RESUMEN
BACKGROUND: Despite the high prevalence of musculoskeletal (MSK) pain in children, there is a lack of instruments to measure the impact of MSK pain on children's activity and participation. OBJECTIVE: To assess the reliability and construct validity of the Pediatric MSK Pain Impact summary score in school children (aged 9 to 12) with MSK pain. METHODS: We used a pragmatic approach in a reflective framework to assess internal consistency, structural validity, convergent validity, and discriminative validity in a sample of 615 children with MSK pain. RESULTS: The confirmatory factor analysis results indicate that the summary score has limited internal consistency and construct validity. The estimated Cronbach's alpha was 0.63, and most goodness of fit indices met the recommended thresholds (SRMR = 0.030; GFI = 0.993, CFI = 0.955, RMSEA 0.073), although they were close to the lower bounds of the thresholds. The convergent validity showed appropriate correlation of the summary score with quality of life (r = -0.33), care-seeking (r = 0.45), and medication intake (r = 0.37). Discriminative validity showed that the instrument can discriminate between the impact of pain on children with frequent and infrequent (2.93; 95% CI: 2.36 - 3.50) MSK pain. CONCLUSION: The Pediatric MSK Pain Impact summary showed limited internal consistency and construct validity; however, it can discriminate between children with frequent and infrequent pain. The results are promising for clinical and research practices as it is a short and convenient tool to be used in school-aged children.
Asunto(s)
Dolor Musculoesquelético , Calidad de Vida , Humanos , Dolor Musculoesquelético/fisiopatología , Niño , Reproducibilidad de los Resultados , Dimensión del Dolor/métodos , Encuestas y Cuestionarios , Psicometría/métodosRESUMEN
BACKGROUND: Estimates of prevalence of musculoskeletal pain in children and adolescents vary considerably and the impact of pain on children's life is often not considered. OBJECTIVE: To determine the one-month prevalence of disabling musculoskeletal pain in children and adolescents. The secondary aims are to: 1) determine the body region with the highest prevalence; 2) understand the characteristics of the children with disabling musculoskeletal pain; and 3) describe the parents' perception of the prevalence. METHODS: This cross-sectional study was conducted in public and private schools in the states of São Paulo and Ceará, Brazil. Children self-reported presence and impact of pain, pain intensity, psychosomatic symptoms, and quality of life. Parents completed parent-proxy versions and perception of the child's sleep quality. Descriptive statistics were used to summarise the data. RESULTS: A total of 2,688 children and adolescents were included in this study. The prevalence of disabling musculoskeletal pain in the previous month was 27.1%. The back was the region most often affected (51.8%). Children with disabling musculoskeletal pain were older, heavier, had worse relationships with their family, perceived their backpacks as heavy, carried their backpacks more with one shoulder, had more negative psychosomatic symptoms, had poorer quality of life, and had higher pain intensity. Parents tended to underestimate the presence of pain in their children. CONCLUSION: The one-month prevalence of activity limiting musculoskeletal pain in children and adolescents was 27.1% with the back being the most often affected body region. Parents tended to underestimate the presence of pain in their children.
