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Development of an enhanced scoring system to predict ICU readmission or in-hospital death within 24 hours using routine patient data from two NHS Foundation Trusts

Por: Pimentel · M. A. F. · Johnson · A. · Darbyshire · J. L. · Tarassenko · L. · Clifton · D. A. · Walden · A. · Rechner · I. · Watkinson · P. J. · Young · J. D.
Rationale

Intensive care units (ICUs) admit the most severely ill patients. Once these patients are discharged from the ICU to a step-down ward, they continue to have their vital signs monitored by nursing staff, with Early Warning Score (EWS) systems being used to identify those at risk of deterioration.

Objectives

We report the development and validation of an enhanced continuous scoring system for predicting adverse events, which combines vital signs measured routinely on acute care wards (as used by most EWS systems) with a risk score of a future adverse event calculated on discharge from the ICU.

Design

A modified Delphi process identified candidate variables commonly available in electronic records as the basis for a ‘static’ score of the patient’s condition immediately after discharge from the ICU. L1-regularised logistic regression was used to estimate the in-hospital risk of future adverse event. We then constructed a model of physiological normality using vital sign data from the day of hospital discharge. This is combined with the static score and used continuously to quantify and update the patient’s risk of deterioration throughout their hospital stay.

Setting

Data from two National Health Service Foundation Trusts (UK) were used to develop and (externally) validate the model.

Participants

A total of 12 394 vital sign measurements were acquired from 273 patients after ICU discharge for the development set, and 4831 from 136 patients in the validation cohort.

Results

Outcome validation of our model yielded an area under the receiver operating characteristic curve of 0.724 for predicting ICU readmission or in-hospital death within 24 hours. It showed an improved performance with respect to other competitive risk scoring systems, including the National EWS (0.653).

Conclusions

We showed that a scoring system incorporating data from a patient’s stay in the ICU has better performance than commonly used EWS systems based on vital signs alone.

Trial registration number

ISRCTN32008295.

Community perceptions, beliefs and factors determining family planning uptake among men and women in Ekiti State, Nigeria: finding from a descriptive exploratory study

Por: Ibikunle · O. O. · Ipinnimo · T. M. · Bakare · C. A. · Ibirongbe · D. O. · Akinwumi · A. F. · Ibikunle · A. I. · Ajidagba · E. B. · Olowoselu · O. O. · Abioye · O. O. · Alabi · A. K. · Seluwa · G. A. · Alabi · O. O. · Filani · O. · Adelekan · B.
Objectives

To examine family planning through the community’s perception, belief system and cultural impact; in addition to identifying the determining factors for family planning uptake.

Design

A descriptive exploratory study.

Setting

Three communities were selected from three local government areas, each in the three senatorial districts in Ekiti State.

Participants

The study was conducted among young unmarried women in the reproductive age group who were sexually active as well as married men and women in the reproductive age group who are currently living with their partners and were sexually active.

Main outcome measures

Eight focus group discussions were conducted in the community in 2019 with 28 male and 50 female participants. The audio recordings were transcribed, triangulated with notes and analysed using QSR NVivo V.8 software. Community perception, beliefs and perceptions of the utility of family planning, as well as cultural, religious and other factors determining family planning uptake were analysed.

Results

The majority of the participants had the perception that family planning helps married couple only. There were diverse beliefs about family planning and mixed reactions with respect to the impact of culture and religion on family planning uptake. Furthermore, a number of factors were identified in determining family planning uptake—intrapersonal, interpersonal and health system factors.

Conclusion

The study concluded that there are varied reactions to family planning uptake due to varied perception, cultural and religious beliefs and determining factors. It was recommended that more targeted male partner engagement in campaign would boost family planning uptake.

Association between breast feeding and food consumption according to the degree of processing in Brazil: a cohort study

Background

The benefits of breast feeding may be associated with better formation of eating habits beyond childhood. This study was designed to verify the association between breast feeding and food consumption according to the degree of processing in four Brazilian birth cohorts.

Methods

The duration of exclusive, predominant and total breast feeding was evaluated. The analysis of the energy contribution of fresh or minimally processed foods (FMPF) and ultra-processed foods (UPF) in the diet was evaluated during childhood (13–36 months), adolescence (11–18 years) and adulthood (22, 23 and 30 years).

