Experience-based Modifications of the Bed Band ReAlised through Co-dEsign (EMBRACE)

Abstract

Background

Upper body limitations are a common disability in neurological conditions including stroke and multiple sclerosis. Care of patients with upper body limitations while in bed involves positioning techniques to maximise comfort and independence. The Bed Band is a nurse-led innovation to support people with limited mobility to maintain a comfortable position in bed, thereby promoting comfort and independence with activities of daily living.

Aim

To co-design and implement adaptations to the Bed Band prototype with recommendations for user instructions towards enhanced product design and future development.

Methods

A co-design approach involving collaboration between academic and industry partners. Expert stakeholders provided feedback on the Bed Band via an online focus group before healthy volunteers tested the product in a healthcare simulation suite. Data were thematically analysed and findings sense checked by expert stakeholders who then prioritised adaptations to the Bed Band using a modified Delphi technique.

Results

Three themes resulted from the analysis: (1) reaction to the Bed Band; (2) potential risks and mitigation; and (3) product adaptations. Simplicity was a strength of the innovation which easily enabled positional support. Adaptations to the Bed Band informed the development of an enhanced prototype for testing in future studies.

Conclusion

Co-design of the Bed Band prototype involving experts and healthy volunteers enabled early identification of potential risks with recommendations to mitigate them and priority adaptations. Further studies are required in hospital patients and community populations with upper mobility issues to determine the efficacy of the Bed Band and optimal duration of use.

WHAT IS ALREADY KNOWN ON THIS TOPIC.

• Conventional approaches to therapeutic positioning of patients while in bed include the simple use of pillows, which slip, or complex multicomponent support systems which are often inaccessible in many health and social care settings.

WHAT THIS STUDY ADDS

• The Bed Band is a simple innovation for positional support in healthy volunteers which has the potential for future use to support and engage patients in activities of daily living while in bed. Adaptations to the Bed Band resulted in a revised prototype for positional support with recommendations for a person-centred approach to risk assessment and use.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

• The Bed Band will require future trials to determine its patient acceptability, safety and effectiveness.

Introduction

The Scottish Health Survey highlights that 32% of adults in Scotland are living with a disability.¹ Disability refers to a wide range of physical or mental health conditions that impair a person’s ability to carry out activities of daily living (ADL). Mobility issues are common among individuals with disabilities, affecting 47% of this population.² Upper body limitations are a common disability in neurological conditions such as stroke and multiple sclerosis and can reduce an individual’s ability to fulfil social roles and perform self-care tasks, leading to a loss of independence and autonomy.³

People with upper body limitations often need support to attain a comfortable position in bed to enable maximum independence. Conventional approaches for therapeutic positioning support (eg, pillows) often place limited emphasis on patient alignment⁴ and pillow slippage prevents maintenance of comfort. Postural care using support systems involves personalised programmes to address body position, including adaptive seating and support equipment while lying down.⁵ Postural support systems usually consist of multiple component parts, secured in place by a base layer or sheet. These systems are complex and often require specialised training to use and maintain multiple components.⁶ In summary, there are simple but largely ineffective solutions for upper body postural comfort and support, for example, pillows, or effective systems which are complex and not accessible to all users. There is a need to create a simple and effective cushioned support that is accessible for people across the continuum of disability.

The Bed Band was conceptualised and developed by RG, a third-year nursing student at the University of the Highlands and Islands, and now company director of Person Centred Solutions, after observing people with limited mobility struggle to maintain a comfortable position in bed. The product was developed to offer semirecumbent positioning support, thereby promoting comfort and independence with ADLs including eating, drinking and reading.

The Bed Band consists of a base unit and two support cushions (figure 1). The base unit is made from polycotton and has eight polypropene heavy-duty straps which can be looped around gaps in the bedframe and secured with Velcro. The support cushions are made from polyether foam and waterproof elastomer PVC. The cushions are covered with polycotton and have rough Velcro pads which secure to soft Velcro pads on the base unit.

Figure 1.

The Bed Band prototype, Person Centred Solutions (2023). (A) Base unit. (B) Support cushions.