Asunto(s)
Dolor Musculoesquelético , Niño , Humanos , Adolescente , Dolor Musculoesquelético/epidemiología , Estudios Transversales , Calidad de Vida , Prevalencia , Brasil/epidemiología , Encuestas y CuestionariosRESUMEN
ABSTRACT: Studies suggest a high economic burden among children and adolescents with musculoskeletal pain. There is no summary in the literature on the overall economic burden of musculoskeletal pain in children and adolescents. The aim of this systematic review of cost-of-illness studies was to synthesize the economic burden of musculoskeletal pain in children and adolescents. We conducted electronic searches on MEDLINE, EMBASE, CINAHL, EconLit, NHSEED, and HTA databases. We included cost-of-illness studies that estimated healthcare, patient/family, lost productivity, and/or societal costs in children and adolescents with musculoskeletal pain. The risk of bias was assessed with the Consolidated Health Economic Evaluation Reporting Standards checklist. All values were adjusted to the same reference year (2021) and converted to American Dollar. We included 45 cost-of-illness studies (n = 665,623). Twenty-two studies estimated the annual healthcare costs that ranged from $143 to $41,379 per patient. Nine studies estimated the annual patient/family costs that ranged from $287 to $27,972 per patient. Seven studies estimated the annual lost productivity costs that ranged from $124 to $4671 per patient. Nine studies estimated the annual societal costs that ranged from $1095 to $69,351 per patient. Children and adolescents with juvenile idiopathic arthritis and musculoskeletal pain had higher annual incremental healthcare costs than those without these conditions (mean difference: $3800 higher, 95% confidence interval [CI]: 50-7550; mean difference: $740 higher, 95% CI: 470-1,010, respectively). In conclusion, the estimated annual economic burden of children and adolescents with musculoskeletal pain ranged from $124 to $69,351.
Asunto(s)
Dolor Musculoesquelético , Niño , Humanos , Adolescente , Estrés Financiero , Atención a la Salud , Costos de la Atención en Salud , Costo de EnfermedadRESUMEN
BACKGROUND: Chronic pain is a major health and socioeconomic burden, which is prevalent in children and adolescents. Among the most widely used interventions in children and adolescents are physical activity (including exercises) and education about physical activity. OBJECTIVES: To evaluate the effectiveness of physical activity, education about physical activity, or both, compared with usual care (including waiting-list, and minimal interventions, such as advice, relaxation classes, or social group meetings) or active medical care in children and adolescents with chronic musculoskeletal pain. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, PEDro, and LILACS from the date of their inception to October 2022. We also searched the reference lists of eligible papers, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared physical activity or education about physical activity, or both, with usual care (including waiting-list and minimal interventions) or active medical care, in children and adolescents with chronic musculoskeletal pain. DATA COLLECTION AND ANALYSIS: Two review authors independently determined the eligibility of the included studies. Our primary outcomes were pain intensity, disability, and adverse events. Our secondary outcomes were depression, anxiety, fear avoidance, quality of life, physical activity level, and caregiver distress. We extracted data at postintervention assessment, and long-term follow-up. Two review authors independently assessed risk of bias for each study, using the RoB 1. We assessed the overall certainty of the evidence using the GRADE approach. We reported continuous outcomes as mean differences, and determined clinically important differences from the literature, or 10% of the scale. MAIN RESULTS: We included four studies (243 participants with juvenile idiopathic arthritis). We judged all included studies to be at unclear risk of selection bias, performance bias, and detection bias, and at high risk of attrition bias. We downgraded the certainty of the evidence for each outcome to very low due to serious or very serious study limitations, inconsistency, and imprecision. Physical activity compared with usual care Physical activity may slightly reduce pain intensity (0 to 100 scale; 0 = no pain) compared with usual care at postintervention (standardised mean difference (SMD) -0.45, 95% confidence interval (CI) -0.82 to -0.08; 2 studies, 118 participants; recalculated as a mean difference (MD) -12.19, 95% CI -21.99 to -2.38; I² = 0%; very low-certainty evidence). Physical activity may slightly improve disability (0 to 3 scale; 0 = no disability) compared with usual care at postintervention assessment (MD -0.37, 95% CI -0.56 to -0.19; I² = 0%; 3 studies, 170 participants; very low-certainty evidence). We found no clear evidence of a difference in quality of life (QoL; 0 to 100 scale; lower scores = better QoL) between physical activity and usual care at postintervention assessment (SMD -0.46, 95% CI -1.27 to 0.35; 4 studies, 201 participants; very low-certainty evidence; recalculated as MD -6.30, 95% CI -18.23 to 5.64; I² = 91%). None of the included studies measured adverse events, depression, or anxiety for this comparison. Physical activity compared with active medical care We found no studies that could be analysed in this comparison. Education about physical activity compared with usual care or active medical care We found no studies that could be analysed in this comparison. Physical activity and education about physical activity compared with usual care or active medical care We found no studies that could be analysed in this comparison. AUTHORS' CONCLUSIONS: We are unable to confidently state whether interventions based on physical activity and education about physical activity are more effective than usual care for children and adolescents with chronic musculoskeletal pain. We found very low-certainty evidence that physical activity may reduce pain intensity and improve disability postintervention compared with usual care, for children and adolescents with juvenile idiopathic arthritis. We did not find any studies reporting educational interventions; it remains unknown how these interventions influence the outcomes in children and adolescents with chronic musculoskeletal pain. Treatment decisions should consider the current best evidence, the professional's experience, and the young person's preferences. Further randomised controlled trials in other common chronic musculoskeletal pain conditions, with high methodological quality, large sample size, and long-term follow-up are urgently needed.
