Elaine Toomey

Implementation fidelity of physiotherapist-delivered group education and exercise interventions to promote self-management in people with osteoarthritis and chronic low back pain: a rapid review part II.

BACKGROUND Implementation fidelity is the extent to which an intervention is delivered as intended by intervention developers, and is extremely important as it increases confidence that changes in study outcomes are due to the effect of the intervention itself and not due to variability in implementation. A paucity of literature exists concerning implementation fidelity in physiotherapy research. DESIGN AND OBJECTIVES This rapid review aimed to evaluate the implementation fidelity of group-based self-management interventions for people with osteoarthritis (OA) and/or chronic low back pain (CLBP). METHOD Group-based self-management interventions delivered by health-care professionals (including at least one physiotherapist) involving adults with OA and/or CLBP were eligible for inclusion. The National Institutes of Health Behaviour Change Consortium Treatment Fidelity checklist was used to assess fidelity and applied independently by two reviewers. RESULTS In total, 22 studies were found. Fidelity was found to be very low (mean score 36%) within the included studies with only one study achieving >80% on the framework. The domain of Training of Providers achieved the lowest fidelity rating (10%) across all studies. CONCLUSIONS Overall levels of implementation fidelity are low in self-management interventions for CLBP and/or OA; however it is unclear whether fidelity is poor within the trials included in this review, or just poorly reported. There is a need for the development of fidelity reporting guidelines and for the refinement of fidelity frameworks upon which to base these guidelines.

Using intervention mapping to develop a theory-driven, group-based complex intervention to support self-management of osteoarthritis and low back pain (SOLAS).

BackgroundThe Medical Research Council framework provides a useful general approach to designing and evaluating complex interventions, but does not provide detailed guidance on how to do this and there is little evidence of how this framework is applied in practice. This study describes the use of intervention mapping (IM) in the design of a theory-driven, group-based complex intervention to support self-management (SM) of patients with osteoarthritis (OA) and chronic low back pain (CLBP) in Ireland’s primary care health system.MethodsThe six steps of the IM protocol were systematically applied to develop the self-management of osteoarthritis and low back pain through activity and skills (SOLAS) intervention through adaptation of the Facilitating Activity and Self-management in Arthritis (FASA) intervention. A needs assessment including literature reviews, interviews with patients and physiotherapists and resource evaluation was completed to identify the programme goals, determinants of SM behaviour, consolidated definition of SM and required adaptations to FASA to meet health service and patient needs and the evidence. The resultant SOLAS intervention behavioural outcomes, performance and change objectives were specified and practical application methods selected, followed by organised programme, adoption, implementation and evaluation plans underpinned by behaviour change theory.ResultsThe SOLAS intervention consists of six weekly sessions of 90-min education and exercise designed to increase participants’ physical activity level and use of evidence-based SM strategies (i.e. pain self-management, pain coping, healthy eating for weight management and specific exercise) through targeting of individual determinants of SM behaviour (knowledge, skills, self-efficacy, fear, catastrophizing, motivation, behavioural regulation), delivered by a trained physiotherapist to groups of up to eight individuals using a needs supportive interpersonal style based on self-determination theory. Strategies to support SOLAS intervention adoption and implementation included a consensus building workshop with physiotherapy stakeholders, development of a physiotherapist training programme and a pilot trial with physiotherapist and patient feedback.ConclusionsThe SOLAS intervention is currently being evaluated in a cluster randomised controlled feasibility trial. IM is a time-intensive collaborative process, but the range of methods and resultant high level of transparency is invaluable and allows replication by future complex intervention and trial developers.

