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Funding | Open access funding provided by University of Lausanne The present study was funded by the ISREC Foundation and Kaiku Health Ltd. | PMC10363070 | ||
Data availability | Not applicable. | PMC10363070 | ||
Declarations | PMC10363070 | |||
Ethics approval and consent to participate | Not applicable. | PMC10363070 | ||
Competing interests | A. | A.D.S.L., C.D., S.G., S.B., G.G., V.A.L., N.M.A., S.L., and A. A. have no relevant financial or non-financial interests to disclose. S.C.L. reports grants from the ISREC Foundation. G.S-B. reports grants from MSD France, grants from Novartis, and personal fees from Bayer, MPNE, and WECAN, outside the submitted work. O.... | PMC10363070 | |
Abbreviations | chronic care modelclinical decision supportclinical information systemsdelivery system designeHealth Enhanced Chronic Care ModeleHealth educationelectronic patient-reported outcomeselectronic patient-reported outcome measuresimmune checkpoint inhibitorsimmune-related adverse eventsmHealth app usability questionnairepat... | PMC10363070 | ||
References | PMC10363070 | |||
Background | CHRONIC LOW BACK PAIN | Chronic low back pain (CLBP) is a common health problem in rural Nigeria but access to rehabilitation is limited. Current clinical guidelines unanimously recommend patient education (PE) including instruction on self‐management, and exercises as frontline interventions for CLBP. However, the specific content of these i... | PMC9948461 | |
Methods | A single-blind, three-arm parallel-group, randomised clinical trial including 120 adult rural dwellers (mean [SD] age, 46.0 [14.7] years) with CLBP assigned to PE plus MCE group ( | PMC9948461 | ||
Results | –9.57, disability, pain | SECONDARY | All the groups showed significant improvements in all the primary and secondary outcomes evaluated over time. Compared with PE alone, the PE plus MCE showed a significantly greater reduction in pain intensity by an additional –1.15 (95% confidence interval [CI], –2.04 to –0.25) points at the 8-week follow-up and –1.25 ... | PMC9948461 |
Conclusions | disability, pain | Among rural community-dwelling adults with CLBP, PE plus MCE led to greater short-term improvements in pain and disability compared with PE alone, although all intervention strategies were associated with improvements in these outcomes. This trial provides additional support for combining PE with MCE, as recommended in... | PMC9948461 | |
Trial registration | ClinicalTrials.gov (NCT03393104), Registered on 08/01/2018. | PMC9948461 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12891-022-06108-9. | PMC9948461 | ||
Keywords | PMC9948461 | |||
Background | low back pain, back pain, pain, Low back pain, prolonged trunk flexion, disability | Low back pain remains the most common musculoskeletal and burdensome condition. It has been the leading cause of disability internationally, accounting for 63.7 million years lived with disability across all age groups since 1990 [As the number of people with low back pain is increasing likely due to global ageing and ... | PMC9948461 | |
Materials and methods | PMC9948461 | |||
Study design | This study was a single-blind, three-arm, parallel-group RCT conducted between March 2018 and January 2020. It was registered prospectively at ClinicalTrials.gov (NCT03393104) on 08/01/2018 and reported according to the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) guidelines [ | PMC9948461 | ||
Study setting | This study was conducted at Tsakuwa Primary Health Care Centre in Tsakuwa town, Dawakin-Kudu Local Government Area, Kano State, Northwestern Nigeria. | PMC9948461 | ||
Study population | low back pain, pain | Multiple village-wide announcements facilitated by village/ward heads (traditional rulers) and adverts via local posters pasted at the research centre and different locations in the community were used to recruit participants until the target sample size was achieved. Potential participants were invited to the primary ... | PMC9948461 | |
Sample size estimation | Oswestry disability, disability, pain | Minimal clinically important difference (MCID) of 2.0–4.0 points for pain measured by numerical pain rating scale (NPRS) and 5.0–17.0% points for disability measured by Oswestry disability index (ODI) have been reported for low back pain studies [ | PMC9948461 | |
Randomisation and blinding | After completing all baseline assessments, the consenting participants were randomly assigned to one of three groups; PE plus MCE, PE alone or MCE alone in a 1:1:1 ratio using a block randomisation procedure. A web-based randomisation tool ( | PMC9948461 | ||
Study interventions | pain | The interventions commenced immediately after baseline assessments and randomisation. Participants in the PE plus MCE group received PE followed by stretching, MCE and aerobic exercise. Participants in the PE alone group received PE followed by stretching and aerobic exercise, whereas those in the MCE received stretchi... | PMC9948461 | |