Asunto(s)
Artritis Juvenil , Dolor Crónico , Dolor Musculoesquelético , Humanos , Niño , Adolescente , Dolor Crónico/terapia , Dolor Musculoesquelético/terapia , Enfermedad Crónica , Ejercicio Físico , Calidad de VidaRESUMEN
BACKGROUND: Musculoskeletal pain in children and adolescents is prevalent and responsible for high levels of disability. Instruments to measure the presence and impact of pain in this population are needed. OBJECTIVE: To translate, cross-culturally adapt, then test the measurement properties (structural validity, reliability and construct validity) of a questionnaire (Presence and Impact of Pain in Kids (PIP-Kids) questionnaire) to measure the presence and impact of pain in children and adolescents. DESIGN: Measurement properties study. METHODS: We conducted a measurement properties study. We translated and culturally adapted the PIP-Kids questionnaire into Brazilian Portuguese. The structural validity was measured by Confirmatory Factor Analysis. Reliability was measured by Kappa Coefficient. Measurement error was measured by the percentage of agreement. Construct validity was measured by Spearman Correlation. RESULTS/FINDINGS: We included 656 children and adolescents from public and private schools. During the translation and cross-cultural adaptation no changes to wording were necessary. Structural validity confirmed two domains. Reliability by Kappa Coefficient ranges from 0.20 to 0.68. Measurement error by the percentage of agreement ranged from 60.2 to 92%. Construct validity was confirmed with 80.5% in accordance with prior hypotheses. CONCLUSION: The PIP-Kids questionnaire translation and cross-cultural adaptation were adequate. The PIP-Kids questionnaire also has adequate structural validity with two dimensions (presence and impact), fair reliability, good agreement, and adequate construct validity.
Asunto(s)
Comparación Transcultural , Dolor Musculoesquelético , Humanos , Adolescente , Niño , Brasil , Reproducibilidad de los Resultados , Portugal , Encuestas y Cuestionarios , Dolor Musculoesquelético/diagnósticoRESUMEN
OBJECTIVE: To estimate the prevalence, incidence, and prognosis of back pain in children and adolescents. DESIGN: Prospective cohort study. METHODS: We followed children and adolescents between the ages of 8 and 18 years with and without back pain over 12 months (3, 6, and 12 months) from public and private schools. At baseline, parents (or guardians) answered questionnaires including sociodemographic characteristics and perception of sleep quality of their children and adolescents. Children and adolescents answered questionnaires including sociodemographic characteristics, presence of back pain, pain intensity, quality of life, and psychosomatic symptoms. At follow-up, children and adolescents answered questions about the presence of back pain. RESULTS: Six hundred fifteen children and adolescents were included, 163 of whom had back pain and 452 of whom had no back pain at baseline. The mean age of participants was 11.6 years (SD = 2.5), and the majority were female (n = 362; 59%). The 1-month prevalence of back pain was 26% (95% confidence interval: 23%-30%). The incidence rate of back pain was 35% (31%-40%) over 12 months. Of the 163 participants who had back pain at baseline, 83% had recovered by 12 months. Of those who recovered within 6 months, 31% had a recurrence of back pain at the 12-month follow-up. CONCLUSION: Two to 3 in every 10 children and adolescents reported back pain in the last month. New cases of back pain were reported by 3-4 in every 10 children and adolescents for a period of 12 months. Nearly all children recover within 12 months, but recurrence seems to be common. J Orthop Sports Phys Ther 2022;52(8):554-562. Epub: 19 June 2022. doi:10.2519/jospt.2022.10819.
