Lessons learned about development and assessment of feasibility of tools for health and rehabilitation services.

BACKGROUND: Given the dire need for health and rehabilitation services internationally, exacerbated during the COVID-19 pandemic, there is a critical need to develop tools to support service delivery. This need is palpable in the Global South where tools developed in Eurocentric contexts are not always adaptable, applicable, or relevant. It is for this reason that the researchers present three case studies of tool development using pilot and feasibility studies in South Africa and share the lessons learned from these studies. OBJECTIVES: To describe three case studies that developed new tools for health and rehabilitation services using pilot and feasibility studies. To synthesize lessons learned from these case studies on the development of tools. METHOD: The researchers describe three case studies that were developed. The case studies are summarized as follows: aims and objectives, context, problem, study design, findings, and what happened after the study. Thereafter, a qualitative cross-case analysis was conducted by the researchers to generate themes. FINDINGS: The case studies are described individually and followed by themes identified through cross-case analysis. DISCUSSION: The lessons learned are discussed. It is essential to develop new tools and protocols, motivated by the need for equitable and contextually relevant practices. Partnerships and collaboration with end-users are critical for success. A critical, scientific process is essential in developing new tools. Pilot and feasibility studies are invaluable in developing tools and assessing the feasibility of tools and implementation. The goal is to develop practical, usable tools and protocols. CONCLUSION: Through the lessons learned, the researchers are hopeful that the international health and rehabilitation professions will continue to strengthen the scientific development of contextually relevant tools and resources.

Emerging professional practices focusing on reducing inequity in speech-language therapy and audiology: a scoping review.

BACKGROUND: For the professions of audiology and speech-language therapy (A/SLT), there continues be a dire need for more equitable services. Therefore there is a need to develop emerging practices which have a specific focus on equity as a driving force in shifting practices. This scoping review aimed to synthesise the characteristics of emerging practices in A/SLT clinical practice in relation to equity with an emphasis on communication professions. METHODS: This scoping review followed the Joanna Briggs Institute guidelines and aimed to map the emerging practices in A/SLT to identify the ways in which the professions are developing equitable practices. Papers were included if they addressed equity, focused on clinical practice and were situated within A/SLT literature. There were no time or language restrictions. The review included all sources of evidence across PubMed, Scopus, EbscoHost, The Cochrane Library and Dissertation Abstracts International, Education Resource Information Centre from their inception. The review uses PRISMA Extension for scoping reviews and PRISMA-Equity Extension reporting guidelines. RESULTS: The 20 included studies ranged from 1997-2020, spanning over 20 years. There were a variety of papers including empirical studies, commentaries, reviews and research. The results demonstrated that the professions were increasingly considering addressing equity through their practice. However, there was a prominent focus around culturally and linguistically diverse populations, with limited engagement around other intersections of marginalisation. The results also showed that while the majority of contributions to theorising equity are from the Global North with a small cluster from the Global South offering critical contributions considering social categories such as race and class. Collectively the contributions from the Global South remain a very small minority of the professional discourse which have a focus on equity. CONCLUSION: Over the last eight years, the A/SLT professions are increasingly developing emerging practices to advance equity by engaging with marginalised communities. However, the professions have a long way to go to achieve equitable practice. The decolonial lens acknowledges the impact and influence of colonisation and coloniality in shaping inequity. Using this lens, we argue for the need to consider communication as a key aspect of health necessary to achieve health equity.

A survey of communication supports in Grade R classrooms in the Western Cape, South Africa.

BACKGROUND:  Early classroom communication supports are critical in influencing oral language development and emergent literacy skills. It is both support from peers and adults, as well as the environment that impacts the quality and efficacy of language learning. Schools in particular play a key role in communication development, which will be further explored in this article. OBJECTIVES:  To describe how communication was being supported in the classroom by teachers in the areas of language-learning environment (LLE), language-learning interactions (LLIs) and language-learning opportunities (LLOs) to focus on classroom communication supports to strengthen literacy outcomes for Grade R learners. METHOD:  A cross-sectional descriptive survey of classrooms was conducted using a structured observation method in 136 classrooms. The Communication Supporting Classroom Observation Tool was used to make 223 observations across classrooms of LLE (19 items), LLI (20 items) and LLO (5 items). A descriptive analysis of frequency of occurrence of items was conducted for each domain. RESULTS:  Language-learning environment had more frequently occurring observations, with 12 out of 19 items being observed with a frequency of occurrence greater than 65%, indicating that the environment had adequate basic resources (e.g. good light). Language-learning interactions scores indicated that 3 out of 20 items were observed frequently, while 17 out of 20 items were observed less frequently (56.5%), including interactive strategies (e.g. turn-taking). Language Learning Opportunities scores indicated that teacher-led behaviours (e.g. including children in small group activities) were infrequently observed on all items. CONCLUSION:  While the physical environment was generally supportive, the behaviours in the interactive domains of LLI and LLO were observed less frequently. There is potential for speech-language therapists to work collaboratively with teachers to develop communication supporting classrooms as a critical primary-level intervention for language-literacy learning.

