure ulcer healing (originally raised by patients and ranked 9th)?

These had also been selected in the voting exercise above. Participants also ranked the following prevention uncertainties highly but did not agree on a whole group set of priorities:

• How effective in preventing pressure ulcers is having a wound care champion (particular staff, managers or personal carers responsible for the prevention of pressure ulcers) (originally raised by health professionals and ranked 17th)?

• For wheelchair users at risk of developing pressure ulcers, what is the most effective method of pressure mapping to assess pressure areas at risk to prevent the development of pressure ulcers (originally raised by patients and ranked 17th)?

• For people in hospital at risk of developing pressure ulcers, is the current organisation of nursing care effective as best practice in the prevention of pressure ulcers (originally raised by patients and ranked 24th)?

• Do staffing levels have an impact on the incidence of pressure ulcers (originally raised by health professionals and ranked joint 4th)?

• How does continuity of care impact on the prevention of pressure ulcers (originally raised by carers and ranked 5th)?

Two uncertainties were identified by PURSUN UK that were different from those in the first exercise and the results were fed into the shortlisting process.

Home and bedside interviews

Although there had been success in engaging, as primary participants, specific patient/service user groups (including wheelchair users, those at home, living independently or supported by family or carers, and people aged 40–64 years), there had been less success in engaging with older people and those living in care settings. We knew from the Leeds prevalence survey (see Chapter 2) that older people and particularly those in nursing homes were under-represented in the prioritisation process. To address this, efforts were made to interview people at risk of pressure ulcers in care homes and a rehabilitation centre. Permission was granted to access three sites and two site visits were made. The rehabilitation centre could not identify anyone at risk who was able to participate. We also found that the formal consent processes required by the conditions of ethics approval were off-putting to residents of care homes, who were willing to speak informally. Although the steering group agreed that this work was important because of the effective disempowerment of people in care settings, the complexity of the task required more resources than available and the group felt that this was something that should be addressed in future research. Health-care professionals and carers had also taken part in the survey, generating uncertainties about all patient groups, and it was hoped that this would, at least to some extent, make up for these missing voices.

Final priority-setting meeting

The pre-workshop questionnaire can be found in Appendix 6. The voting scores from each round are available on request.

Consultation with participants at the launch event

The launch event for this programme grant took place during September 2009 and consisted of presentations, dedicated stands for each workstream, refreshments and opportunities for informal networking. The stand for workstream 3 included demonstration of, and access to, The Cochrane Library where delegates could attempt searches on research questions of interest to them if they wished. This helped to stimulate informal discussion about what could be important topics for evidence synthesis and provided a valuable opportunity to discuss possible uncertainties relating to practice. Delegates were invited to leave their contact details indicating an interest in contributing to workstream 3 in terms of further follow up, discussion and consultation. During the launch day presentations, delegates were invited to put forward topic ideas for evidence synthesis; some ideas came to light in the discussion period immediately following the presentations, whereas others filtered through to the programme grant team after the launch day, either directly (e.g. by e-mail or via the website) or via the clinical teams.

Consultation with community clinical teams

During January 2010, SO’M attended two routine meetings of community clinical teams in Leeds: podiatry and nursing (consisting of members of the tissue viability nursing team, community nurses and intermediate care nurses). In both instances, clinicians had been provided with details of the consultation exercise in advance and had been asked to reflect on possible topic ideas and uncertainties for evidence synthesis prior to the meetings. During both meetings, SO’M explained the purpose of the consultation exercise, emphasising the importance of having a list of ideas that had originated from health practitioners rather than from researchers. She then explained that, in particular, questions and uncertainties relating to treatment effectiveness were sought, but that any type of research question could be considered in the wider context of the programme grant and future research agenda. She made a brief presentation in which the following were explained: the purpose of the programme grant; the collaboration between Leeds NHS and the University of York; the focus on complex wounds; and a brief overview of the three workstreams. Finally, a structure for research question formulation was presented, based on the key domains of PICO. 174 Participants were invited to use this if they wished, to help structure research ideas. Relevant examples were provided (Tables 51 and 52) and hard copies of similar information were tabled, having already been circulated prior to the meeting. There then followed a period of discussion during which participants raised and discussed ideas; all were noted for later collation and assessment against existing literature. A follow-up e-mail was sent to group members during February 2010 to capture ideas emerging later and to target those who had been unable to attend the team meetings. In addition, the leaders of each clinical team forwarded any other ideas expressed to them by team members individually that had not already been captured.

Enquiries sent via the programme grant website

During February 2010, follow up e-mails were sent to delegates who had indicated an interest in workstream 3 during the launch event and also to members of the two clinical teams to invite submission of later ideas. Web pages were set up to enable submission of ideas online and information about PICO was posted on the website to assist with question formulation and focusing of uncertainties.