Asunto(s)
Dolor de Espalda , Calidad de Vida , Adolescente , Dolor de Espalda/epidemiología , Brasil/epidemiología , Niño , Femenino , Humanos , Incidencia , Lactante , Masculino , Prevalencia , Pronóstico , Estudios Prospectivos , Encuestas y CuestionariosRESUMEN
BACKGROUND: Psychosomatic symptoms seem to influence both the onset and development of pain. There is lack of Brazilian-Portuguese questionnaires that measure psychosomatic symptoms in children and adolescents. OBJECTIVE: To translate and cross-culturally adapt the Psychosomatic Questionnaire for Children and Adolescents into Brazilian-Portuguese and English and test the measurement properties of the Brazilian-Portuguese version. METHODS: The translation and cross-cultural adaptation (from Dutch to Brazilian-Portuguese and English) followed six steps. Interviews were conducted in 33 Brazilian children and adolescents. We also recruited 107 children and adolescents with musculoskeletal pain from schools to test the measurement properties of the Brazilian-Portuguese version. The questionnaire was completed twice with a 7-day interval. Ceiling and floor effects, missing data, internal consistency, reliability, measurement error and construct validity were assessed. RESULTS: We recruited 140 children and adolescents from public and private schools. During the cross-cultural adaptation process, no major difficulty answering and understanding the questionnaire were reported by children and adolescents. The questionnaire did not show ceiling or floor effects and had minimal missing data (0.37%). Internal consistency by the Cronbach's Alpha was 0.69. Test-retest reliability by the Intraclass Correlation Coefficient was 0.75 (95% CI: 0.64, 0.84). The smallest detectable change was 6.5 points out of 18 points. We observed a moderate correlation of 0.54 (p<0.01) with the Spence Children's Anxiety Scale, consistent with our a-priori hypothesis. CONCLUSION: The Brazilian-Portuguese version of the Psychosomatic Questionnaire for Children and Adolescents has acceptable measurement properties and is a good option for assessing psychosomatic symptoms in clinical practice and research.
Asunto(s)
Comparación Transcultural , Dolor Musculoesquelético , Adolescente , Brasil , Niño , Humanos , Portugal , Psicometría , Reproducibilidad de los Resultados , Encuestas y CuestionariosRESUMEN
ABSTRACT: Telehealth is a promising approach to support self-management with the potential to overcome geographical barriers. Understanding patient perspectives will identify practical challenges to delivering self-management strategies by telehealth. The aim of this study was to synthesize the perceptions of people with chronic musculoskeletal pain for engaging in interventions delivered using telehealth. We searched MEDLINE, Embase, CINAHL, LILACS, and PsycINFO databases. We included qualitative studies that explored perceptions or experiences or attitudes of people with chronic musculoskeletal pain engaging with telehealth. We assessed the methodological quality using the Critical Appraisal Skills Programme checklist. Meta-synthesis was guided by a thematic synthesis approach. The level of confidence of review findings was assessed using the Confidence in the Evidence from Reviews of Qualitative Studies (GRADE-CERQual). Twenty-one studies were included (n = 429). Telehealth comprised web-based, videoconference-based, telephone-based, video-based, and smartphone app-based programs delivered solely or combined. Chronic musculoskeletal conditions included people with knee or hip osteoarthritis, chronic low back pain, persistent pain (chronic joint pain or nonspecific chronic musculoskeletal pain), rheumatoid arthritis, and functional fatigue syndrome. The enablers for engaging in telehealth interventions were as follows: (1) "at my own pace, space, and place" and (2) empowered patient. Barriers to engaging in telehealth interventions were as follows: (1) impersonal, (2) technological challenges, (3) irrelevant content, and (4) limited digital (health) literacy. Telehealth interventions with well-designed interactive platforms, flexibility to fit patients' routine, and the broad availability of material may favor better engagement. Encouragement of self-efficacy is linked to successful telehealth-delivered self-management programs.
