Objectives To examine care home resident and staff perceptions of the acceptability of participating in a feasibility trial evaluating nutritional interventions in the treatment of malnutrition.
Design Exploratory qualitative methodology was used to gather descriptions of resident and staff perceptions of trial procedures, using semi-structured interviews with residents and focus groups with staff. The interviews were used to explore individual perceptions of the acceptability of the assigned intervention and the outcomes measured. Focus groups were used to explore staff experiences of trial participation and perspectives of nutritional support interventions.
Setting The study was embedded within a cluster randomised feasibility trial, which randomised six care homes to provide standard care (SC), food-based (FB) intervention or oral nutritional supplement (ONS) intervention to residents with, or at risk of, malnutrition.
Participants Residents in the trial with capacity to consent (n=7) formed the sampling frame for inclusion. Four agreed to be approached by the researcher and to take part in the individual interviews. All were women, representing two arms of the trial (ONS and SC). Twelve staff participated in six focus groups, one at each care home. All participants were women, representing all three arms of the trial.
Results Major themes that emerged from both interviews and focus groups included the perceived acceptability of trial involvement, the value of residents completing participant-reported outcome measures and the challenges associated with outcomes measurement in this setting. Themes that emerged from the focus groups alone, included the importance of individualising an intervention, and the perceived value of FB and ONS interventions and dietetic input.
Conclusions Residents and staff perceived involvement in a trial evaluating nutritional interventions to be acceptable, although the challenges associated with research in this setting were acknowledged. Resident preferences were highlighted by staff as an important consideration when implementing a nutrition support plan.
Trial registration number ISRCTN38047922
- care homes
- older adults
- geriatric medicine
- focus groups
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Strengths and limitations of this study
This is the first study to inform understanding of the feasibility and acceptability of conducting a clinical trial evaluating nutritional interventions in the care home setting from the perspectives of staff and residents.
Use of individual interviews gave each resident the chance to freely voice their views.
The dynamic interaction of the staff focus groups were perceived by the researcher as open and positive, and provided insight into shared viewpoints within and between care home sites.
The study was limited by small sample size, particularly with regard the number of residents interviewed, but a staff focus group was conducted at each care home site, providing representativeness from each arm of the trial, and capturing the views of both nursing and care staff.
Exploration of staff experiences of feasibility and acceptability was carried out in engaged and motivated care homes, which may limit transferability to the national care home population.
Care home residents in the UK are a distinct group of approximately 416 000 people (including 16% of those aged over 85 years)1 with different mortality,2 health status and health and care needs3compared with individuals of the same age residing in their own homes. Research outcomes established for older adults living within their own homes cannot be considered valid for care home residents and cannot therefore be used to guide best practice.4
The public health and social care expenditure associated with malnutrition in England from 2011 to 2012 was estimated at £19.6 billion; 15% of the total expenditure on health and social care.5 Approximately 30%–42% of care home residents are estimated to be at risk of malnutrition6–8 placing them at increased risk of infection and pressure ulcers, clinical complications and depression and reducing their overall quality of life.9 10 There is a need therefore to improve the evidence-based nutritional care provided to this population. However, research in care homes presents challenges, and consequently many studies exclude care home residents on the basis that their inclusion would present the team with ethical and practical dilemmas.11 Recruitment difficulties due to physical and cognitive impairments12 have been highlighted as a particular challenge, along with the consent process,12 13 responding to family and carer concerns12 and high attrition.12 14 Additional issues for the researcher can include data collection within a busy care home schedule and difficulties for staff in adhering to assigned interventions and methodological protocols.12 These challenges have led to nutrition intervention trials often excluding those at highest risk of malnutrition, including residents with advanced dementia and immobility.15–18
Existing studies of nutrition interventions for malnutrition within this setting have also tended to use a quantitative approach, which while useful for determining quantitative outcomes such as nutrient intake and weight change, have provided limited information on resident and staff perspectives of nutritional care and the reasons why the care home environment poses challenges for the researcher. During the last 20 years, researchers have identified the need for employing a range of methodologies to enhance understanding of healthcare complexities and to ensure that disempowered groups are heard.19 Exploring feasibility outcomes with trial participants is a way to ensure that resident and staff perspectives can be used to inform the design and conduct for future definitive trials in this complex research setting.