Between-Rater Reliability of the 6-Minute Walk Test, Berg Balance Scale, and Handheld Dynamometry in People with Multiple Sclerosis

This study investigated the between-rater reliability of the Berg Balance Scale (BBS), 6-Minute Walk test (6MW), and handheld dynamometry (HHD) in people with multiple sclerosis (MS). Previous studies that examined BBS and 6MW reliability in people with MS have not used more than two raters, or analyzed different mobility levels separately. The reliability of HHD has not been previously reported for people with MS. In this study, five physical therapists assessed eight people with MS using the BBS, 6MW, and HHD, resulting in 12 pairs of data. Data were analyzed using intraclass correlation coefficients (ICCs), Spearman correlation coefficients (SCCs), and Bland and Altman methods. The results suggest excellent agreement for the BBS (SCC = 0.95, mean difference between raters [d̄] = 2.08, standard error of measurement [SEM] = 1.77) and 6MW (ICC = 0.98, d̄ = 5.22 m, SEM = 24.76 m) when all mobility levels are analyzed together. Reliability is lower in less mobile people with MS (BBS SCC = 0.6, d̄ = -1.83; 6MW ICC = 0.95, d̄ = 20.04 m). Although the ICC and SCC results for HHD suggest good-to-excellent reliability (0.65-0.85), d̄ ranges up to 17.83 N, with SEM values as high as 40.95 N. While the small sample size is a limitation of this study, the preliminary evidence suggests strong agreement between raters for the BBS and 6MW and decreased agreement between raters for people with greater mobility problems. The mean differences between raters for HHD are probably too high for it to be applied in clinical practice.

Physical rehabilitation interventions in nonambulatory people with multiple sclerosis: a systematic review.

There is an expanding body of research on exercise intervention for multidisciplinary rehabilitation of people with multiple sclerosis (PwMS). Most of this research focuses on people with mild/moderate MS who are ambulatory. As the costs of care increases with increasing disability, it is important to evaluate the evidence for interventions in nonambulatory PwMS. The aim of this study was to evaluate the evidence regarding physical rehabilitation interventions in nonambulatory PwMS. The databases AMED, CINAHL, MEDLINE, EMBASE and PSYCHARTICLES were searched up to 31 May 2011. Reference lists, Google Scholar and PEDro were also searched. Trials of physical rehabilitation interventions in nonambulatory PwMS that analysed nonambulatory results separately were included. Pharmacological, surgical, medical and assistive device interventions were excluded. Risk of bias was assessed and the GRADE approach was used to classify the quality of evidence. Sixteen low-grade studies, only three of which were randomized controlled trials (RCTs), were found. There are trends of improvement following some interventions such as cooling suits, respiratory training and multidisciplinary rehabilitation, but there is no high-grade evidence in terms of the benefits of interventions in this population. The effectiveness of physical rehabilitation interventions in nonambulatory PwMS remains unclear. Although trends in the results suggest positive benefits, conclusions cannot be drawn about the effectiveness of interventions in this population because of the small number and poor quality of studies. As approximately 25% of PwMS are nonambulatory and considerable costs are associated with their care, it is imperative that efforts be to increase the quality of evidence for nonambulatory PwMS.

Development of a Feasible Implementation Fidelity Protocol Within a Complex Physical Therapy-Led Self-Management Intervention.

Background Implementation fidelity is poorly addressed within physical therapy interventions, which may be due to limited research on how to develop and implement an implementation fidelity protocol. Objective The purpose of this study was to develop a feasible implementation fidelity protocol within a pilot study of a physical therapy–led intervention to promote self-management for people with chronic low back pain or osteoarthritis. Design A 2-phase mixed-methods design was used. Methods Phase 1 involved the development of an initial implementation fidelity protocol using qualitative interviews with potential stakeholders to explore the acceptability of proposed strategies to enhance and assess implementation fidelity. Phase 2 involved testing and refining the initial implementation fidelity protocol to develop a finalized implementation fidelity protocol. Specifically, the feasibility of 3 different strategies (physical therapist self-report checklists, independently rated direct observations, and audio-recorded observations) for assessing implementation fidelity of intervention delivery was tested, followed by additional stakeholder interviews that explored the overall feasibility of the implementation fidelity protocol. Results Phase 1 interviews determined the proposed implementation fidelity strategies to be acceptable to stakeholders. Phase 2 showed that independently rated audio recordings (n=6) and provider self-report checklists (n=12) were easier to implement than independently rated direct observations (n=12) for assessing implementation fidelity of intervention delivery. Good agreement (79.8%–92.8%) was found among all methods. Qualitative stakeholder interviews confirmed the acceptability, practicality, and implementation of the implementation fidelity protocol. Limitations The reliability and validity of assessment checklists used in this study have yet to be fully tested, and blinding of independent raters was not possible. Conclusions A feasible implementation fidelity protocol was developed based on a 2-phase development process involving intervention stakeholders. This study provides valuable information on the feasibility of rigorously addressing implementation fidelity within physical therapy interventions and provides recommendations for researchers wanting to address implementation fidelity in similar areas.

