Background:

Approximately 56% of people with multiple sclerosis (MS) will fall in any 3-month period, with the potential for physical, psychological, and social consequences. Fall-prevention research for people with MS is in its infancy, with a timely need to develop theory-based interventions that reflect the complexity of falls. The clear articulation of the development of any complex intervention is paramount to its future evaluation, usability, and effectiveness. Our aim was to describe how the development of Better Balance, a complex multicomponent fall-prevention intervention for people with MS, was guided by the Medical Research Council framework for the development of complex interventions.

Methods:

Sources of information included existing literature, original research, clinician interviews, and views of people with MS. These sources were synthesized and refined through an iterative process of intervention development involving researchers, clinicians, and people with MS.

Results:

The resulting intervention is outlined through a variety of key tasks supplementing the original Medical Research Council framework. Use of this framework resulted in a theoretically based and user-informed complex intervention designed to address the physiological, personal, and behavioral risk factors associated with falls in people with MS.

Conclusions:

The articulation of the systematic process used to develop Better Balance will inform the future evaluation and usability of the intervention.

Multiple sclerosis (MS) is an inflammatory-mediated disease that causes demyelination of the central nervous system.1  Symptoms of the disease, such as balance and mobility limitations, are established risk factors for falls in this population.2  Falls are recognized as a consequence of MS, with a previous meta-analysis estimating that 56% of people with MS will fall in any 3-month period.3 

Falls in MS are likely multifactorial, with physiological, psychological, behavioral, and environmental influences.4,5  This diversity in risk factors for people with MS necessitates interventions to reduce falls be theory-driven and complex.5  Complex interventions are characterized by several interacting core components with further consideration of elements such as tailoring, addressing potential variance in delivery and specificity of intended users.6  At present, fall-prevention research for people with MS is in its infancy. Findings from a systematic review by Sosnoff and Sung7  highlight limitations in MS fall-prevention intervention research to date and help build a case for complex interventions to address the fall-prevention needs of people with MS. Those authors describe the need for future studies to place greater emphasis on the multifactorial nature of falls, incorporating additional strategies to target physiological and behavioral risk factors.

Developing complex interventions is inherently challenging, and a lack of rigor in intervention development in rehabilitation research is well acknowledged.8  Evidence to date points to the importance of transparency during the development of a complex intervention to inform future evaluation and usability.9  Descriptions of the theoretical underpinnings of a complex intervention and mechanisms of action, in particular, are essential to the development of operational hypotheses to be tested through proof-of-concept, pilot, and larger studies.911  Rehabilitation interventions have a tendency to assess effectiveness directly, avoiding phased approaches to the research process, which should begin with a clear rationale for elements such as relevance, intended users, theoretical underpinning, mechanisms of action, and implementation considerations,10,12  which are crucial to reduce “research waste.”13 

The opportunity to develop more comprehensive and effective fall-prevention interventions for people with MS clearly exists, and this work can be informed by the Medical Research Council (MRC) framework for the development of complex interventions described by Craig et al.6  This framework suggests that the development and evaluation of complex interventions is a cyclical and interacting process and places emphasis on the developmental and early piloting phases. The attention that the framework gives to influences on programmatic success includes, but is not limited to, 1) possessing a well-founded theoretical and empirical underpinning and 2) communicating mechanisms of action, which are of critical concern to MS fall-prevention researchers.

In this paper, our aim was to describe how the development of Better Balance, a complex fall-prevention intervention for people with MS, was guided by the MRC framework for the development of complex interventions.

The MRC framework6  development phase comprises three stages: 1) identifying the evidence base, 2) identifying/developing theory, and 3) modeling processes and outcomes. Campbell et al10  identified a variety of key tasks in each stage (Table 1) that will be used to structure the reporting of the development of Better Balance.

Table 1.

MRC development phase stages6  with Campbell et al10  key tasks

MRC development phase stages6 with Campbell et al10 key tasks
MRC development phase stages6 with Campbell et al10 key tasks

Sources Informing Development

The development of the Better Balance intervention was informed by a variety of sources, including but not limited to literature reviews, systematic reviews, and original research. The sources informing each task are provided in Table S1, which is published in the online version of this article at ijmsc.org, and are summarized herein.