While the end users of the final Bed Band product will be people with upper mobility issues, it would be unsafe, and indeed unethical, to begin testing in this population. For example, people with upper mobility issues caused by neurological conditions may also have cognitive impairment limiting their capacity to give informed consent. Additionally, potential users may rely on community care and be dependent on others to remove or reposition the Bed Band. In essence, potential users of the Bed Band may be vulnerable. However, product development needs to start somewhere and it is recommended that the first stage in product development is proof-of-concept testing. This involves feedback on ‘looks like’ or ‘feels like’ testing usually with a sample of the healthy population. This early development testing will help gauge whether and how the concept could be further developed while proactively managing risk towards a refined prototype for future device registration and clinical testing.⁷

Aim

This project aimed to obtain feedback on ‘looks like’ and ‘feels like’ testing by collecting the initial impressions from healthy volunteers in a safe simulated ward environment and by gathering perspectives from expert stakeholders to further co-design the Bed Band design and function for testing in a future trial.

Methods

Design

A co-design approach and philosophy was used to direct the project.^{8 9} Co-design project partners were nursing academics (academic partners) and designers (industry partners) with participant input from healthy volunteers and expert stakeholders. The latter were ‘experts of their experience’¹⁰ and played a vital role in idea generation for product development. The development of the project, and the successful realisation of the revised product, relied on collaborative efforts between academic and industry partners.¹¹

The project was designed in four phases. The first phase involved an online focus group with expert stakeholders. In the second phase, healthy volunteers trialled the product in a simulation suite and provided feedback in terms of comfort, perceived utility and clarity of draft instructions for use. The third phase involved expert stakeholders in an online presentation and discussion to sense check findings from product testing and achieve consensus on priority adaptations for the Bed Band.¹² The final phase involved academic and industry partners agreeing on adaptations to the Bed Band prototype based on findings and cost.

Patient and public involvement

Patients were not involved in the design or conduct of this study.

Expert stakeholders were nursing and allied health professionals sampled purposively from the professional networks of academic partners with experience of caring for people with upper mobility limitations. Participants were recruited using email correspondence.

Healthy volunteers were a convenience sample of nursing students or staff from the Centre for Health Sciences (CFHS) recruited via a post on the students’ virtual learning environment or an email advert distributed across CFHS. To avoid any conflict of interest, students were not eligible to participate if they were in the same cohort as the student who designed the Bed Band.

Data collection

Focus group 1

Expert stakeholders (n=7) consisting of nurses, specialist nurses, occupational therapists and specialist physiotherapists were provided with participant information before providing consent via email to participate in a virtual focus group. The focus group was facilitated by two researchers (KM and MB) who provided a 3 min video demonstration of the Bed Band and set-up process. Thereafter, a semistructured focus group guide was used to facilitate a group discussion and feedback based on the experts’ initial impressions of the product. The focus group was conducted over 1 hour and recorded via the MS Teams platform.

Testing event

Healthy volunteers (n=22) were provided with participant information before providing paper-based consent to participate in the testing event. During simulation they were given draft instructions to set up the Bed Band before testing its use on a hospital-style bed while answering semistructured interview questions regarding ease of set-up, comfort and perceived utility. Data were collected by KM and MB with assistance from two other staff members from the Department of Nursing and Midwifery. Interviews were scheduled in 15 min slots with the actual duration ranging from 7 min 46 s to 20 min 12 s. Interviews were recorded using digital voice recorders.

Focus group 2: informed consensus building

Expert stakeholders (n=5) participated in an online group discussion via MS Teams facilitated by KM and MB to reach consensus on priority adaptations to the Bed Band. First, the experts were presented with a summary of findings from the first focus group and simulated testing event including potential product adaptations. Findings were discussed, and a modified Delphi technique¹³ was used to prioritise the top five adaptations. Each expert chose five priority adaptations and then ranked these by assigning a score between 1 and 5 (1=lowest priority, 5=highest priority). The duration of the online discussion was 1 hour.

Data analysis

Data from the first focus group and simulation testing were combined and analysed thematically using a six-step inductive approach¹⁴ by KM: (1) focus group/interview recordings were transcribed verbatim and then reviewed multiple times for data familiarisation; (2) data were coded using NVivo; (3) initial codes were clustered into provisional themes through a process of development, revision and refinement; (4) themes were reviewed in relation to codes and the entire data set to consider alternative options for pattern development; (5) a detailed thematic framework was produced with descriptions of themes; and (6) an analytical narrative was developed to illustrate the data, incorporating data extracts, and occasional frequency counting to highlight salient information. Analytical processes were discussed regularly among the research team and an audit trail maintained for transparency.