Using mixed methods to assess fidelity of delivery and its influencing factors in a complex self-management intervention for people with osteoarthritis and low back pain

Objectives and design Despite an increasing awareness of the importance of fidelity of delivery within complex behaviour change interventions, it is often poorly assessed. This mixed methods study aimed to establish the fidelity of delivery of a complex self-management intervention and explore the reasons for these findings using a convergent/triangulation design. Setting Feasibility trial of the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention (ISRCTN49875385), delivered in primary care physiotherapy. Methods and outcomes 60 SOLAS sessions were delivered across seven sites by nine physiotherapists. Fidelity of delivery of prespecified intervention components was evaluated using (1) audio-recordings (n=60), direct observations (n=24) and self-report checklists (n=60) and (2) individual interviews with physiotherapists (n=9). Quantitatively, fidelity scores were calculated using percentage means and SD of components delivered. Associations between fidelity scores and physiotherapist variables were analysed using Spearmans correlations. Interviews were analysed using thematic analysis to explore potential reasons for fidelity scores. Integration of quantitative and qualitative data occurred at an interpretation level using triangulation. Results Quantitatively, fidelity scores were high for all assessment methods; with self-report (92.7%) consistently higher than direct observations (82.7%) or audio-recordings (81.7%). There was significant variation between physiotherapists’ individual scores (69.8% - 100%). Both qualitative and quantitative data (from physiotherapist variables) found that physiotherapists’ knowledge (Spearmans association at p=0.003) and previous experience (p=0.008) were factors that influenced their fidelity. The qualitative data also postulated participant-level (eg, individual needs) and programme-level factors (eg, resources) as additional elements that influenced fidelity. Conclusion The intervention was delivered with high fidelity. This study contributes to the limited evidence regarding fidelity assessment methods within complex behaviour change interventions. The findings suggest a combination of quantitative methods is suitable for the assessment of fidelity of delivery. A mixed methods approach provided a more insightful understanding of fidelity and its influencing factors. Trial registration number ISRCTN49875385; Pre-results.

Sexual counselling for patients with cardiovascular disease: protocol for a pilot study of the CHARMS sexual counselling intervention

Introduction Sexual problems are common with cardiovascular disease, and can negatively impact quality of life. To address sexual problems, guidelines have identified the importance of sexual counselling during cardiac rehabilitation, yet this is rarely provided. The Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention aims to improve the provision of sexual counselling in cardiac rehabilitation in Ireland. Methods and analysis This is a multicentre pilot study for the CHARMS intervention, a complex, multilevel intervention delivered within hospital-based cardiac rehabilitation programmes. The intervention includes (1) training in sexual counselling for staff, (2) a staff-led patient education and support intervention embedded within the cardiac rehabilitation programme, (3) a patient information booklet and (4) an awareness raising poster. The intervention will be delivered in two randomly selected cardiac rehabilitation centres. In each centre 30 patients will be recruited, and partners will also be invited to participate. Data will be collected from staff and patients/partners at T1 (study entry), T2 (3-month follow-up) and T3 (6-month follow-up). The primary outcome for patients/partners will be scores on the Sexual Self-Perception and Adjustment Questionnaire. Secondary outcomes for patients/partners will include relationship satisfaction; satisfaction with and barriers to sexual counselling in services; sexual activity, functioning and knowledge; physical and psychological well-being. Secondary outcomes for staff will include sexuality-related practice; barriers to sexual counselling; self-ratings of capability, opportunity and motivation; sexual attitudes and beliefs; knowledge of cardiovascular disease and sex. Fidelity of intervention delivery will be assessed using trainer self-reports, researcher-coded audio recordings and exit interviews. Longitudinal feasibility data will be gathered from patients/partners and staff via questionnaires and interviews. Ethics and dissemination This study is approved by the Research Ethics Committee (REC) of the National University of Ireland, Galway. Findings will be disseminated to cardiac rehabilitation staff, patients/partners and relevant policymakers via appropriate publications and presentations.