The aim of this study therefore, was to seek an in-depth understanding of the experience of participating in a cluster randomised feasibility trial, which evaluated nutritional interventions in the treatment of malnutrition.8 The study had two objectives:
To examine perceptions of the acceptability of trial procedures (including the intervention protocol, outcome measures and data collection methods) with care home staff and residents.
To examine care home staff perspectives of nutritional interventions and dietetic care in the treatment of malnutrition.
Design and setting
This study used a pragmatic, exploratory approach to qualitative research, embedded within a cluster randomised feasibility trial (ISRCTN38047922)8 to understand the experience of participating in a trial investigating nutritional interventions in the treatment of malnutrition. The study used semi-structured interviews with residents and focus groups with staff, which were consistent with the exploratory aim of the study.20 Topic guides (table 1) were used to ensure that core questions were asked, while allowing for flexibility to follow-up on novel information.21 Due to the paucity of previous work in this area, a specific theoretical framework was not adopted. The study is reported in line with the Consolidated Criteria for Reporting Qualitative Research.22
The feasibility trial was conducted within the West Midlands, in England, where 17 care homes providing accommodation for older adults (over 65 years) were receiving regular dietetic input. This was being provided by the community nutrition support dietetic service where the lead researcher (female) (RS) was working as a dietitian at the time of the study. Purposive sampling was used to select and invite six, privately owned care homes with a diverse sample based on type of care provided (residential or nursing/nursing and residential) to take part in the trial. All care home sites were made aware that the trial was being conducted as part of a student MRes project by the lead researcher (RS). The care home sites were cluster randomised to provide standard care (SC) (n=2), food-based (FB) intervention (n=2) or oral nutritional supplement (ONS) intervention (n=2) for 6 months to residents identified with, or at risk of malnutrition. Outcomes were trial feasibility and the acceptability of the design, the nutritional interventions and the outcomes being assessed at 3 and 6 months. These included anthropometry, dietary intake, healthcare resource usage and participant-reported outcome measures (PROMs).
The Research Ethics Committee felt that the inclusion of residents lacking capacity in the collection of PROMs and in the qualitative study could not be justified in accordance with the Mental Capacity Act.23 Within the care home setting, capacity is assessed by trained care home staff or the general practitioner. Written consent for PROMS data collection and for the qualitative study was sought on an individual basis from eligible residents that had been assessed as having capacity. Residents were provided with a full explanation of their required participation alongside a Participant Information Sheet. They were given 1 week to ask questions and decide whether they would like to provide information on quality of life, health state and dietary satisfaction. Each resident was asked to sign a consent form for PROMs and to indicate whether they would like to be considered for the individual interviews in the qualitative study.
Sampling and recruitment
Those residents with capacity to consent who had indicated on the trial consent form that they would like to be considered for individual interviews and had completed the 6-month trial intervention (n=7), formed the sampling frame for potential inclusion. The care home staff made the initial approach to the seven potential participants to discuss their involvement. Those that remained interested in participation (n=4) were introduced to the dietitian researcher (RS) to provide further verbal information and a written information sheet and consent form. The three residents that declined to take part did not give specific reasons to the care home staff.
A focus group of staff (two to three) took place within each of the care home sites that had participated in the trial. Care home staff were selected on the basis that they had participated in the trial24 and were provided with information sheets and consent forms. Six focus groups, covering all three arms of the trial were conducted.
The dietitian researcher (RS) conducted individual semi-structured interviews lasting 30–60 min with care home residents to enable exploration of reality from narratives related to their own experiences of trial participation.25 The interviews were organised around topic guides (table 1), developed using the trial feasibility objectives and discussions with care home staff. The basic research question explored was the experience and acceptability of participation in the trial. Themes and core questions were refined following the 6-month dietary intervention and the collection of PROMs.
Interviews allowed for greater exploration of individual perceptions of the acceptability of the assigned intervention and understanding and perception of the anthropometric assessments and the PROMs questionnaires than would have been possible with the use of focus groups.26–28 RS is an experienced nutrition support dietitian with an interest in malnutrition in the older adult population, and who had worked for several years with the care home population. This relevant background allowed for the effective exploration of individual dietary satisfaction while on the allocated nutritional intervention plan. Use of the interview technique enabled residents to ask for questions to be further explained, which allowed for the identification of any problems with comprehension and for questions to be rephrased as appropriate. This was felt to be important with the care home population and may have been less feasible within a group setting.29 RS was responsible for audio taping the interviews, and transcribing the audio recordings verbatim.