Asunto(s)
Dolor Crónico , Dolor Musculoesquelético , Automanejo , Telemedicina , Dolor Crónico/terapia , Humanos , Investigación CualitativaRESUMEN
BACKGROUND: Chronic musculoskeletal pain represents an enormous burden in society. Best-practice care for chronic musculoskeletal pain suggests adoption of self-management strategies. Telehealth interventions (e.g., videoconferencing) are a promising approach to promote self-management and have the potential to overcome geographical barriers between patient and care providers. Understanding patient perspectives will inform and identify practical challenges towards applying the self-management strategies delivered via telehealth to everyday lives. The aim of this study is to synthesize the perceptions of individuals with musculoskeletal pain with regards to enablers and barriers to engaging in telehealth interventions for chronic musculoskeletal pain self-management. METHODS: A systematic review of qualitative studies will be performed based on searches of MEDLINE, EMBASE, CINAHL, LILACS, and PsycINFO databases. Screening of identified titles will be conducted by two independent investigators. Data extraction will retrieve detailed qualitative information from selected articles. The critical appraisal skills program (CASP) checklist will be used for critical appraisal of included studies, and the level of confidence in the findings will be assessed using the confidence in the evidence from reviews of qualitative research (GRADE-CERQual). A thematic synthesis approach will be used to derive analytical themes. DISCUSSION: This review will systematically identify, synthesize, and present enablers and barriers reported by people with musculoskeletal pain to engage in telehealth interventions. The review will provide information required to support the design and improvement of telehealth services. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019136148.
Asunto(s)
Dolor Crónico , Dolor Musculoesquelético , Automanejo , Telemedicina , Dolor Crónico/terapia , Humanos , Dolor Musculoesquelético/terapia , Investigación Cualitativa , Revisiones Sistemáticas como AsuntoRESUMEN
OBJECTIVE: To determine the magnitude of the association between cardiovascular disease and chronic musculoskeletal pain. DESIGN: Systematic review with meta-analysis. METHODS: A comprehensive search was performed in five electronic databases. Population-based studies reporting the prevalence of cardiovascular diseases in adults stratified by chronic musculoskeletal pain status were considered eligible. Two independent reviewers performed the screening of the records following the inclusion criteria, extracted data, and evaluated the risk of bias of the included studies using an assessment tool of risk of bias for observational studies. In addition, we assessed the overall quality of evidence using an adaptation of the GRADE approach for prognosis. RESULTS: Twenty studies were included in this review. There was high-quality evidence that people with chronic musculoskeletal pain are 1.91 times more likely to report having a cardiovascular disease compared with those without chronic musculoskeletal pain (risk ratio = 1.91, 95% confidence interval = 1.64-2.21). CONCLUSIONS: Our findings demonstrated associations between chronic musculoskeletal pain and any cardiovascular diseases. Future studies are still warranted to better understand the association between chronic musculoskeletal pain and the specific types of cardiovascular diseases.