Effects of healthcare professional delivered early feeding interventions on feeding practices and dietary intake: A systematic review

BACKGROUND Childhood obesity is a global public health challenge. Parental feeding practices, such as responsive feeding, are implicated in the etiology of childhood obesity. PURPOSE This systematic review aimed to examine of effects of healthcare professional-delivered early feeding interventions, on parental feeding practices, dietary intake, and weight outcomes for children up to 2 years. The role of responsive feeding interventions was also specifically examined. METHODS Databases searched included: CINAHL, the Cochrane Library, EMBASE, Medline, PubMed, PsycINFO, and Maternity and Infant Care. INCLUSION CRITERIA participants are parents of children ≤2 years; intervention includes focus on early child feeding to prevent overweight and obesity; intervention delivered by healthcare professionals. RESULTS Sixteen papers, representing 10 trials, met inclusion criteria for review. Six interventions included responsive feeding components. Interventions demonstrated inconsistent effects on feeding practices, dietary intake, and weight outcomes. Findings suggest some reductions in pressure to eat and infant consumption of non-core beverages. Responsive feeding based interventions demonstrate greater improvements in feeding approaches, and weight outcomes. CONCLUSIONS The findings of this review highlight the importance of incorporating responsive feeding in healthcare professional delivered early feeding interventions to prevent childhood obesity. Observed inconsistencies across trials may be explained by methodological limitations.

Parental experiences and perceptions of infant complementary feeding: a qualitative evidence synthesis: Infant complementary feeding experiences and perceptions

Interventions to prevent childhood obesity increasingly focus on infant feeding, but demonstrate inconsistent effects. A comprehensive qualitative evidence synthesis is essential to better understand feeding behaviours and inform intervention development. The aim of this study is to synthesize evidence on perceptions and experiences of infant feeding and complementary feeding recommendations.

Parental experiences and perceptions of infant complementary feeding: a qualitative evidence synthesis.

Background: Current childhood obesity interventions increasingly focus on infant feeding but often do so without considering parental perceptions and experiences. Qualitative research on infant feeding has yet to be systematically evaluated to inform intervention development. A qualitative evidence synthesis (QES) of the extant literature focusing on experiences, barriers and facilitators to healthy infant feeding and feeding guideline adherence is therefore crucial. Methods: A QES of papers examining caregivers’ experiences of complementary feeding and weaning of infants (< 2 years) was conducted. Twenty-three papers, comprising 1047 participants, were included in the QES. A ‘Best Fit’ Framework Synthesis approach, with the COM-B model as the analysis framework, was used. Themes emerging from the data that were not accounted for by the COM-B model were added to the coding framework. Results: Beliefs about health and behavioural outcomes, and daily pressures and time constraints, are important considerations for parental feeding approaches. Infant feeding guidelines and advice are more likely valued and adhered to when they are consistent, from a trusted and experienced source, and are compatible with caregiver experiences. The role of ‘maternal instinct’ guides much infant feeding and often justifies lack of adherence to feeding guidelines. Discussion: The key factors in infant feeding relate to presentation and trust in infant feeding advice. How guidelines correspond to feeding beliefs, experiences and beliefs about capabilities further influence parental engagement in healthy feeding practices. The findings of this review highlight key areas for intervention to help improve infant feeding for childhood overweight and obesity.