Findings

Three themes developed from the thematic analysis: (1) reaction to the Bed Band; (2) potential risk and mitigation; and (3) product adaptations.

Theme 1: reaction to the Bed Band

The reaction to the Bed Band was positive from both expert stakeholders (E) and healthy volunteers (HV). Both groups commended the innovation and suggested that it showed promise for development and future use in practice. Healthy volunteers, who trialled the product in person, provided feedback relating to product design.

It doesn’t crease… it’s flat to the bed… no risk of any sort of pressures from like creases or skin marking…it’s very thin… there’s no bulkiness from it or anything. (HV11)

The main benefits of the Bed Band were perceived to be positional support and comfort. Almost all volunteers (95%) reported being comfortable while trialling the Bed Band. Most suggested that the support cushions were sufficiently robust yet comfortable to provide positional support.

I’m aware of the wedges [support cushions] but it’s not uncomfortable in any way and I feel like if it was there for a long time, it wouldn’t become uncomfortable, they’re soft, they’re supportive, they’re not obstructive in anyway. (HV14)

The strength of the product was perceived to be in the simplicity of the design.

I think the simplicity appeals definitely…I think that there is kind of a niche to that. (E7)

Simplicity, as a strength of the Bed Band, was reinforced by expert knowledge of existing systems for postural support which were described to be ‘complicated’ (E7). The Bed Band was also compared with existing practices for positional support using pillows which risked dislodgement and patient discomfort. The Bed Band was considered to be a more dignified and a safer alternative capable of providing more robust support.

You’re in a good, seated position and not using stuff like pillows or blankets rolled up … these are soft [support cushions], it feels like it’s probably less of a risk for like anything, pressure on your elbows and stuff, like instead of having things wedged under. (HV5)

Most volunteers did not experience positional change due to slippage nor did they feel constrained while using the Bed Band.

I don’t think it would be restrictive at all, no, I wouldn’t say so…I still feel like I can move my arms and I’d be able to reach out. (HV1)

Experts and volunteers suggested that the product could reduce the need for frequent positional adjustments and risk of injury to practitioners during manual handling.

I think also it would help reduce back injury to staff… because they’re really busy…I think something like this will maybe give them a bit more time and allow position change to be timed and organised better. (HV18)

The Bed Band was considered by participants to be appropriate for use for people with upper body limitations including neurological disability and patients with palliative and respiratory conditions. The product was thought to have potential utility for hospital patients, care home residents and those living with mobility issues in the community to engage in ADL while in bed. The most perceived use was to aid people with positional support while eating and drinking (figure 2).

Figure 2.

Activities of daily living that may be supported by the Bed Band.

Set-up instructions

Set-up instructions were provided to healthy volunteers as part of product testing to facilitate the Bed Band set-up process. Most volunteers (63%) suggested that the instructions required revision for clarity. However, 68% reported the set-up process as being easy or straightforward. Recommendations for set-up instructions based on participant feedback are provided in the online supplemental material.

Theme 2: potential risks and mitigation

Both experts and healthy volunteers identified potential risks associated with use of the Bed Band. Tissue damage, discomfort and risks due to inappropriate use were discussed. Despite the promotion of independence being an aim of the Bed Band, participants perceived a loss of patient/person autonomy as being a possible risk. Strategies were also recommended to mitigate the risks identified. Table 1 shows the main risks identified with corresponding suggestions for risk mitigation.

Table 1.