Patient education | paina, low back paina, Pain, pain | A face-to-face, group biopsychosocial-based PE session was delivered for 8 weeks by the lead author in the local language (Hausa). The content of the education programme was guided by available evidence on advice and education for patients with CLBP [Overview of the patient education programmea. Interactive session/dis... | PMC9948461 | |
Motor control exercises | The MCE programme was designed to improve function of specific muscles of the lumbopelvic region and control of posture and movement [ | PMC9948461 | ||
Aerobic exercise | Participants were advised to perform a preferred aerobic exercise such as overground walk or bicycling at a desirable speed at home for a minimum of 30 min, 5 times per week (Table | PMC9948461 | ||
Outcome measures | back pain, disability, pain | SECONDARY | Participants’ demographic data were collected using researcher-designed data forms in line with the recommendation of the National Institute of Health (NIH) task force on research standards for CLBP. Primary outcomes (pain intensity and disability level) and secondary outcomes (QoL, global perceived recovery, fear-avoi... | PMC9948461 |
Primary outcomes | Pain, pain | Pain intensity was assessed using the reliable, valid and responsive Hausa version of the numerical pain rating scale (NPRS) [ | PMC9948461 | |
Secondary outcomes | Quality of life was assessed using the reliable and valid Hausa version of the 12-item short-form health survey (SF-12) [ | PMC9948461 | ||
Adverse events | ADVERSE EVENTS | Participants in all the groups were asked to document any serious adverse events related to the study interventions during the intervention and follow-up periods and report to the project coordinator. | PMC9948461 | |
Statistical analyses | All statistical analyses were performed on IBM SPSS version 24.0 (IBM Co., Armonk, NY, USA) at an alpha level of 0.05. Data were summarised using mean (SD) for continuous variables and frequency (percentage) for discrete variables. Comparison of baseline categorical variables among the different treatment groups (PE pl... | PMC9948461 | ||
Intention to treat analysis | Intention-to-treat analysis was the main analysis and performed with randomised participants included in the treatment groups in which they were originally allocated [ | PMC9948461 | ||
Sensitivity analysis | low back pain, disability, pain | As part of the sensitivity analysis, additional intention-to-treat LMMs analyses for the primary outcomes were conducted while adjusting for age, gender, BMI, low back pain duration, and educational level. Responder analyses for the number of participants reporting ≥ 30% (MCID) reduction from baseline in pain intensity... | PMC9948461 | |
Results | PMC9948461 | |||
Treatment adherence and adverse events | Adherence to intervention was high with 92.5% in the PE plus MCE group (37/40) and 95% in both the PE alone group (38/40) and MCE alone group (38/40) receiving the allocated interventions (Fig. | PMC9948461 | ||
Intervention effectiveness | PMC9948461 | |||
Intention to treat analysis for secondary outcomes | pain | SECONDARY | All the secondary outcomes at baseline were similar among the three groups and showed significant improvements at all follow-up time points except that MCS-12 scores for the PE alone and MCE alone groups levelled off at the 20-week follow-up (Figs. Physical health and mental health scores for all groups across time. No... | PMC9948461 |
Discussion | PMC9948461 | |||
Summary of findings | diabetes, low back pain, hypertension | DIABETES, SAID, DISEASES, HYPERTENSION | To our knowledge, this is the first powered RCT to evaluate the effectiveness of adding PE to MCE compared with either therapy alone among community-dwelling adults with CLBP in a rural Nigerian or African context. The population of this study can be said to be a true representative of rural Nigerian dwellers as the ma... | PMC9948461 |
Pain intensity and disability | biopsychosocial disorder | Given that CLBP is widely recognised as a complex biopsychosocial disorder [ | PMC9948461 | |
Quality of life | pain, disability, CLBP disorder | Improving the QoL of individuals with CLBP disorder is pivotal in rehabilitation as pain and disability often interfere with daily activities of living and so reducing QoL [ | PMC9948461 | |
Global perceived recovery | disability, pain | Improvement in global perceived effect in all the groups with no significant difference observed between the groups at any follow-up time points further substantiates the usefulness of each of the study interventions. However, participants in the combined group had slightly better GRCS scores relative to those in the P... | PMC9948461 | |
Fear-avoidance beliefs | disability | Fear-avoidance beliefs have been reported to be among the important predictors of disability in rural Nigeria [ | PMC9948461 | |