The dietitian researcher (RS) led and audio-taped focus group discussions lasting 45–60 min in each of the six care homes with between two and three care home staff in each. The topic guide (table 1) was developed using the feasibility objectives from the trial alongside discussions with care home staff and was later refined following delivery of the 6-month nutritional intervention and collection of outcomes data. Focus groups were used to enable the views of more people to be included,25 to highlight any variations in perspectives between the staff within each home and between care home types30 and to collect information from those staff that were reluctant to be interviewed on their own or who felt they had less to contribute.31 32 As the staff within a care home work closely together, holding a focus group within each individual home was found to stimulate engagement and discussion31 33 and it was possible to explore knowledge, experiences and perceptions of participating in a trial, with a focus on the assigned intervention and protocol for delivery, the data collection process, the data collection tools and the outcomes from the trial. With a strong background in nutrition support within the care home setting and a working relationship with the care home staff as a dietetic practitioner, RS was able to appreciate the significance of the aspects discussed and to effectively follow-up on the relevant points.34 RS was responsible for transcribing the focus group audio recordings verbatim.
Nutritional interventions and outcome measures
All six care homes had received training and support to provide a standard care intervention to residents with or at risk of malnutrition. The food-based intervention choices and recipes were based on local nutrition support guidelines, national guidance and best practice resources35 36 and were intended to increase the participating resident’s daily nutritional intake by approximately 600 kcal and 20–25 g of protein. The ONS intervention consisted of two daily liquid ONS containing 600 kcal and 24 g protein.
The outcomes measured or collected in the trial by the care home staff included height, weight, body mass index, healthcare resource usage, compliance with the assigned intervention and completion of the standardised mini-mental state examination. PROMs data were collected from those residents that had capacity and had consented to completing quality of life and health state questionnaires and a visual analogue scale related to dietary satisfaction.
Patient and public involvement
The care home residents involved in this study were not involved in the development of the research question, the outcome measures or the study design. However, the focus of the study and the development of the topic guides was informed via care home staff discussions and the insight of a carer, who supported the trial steering groups. Participants were recruited through the care homes that participated in the trial as described above. There are no plans to disseminate the qualitative study results to participants directly; however, results will be published in open-access peer-reviewed publications.
Interview and focus group discussions continued until no new emerging ideas were being obtained and it was felt that thematic data saturation had been reached with the study participants.37 The qualitative data were analysed using the framework analyses by Krueger38 and Ritchie and Spencer.39 ,39 The process of data analysis began during data collection, through the effective facilitation and audiotaping of the interview and focus group discussions. As RS undertook all of the interviews and focus groups, this reduced the time taken to become fully familiar with the data.23 RS transcribed the audiotapes and then cross-referenced the transcripts against the recordings for accuracy and to identify the major themes. Concepts, ideas and short phrases were identified within the text and were used to develop thematic frameworks. The initial frameworks and themes were informed by the study objectives and the structure of the topic guides and were developed through deductive analyses and the identification of subthemes. These were then refined, combined and developed by annotating the themes from the draft frameworks on the transcripts, further immersing RS in the data, and enabling the themes and subthemes to be adjusted and made clearer.23 40
Once the frameworks had been refined, the data were indexed using a process of sorting, highlighting and arranging quotations (using CH1 to CH6 to indicate the care home source and R1 to R4 to indicate the source of the resident interview quotations). At this stage, RS consulted with AR in a process of peer debriefing, to determine whether the themes and subthemes were appropriately clear and comprehensive and to agree the final frameworks.41 The last stage of analysis involved mapping and interpreting the data, enabling comparison of themes and subthemes and cross-checking against the original transcripts and audio recordings to ensure appropriate context and enhancing rigour.42 No further changes were made to the themes or subthemes at this stage.
Data collected from the staff focus groups and resident interviews for objective 1 were considered alongside each other, to identify perceptions about trial acceptability that were common to both sets of participants.
Twelve staff participants took part in six focus groups, one at each of the care home sites. All participants were women and all three arms of the trial were represented. The participants were all involved with the trial for the full 6-month intervention. The main reason for care home staff that had participated in the trial being unable to attend the focus groups was the busy care home schedule and staff shift patterns.