An overarching literature review14  was conducted in May 2016 using the search terms multiple sclerosis AND accidental falls OR fall* through relevant databases. Articles of interest included systematic reviews, empirical evidence, and theoretical approaches. An alert was set up to inform us of new literature, which was reviewed and integrated as appropriate on an ongoing basis. Returned articles were integrated with consideration of methodological quality and the hierarchical framework of evidence.15  Further sources of research evidence included systematic reviews and meta-analyses conducted by the researchers, leading to the development of the Better Balance intervention examining postural control deficits in people with MS16,17  and the clinical utility of balance measures in people with MS.18  Additional original research conducted by the lead author (L.C.) and the research team to inform intervention development included an exploration of psychosocial factors related to falls in people with MS,19  an examination of medications as a risk factor for falls in people with MS,20  and an investigation of the responsiveness of participation outcome measures (McKenna, Comber, and Coote, unpublished data, 2017).

Significant gaps in information relating to intervention content and structure for fall prevention in people with MS were identified. To address these gaps, input was sought from members of the target audience in the development process as advocated by the MRC.6  Patient expectations were collected through a structured telephone survey. This study was reviewed and approved by the local ethics committee (University of Limerick). We developed the survey used in this study, and it is based on a survey used in previous studies of patients with MS.21,22  For the purpose of this research, only information relating to the following were included: 1) the causes and context of falls for people with MS and 2) participants’ preferences regarding intervention content and structure. Data were coded, entered, screened, cleaned, and analyzed using SPSS Statistics for Windows, version 22.0 (IBM Corp). One hundred forty participants completed the survey, of which data from 83 are presented herein, reflecting the disability level that the presented intervention is directed toward (Expanded Disability Status Scale [EDSS] score <6.0). Clinical expertise was collected using semistructured interviews with practicing physiotherapists and occupational therapists. The semistructured interviews consisted of three main topic areas concerning people with MS: current fall prevention, barriers and facilitators to fall prevention, and feasibility of future fall-prevention interventions. Purposeful sampling was undertaken to collect data from clinicians who regularly (n = 5) and irregularly (n = 7) worked with people with MS. The interviews were transcribed verbatim and thematically analyzed by two of us (L.C. and S.C.) following the six steps outlined by Braun and Clarke.23  An overview of the main themes and subthemes identified from these interviews, with supporting quotations, is provided in Item S1.

Process of Development

The process of development for the Better Balance intervention is illustrated in Figure S1. An intervention development panel was formed to synthesize the information from the sources outlined previously herein. The panel included two occupational therapy researchers, one physiotherapy researcher, one PhD candidate, and one research assistant. The intervention development panel was formed to provide consensus on key aspects of the intervention, with a multidisciplinary approach used to strengthen the overall process.24 

The sources of information were collaboratively interpreted by the intervention development panel with a hierarchy of evidence considered whereby research evidence and its overall quality was considered the predominant influence, with patient values and clinical expertise strengthening and expanding the evidence base overall.15,25  The intervention development panel was initially engaged to reach preliminary consensus on intervention content and scheduling based on the best available research evidence, patient opinion, and clinical expertise. This process involved independent appraisal of content followed by group discussion and deliberations. Meetings were facilitated by the lead author and included methods such as group brainstorming, problem solving, synthesis of ideas, and deliberation of outstanding issues.

Once consensus had been reached, the totality of information was mapped by the lead author onto the key tasks identified by Campbell et al.10  Findings were then presented to an MS research group for discussion and feedback focused on the development of a core exercise set and topic guides of coaching sessions for Better Balance. Next, the intervention development panel was engaged again to draft the intervention through an iterative process. The content and structure of the intervention was subsequently presented to a panel of people with MS at a local MS center for feedback. Further meetings with the intervention development panel were conducted to enable further refinement based on this feedback and to make final amendments to Better Balance.