Pain catastrophising | disability | Catastrophising has been also reported as one of the significant predictors of disability in rural Nigeria [ | PMC9948461 | |
Back pain consequences belief | low back pain | Modifying negative beliefs about low back pain is fundamental; especially among low-literate individuals since low education levels may be considerably associated with these beliefs. A prior trial [ | PMC9948461 | |
Pain medication use | Pain, pain | The use of pain tablets decreased in all groups at the end of the intervention, but superior improvement was observed for the PE plus MCE compared with the PE alone. This could have been related to the positive reinforcement effects as a result of combining PE with MCE leading to better pain relief as evidenced by the ... | PMC9948461 | |
Strengths and limitations | low back pain, pain | BLIND | As regards the strength of this study, the results are justified by some important methodological features known to minimise bias in clinical trials. These features include RCT design, power analysis, concealed allocation, blind outcome assessment and intention-to-treat analysis. Additionally, per-protocol and responde... | PMC9948461 |
Implications for clinical practice and future research | Although adding PE to MCE in the current trial reflects current clinical guideline recommendations [ | PMC9948461 | ||
Conclusions | disability, pain | Among rural community-dwelling adults with CLBP, PE plus MCE led to greater short-term improvements in pain and disability compared with PE alone, although all intervention strategies were associated with improvements in these outcomes. This trial provides additional support for combining PE with MCE, as recommended in... | PMC9948461 | |
Acknowledgements | RECRUITMENT | The authors gratefully acknowledge Tsakuwa Primary Health Care Centre for granting permission to conduct this trial and all the necessary support including logistics during the conduct of the study. We would like to thank Alhaji Ismaila Santali, the village head of Tsakuwa, Dawakin-Kudu Local Government Area for the sp... | PMC9948461 | |
Authors’ contributions | AAI, MOA, and SOG were involved in conceiving the study and development of the interventions. AAI developed the first draft of the manuscript. MOA and SOG supervised the study. AAI and SOG reviewed and edited the manuscript. All authors contributed to the trial design and have read, contributed to, and approved the fin... | PMC9948461 | ||
Funding | This research received no grant from any funding agency. | PMC9948461 | ||
Availability of data and materials | Data will be made available on request from the corresponding author. | PMC9948461 | ||
Declarations | PMC9948461 | |||
Ethics approval and consent to participate | The Health Research Ethics Committee, Ministry of Health, Kano State, Nigeria approved the study (Ref: MOH/Off/797/T.I./632). All participants provided written/signed informed consent before participating in the study. All methods were carried out in accordance with the recommendations of the Declaration of Helsinki. | PMC9948461 | ||
Consent for publication | Not applicable. | PMC9948461 | ||
Competing interests | The authors declare no conflict of interest. | PMC9948461 | ||
References | PMC9948461 | |||
Background | JC and JK are joint first authors.NC and LFP are joint senior authors.This study aims to describe the use of a paediatric advice line (PAL) provided to parents whose infants were recruited to a large randomised controlled trial (RCT), including the number and types of medical concerns addressed, seasonal variability an... | PMC9923309 | ||
Methods | Allergy, Infection | ALLERGY, INFECTION | Prospective cohort of 1246 children nested in the Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) RCT. All MIS BAIR participants were offered access to the PAL. Data were collected over the initial 2 years of a 5-year follow-up. Data were analysed using χ | PMC9923309 |
Results | The PAL was used by 230 (18.5%) participants, who made a total of 586 calls during the 2-year study period. The reasons for calling the PAL were dermatological (24%); gastrointestinal (18%); disturbances in feeding, sleeping and crying (14%); respiratory (7%); and developmental/neurological (6%). Analysis revealed that... | PMC9923309 | ||
Conclusions | MINOR | A cost-effective PAL service for clinical trial participants was used appropriately by parents for relatively minor concerns and may have a role in trials to promote participant engagement and reduce demand for other health services. | PMC9923309 | |
WHAT IS ALREADY KNOWN ON THIS TOPIC | Paediatric advice services improve patient satisfaction, help-seeking and informed decision making.Medical advice hotlines have yet to be studied in paediatric clinical trials. | PMC9923309 | ||