Results

Those who were predominantly breastfed for less than 4 months had a higher UPF consumption (β 3.14, 95% CI 0.82 to 5.47) and a lower FMPF consumption (β –3.47, 95% CI –5.91 to –1.02) at age 22 years in the 1993 cohort. Exclusive breast feeding (EBF) for less than 6 months was associated with increased UPF consumption (β 1.75, 95% CI 0.25 to 3.24) and reduced FMPF consumption (β –1.49, 95% CI –2.93 to –0.04) at age 11 years in the 2004 cohort. In this same cohort, total breast feeding for less than 12 months was associated with increased UPF consumption (β 1.12, 95% CI 0.24 to 2.19) and decreased FMPF consumption (β –1.13, 95% CI –2 .07 to –0.19). Children who did not receive EBF for 6 months showed an increase in the energy contribution of UPF (β 2.36, 95% CI 0.53 to 4.18) and a decrease in FMPF (β –2.33, 95% CI –4 .19 to –0.48) in the diet at 13–36 months in the 2010 cohort. In this cohort, children who were breastfed for less than 12 months in total had higher UPF consumption (β 2.16, 95% CI 0.81 to 3.51) and lower FMPF consumption (β –1.79, 95% CI –3.09 to –0.48).

Conclusion

Exposure to breast feeding is associated with lower UPF consumption and higher FMPF consumption in childhood, adolescence and adulthood.

Prevalence and correlates of paediatric guideline non-adherence for initial empirical care in six low and middle-income settings: a hospital-based cross-sectional study

Por: Shawon · R. A. · Denno · D. · Tickell · K. D. · Atuhairwe · M. · Bandsma · R. · Mupere · E. · Voskuijl · W. · Mbale · E. · Ahmed · T. · Chisti · M. J. · Saleem · A. F. · Ngari · M. · Diallo · A. H. · Berkley · J. · Walson · J. · Means · A. R.
Objectives

This study evaluated the prevalence and correlates of guideline non-adherence for common childhood illnesses in low-resource settings.

Design and setting

We used secondary cross-sectional data from eight healthcare facilities in six Asian and African countries.

Participants

A total of 2796 children aged 2–23 months hospitalised between November 2016 and January 2019 with pneumonia, diarrhoea or severe malnutrition (SM) and without HIV infection were included in this study.

Primary outcome measures

We identified children treated with full, partial or non-adherent initial inpatient care according to site-specific standard-of-care guidelines for pneumonia, diarrhoea and SM within the first 24 hours of admission. Correlates of guideline non-adherence were identified using generalised estimating equations.

Results

Fully adherent care was delivered to 32% of children admitted with diarrhoea, 34% of children with pneumonia and 28% of children with SM when a strict definition of adherence was applied. Non-adherence to recommendations was most common for oxygen and antibiotics for pneumonia; fluid, zinc and antibiotics for diarrhoea; and vitamin A and zinc for SM. Non-adherence varied by site. Pneumonia guideline non-adherence was more likely among patients with severe disease (OR 1.82; 95% CI 1.38, 2.34) compared with non-severe disease. Diarrhoea guideline non-adherence was more likely among lower asset quintile groups (OR 1.16; 95% CI 1.01, 1.35), older children (OR 1.10; 95% CI 1.06, 1.13) and children presenting with wasting (OR 6.44; 95% CI 4.33, 9.57) compared with those with higher assets, younger age and not wasted.

Conclusions

Non-adherence to paediatric guidelines was common and associated with older age, disease severity, and comorbidities, and lower household economic status. These findings highlight opportunities to improve guidelines by adding clarity to specific recommendations.

Knowledge, attitudes, and practices regarding antibiotic use in Bangladesh: Findings from a cross-sectional study

by Md. Abu Raihan, Md. Saiful Islam, Shariful Islam, A. F. M. Mahmudul Islam, Khandaker Tanveer Ahmed, Tania Ahmed, Md. Nahidul Islam, Shamsunnahar Ahmed, Mysha Samiha Chowdhury, Dipto Kumar Sarker, Anika Bushra Lamisa

Background

Escalating antibiotic resistance presents a notable worldwide dilemma, pointing a large involvement of general population. The objective of this study was to assess knowledge, attitudes, and practices regarding the utilization of antibiotics among Bangladeshi residents.

Methods

A cross-sectional study, conducted from January 01 to April 25, 2022, included 1,947 Bangladeshi adults with a history of antibiotic use, via online surveys and face-to-face interviews using a pretested semi-structured questionnaire. Descriptive statistics, Chi-square tests, and multivariate linear regression models were employed.

