Patient-Reported Outcome Measures in Key Sub-Saharan African Languages to Promote Diversity: A Scoping Review.

OBJECTIVES: Sub-Saharan Africa is a world region rich and diverse in cultures and languages; yet, it is also challenged with regard to resources that may facilitate the cultural adaptation or development of patient-reported outcome measures (PROMs). Systematic exclusion of patients' "voices," because of gaps in the availability of PROMs, may perpetuate health inequity. Hence, the objective is to describe the availability of PROMs in the non-English, sub-Saharan African languages. METHODS: A scoping review was conducted to identify PROMs that had been translated, validated, or developed for use in 32 selected, non-English, sub-Saharan African languages pertaining to health outcomes. Four databases were searched (May 7, 2021), and additional articles were identified through reference screening and via corresponding authors. Data were extracted in terms of country, language, population, construct, and PROM characteristics (eg, number of items). RESULTS: A total of 220 unique articles were included from 7451 records, leading to the identification of 126 unique PROMs. Most studies were conducted in either Ethiopia, Nigeria, or South Africa. As such, prevalent languages included Amharic, Yoruba, and non-English languages common to South Africa (eg, Setswana, Xhosa, and Zulu). No PROMs were identified in any of the languages for 27 sub-Saharan African countries or 10 of the 32 included languages. CONCLUSIONS: There are significant gaps in the availability of PROMs across the non-English African languages included. Nevertheless, the PROMs that were identified largely align with core outcome sets relevant to the prevalent disease burden in this world region. Consensus-based priority setting may inform the most pertinent gaps to be addressed.

Unravelling 'low-resource settings': a systematic scoping review with qualitative content analysis.

INTRODUCTION: The effects of healthcare-related inequalities are most evident in low-resource settings. Such settings are often not explicitly defined, and umbrella terms which are easier to operationalise, such as 'low-to-middle-income countries' or 'developing countries', are often used. Without a deeper understanding of context, such proxies are pregnant with assumptions, insinuate homogeneity that is unsupported and hamper knowledge translation between settings. METHODS: A systematic scoping review was undertaken to start unravelling the term 'low-resource setting'. PubMed, Africa-Wide, Web of Science and Scopus were searched (24 June 2019), dating back ≤5 years, using terms related to 'low-resource setting' and 'rehabilitation'. Rehabilitation was chosen as a methodological vehicle due to its holistic nature (eg, multidisciplinary, relevance across burden of disease, and throughout continuum of care) and expertise within the research team. Qualitative content analysis through an inductive approach was used. RESULTS: A total of 410 codes were derived from 48 unique articles within the field of rehabilitation, grouped into 63 content categories, and identified nine major themes relating to the term 'low-resource setting'. Themes that emerged relate to (1) financial pressure, (2) suboptimal healthcare service delivery, (3) underdeveloped infrastructure, (4) paucity of knowledge, (5) research challenges and considerations, (6) restricted social resources, (7) geographical and environmental factors, (8) human resource limitations and (9) the influence of beliefs and practices. CONCLUSION: The emerging themes may assist with (1) the groundwork needed to unravel 'low-resource settings' in health-related research, (2) moving away from assumptive umbrella terms like 'low-to-middle-income countries' or 'low/middle-income countries' and (3) promoting effective knowledge transfer between settings.

Patient-Reported OUtcome measures in key African languages to promote Diversity in research and clinical practice (PROUD)-protocol for a systematic review of measurement properties.

INTRODUCTION: Sub-Saharan Africa is a subcontinent with a proud cultural richness and diversity, yet inexplicably also a region with severe health care challenges and inequity. To challenge this health equity gap and reduce the burden of disease, the patient's voice in monitoring and evaluation of health and health care interventions is paramount. The aim of this two-phased review is to map the availability of patient-reported outcome measures (PROMs) in a selection of non-English, African Languages, and systematically evaluate the measurement properties of the PROMs that were identified. METHODS: This systematic review will be conducted in two phases. In phase 1, we will scope the literature for patient-reported outcome measures (PROMs), either developed from scratch or through translation and validation in a sub-Saharan African country and a selection of non-English, African languages (n = 31; spoken in > 10 million people and/or a national language). The availability of PROMs will be mapped against the previously reported burden of disease in the respective countries included. Subsequently, in phase 2, we systematically evaluate the measurement properties of these PROMs using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology for systematic reviews on PROMs. To ensure rigour, secondary searches will be developed to specifically locate articles that report on the measurement properties of the PROMs identified during phase 1. The evidence will be graded using the modified GRADE approach. DISCUSSION: This review will provide a comprehensive overview and quality appraisal of PROMs developed in non-English, African languages. Consequently, this review when concluded may be an important first step in promoting access to these PROMs for use in clinical practice and research, as well as facilitate identification and prioritization of key knowledge gaps.