MRC Development Stage 1: Identifying Evidence Base for Better Balance

Define and Quantify Problem

Lamb et al26  defined a fall as “an unexpected event in which the participants come to rest on the ground, floor, or lower level,” and this definition has been recommended for use in MS populations.26(p1619),27  Using this definition, a recent study amalgamating prospective fall incidence from 537 individuals with MS found that 56% of people with MS will report a fall in any 3-month period, with 37% categorized as frequent fallers.3 

Falls in people with MS can negatively affect the physical, psychological, and social well-being of the individual. Injurious falls are common, with rates of 0.18 to 0.23 per person per year,28,29  and people with MS are at significantly higher risk for injuries resulting from falls compared with healthy age-matched controls.30  In terms of psychological and social impact, people with MS who have fallen experience considerable levels of fear of falling, reduced fall self-efficacy, and reduced perceived control over future falls, and they restrict their activities as a result of overall concern.19,21 

Collectively, these findings suggest that falls are a considerable consequence of MS with physical, psychological, and social implications for the individual, and there is a need to develop interventions to reduce their incidence.

Identify and Quantify Populations Most Affected, Most at Risk, or Most Likely to Benefit

History of a previous fall is one of the strongest predictors of future falls for people with MS.2  Nilsagard et al3  report an increased risk of falling at EDSS scores between 4.0 and 6.0 inclusive, with odds ratios ranging from 2.7 to 5.3 at these stages and significance levels dropping after an EDSS score of 6.5. Kasser et al31  further identify increased odds of falling as EDSS scores increase, and Coote et al32  report the highest level of recurrent fallers being those who have walking limitations but do not use a walking aid.

Systematic reviews of evidence for interventions targeting falls,7  balance impairment,33  muscular strength,34  cognitive-motor interference,35  and walking impairment36  in people with MS highlight that most primary research studies have been performed with individuals with mean EDSS scores of 6.0 or less.

The totality of evidence indicates that individuals who have previously experienced a fall and have an EDSS score of 4.0 to 6.0 inclusive, implying the presence of walking limitations with or without the need for a unilateral aid to walk 100 m,37  possess the strongest evidence base on which to build interventions for fall prevention at present.

Understand Pathways by Which Falls Are Caused and Sustained

In terms of physiological risk, the pathologic course of MS can affect the motor, sensory, and cognitive function of the individual.38  Risk factors for falls in MS reflect these pathologic impairments, with two meta-analyses highlighting balance impairment, cognitive dysfunction, gait deficits, and mobility aids as significant risk factors for falls in this population.2,39  Further physiological risk factors identified through prospective cohort studies include fatigue,40  balance confidence,41  urinary incontinence,42,43  and reduced dual-task ability.44  The use of certain medications and possibly the use of a greater number of medications have also been shown to increase an individual’s likelihood of being a faller.20,42,45  Such risk factors may reduce an individual’s ability to maintain balance during static, dynamic, and reactive postural tasks and increase the likelihood of falls. Two systematic reviews and meta-analyses conducted by Comber et al16,17  investigated deficits in postural control in people with MS compared with controls during gait and static and reactive task conditions. Significant deficits were found regardless of sensory condition or task complexity, signifying that deficits in postural control are diverse in nature.

Personal risk factors, including fear of falling, compromised fall self-efficacy, and activity curtailment due to fear of falling, may contribute significantly to falls being sustained by people with MS.19  Compromised fall self-efficacy, in particular, has been shown to be predictive of future falls irrespective of fall history.46  Such psychosocial influencers can affect an individual’s appraisal of their ability and may reduce participation or increase engagement in risk-taking behaviors.

Behavioral risk factors, such as the realistic appraisal of ability, organization/planning of activities, adjustment/replacement of activities, and emotional adaption through awareness and acceptance of limitations, are important considerations for interventions.47,48  In addition, Gunn et al49  highlight that people with MS have considerable disparities between physiological risk and perceived risk of falls. Such disparities may present as an overheightened restriction of activity or an increase in risk-taking, both of which may result in falls.