Results

Mean scores for knowledge, attitudes, and practices were 6.59±1.20, 8.34±1.19, and 12.74±2.59, with correct rates of 73.22%, 92.67%, and 57.91%. Positive predictors for knowledge included being unmarried (β = 0.10, p = 0.001), higher education (College: β = 0.09, p = 0.025; Bachelor: β = 0.22, p Conclusions

Participants exhibited adequate knowledge and positive attitudes but lagged behind in proper practice of antibiotic use. Proper initiatives should be tailored to enhance prudent antibiotic use and mitigate the risk of antimicrobial resistance.

Analysis and clinical determinants of post-COVID-19 syndrome in the Lombardy region: evidence from a longitudinal cohort study

Por: Borgonovo · F. · Lovaglio · P. G. · Mariani · C. · Berta · P. · Cossu · M. V. · Rizzardini · G. · Vittadini · G. · Capetti · A. F.
Objective

To define macro symptoms of long COVID and to identify predictive factors, with the aim of preventing the development of the long COVID syndrome.

Design

A single-centre longitudinal prospective cohort study conducted from May 2020 to October 2022.

Setting

The study was conducted at Luigi Sacco University Hospital in Milan (Italy). In May 2020, we activated the ARCOVID (Ambulatorio Rivalutazione COVID) outpatient service for the follow-up of long COVID.

Participants

Hospitalised and non-hospitalised patients previously affected by COVID-19 were either referred by specialists or general practitioners or self-referred.

Intervention

During the first visit, a set of questions investigated the presence and the duration of 11 symptoms (palpitations, amnesia, headache, anxiety/panic, insomnia, loss of smell, loss of taste, dyspnoea, asthenia, myalgia and telogen effluvium). The follow-up has continued until the present time, by sending email questionnaires every 3 months to monitor symptoms and health-related quality of life.

Primary and secondary outcome measures

Measurement of synthetic scores (aggregation of symptoms based on occurrence and duration) that may reveal the presence of long COVID in different clinical macro symptoms. To this end, a mixed supervised and empirical strategy was adopted. Moreover, we aimed to identify predictive factors for post-COVID-19 macro symptoms.

Results

In the first and second waves of COVID-19, 575 and 793 patients (respectively) were enrolled. Three different post-COVID-19 macro symptoms (neurological, sensorial and physical) were identified. We found significant associations between post-COVID-19 symptoms and (1) the patients’ comorbidities, and (2) the medications used during the COVID-19 acute phase. ACE inhibitors (OR=2.039, 95% CI: 1.095 to 3.892), inhaled steroids (OR=4.08, 95% CI: 1.17 to 19.19) and COVID therapies were associated with increased incidence of the neurological macro symptoms. Age (OR=1.02, 95% CI: 1.01 to 1.04), COVID-19 severity (OR=0.42, 95% CI: 0.21 to 0.82), number of comorbidities (OR=1.22, 95% CI: 1.01 to 1.5), metabolic (OR=2.52, 95% CI: 1.25 to 5.27), pulmonary (OR=1.87, 95% CI: 1.10 to 3.32) and autoimmune diseases (OR=4.57, 95% CI: 1.57 to 19.41) increased the risk of the physical macro symptoms.

Conclusions

Being male was the unique protective factor in both waves. Other factors reflected different medical behaviours and the impact of comorbidities. Evidence of the effect of therapies adds valuable information that may drive future medical choices.

Effectiveness of dexmedetomidine during surgery under general anaesthesia on patient-centred outcomes: a systematic review and Bayesian meta-analysis protocol

Por: Verret · M. · Le · J. B. P. · Lalu · M. M. · McIsaac · D. I. · Nicholls · S. · Turgeon · A. F. · Hutton · B. · Zivkovic · F. · Graham · M. · Le · M. · Geist · A. · Berube · M. · Gilron · I. · Poulin · P. · Daudt · H. · Martel · G. · McVicar · J. · Moloo · H. · Fergusson · D. A.
Introduction

Dexmedetomidine is a promising pharmaceutical strategy to minimise opioid use during surgery. Despite its growing use, it is uncertain whether dexmedetomidine can improve patient-centred outcomes such as quality of recovery and pain.