Cardiac rehabilitation delivery in low/middle-income countries.

OBJECTIVE: Cardiac rehabilitation (CR) availability, programme characteristics and barriers are not well-known in low/middle-income countries (LMICs). In this study, they were compared with high-income countries (HICs) and by CR funding source. METHODS: A cross-sectional online survey was administered to CR programmes globally. Need for CR was computed using incident ischaemic heart disease (IHD) estimates from the Global Burden of Disease study. General linear mixed models were performed. RESULTS: CR was identified in 55/138 (39.9%) LMICs; 47/55 (85.5% country response rate) countries participated and 335 (53.5% programme response) surveys were initiated. There was one CR spot for every 66 IHD patients in LMICs (vs 3.4 in HICs). CR was most often paid by patients in LMICs (n=212, 65.0%) versus government in HICs (n=444, 60.2%; p<0.001). Over 85% of programmes accepted guideline-indicated patients. Cardiologists (n=266, 89.3%), nurses (n=234, 79.6%; vs 544, 91.7% in HICs, p=0.001) and physiotherapists (n=233, 78.7%) were the most common providers on CR teams (mean=5.8±2.8/programme). Programmes offered 7.3±1.8/10 core components (vs 7.9±1.7 in HICs, p<0.01) over 33.7±30.7 sessions (significantly greater in publicly funded programmes; p<0.001). Publicly funded programmes were more likely to have social workers and psychologists on staff, and to offer tobacco cessation and psychosocial counselling. CONCLUSION: CR is only available in 40% of LMICs, but where offered is fairly consistent with guidelines. Governments should enact policies to reimburse CR so patients do not pay out-of-pocket.

Patient-centred rehabilitation for non-communicable disease in a low-resource setting: study protocol for a feasibility and proof-of-concept randomised clinical trial.

INTRODUCTION: Non-communicable diseases (NCDs) are the leading cause of death globally. Even though NCD disproportionally affects low-to-middle income countries, these countries including South Africa, often have limited capacity for the prevention and control of NCDs. The standard evidence-based care for the long-term management of NCDs includes rehabilitation. However, evidence for the effectiveness of rehabilitation for NCDs originates predominantly from high-income countries. Despite the disproportionate disease burden in low-resourced settings, and due to the complex context and constraints in these settings, the delivery and study of evidence-based rehabilitation treatment in a low-resource setting is poorly understood. This study aims to test the design, methodology and feasibility of a minimalistic, patient-centred, rehabilitation programme for patients with NCD specifically designed for and conducted in a low-resource setting. METHODS AND ANALYSIS: Stable patients with cancer, cardiovascular disease, chronic respiratory disease and/or diabetes mellitus will be recruited over the course of 1 year from a provincial day hospital located in an urban, low-resourced setting (Bishop Lavis, Cape Town, South Africa). A postponed information model will be adopted to allocate patients to a 6-week, group-based, individualised, patient-centred rehabilitation programme consisting of multimodal exercise, exercise education and health education; or usual care (ie, no care). Outcomes include feasibility measures, treatment fidelity, functional capacity (eg, 6 min walking test), physical activity level, health-related quality of life and a patient-perspective economic evaluation. Outcomes are assessed by a blinded assessor at baseline, postintervention and 8-week follow-up. Mixed-method analyses will be conducted to inform future research. ETHICS AND DISSEMINATION: This study has been approved by the Health Research and Ethics Council, Stellenbosch University (M17/09/031). Information gathered in this research will be published in peer-reviewed journals, presented at national and international conferences, as well as local stakeholders. TRIAL REGISTRATION NUMBER: PACTR201807847711940; Pre-results.