Emerging professional practices focusing on reducing inequity in speech-language therapy and audiology: a scoping review protocol.

BACKGROUND: Human communication is essential for socialising, learning and working. Disabilities and social disadvantage have serious negative consequences on communication which can impact development from early life into adulthood. While speech-language therapists and audiologists (SLT/As) have an important role to play in addressing communication disability and disadvantage, services continue to be inaccessible, unaffordable and unattainable for the majority population. In order to support this large population, it is necessary to reimagine SLT/A practices in line with equity and social inclusion. Recently in the literature, there have been increasing calls for professions to reduce inequities in practice as indicated by the sustainable development goals, human rights and social inclusion approaches increasing in prominence. For the scoping review, equity is understood using the colonial matrix of power to understand how intersections of race, gender, class, disability, geography, heteronormativity and language create the context for inequity. As such, the aim of the scoping review is to address the following question: what are the emerging professional practices in SLT/A focused on reducing inequities? METHODS: Following the Joanna Briggs Institute guidelines, this scoping review will focus on systematically mapping the documented emerging clinical practices in SLT/A in the literature to identify how the professions are developing equitable practices. The search will include electronic databases and grey literature including PubMed, Scopus, EbscoHost, The Cochrane Library and Dissertation Abstracts International, Education Resource Information Centre from their inception onwards. Published and unpublished literature including all evidence sources will be considered. There should be a clear focus on clinical practice addressing equity in SLT/A. There will be no language limitations for the study. The authors will endeavour translate to have abstracts of articles translated. There will be no time restrictions on date of publication of the literature. DISCUSSION: We aim to review the current literature on emerging professional practices in relation to equity in SLT/A to identify emerging trends in clinical practice. It is our goal to provide a synthesis of emerging directions for practice, particularly to inform future practices in the Global South. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework ( osf.io/3a29w ).

Comprehensive Morpho-Functional and Dental Rehabilitation of a Complete Unilateral Cleft Lip and Palate Patient.

Congenital clefts cause compromised function and esthetics, inadvertently affecting a patient's social and mental health. These defects can be successfully managed by a multidisciplinary team that can provide holistic care from birth till adulthood and beyond. A 17-year-old girl with left side congenital cleft, who had undergone cleft surgeries at our center, reported with a chief complaint of a missing front tooth in the upper region. Clinical and radiographic investigations showed a need for tertiary grafting, which was done using an autologous iliac graft. After six months, a dental implant was placed and immediately loaded after implant stability quotient assessment. Treatment of cleft patients is arduous and technique sensitive and should be done following pre-defined protocols. Each case should be handled by a multidisciplinary team giving attention to each aspect of the treatment requirement. It is an added advantage if the treatment is holistically catered at a single center as it provides patient comfort and avoids patient dependence on past records.

Assessment of Outcomes of Immediately Loaded Dental Implants in Orofacial Cleft Patients: Protocol for a Single-Arm Clinical Trial.

BACKGROUND: Orofacial cleft, one of the most common congenital deformities, presents with a plethora of defects, subjecting the patient to a multitude of treatments from a young age. Among the oral hard tissue problems, absence of a maxillary permanent tooth in the cleft region either due to congenital absence or extraction due to compromised prognosis is a common finding. Conventionally, the missing tooth is replaced using a removable or fixed partial denture; however, the treatment modality does not satisfactorily meet patient expectations. The most recent decade has seen increasing use of dental implants in the cleft region; however, the outcome of an immediately loaded dental implant is still elusive for orofacial cleft patients. OBJECTIVE: This protocol is for a single-arm clinical trial aimed at determining the treatment outcome of immediately loaded dental implants in patients with a nonsyndromic orofacial cleft. METHODS: Patients meeting the set criteria will be sequentially enrolled until a sample size of 30 dental implants is met and will undergo the proposed treatment according to the predecided protocol. All patients will be followed up at the designated time intervals to record various clinical and radiographic parameters. Implant success will be defined based on the criteria elucidated by Misch et al in the Pisa, Italy Consensus. A quality-of-life assessment questionnaire will also be recorded at the end of patient's follow-up to determine their acceptance of the treatment. RESULTS: A total of 30 dental implants will be placed in patients with a nonsyndromic orofacial cleft. Obtained results will be statistically analyzed to determine the treatment outcomes and success. CONCLUSIONS: This study will help determine the feasibility of immediately loaded dental implants in compromised bone sites such as those presented in cleft patients and will help in generating findings that can be used to fill the lacunae currently present in the holistic treatment of cleft patients. TRIAL REGISTRATION: Clinical Trial Registry of India CTRI/2020/09/027997; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=47659&EncHid=&userName=dental%20implants. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/25244.