Given the diversity of fall risk factors for people with MS, we propose Better Balance be multicomponent in nature to target the physiological, personal, and behavioral risk pathways associated with falls.

Explore Whether Risk Factors Are Amenable to Change and at What Points

In terms of physiological risk factors, impaired balance has been shown to be amenable to exercise interventions.33  Similarly, the literature highlights positive results in exercise training for strength,34  mobility,36  reactive stepping50 (note that references 50–80 are provided in Appendix S1), and cognitive-motor interference.35  The exercise component of Better Balance has been structured on learnings from these studies.

Regarding personal and behavioral risk, the use of educational and behavioral programs has further shown promising preliminary results. Specifically, the pilot study of the Safe at Home BAASE program conducted by Finlayson et al51 suggests that this intervention has the potential to foster positive changes in attitudes (eg, fall self-efficacy), knowledge (eg, impact of MS symptoms on fall risk), skills (eg, safely engaging in activity or exercise), and behavior (eg, using action plans) associated with reduced personal fall risk. Of note, those authors placed a particular emphasis on the use of group facilitation and group coaching in favor of more structured educational strategies. Development and adaptation of the original Safe at Home BAASE program underpins the group coaching component of Better Balance. Collectively, evidence to date suggests that most risk factors associated with falls in people with MS are modifiable.

Identify Feasible and Valid Outcome Measures

Literature concerning outcomes of fall-prevention interventions intended for older adults consistently recommends the use of prospective recording of falls in diaries. This has been found to be feasible for people with MS29  and should be a primary outcome of future fall interventions for this population.27 

In terms of measuring physiological risk, clinical tools have displayed poor discriminative ability for predicting future falls in people with MS.52 However, changes in balance and gait are considered important when examining intervention effect on actual falls.7  Use of the Mini-Balance Evaluation Systems Test seems to be an appropriate means of identifying impairments in postural control for people with MS and provides a directive for intervention.53 It is a valid and responsive measure and seems to offer advantages in terms of ceiling effects compared with more traditional clinical measures.53,54 When considering outcome measurements relating to gait, it is important to consider the specific elements of gait that an intervention aims to address. Given that a reduction in gait speed may serve as a protective mechanism for the maintenance of stability16  and, hence, a strategy of intervention, timed gait tests may be inappropriate. Thus, observational gait screening will be used to assess and promote safety during mobility, transitions, and walking aid use. Furthermore, self-report measures of an individual’s balance and walking ability are important inclusions given that intervention effects may reflect more so in a person’s self-appraisal of ability. The 12-item Multiple Sclerosis Walking Scale is a valid, responsive, and reliable measure,55,56 as is the Activities-specific Balance Confidence scale,57 and they serve as appropriate self-report measures of gait and balance for people with MS.

When measuring factors relating to the personal and behavioral influences of falls for patients with MS, evidence to date suggests that fear of falling measured through a Likert response,21  activity curtailment measured through a dichotomous response,21  fall self-efficacy measured by the Falls Efficacy Scale-International,58 and perceived control measured by the Falls Control Scale59 are appropriate measures. Importantly, despite previously being considered proxy measures of fear of falling, each of these factors are distinct and each, therefore, warrants assessment.19  In terms of behaviors relating to fall risk, the Falls Prevention Strategies Survey has undergone validation60 and has been used previously.51,61 The inclusion of a participation measure for fall intervention is a significant consideration of future fall-prevention interventions.62 The Impact on Participation and Autonomy Questionnaire has been shown to be valid and reliable in people with chronic illness63 and responsive to change in people with MS (McKenna, Comber, and Coote, unpublished data, 2017).

As such, we propose an assessment during the evaluation of Better Balance that reflects the multidimensional nature of falls for people with MS. Feasible and valid outcome measurements have been proposed to reflect the previously mentioned findings and are provided in Table S2.