Four resident participants took part in the individual interviews. All participants were women and two arms of the trial were represented; the ONS arm and the SC arm. None of the residents approached by the dietitian researcher (RS) refused to participate in the interviews, or dropped out.
Care home staff and residents' perceptions of the acceptability of trial procedures
The themes and subthemes identified from the care home staff focus group data and resident interview data are shown in table 2, along with supporting quotations. Major themes that emerged from the data included: the perceived acceptability of being involved in the trial, the value of residents completing PROMs questionnaires and voicing their opinion and the challenge of undertaking physical measurements and delivering an intervention protocol with some groups of residents.
Eight staff participants commented that involvement in the trial did not pose an additional workload, although some participants stressed the importance of ensuring that all staff in the home were aware of the trial and what was required of them. The four resident participants did not consider taking part in the PROMs data collection to be a ‘burden’ with two of them commenting that it did not take up too much of their time. Six staff participants indicated that they believed more of the residents could have completed the PROMs questionnaires within the trial, with one specifically making a positive reference to the COOP quality of life tool. Three staff participants and all four resident participants commented on the usefulness of residents voicing their opinion through completion of these types of questionnaires.
Eight staff participants commented on the challenge of undertaking physical measurements such as anthropometry, with care home residents and four commented on the challenges associated with delivering a nutritional intervention in this setting. Particular reference was made to the challenges posed by the fluctuating mood and capacity of many of the residents. The four resident participants commented on the acceptability of the physical measurements and the nutritional interventions, although it must be noted that these four residents all had capacity. One resident mentioned that mood might determine the acceptability of the measurements.
Care home staff perspectives of nutritional interventions and dietetic care in the treatment of malnutrition
The themes and subthemes identified from the care home staff focus group data are shown in table 3, along with supporting quotations. Major themes that emerged from the data included the importance of considering resident preference and the potential for personalised plans, the perceived value of FB and ONS interventions by staff and families and the perceived value of dietetic input.
Seven staff participants commented on how resident preference influenced adherence to the intervention schedule, with two participants making reference to the importance of flexible and personalised approaches. Eight staff participants commented on the value of FB and ONS interventions, making reference to improvements in well-being, weight and behaviour. Two of the participants also mentioned that the families of some of the residents viewed the FB and ONS interventions positively and would have liked them to continue beyond trial completion. Four of the staff participants made reference to the value and usefulness of dietetic visits to the care home with one participant commenting that residents would do better with dietetic intervention.
Care home staff and residents' perceptions of the acceptability of trial procedures
This is the first study that has examined the perceptions of the acceptability of trial procedures in the care home setting with staff and residents, a topic which has not previously been explored within the literature. Consideration of the data gathered from the focus groups and semi-structured interviews for objective 1 highlighted some common themes for both those that reside in and those that work in the care homes. Both the staff and residents felt their involvement in the trial to be acceptable. It was not viewed as creating additional work for the staff, and the residents perceived it to take up little of their time. The use of PROMs to assess self-perceived quality of life and health state and as a means of enabling residents to voice their opinion of the food and nutritional interventions was viewed as positive and of value to the trial, with the tools and questionnaires perceived as acceptable for residents to complete. Both groups of participants felt that more of the residents that took part in the trial could have completed the PROMs. The restrictions imposed by the approving Research Ethics Committee (REC) meant that those residents lacking capacity were excluded from the collection of these data on the basis that their involvement would not benefit other people with the same or similar impairing condition.8 36 The perceived acceptability of the tools by staff and residents in this study supports the future assessment of feasibility and acceptability with a more representative care home population, giving scope to investigate the relationship between nutrition support and PROMs and to further explore resident experience of mealtimes and interventions, both areas that have been highlighted within the literature as requiring further research within this setting.43 44
Staff noted the value in finding out what the residents think through the use of PROMs, with one stating that ‘sometimes this generation like to agree with everything’. Care home residents have been described previously within the literature as ‘silent recipients of care’,45 tending not to highlight concerns or make clear their preferences, either due to cognitive impairment or because of the cultural norms of their generation.46 The use of tools and questionnaires within the care home setting may provide residents with a non-verbal means of expressing their opinions of care and may assist in the effective delivery of person-centred health and social care, as advocated by the Care Quality Commission.47
The tendency ‘to agree’ may also explain the ‘directness’ of the quotes obtained from the resident participants during interviews, even following probing for expansion on particular points. It is possible that the residents may have been reticent to raise concerns or negative points about their involvement in the trial, perhaps introducing an element of response bias and limiting the depth of understanding of resident experiences that could be achieved in this study.