Perceived risks associated with the Bed Band with suggested mitigation strategies

Perceived risk		Risk factor	Mitigation
			M1	M2	M3	M4	M5	M6	M7	M8
1	Tissue damage
	Pressure	Prolonged duration of general use	X	X	X		X	X	X	X
		Prolonged axilla pressure (support cushions)	X		X	X	X	X	X	X
		Extreme patient BMI	X	X	X	X		X	X	X
		↑Heat and moisture	X	X	X	X
	Shearing	Semirecumbent position					X
		Support cushions (potential dislodgement)	X				X
		Support cushions (do not extend to pelvis)*					X
2	Discomfort	Prolonged duration of general use	X	X	X		X	X	X	X
		Prolonged axilla pressure	X		X	X	X	X	X	X
3	↓Patient autonomy	Functional limitations	X					X	X	X
		Restrictions/restraint	X					X	X	X
4	Inappropriate use	Use with airflow mattresses						X	X	X
		Use with unsupervised people unable to independently change position						X	X	X

M1 (↓duration of use); M2 (↑positional change); M3 (↑skin monitoring); M4 (pressure analysis); M5 (strategic bed positioning); M6 (indications and contraindications for use); M7 (risk assessment); M8 (prescribed use).

*Potential for torso/pelvic misalignment and shearing injury.

BMI, body mass index.

Table 2 provides a more detailed account of the risk mitigation strategies with representative participant quotes. Most participants recognised how potential risks could be mitigated through person-centred care, risk assessment and tailoring the use of the Bed Band to each individual user.

Table 2.

Recommendations towards mitigation strategies for risk reduction while using the Bed Band

Mitigation		Representative quote
M1	↓Duration of use	‘Half an hour initially for trialling on a new patient.’ (E2)
M2	↑Positional change	‘I think you should be changing positions, especially when you're trialling a new product every half an hour.’ (E6)
M3	↑Skin monitoring	‘If I’m using line support systems, people normally start with an hour and then assess their tissue integrity, you know, for redness, and redness that should fade.’ (E7)
M4	Pressure analysis	‘Using pressure mapping … as an integral part of that, so you can really kind of get some ideas what it kind of does.’ (E7)
M5	Strategic bed positioning	‘They’d always have the knee bend if they were sitting in the upright position.’ (E1)
M6	Indications and contraindications	‘There has to be a lot of information about who this is suitable for and who it’s not.’ (E4)
M7	Risk assessment	‘I think it’s very client based …. and I think that will have a lot to do with how it’s marketed, for its success, because one shoe doesn’t fit all.’ (E4)
M8	Prescribed use	‘The other question I had is who’s going to issue it and, you know, who’s judgement call is it?’ (E3)

Participants showed insight into when risk assessment and tailored use of the Bed Band would be of prime consideration. The lateral support provided by the Bed Band was considered less effective for people with complex body shapes including scoliosis and rib cage shape changes (E7). Similarly, use of the product for people with altered body weight distribution would require consideration.

If someone, you know, is actually, quite, got quite a lot of a one-sided weakness, are they going to be leaning quite heavily on the Velcro? Is it actually going to be strong enough to withhold someone’s entirety of their body weight? (E3)

Some participants suggested that confusion and agitation associated with cognitive impairment could pose barriers to effective use.

I think they would need to have a cognitive element that they’d be able to understand what it’s for and how it’s used. (E3)

One participant highlighted the variations within cognitive impairment and need for an individualised and person-centred approach.

We do have others that are quite advanced cognitive impairment, as long as they’re comfortable, they’d be quite happy. So again, it’s individualised. So, my initial reaction would be, yes, cognitive impairment, but actually, no, it’s each person. (E2)

Caution was recommended when using the Bed Band overnight due to reduced patient contact and opportunities for safe and effective monitoring of skin integrity.

When you’ve got your eyes on the person, so you’re always checking them, monitoring, but during the night, I don’t know how it would benefit. (HV3)

Participants also questioned the suitability of the Bed Band for patients with surgical wounds and drains (HV9; HV13), and for patients demonstrating suicidal ideation due to the side straps presenting a potential ligature risk (HV22).

Theme 3: adaptations

The base unit was recommended to be adapted for use with patients of varied size including bariatric patients.

I know one size doesn’t fit all so, I don’t know if there’s a way of adjusting it for taller people, shorter people. (HV12)

Volunteers suggested that the base unit material could be adapted by using antislip material (HV2; HV12) and material protective of skin integrity (HV19), including materials that allowed for better air circulation (HV21). Volunteers also noted that an adaptation to the side straps was necessary to ensure that they were long enough to loop around different bedframes and back onto the base unit. Minimising the size, or covering, the exposed Velcro on the base unit with a flap of material was recommended to mitigate risk of skin damage from direct contact.