Quantify Potential for Improvement

Despite being a relatively novel area of rehabilitation research, fall-prevention interventions have demonstrated reductions in falls and fall risk for people with MS,7  albeit with methodological limitations. Collectively, existing evidence suggests that most risk factors associated with falls in people with MS are amenable to change. Fall-prevention interventions to date have largely focused on physiological risk, with little consideration of aspects relating to personal and behavioral risk.7  Individually, programs addressing fall risk through exercise7  and group coaching51 demonstrate promising results.

Interviews with clinicians suggest that exercise and education components to target the physiological, personal, and behavioral risk pathways are important to include. Furthermore, clinicians emphasized the need for exercises to be sufficiently challenging and preferably functional. Clinicians also highlighted the importance of backward chaining to educate a participant how to get up after a fall, which has not been considered in previous interventions. This element seems worthy of inclusion considering that delayed initial recovery is common, and many people with MS require help to get up from a fall.64

We propose a multicomponent approach to reducing falls for people with MS incorporating a comprehensive assessment of risk factors and a tailored intervention based on identified risk factors. An exercise component addressing physiological risk factors such as balance, strength, and mobility is proposed, with a core set of exercises provided in Table 2. We also propose a group coaching component addressing personal and behavioral risk factors such as realistic appraisal of ability and facilitation of fall-management strategies to address behavioral and environmental influences. An overview of proposed topics for inclusion and set learning objectives is provided in Tables S2 and S3. It is hypothesized that the individual strengths of interventions addressing physiological risk and those targeting personal risk will be augmented when used in parallel.

Table 2.

Balance deficits with tailored challenges using core exercises

Balance deficits with tailored challenges using core exercises
Balance deficits with tailored challenges using core exercises

MRC Development Stage 2: Identifying or Developing Theory for Better Balance

Identify Mechanisms by Which Intervention Will Lead to Improved Outcomes

The fundamental theoretical underpinning of this intervention is the person, environment, and occupation model identified by Law et al.65 This model emphasizes that these three elements are strongly interlinked and cannot be separated, highlighting that they must always be considered in light of each other when examining falls and fall risk.

The physiological risk factors associated with falls in people with MS seem largely modifiable through exercise, including gait retraining, balance training, and strengthening. Such exercises should be well founded in terms of the principles of training: specificity, overload, and progression.66 Of note, the inclusion of altering sensory conditions and dual-task challenges seems to be a significant contribution to future fall-prevention interventions for this population.67–69 Cameron and Lord’s70 hypotheses regarding problems with sensorimotor and central integration promotes the use of varying sensory inputs and dual-task conditions. The theoretical base for dual-task training is targeting cognitive-motor interference through the widely used attentional capacity theory, in which an individual is thought to have a limited capacity for more than one task; once capacity is reached, a detriment will be seen in one or both tasks, for example, walking and talking.71 Therefore, we propose including tailored challenges to each exercise based on the preliminary assessment of each participant (Table 2).

In terms of personal and behavioral risk management, consideration must be given to the behavioral and environmental aspects of fall risk. Methods to address such risk factors are well reflected in the concepts and processes presented through cognitive behavioral therapies with self-appraisal of limitations and functioning, reconceptualization of unrealistic thinking, and compensatory and preventive skills aiming to augment self-efficacy and encourage behavioral modification where necessary.72,73 Of note, the central focus of building self-efficacy as a means to influence behavioral change seems noteworthy.74

A further consideration for fall-prevention interventions for patients with MS is the promotion of long-term adherence beyond a formal intervention period.33  Given the chronic nature of MS, strategies to promote self-management, independence, and the ongoing use of strategies are crucial to include. Strategies addressing knowledge, risk perception, outcome expectation, self-efficacy, coping, action control, and outcome experience have been suggested to be advantageous when considering exercise therapy for chronic diseases.75 The embedding of such strategies when considering intervention techniques relating to behavioral risk may prove advantageous in terms of promoting self-management and long-term adherence.

Therefore, as highlighted in Table S3, we propose that the exercise portion of Better Balance target specifically identified deficits in balance, with particular attention given to sensory and dual-task conditions. We propose the use of group coaching and facilitation incorporating strategies such as knowledge provision, group brainstorming, group problem solving, and task analysis to enable the facilitation of learning and promotion of fall-risk management strategies in an effort to augment self-efficacy. Furthermore, we propose the embedding of strategies to promote long-term adherence beyond the formal intervention.