Despite the perceived acceptability of involvement in the trial, the care home staff highlighted the challenges associated with taking physical measurements with residents and delivering a nutritional intervention protocol in this setting. These barriers included fluctuating mood and capacity of some residents, as well as reference to the high proportion of residents with a primary diagnosis of dementia (75%).8 Other trials conducted in populations with fluctuating capacity have noted similar challenges when taking measurements such as tricep skinfold thickness48 and handgrip strength.43 49While the residents interviewed felt that the physical measurements were acceptable and not deemed to be time consuming, one resident mentioned that daily mood and individual preferences can sometimes result in a lack of acceptance with an assessment schedule or an intervention.
A theme that emerged only from staff focus groups was the interest in care home staff receiving training to enable them to take anthropometric and functionality measures including mid-upper arm circumference, tricep skinfold thickness and handgrip strength. Some felt that this might have been useful within the trial, as a means of enabling measurements to be taken when residents were in a better mood, or having a good day. Others felt that it would be helpful for staff to be upskilled in this way outside of the trial setting, to support in their assessment of nutritional status. The emergence of this theme may be related to the perceived value placed on nutritional screening (‘MUST’) training by the staff, and their subsequent self-perceived confidence and competence in completing resident screening as part of usual care. Improvements in ‘MUST’ documentation and accuracy following dietetic-led projects are supported within the literature.50 51 The interest from staff to expand their skill base could provide scope to introduce more comprehensive staff-led assessments of nutritional status within the care home setting. There are however, challenges associated with taking these measurements, including measurement error due to poor technique and substantial differences when measurements are made on the same individual by different observers.52 If such an approach were to be implemented in practice, it would require a standardised protocol and regular training updates.
Care home staff perspectives of nutritional interventions and dietetic care in the treatment of malnutrition
A major theme which emerged from the focus group data was the perceived value placed by staff on the nutritional interventions, both FB and ONS, when compared with the standard nutritional care provided by the homes. A common perception among the staff was that they would expect the introduction of either intervention to be associated with improved outcomes, particularly weight. They also noted that the families of residents involved in the trial viewed the interventions as valuable and wished the residents to continue beyond the assigned protocol. Good staff knowledge of the nutritional interventions available to address malnutrition, and a positive attitude towards these interventions has been shown previously in the literature,53 54 demonstrating that this is perhaps an aspect of nutritional care that is familiar to care home staff and is therefore perceived to be of value.
Another theme which emerged from the focus groups was the perceived value of dietetic input, with some staff expressing the opinion that residents requiring nutrition support ‘would do better with dietetic intervention’ and others mentioning that it was of benefit to have the dietitian visit the home more often. Previous research focusing on the knowledge of care home staff has highlighted the greatest knowledge deficits to be associated with nutrient and food requirements in older adults,53 55 which perhaps explains the value placed on dietetic expertise by care home staff in this study. As the nutritional interventions used in this trial were delivered by the dietitian, an interesting area for future research, might be to explore the care home staff perceptions of the nutritional interventions (FB or ONS) when delivered without dietetic input.
A prominent subtheme that emerged in relation to the nutritional interventions was the importance placed by staff on resident preferences and the scope to provide a personalised plan. This subtheme illustrates a commonality with the feedback provided by residents when discussing the acceptability of the interventions, with some expressing a preference for certain types of oral nutritional supplements and others stating that they would have preferred a homemade drink. The importance of involving residents in decisions about their care, including nutrition and mealtimes has been highlighted by the British Geriatrics Society56 and has been shown to be positively associated with quality of life.57 A recent study by Watkins et al,58 which used semi-structured interviews to explore resident’s experiences of mealtimes concluded that freedom of choice is a key component of their experiences of care. While it may not always be possible for residents to make decisions on all aspects of their care, it is apparent from this study that resident preferences should be considered alongside clinical reasoning when implementing a nutrition support plan. The individualisation of an intervention to suit a client’s needs is a core component of the shared decision making underpinning dietetic practice as outlined within the British Dietetic Association’s ‘Model and Process for Nutrition and Dietetic Practice’.59 This study highlights the importance of this approach within the care home setting.