Is it something as simple as putting a wee cover on it [Velcro] … soft material could go over the top to protect their skin. (E3)

Support cushions were recommended to be adapted for optimal support for patients with both high and low body mass index.

The way I’m looking at it is that there may be different sizes of wedges [support cushions], different thickness, different depths etcetera depending on your, what position you want, bariatric patients etcetera. (E4)

Adaptations to support cushions were also recommended for optimal comfort, durability and temperature regulation.

You can also get more moulding rather than just foam, foam is quite sweaty … like you get your memory foam mattresses and there’s lots of different materials that you use to cover that to stop the foam having the heat element to it, so you get like a space blanket that goes over your foam mattress and then you have your waterproof covering over the top of that, so it’s like a multi-layered thing to stop the heat from the foam. (HV13)

Having a variety of different sized support cushions was thought to contribute to a more flexible product with opportunities to reduce shearing risks at the pelvis through more effective positional support.

If you were thinking about smaller blocks [support cushions] which would be helpful with the patient size… and also potentially you could use smaller blocks to block the pelvis as well. (E7)

Rounding the top corners of the support cushions was recommended to improve patient comfort and reduce the risk of skin injury.

I don’t know if maybe the shape of the arm bits could be not triangular, they’re a bit, cause sometimes if they’re sitting like right in your arm pits it’s a wee bit uncomfy. (HV22)

The prototype was perceived not to be suitable for use with all hospital beds as there are different types of bedframes used. Additionally, participants identified that not all people requiring care in the community have access to hospital-style beds.

It’s not just for a hospital bed, a lot of our patients are in normal divans at home etcetera, you know, is it adaptable? I appreciate it’s the initial concept, which is really good, but from a marketing point of view, could it have been in a divan bed, could it be adapted as a large sleeve for a double bed? (E4)

The Bed Band was recommended to be made available with spare component parts and covers. Variation in colouring was considered aesthetically pleasing and could help distinguish between different sized component parts and reduce the risk of parts going missing. Participants also discussed the potential use of the Bed Band to provide positional support for side lying in bed and for people while sitting in chairs.

Table 3 shows the recommended adaptations to the Bed Band as prioritised by experts using the Delphi technique. Each adaptation is presented with the potential risk that it addresses.

Table 3.

Priority adaptations for the Bed Band

Rank	Adaptation	Potential risk addressed
		R1	R2	R3	R4
1	Cover exposed Velcro on base unit.	X	X
2	Adapt for use with all beds.*				X
3	↑ Length of side straps.				X
4	Improve material (enhanced airflow).	X	X
5	Provide support cushions in assorted sizes.	X	X	X	X
6	Improve material (enhanced grip).	X	X
7	Provide base unit in assorted sizes.	X	X		X
7	Improve/maximise Velcro integrity.	X	X
7	Colour coordinate units/cushions.				X
8	↓Velcro size on base unit.	X	X
8	Round edges on support cushions.	X	X
8	Consider durability of support cushions.	X	X
8	Supply spare component parts/covers.				X

R1 (tissue damage—pressure/slippage/shear); R2 (discomfort); R3 (↓patient autonomy); R4 (inappropriate use).

*Hospital and community.

Academic and industry partners met to discuss the findings from the product testing and feedback from expert stakeholders. Adaptations to the Bed Band prototype were agreed and implemented by the textile company.

Discussion

This project used a co-design approach to test the proof of concept and enhance the Bed Band prototype. In doing so, feedback from expert stakeholders and healthy volunteers was used to prioritise adaptations to further develop the product. One of the key findings from this project was the simplicity of the Bed Band which may enhance user experience.¹⁵ This product helps fill the gap between the simple yet often ineffective use of pillows and complex systems that exist for postural support. Simplicity, as a strength of the Bed Band, may also translate to time-saving benefits for practitioners with increased job satisfaction, well-being and performance outcomes.¹⁶

The Bed Band is a remarkable student nurse-led innovation which has the future potential to improve patient experience and comfort.¹⁷ Nursing students in this study recognised the potential of the product to provide positional support. Benefits of semirecumbent positional support are well documented including improved lung function,¹⁸ reduced risk of nosocomial pneumonia^{19 20} and enhanced situational awareness.²¹ Testing in simulation established the Bed Band as being supportive and comfortable which can have a positive impact on health and well-being. Potential activities such as reading and gaming could be enabled while support for eating and drinking could help avoid weight loss, dehydration, aspiration and pulmonary infections.²²