Real-Time Assessment of Fatigue in Patients With Multiple Sclerosis: How Does It Relate to Commonly Used Self-Report Fatigue Questionnaires?

OBJECTIVES: (1) To assess real-time patterns of fatigue; (2) to assess the association between a real-time fatigue score and 3 commonly used questionnaires (Checklist Individual Strength [CIS] fatigue subscale, Modified Fatigue Impact Scale (MFIS), and Fatigue Severity Scale [FSS]); and (3) to establish factors that confound the association between the real-time fatigue score and the conventional fatigue questionnaires in patients with multiple sclerosis (MS). DESIGN: Cross-sectional study. SETTING: MS-specialized outpatient facility. PARTICIPANTS: Ambulant patients with MS (N=165) experiencing severe self-reported fatigue. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A real-time fatigue score was assessed by sending participants 4 text messages on a particular day (How fatigued do you feel at this moment?; score range, 0-10). Latent class growth mixed modeling was used to determine diurnal patterns of fatigue. Regression analyses were used to assess the association between the mean real-time fatigue score and the CIS fatigue subscale, MFIS, and FSS. Significant associations were tested for candidate confounders (eg, disease severity, work status, sleepiness). RESULTS: Four significantly different fatigue profiles were identified by the real-time fatigue score, namely a stable high (n=79), increasing (n=57), stable low (n=16), and decreasing (n=13). The conventional questionnaires correlated poorly (r<.300) with the real-time fatigue score. The Epworth Sleepiness Scale significantly reduced the regression coefficient between the real-time fatigue score and conventional questionnaires, ranging from 15.4% to 35%. CONCLUSIONS: Perceived fatigue showed 4 different diurnal patterns in patients with MS. Severity of sleepiness is an important confounder to take into account in the assessment of fatigue.

The effectiveness of aerobic training, cognitive behavioural therapy, and energy conservation management in treating MS-related fatigue: the design of the TREFAMS-ACE programme.

BACKGROUND: TREFAMS is an acronym for TReating FAtigue in Multiple Sclerosis, while ACE refers to the rehabilitation treatment methods under study, that is, Aerobic training, Cognitive behavioural therapy, and Energy conservation management. The TREFAMS-ACE research programme consists of four studies and has two main objectives: (1) to assess the effectiveness of three different rehabilitation treatment strategies in reducing fatigue and improving societal participation in patients with MS; and (2) to study the neurobiological mechanisms of action that underlie treatment effects and MS-related fatigue in general. METHODS/DESIGN: Ambulatory patients (n = 270) suffering from MS-related fatigue will be recruited to three single-blinded randomised clinical trials (RCTs). In each RCT, 90 patients will be randomly allocated to the trial-specific intervention or to a low-intensity intervention that is the same for all RCTs. This low-intensity intervention consists of three individual consultations with a specialised MS-nurse. The trial-specific interventions are Aerobic Training, Cognitive Behavioural Therapy, and Energy Conservation Management. These interventions consist of 12 individual therapist-supervised sessions with additional intervention-specific home exercises. The therapy period lasts 16 weeks. All RCTs have the same design and the same primary outcome measures: fatigue - measured with the Checklist Individual Strength, and participation - measured with the Impact on Participation and Autonomy questionnaire. Outcomes will be assessed 1 week prior to, and at 0, 8, 16, 26 and 52 weeks after randomisation. The assessors will be blinded to allocation. Pro- and anti-inflammatory cytokines in serum, salivary cortisol, physical fitness, physical activity, coping, self-efficacy, illness cognitions and other determinants will be longitudinally measured in order to study the neurobiological mechanisms of action. DISCUSSION: The TREFAMS-ACE programme is unique in its aim to assess the effectiveness of three rehabilitation treatments. The programme will provide important insights regarding the most effective treatment for MS-related fatigue and the mechanisms that underlie treatment response. A major strength of the programme is that the design involves three almost identical RCTs, enabling a close comparison of the treatment strategies and a strong overall meta-analysis. The results will also support clinical practice guidelines for the treatment of MS-related fatigue. TRIAL REGISTRATIONS: Current Controlled Trials ISRCTN69520623, ISRCTN58583714, and ISRCTN82353628.