WHAT THIS STUDY ADDS | Parental demand for non-urgent advice within a clinical trial exists for a variety of medical concerns.First-time parents and mothers with a university degree were more likely to use the paediatric advice line. | PMC9923309 | ||
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY | Advice lines for non-urgent medical concerns offer an economical and valuable means of parental engagement in paediatric clinical trials. | PMC9923309 | ||
Introduction | Allergy, infections, asthma, allergies, Infection, eczema | ALLERGY, INFECTIONS, ASTHMA, ALLERGIES, INFECTION, ECZEMA | The Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) is an ongoing, multicentre randomised controlled trial (RCT) to determine the off-target effects of neonatal BCG vaccination on allergies, eczema, infections and asthma in Australian infants. | PMC9923309 |
Methods | PMC9923309 | |||
Study setting and PAL development | Allergy, rash, Infection | SKIN CONDITION, ALLERGY, INFECTION | In the MIS BAIR trial, 8552 participants were assessed for eligibility with 7280 excluded and 1272 healthy neonates randomised to receive BCG-Denmark vaccine or no vaccine within 10 days of birth (CONSORT diagram for MIS BAIR PAL study.MIS BAIR, Melbourne Infant Study: BCG for Allergy and Infection Reduction; PAL, paed... | PMC9923309 |
Data collection | Details of all calls were recorded by the clinical member answering the call using a Research Electronic Data Capture (REDCap) database, including principal concerns and outcome of the call. Follow-up calls were recorded in chronological order and linked to the same participant number. The data were subsequently cleane... | PMC9923309 | ||
Definitions | BCG VACCINE | A PAL caller was defined as a parent who remained in the trial for at least 3 months (completed at least one of the 3-monthly questionnaires) and who called the PAL at least once during the first 2 years of their participation in the trial. A PAL non-caller was defined as a parent who remained in the trial for at least... | PMC9923309 | |
Statistical analysis | The sociodemographic characteristics of PAL callers were compared with non-callers using χ | PMC9923309 | ||
Patient and public involvement | The MIS BAIR PAL was developed with the interests of the public and the MIS BAIR participants at the forefront of the study design. The primary outcome was to develop a PAL and observe parental use with the aim of improving patient and parental engagement. Patients were not directly involved in the development of the s... | PMC9923309 | ||
Results | A total of 1246 participants were included in the final analysis and 26 were lost to follow-up after randomisation (2.0%) (PAL study parent and infant demographicsReported as number (%) and p value calculated using χ*Reported as median (IQR), p value calculated using Wilcoxon-Mann-Whitney test.†Reported as mean (SD), p... | PMC9923309 | ||
Reasons for call |
Age distribution of infants, in months, at the time of the parents’ call to the paediatric advice line categorised by reasons.Frequency of paediatric advice line calls for each reason at different infant ages. | PMC9923309 | ||
Seasonal variability | Reasons for PAL calls showed seasonal variability (
Seasonal distribution of calls to the paediatric advice line for each reason during the first 2 years of life. Season and the proportion of calls for each season are displayed on the x-axis. The proportion of calls for each reason within a specific season is displayed... | PMC9923309 | ||
Call outcomes | Of the 586 calls to the PAL, 314 (53.6%) of the parents’ concerns were resolved in a single call, 185 (31.7%) in two calls and 87 (14.8%) in three or more calls. For the 268 calls for which this information was available, the outcomes were verbal medical advice given by a paediatrician (141 calls, 52.6%), verbal advice... | PMC9923309 | ||
Sociodemographics of PAL callers | The sociodemographic characteristics of PAL callers and non-callers were compared ( | PMC9923309 | ||
Multivariate analysis | REGRESSION | Univariate and multiple logistic regression analyses are outlined in Univariate and multiple logistic regression analyses predicting PAL callers*OR calculated using logistic regression method.†IVF was not included in the multivariate analysis due to missing data resulting in loss of statistical power.PAL, paediatric ad... | PMC9923309 | |
Discussion | viral exanthems, anxiety, atopic dermatitis, miliaria, unawareness | MILIARIA, ATOPIC DERMATITIS, VIRAL EXANTHEM | Paediatric advice services provide guidance for parents, enhance clinician–patient communication, and improve parental satisfaction and accessibility to non-urgent health advice.The PAL operated via a single mobile phone attended by a clinical staff member during standard business hours on a voluntary rotating roster b... | PMC9923309 |
Supplementary Material | PMC9923309 | |||
Reviewer comments | PMC9923309 | |||
Data availability statement | Data are available in a public, open-access repository. | PMC9923309 | ||