All innovations for use in healthcare settings entail an inherent degree of risk that will persist despite mitigation efforts.²³ Risk-informed product development can improve the safety of innovations and increase their chance of success.²⁴ While our findings suggest that there is a possible risk of tissue damage due to pressure and/or shearing when using the Bed Band, this is a risk for any product that encourages fixed positioning over time, including pillows. Strategies to mitigate risks of tissue damage included reduced pressure duration and repositioning. Specific time interval recommendations for repositioning are not provided in international guidelines.²⁵ Instead, repositioning frequency is based on patient-specific factors and treatment objectives.²⁶ The Bed Band does not support repositioning in a lateral position, and it is not clear how a 30° tilt²⁷ would impact load distribution at the upper limbs. Pressure mapping techniques can help determine pressure distribution and may support useful recommendations for optimal head of bed elevation, strategic bed positioning and repositioning techniques for patients using the Bed Band.²⁸ A clinical trial would be needed to establish recommendations for the safe duration of use.

Adaptations to the Bed Band prototype were recommended to enhance safety and comfort and avoid inappropriate use. Covering exposed areas of Velcro on the base unit was a priority recommendation to avoid skin irritation and discomfort. The use of multilayer textiles and spacer fabrics was suggested to enhance airflow and maintain an optimal microclimate around the patient’s skin.²⁹ For optimal adoption, diffusion and scaling of the Bed Band, product redesign will be necessary for compatibility with all hospital beds and beds in the community.³⁰ Interim adaptations to increase the length of the side straps on the base unit will ensure fit and usability with some hospital beds. Provision of support cushions in different shapes and sizes may address patient and organisational risk factors while providing solutions for pelvic support.

Development of indications and contraindications may help ensure the appropriate use of the Bed Band. However, based on our findings, and in alignment with healthcare approaches, we would recommend a person-centred approach to assessment with clear clinical reasoning.³¹ Risk assessment tools incorporating device-specific risks with patient and organisational factors will require development with reliability, validity, sensitivity and specificity to consistently and accurately identify individuals who are suitable for the Bed Band, and those who are not.^{25 32} The provision of comprehensive set-up instructions for the Bed Band will also mitigate risk. Education for health professionals on the use of the product, good positioning and pressure care are likely to further improve safety and increase chances of future product development and success.³³

A limitation to the Bed Band prototype, as the name suggests, is that the product can only be used while in bed. When considering enablement and promoting self-care in most situations, the recommendation would be to not stay in bed and mobilise wherever possible, or even sit in a chair. This has been recognised by the product designer and the Bed Band can be easily adapted for wider applicability with a subsequent change of name.

Limitations

Expert opinion was limited by a conceptual understanding of the Bed Band from a brief online presentation considering feasibility in terms of practitioners’ time and availability. It is important to note that experts did not hold or use the product, which may have limited their perspectives on adaptations. However, all experts had experience of using various support strategies for people with limited mobility. Additionally, testing the use of the Bed Band was conducted in simulation by healthy volunteers as opposed to those with mobility limitations; therefore, the findings here may not apply to the target population or end users. However, many of the healthy participants were student nurses with care experience. The size and scale of the project also limited the product to be tested in simulation with healthy volunteers as an important first step in product safety development.

Conclusion

The Bed Band is a unique and simple product designed to aid positional support and comfort for patients while in bed. Adaptations to the Bed Band prototype have resulted in a more comfortable product mitigating risk of tissue damage and inappropriate use. The development of user instructions will further contribute to patient safety and outcomes. Future product development might place consistent attention on risk mitigation and prioritise individualised risk assessment strategies with focus on usage duration and positioning. Adopting these practices will shift the product development towards trials of patient acceptability and clinical effectiveness potentially resulting in future regulation of the Bed Band as a medical device.

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information. Participant consent was gained for anonymised data including participant quotations to be used in academic publications. Consent was not obtained to deposit data in repositories.

Ethics statements

Patient consent for publication

Not applicable.

Ethics approval

This study involves human participants and was approved by the University Research Ethics Committee (ETH2223-0988). Participants gave informed consent to participate in the study before taking part.