Sensitivity of methods for analyzing continuous outcome from stratified cluster randomized trials - an empirical comparison study.

The assessment of the sensitivity of statistical methods has received little attention in cluster randomized trials (CRTs), especially for stratified CRT when the outcome of interest is continuous. We empirically examined the sensitivity of five methods for analyzing the continuous outcome from a stratified CRT - aimed to investigate the efficacy of the Classroom Communication Resource (CCR) compared to usual care to improve the peer attitude towards children who stutter among grade 7 students. Schools - the clusters, were divided into quintile based on their socio-political resources, and then stratified by quintile. The schools were then randomized to CCR and usual care groups in each stratum. The primary outcome was Stuttering Resource Outcomes Measure. Five methods, including the primary method, were used in this study to examine the effect of CCR. The individual-level methods were: (i) linear regression; (ii) mixed-effects method; (iii) GEE with exchangeable correlation structure (primary method of analysis). And the cluster-level methods were: (iv) cluster-level linear regression; and (v) meta-regression. These methods were also compared with or without adjustment for stratification. Ten schools were stratified by quintile, and then randomized to CCR (223 students) and usual care (231 students) groups. The direction of the estimated differences was same for all the methods except meta-regression. The widths of the 95% confidence intervals were narrower when adjusted for stratification. The overall conclusion from all the methods was similar but slightly differed in terms of effect estimate and widths of confidence intervals. TRIALREGISTRATION: Clinicaltrials.gov, NCT03111524. Registered on 9 March 2017.

A cluster randomised trial of a classroom communication resource program to change peer attitudes towards children who stutter among grade 7 students.

BACKGROUND: Classroom-based stuttering intervention addressing negative peer attitudes, perceptions, teasing and bullying of children who stutter (CWS) is required as part of holistic stuttering management because of its occurrence in primary school. This study was conducted in 2017, in 10 primary schools in the Western Cape, South Africa within lower (second and third) and higher (fourth and fifth) quintiles. OBJECTIVES: The primary objective of this study was to determine treatment effect at six months after intervention of grade 7 participants (Classroom Communication Resource [CCR] intervention versus no CCR) using global Stuttering Resource Outcomes Measure (SROM) scores in school clusters. The secondary objective was to determine grade 7 participant treatment effect on the SROM subscales including Positive Social Distance (PSD), Social Pressure (SP) and Verbal Interaction (VI). The subgroup objective was to determine any difference in the primary outcome between schools between and across quintile clusters (lower and higher). METHODS: Once schools were stratified into lower and higher quintile (which are defined according to geographical location, fee per school and resources) subgroup clusters, schools were assigned randomly to control and intervention groups consisting of grade 7 participants who were typically aged ≥ 11 years. Teachers received 1 h of training before administering the single-dose CCR intervention over a 60-90-min session. The CCR intervention included a social story, role-play and discussion. All participants viewed a video of a CWS and stuttering was defined at baseline. The SROM measured peer attitudes at six months after intervention. Randomisation was stratified by quintile group using a 1:1 allocation ratio. Full blinding was not possible; however, the outcome assessor was partially blinded and the analyst was also blinded. Generalised estimating equations (GEE) was used assuming an exchangeable correlation structure to analyse the data adopting an intention-to-treat principle. Multiple imputation was used to handle missing data. Criterion for statistical significance was set at alpha = 0.05. RESULTS: Ten schools were randomly allocated to control (k = 5) and intervention groups (k = 5), with n = 223 participants allocated to intervention and n = 231 to control groups. A total of 454 participants completed the SROMs in control (n = 231) and intervention (n = 223) groups and were analysed at baseline and six months after intervention. There was no statistically significant difference on the global SROM score (mean difference - 0.11; 95% confidence interval [CI] - 1.56-1.34; p = 0.88). There were also no significant differences on SROM subscales: PSD (mean difference 1.04; 95% CI - 1.02-311; p = 0.32), SP (mean difference - 0.45; 95% CI - 1.22-0.26; p = 0.21) and VI (mean difference 0.05; 95% CI - 1.01-1.11; p = 0.93). Additionally, there was no significant subgroup effect on the global SROM score (lower versus higher quintile subgroups) (interaction p value = 0.52). No harms were noted or reported. CONCLUSION: No statistically significant differences were noted. It is possible that the time frame was too short to note changes in peer attitudes and that further study is required to confirm the findings of this study. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03111524 . Registered on 9 March 2017.