MRC Development Stage 3: Modeling Processes and Outcomes of Better Balance

Identify Key Processes and Outcomes

In the series of semistructured interviews, clinicians expressed that interventions should be individualized and targeted toward specific risk factors. Both novice and experienced clinicians highlighted that this was key to successful interventions and should be based on a comprehensive assessment encompassing all potential risk factors.

Risk factors for falls in people with MS can be considered modifiable (eg, balance and strength deficits) or unmodifiable (eg, age and history of falls). Through a comprehensive assessment of all potential risk factors, each individual risk factor must be characterized as being modifiable or unmodifiable for the individual. The decision of which category each risk factor corresponds to will then direct whether an intervention aims to improve or manage this factor.

Intuitively, a person with MS might restrict activity to reduce their fall rate; however, such strategies can be disadvantageous for people with MS when activities that can be safely undertaken are curtailed because regular engagement in physical activity benefits the physical, psychological, and social well-being of the individual.34,76

Therefore, we propose that the overarching goal of Better Balance for falls should be a reduction of fall incidence by addressing modifiable risk factors while maintaining or safely increasing physical activity and/or participation.

Identify Barriers to Application

The interviewed clinicians identified three types of barriers to implementing fall-prevention interventions: service factors, therapist factors, and patient factors. Concerns relating to service primarily centered on resources such as time, equipment, and staffing. Such concerns seem to indicate the necessity of a group method of delivery in the community setting to reduce demands on strained resources. Group interventions further offer advantages beyond effective utilization of resources. Our survey indicated that 89% of people with MS (n = 73) would be in favor of this approach, and group-based interventions involving people with MS and older adults have been shown to support development of fall self-efficacy.51,59

Therapist factors highlighted by interviewed clinicians included the need for peer support when delivering an intervention and the need for adequate training to deliver the intervention. It was further suggested that the use of a manualized program would facilitate implementation.

Patient factors identified by interviewed clinicians included concern regarding acceptance and readiness to change. Such factors were highlighted as being challenging when considering cognition, disease progression, changing the home environment, and use of mobility aids. Therapists cited the necessity of family involvement and acceptance and the empowerment of the patient as facilitators of implementation. When surveyed, 57% of people with MS (n = 47) indicated that they would like to have the option to bring a family member or caregiver to an intervention with them.77

Logistical elements, such as scheduling, duration, and content, may be barriers for participants. In a study by Comber et al,77 most of the 82 people with MS surveyed highlighted that the intervention should be 1 to 2 hours (n = 75 [91%]), on weekdays (n = 47 [57%]), during the morning (n = 42 [51%]), and led by a physiotherapist (n = 71 [87%]).

Therefore, we propose that Better Balance be a physiotherapy-led group intervention with the use of a manualized program that can be tailored depending on each individual’s specific deficits. Furthermore, we propose that participants be given the option of a family member or friend attending Better Balance for appropriate sessions.

Consider Best-Achievable Combination of Components and Intensities

When considering the duration of a fall-prevention intervention for people with MS, evidence suggests that a 12-week intervention period is required; this duration reflects both the necessary time to establish an adequate training effect and the reduction in effect of previous exercise interventions for patients with MS after 12 weeks.33,36  Regarding the frequency of intervention, Gunn et al33  highlight the importance of volume for future fall-prevention interventions for people with MS, with an increase in volume exhibiting increases in overall effect.