Strengths and limitations
A key strength of this study is that it is the first to inform understanding of the feasibility and acceptability of conducting a clinical trial evaluating nutritional interventions in the care home setting, by exploring the opinions and perspectives of the staff and the residents involved in the trial. The inclusion of care home residents, highlighted as an under-represented group within the research literature12 has added to our understanding of their experiences of being involved with research and of nutritional care within this setting. Use of individual interviews gave each resident the chance to freely voice their views. The dynamic interaction of the staff focus groups were perceived by the researcher as open and positive, and provided insight into shared viewpoints within and between care home sites.
A limitation of this study is the small sample size, particularly with regard the number of residents interviewed. The views held by this small sample of residents, who were all female and had capacity, may not be representative of the other residents that took part in the trial and may limit the depth of understanding of resident experiences that can be gained from this study. There was a lack of representation from residents in the FB intervention arm, but a staff focus group was conducted at each care home site, therefore providing representativeness from staff in each arm of the trial, and capturing the views of both nursing and care staff. The directness of quotes obtained from the resident participants has already been commented on, but this was also found to be a feature of the staff focus groups, despite the perceived positive engagement of the participants. The lack of extensive discussion may have been a consequence of the focus groups being held at the care home sites, necessitating the balance of research activities alongside extremely busy care roles.60 The experience of trial involvement also appeared to have been largely acceptable to the care home staff. It is possible that they may have had more to say had they been dissatisfied with the experience or felt that it had increased their workload.
It is possible that the care homes recruited into this study do not necessarily represent the national care home population. All sites had been in receipt of long-term and regular input from the local dietetic service and were engaged in a programme of staff training. The dietitian researcher (RS) had an established relationship with the managers and staff at the homes, which may have made it easier to recruit to and facilitate the staff focus groups. This relationship may also have influenced the participants in giving what would be perceived as more desirable responses. However, with the focus on the exploration of feasibility outcomes to ensure that resident and staff perspectives can be used to inform the design and conduct of future definitive trials, there was not felt to be a desired outcome of this study and the participants were encouraged to say how they really felt.
The exploration of staff experiences of feasibility and acceptability was carried out in engaged and motivated care homes, which may limit transferability. However, the focus groups and interviews have informed our understanding of the experiences of trial involvement and the perceived acceptability and value of nutritional interventions from the perspectives of both care home staff and residents.
From staff focus groups and interviews with residents, involvement in a clinical trial evaluating nutritional interventions for malnutrition in the care home setting was perceived as acceptable, although the challenges associated with research in this setting were acknowledged. Both staff and residents agreed that the use of PROMs within the trial was positive and valuable and that more residents could have completed them. Care home staff demonstrated a positive attitude towards both the nutritional interventions used in the trial, and the value added by dietetic input. Resident preferences were identified as important, because they are likely to affect compliance with an intervention. To ensure that these are accounted for, it is suggested that a nutrition support plan be developed collaboratively between the dietitian and the staff, the resident and their relatives, to meet both the clinical needs and the preferences of the individual.
The authors would like to thank the participants in the study for sharing their experiences and views. The authors would also like to thank Susan Boex, a carer, who supported the trial steering groups that provided an overview of the trial and the embedded qualitative study.
Contributors RES designed the study, performed the interviews and focus groups and drafted the article. RES analysed the data following peer debriefing and agreement of the final themes with ABR. ABR and CHS have made substantial contributions to the conception, design and data interpretation of the study. All authors have read and approved the final manuscript.
Funding This study was undertaken as a student project (RS was the MRes student), as part of the National Institute for Health Research (NIHR) Clinical Academic Training Programme for AHP’s (Masters in Research). The study was self-funded and involved no research costs for the NHS trust sponsoring the research (The Heart of England NHS Foundation Trust).
Competing interests None declared.
Patient consent Not required.
Ethics approval The trial was approved by the West Midlands NHS Local Research Ethics Committee (Ref: 13/WM/0390) and the Research and Development Department of the Heart of England NHS Foundation Trust prior to commencement.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No further unpublished data are available.