Asunto(s)
Enfermedades Cardiovasculares , Dolor Crónico , Enfermedades Musculoesqueléticas , Dolor Musculoesquelético , Adulto , Sesgo , Enfermedades Cardiovasculares/epidemiología , Dolor Crónico/epidemiología , Humanos , Enfermedades Musculoesqueléticas/epidemiología , Dolor Musculoesquelético/diagnóstico , Dolor Musculoesquelético/epidemiología , PrevalenciaRESUMEN
BACKGROUND: Language is a barrier to implementing research evidence into practice. Whilst the majority of the world's population speak languages other than English, English has become the dominant language of publication for research in healthcare. OBJECTIVE: The aim of this study was to quantify the usage of the Physiotherapy Evidence Database (PEDro) web-site (www.pedro.org.au) and training videos by language, including the use of online translation, and to calculate relative usage of the different sections of the web-site. METHODS: Google Analytics was used to track usage of the PEDro web-site for July 2017 to June 2018. The number of views of each of the PEDro training videos was downloaded from YouTube for January 2015 to August 2018. The pageviews and videos were categorized by language and, for pageviews, web-site section. RESULTS: 2,828,422 pageviews were included in the analyses. The English-language sections had the largest number of pageviews (58.61%), followed by Portuguese (15.57%), and Spanish (12.02%). Users applied online translation tools to translate selected content of the PEDro web-site into 41 languages. The PEDro training videos had been viewed 78,150 times. The three most commonly viewed languages were English (58.80%), Portuguese (19.83%), and Spanish (6.13%). CONCLUSIONS: There was substantial use of some of the translated versions of the resources offered by PEDro. Future efforts could focus on region-specific promotion of the language resources that are underutilized in PEDro. The developers of PEDro and PEDro users can work collaboratively to facilitate uptake and translate resources into languages other than English to reduce the language barrier in using research to guide practice.
Asunto(s)
Barreras de Comunicación , Bases de Datos Factuales , Medicina Basada en la Evidencia , Humanos , Lenguaje , Modalidades de Fisioterapia , Encuestas y Cuestionarios , TraducciónRESUMEN
BACKGROUND: Insomnia is a highly prevalent and debilitating comorbidity that is often not addressed in therapy for chronic spinal pain (CSP). Given the close interaction between insomnia and CSP severity and related disability, targeting sleep problems during therapy could improve treatment outcomes in these patients. OBJECTIVE: Can cognitive behavioral therapy for insomnia (CBT-I) combined with the modern neuroscience approach (i.e. pain neuroscience education and cognition-targeted exercise therapy) reduce pain and improve sleep, physical activity and function in people with CSP and comorbid insomnia? METHODS: Participants: One-hundred-twenty participants with chronic spinal pain and comorbid insomnia Intervention: CBT-I combined with the modern neuroscience approach (experimental) compared to the modern neuroscience approach alone (control). Both interventions start with three sessions of pain neuroscience education, followed by six sessions of CBT-I and nine sessions of cognition-targeted exercise therapy in the experimental group, or 15 sessions of cognition-targeted exercise therapy in the control group. MEASUREMENTS: Primary outcome measure: self-reported pain severity (Brief Pain Inventory). SECONDARY OUTCOME MEASURES: pain sensitivity (pressure pain thresholds, and online questionnaires), sleep-related outcomes (home-based polysomnography and online questionnaires), physical activity (actigraphy), and function (online questionnaires). Online questionnaires will be completed at baseline, directly post-treatment, and at 3, 6 and 12 months post-treatment. Polysomnography, pressure pain thresholds and actigraphy will be carried out at baseline, post-treatment and at 12 months follow-up. DISCUSSION: Findings may provide (1) a novel therapeutic approach for people with CSP and comorbid insomnia to improve pain, sleep, physical activity and function, and (2) new treatment guidelines for professionals. TRIAL REGISTRATION: Clinicaltrials.gov NCT03482856 (https://clinicaltrials.gov/ct2/show/NCT03482856).
Asunto(s)
Dolor Crónico/fisiopatología , Terapia Cognitivo-Conductual , Polisomnografía/instrumentación , Trastornos del Inicio y del Mantenimiento del Sueño/terapia , Fases del Sueño/fisiología , Dolor Crónico/terapia , Humanos , Modalidades de Fisioterapia , Trastornos del Inicio y del Mantenimiento del Sueño/fisiopatología , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to.
Asunto(s)
Dolor de la Región Lumbar/fisiopatología , Osteoartritis de la Rodilla/fisiopatología , Terapia por Ejercicio/normas , Obesidad/complicaciones , Resultado del Tratamiento , Estilo de Vida Saludable , Articulación de la Rodilla/fisiologíaRESUMEN
BACKGROUND: These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. METHOD: These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. CONCLUSIONS: A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to.