A frequency of three times per week of 45 minutes for the exercise component is required to satisfy the adequate dosage of 50 hours per 6 months set out by Sherrington et al.78 The use of a combination of supervised and home exercise seems favorable to dose and feasibility, with similar outcomes seen in both methods for people with MS.79 In terms of exercise intensity, balance elements should be sufficiently challenging to induce a treatment effect33  and should be targeted toward identified deficits. Strengthening exercises should be aimed at achieving two sets of 10 to 15 repetitions at a sufficient intensity that the individual finds the last repetition to be just achievable.34  Where possible, altering sensory conditions and dual-task challenges should be incorporated in all aspects of exercise.70

In collaboration with the original authors, the Safe at Home BAASE program originally presented by Finlayson et al51 has been adapted to embed topics and strategies suitable to the target population of Better Balance and to reflect updated fall-prevention literature for patients with MS. The proposed changes have been made with consideration of the original theories used to remain true to the original development of the Safe at Home BAASE program. Topic guides have been developed to facilitate the individual in formulating management strategies for fall-risk factors with consideration of the person, occupation, and environment. This adapted program will be aligned with and used in conjunction with the exercise component of the intervention to provide parallel learning opportunities for participants during the Better Balance intervention.

As summarized in Table S3, we propose a 12-week group intervention three times per week that is tapered progressively from supervised to home exercise. Exercise and coaching components should be used in parallel to facilitate learning opportunities for the participants to apply fall-risk management strategies. Management strategies addressing individuals’ knowledge, behavioral risk, and long-term adherence will align with the exercise component to equip the individual with skills and information to apply to their daily lives.

There is a need to develop theory-based fall-prevention interventions that reflect the complexity of falls for people with MS. In this paper, we articulate the development of the multicomponent Better Balance fall-prevention intervention for people with MS, fulfilling the key tasks of the MRC framework6  development stage highlighted by Campbell et al.10 

The findings from each stage of the development phase of the MRC framework6  have been summarized to present an intervention that is multicomponent in nature in an effort to address the physiological, personal, and behavioral risk pathways associated with falls in MS. The Better Balance program aims to equip people with MS with the knowledge and tools to facilitate the participant in managing their fall risk. Building on current knowledge from existing literature, the views of clinicians, and the opinions of people with MS, careful consideration has been given to the development of both the exercise and group coaching elements.

Use of the MRC framework,6  supplemented by the key tasks presented by Campbell et al,10  enabled the robust development of this intervention. To date, the clear articulation of the development of fall-prevention interventions for people with MS has been rare. Despite requiring a substantial degree of effort, the MRC framework6  has proved to be a useful tool that enabled us to communicate the theoretical underpinning of the intervention, prioritize intervention content, and articulate theory-driven and user-informed outcomes. The creation of tools such as the TIDieR (template for intervention description and replication) checklist by the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network80 highlights the increasing awareness of the need to make interventions transparent, a process that is grounded in the clear articulation of the development phase of an intervention.

By clearly articulating the development process behind Better Balance, a phased approach to the research process has been initiated. The approach used carefully considers the theoretical underpinnings of a new complex intervention for fall prevention in people with MS and creates a stable foundation on which to evaluate it. Better Balance will now be evaluated to determine the utility of the intervention through a proof-of-concept study, which will inform important considerations of the feasibility of the intervention, such as willingness to participate, adherence, and stakeholder satisfaction.

PRACTICE POINTS
  • Falls are a considerable problem for people with MS. Risk factors for falls in this population are diverse and include physiological, personal, behavioral, and environmental influences.

  • There is a timely need to develop theory-based interventions that address the complexity of falls for people with MS. Such interventions should be robustly developed in a phased manner, with their mechanisms of action clearly articulated.

  • Better Balance is a complex multicomponent fall-prevention intervention for people with MS that has been developed through a systematic process incorporating research evidence, clinician opinion, and patient input.

The authors declare no conflicts of interest.

Ms Comber was a PhD candidate funded by the Multiple Sclerosis Society of Ireland through the Ireland Fund.

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Author notes

From the School of Allied Health (LC, NO, RG, SC) and Health Research Institute (NO, RG, SC), Faculty of Education & Health Sciences, University of Limerick, Limerick, Ireland; College of Applied Health Sciences, Department of Occupational Therapy, University of Illinois at Chicago, USA (EP); and School of Rehabilitation Therapy, Faculty of Health Sciences, Queen’s University at Kingston, Kingston, ON, Canada (MF).

Note: Supplementary material for this article is available at ijmsc.org.

Supplementary Material