Ethics statements | PMC9923309 | |||
Patient consent for publication | Not applicable. | PMC9923309 | ||
Ethics approval | Allergy, Infection | ALLERGY, R12, INFECTION | This study involves human participants and the paediatric advice line was included in the Melbourne Infant Study: BCG for Allergy and Infection Reduction ethical and governance approval by Mercy Health Human Research Ethics Committee (HREC, number R12-28) and Royal Children’s Hospital HREC (number 33025) with additiona... | PMC9923309 |
References | PMC9923309 | |||
Abstract | PMC9874464 | |||
Background | Corticosteroids improve outcomes in patients with severe COVID‐19. In the COVID STEROID 2 randomised clinical trial, we found high probabilities of benefit with dexamethasone 12 versus 6 mg daily. While no statistically significant heterogeneity in treatment effects (HTE) was found in the conventional, dichotomous subg... | PMC9874464 | ||
Methods | respiratory failure | RESPIRATORY FAILURE, REGRESSIONS | We assessed whether HTE was present for days alive without life support and mortality at Day 90 in the trial according to baseline age, weight, number of comorbidities, category of respiratory failure (type of respiratory support system and oxygen requirements) and predicted risk of mortality using an internal predicti... | PMC9874464 |
Results | There was no strong evidence for substantial HTE on either outcome according to any of the baseline variables assessed with all | PMC9874464 | ||
Conclusions | hypoxaemia | We found no strong evidence for HTE with 12 versus 6 mg dexamethasone daily on days alive without life support or mortality at Day 90 in patients with COVID‐19 and severe hypoxaemia, although these results cannot rule out HTE either.
| PMC9874464 | |
Editorial Comment | In this post hoc explorative sub‐study of the COVID STEROID 2 trial, no strong evidence for substantial heterogeneity in treatment effects was found. The authors included the | PMC9874464 | ||
INTRODUCTION | respiratory failure, pulmonary inflammation, hypoxaemia | RESPIRATORY FAILURE, CRITICAL ILLNESS, CORONAVIRUS DISEASE 2019, PULMONARY INFLAMMATION | Coronavirus disease 2019 (COVID‐19) may cause critical illness and high mortality rates due to severe pulmonary inflammation and hypoxaemia.In the COVID STEROID 2 randomised controlled trial, we assessed 12 versus 6 mg of dexamethasone for patients with COVID‐19 and severe hypoxaemia and found high probabilities of ben... | PMC9874464 |
METHODS | These post hoc exploratory analyses of HTE in the COVID STEROID 2 trial were conducted according to a statistical analysis plan, which was written after the pre‐planned analyses of the trial were reported, | PMC9874464 | ||
The | The COVID STEROID 2 trial was an investigator‐initiated, international, parallel‐group, stratified, blinded (including patients, clinicians, investigators and outcome assessors) randomised clinical trial, approved by the regulatory authorities and ethics committees in all participating countries. | PMC9874464 | ||
Outcomes and patients assessed | KIDNEY REPLACEMENT | In this sub‐study, we assessed the following two outcomes at 90 days:Days alive without life support (including invasive mechanical ventilation, circulatory support and kidney replacement therapy; the actual number of days was used without assigning dead patients the worst possible value).Mortality.Of note, the primary... | PMC9874464 | |
Statistical analyses | PMC9874464 | |||
Descriptive data | We present descriptive data for all baseline and outcome variables assessed in this study in both treatment groups with continuous variables presented as medians with interquartile ranges (IQRs) and full ranges, and binary and categorical variables presented as numbers with percentages. | PMC9874464 | ||
Heterogeneity in treatment effects | respiratory failure | ISCHEMIC HEART DISEASE, RESPIRATORY FAILURE, DIABETES MELLITUS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HEART FAILURE | We assessed HTE using frequentist analyses without adjustment according to the following four baseline characteristics:Age (years)Weight (kg)Category of respiratory failure on a 1–6‐point scale defined as follows:Open system, low oxygen flow (oxygen flow rate ≤ median oxygen flow rate in all patients on open systems).O... | PMC9874464 |
Analytical strategy | respiratory failure | REGRESSION, RESPIRATORY FAILURE, REGRESSIONS | We assessed HTE on the continuous scale for age, weight and predicted mortality risk using generalised additive models (linear/logistic regressions, respectively, for the two outcomes) with cubic regression splines, fixed degrees of freedom and five knots at the 5, 27.5, 50, 77.5 and 95 percentiles.HTE according to the... | PMC9874464 |
Internal prediction model | We developed an internal prediction modelContinuous variables were modelled using multivariable fractional polynomials | PMC9874464 |
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