A pilot study to determine the feasibility of a cluster randomised controlled trial of an intervention to change peer attitudes towards children who stutter.

BACKGROUND:  While randomised controlled trials (RCTs) are considered the gold standard of research, prior study is needed to determine the feasibility of a future large-scale RCT study. Objectives: This pilot study, therefore, aimed to determine feasibility of an RCT by exploring: (1) procedural issues and (2) treatment effect of the Classroom Communication Resource (CCR), an intervention for changing peer attitudes towards children who stutter. Method: A pilot cluster stratified RCT design was employed whereby the recruitment took place first at school-level and then at individual level. The dropout rate was reported at baseline, 1 and 6 months post-intervention. For treatment effect, schools were the unit of randomisation and were randomised to receive either the CCR intervention administered by teachers or usual practice, using a 1:1 allocation ratio. The stuttering resource outcomes measure (SROM) measured treatment effect at baseline, 1 and 6 months post-intervention overall and within the constructs (positive social distance, social pressure and verbal interaction). Results: For school recruitment, 11 schools were invited to participate and 82% (n = 9) were recruited. Based on the school recruitment, N = 610 participants were eligible for this study while only n = 449 were recruited, where there was n = 183 in the intervention group and n = 266 in the control group. The dropout rate from recruitment to baseline was as follows: intervention, 23% (n = 34), and control, 6% (n = 15). At 1 month a dropout rate of 7% (n = 10) was noted in the intervention and 6% (n = 15) in the control group, whereas at 6 months, dropout rates of 7% (n = 10) and 17% (n = 44) were found in the intervention and control groups, respectively. For treatment effect on the SROM, the estimated mean differences between intervention and control groups were (95% Confidence Interval (CI): -1.07, 5.11) at 1 month and 3.01 (95% CI: -0.69, 6.69) at 6 months. A statistically significant difference was observed at 6 months on the VI subscale of the SROM, with 1.35 (95% CI: 0.58, 2.13). Conclusion: A high recruitment rate of schools and participants was observed with a high dropout rate of participants. Significant differences were only noted at 6 months post-intervention within one of the constructs of the SROM. These findings suggest that a future RCT study is warranted and feasible.

The Classroom Communication Resource (CCR) intervention to change peer's attitudes towards children who stutter (CWS): study protocol for a randomised controlled trial.

BACKGROUND: Children who stutter (CWS) are at a high-risk of being teased and bullied in primary school because of negative peer attitudes and perceptions towards stuttering. There is little evidence to determine if classroom-based interventions are effective in changing peer attitudes towards stuttering. The primary objective is to determine the effect of the Classroom Communication Resource (CCR) intervention versus usual practice, measured using the Stuttering Resource Outcomes Measure (SROM) 6-months post-intervention among grade 7 students. The secondary objective is to investigate attitude changes towards stuttering among grade participants on the SROM subscales. METHODS: A cluster randomised controlled trial (RCT) will be conducted with schools as the unit of randomization. Schools will be stratified into quintile groups, and then randomized to receive the CCR intervention or usual practice. Quintile stratification will be conducted in accordance to the Western Cape Department of Education classification of schools according to geographical location, fee per school and allocation of resources and funding. Participants will include primary schools in the lower (second and third) and higher (fourth and fifth) quintiles and children aged 11 years or older in grade 7 will be included. The study will consist of the CCR intervention program or usual practice as a no-CCR control. The CCR is a classroom-based, teacher led intervention tool including a story, role-play and discussion. The grade 7 teachers allocated to the CCR intervention, will be trained and will administer the intervention. The analysis will follow intention-to-treat (ITT) principle and generalized estimating equations (GEE) to compare groups on the global SROM and its subscales to account for possible clustering within schools. The subgroup hypothesis will be tested by adding an interaction term of quintile group x intervention. DISCUSSION: This study is designed to assess whether the CCR intervention versus usual practice in schools will lead to positive shift in attitudes about stuttering at 6-months post-intervention among grade 7 participants. TRIAL REGISTRATION: The trial number is NCT03111524 . It was registered with clinical trials.gov Protocol registration and results system (PRS) retrospectively on 9 March 2017.