Methods and analysis

We will conduct a systematic review and meta-analysis following the recommendations of the Cochrane Handbook for Systematic Reviews. We will search MEDLINE, Embase, CENTRAL, Web of Science and CINAHL approximately in October 2023. We will include randomised controlled trials evaluating the impact of systemic intraoperative dexmedetomidine on patient-centred outcomes. Patient-centred outcome definition will be based on the consensus definition established by the Standardised Endpoints in Perioperative Medicine initiative (StEP-COMPAC). Our primary outcome will be the quality of recovery after surgery. Our secondary outcomes will be patient well-being, function, health-related quality of life, life impact, multidimensional assessment of postoperative acute pain, chronic pain, persistent postoperative opioid use, opioid-related adverse events, hospital length of stay and adverse events. Two reviewers will independently screen and identify trials and extract data. We will evaluate the risk of bias of trials using the Cochrane Risk of Bias Tool (RoB 2.0). We will synthesise data using a random effects Bayesian model framework, estimating the probability of achieving a benefit and its clinical significance. We will assess statistical heterogeneity with the tau-squared and explore sources of heterogeneity with meta-regression. We have involved patient partners, clinicians, methodologists, and key partner organisations in the development of this protocol, and we plan to continue this collaboration throughout all phases of this systematic review.

Ethics and dissemination

Our systematic review does not require research ethics approval. It will help inform current clinical practice guidelines and guide development of future randomised controlled trials. The results will be disseminated in open-access peer-reviewed journals, presented at conferences and shared among collaborators and networks.

PROSPERO registration number

CRD42023439896.

External validation of the QCovid 2 and 3 risk prediction algorithms for risk of COVID-19 hospitalisation and mortality in adults: a national cohort study in Scotland

Por: Kerr · S. · Millington · T. · Rudan · I. · McCowan · C. · Tibble · H. · Jeffrey · K. · Fagbamigbe · A. F. · Simpson · C. R. · Robertson · C. · Hippisley-Cox · J. · Sheikh · A.
Objective

The QCovid 2 and 3 algorithms are risk prediction tools developed during the second wave of the COVID-19 pandemic that can be used to predict the risk of COVID-19 hospitalisation and mortality, taking vaccination status into account. In this study, we assess their performance in Scotland.

Methods

We used the Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 national data platform consisting of individual-level data for the population of Scotland (5.4 million residents). Primary care data were linked to reverse-transcription PCR virology testing, hospitalisation and mortality data. We assessed the discrimination and calibration of the QCovid 2 and 3 algorithms in predicting COVID-19 hospitalisations and deaths between 8 December 2020 and 15 June 2021.

Results

Our validation dataset comprised 465 058 individuals, aged 19–100. We found the following performance metrics (95% CIs) for QCovid 2 and 3: Harrell’s C 0.84 (0.82 to 0.86) for hospitalisation, and 0.92 (0.90 to 0.94) for death, observed-expected ratio of 0.24 for hospitalisation and 0.26 for death (ie, both the number of hospitalisations and the number of deaths were overestimated), and a Brier score of 0.0009 (0.00084 to 0.00096) for hospitalisation and 0.00036 (0.00032 to 0.0004) for death.

Conclusions

We found good discrimination of the QCovid 2 and 3 algorithms in Scotland, although performance was worse in higher age groups. Both the number of hospitalisations and the number of deaths were overestimated.

New methodology to assess the excess burden of antibiotic resistance using country-specific parameters: a case study regarding E. coli urinary tract infections

Por: Godijk · N. G. · McDonald · S. A. · Altorf-van der Kuil · W. · Schoffelen · A. F. · Franz · E. · Bootsma · M. C. J.
Objectives

Antimicrobial resistant (AMR) infections are a major public health problem and the burden on population level is not yet clear. We developed a method to calculate the excess burden of resistance which uses country-specific parameter estimates and surveillance data to compare the mortality and morbidity due to resistant infection against a counterfactual (the expected burden if infection was antimicrobial susceptible). We illustrate this approach by estimating the excess burden for AMR (defined as having tested positive for extended-spectrum beta-lactamases) urinary tract infections (UTIs) caused by E. coli in the Netherlands in 2018, which has a relatively low prevalence of AMR E. coli, and in Italy in 2016, which has a relatively high prevalence.

Design

Excess burden was estimated using the incidence-based disability-adjusted life-years (DALYs) measure. Incidence of AMR E. coli UTI in the Netherlands was derived from ISIS-AR, a national surveillance system that includes tested healthcare and community isolates, and the incidence in Italy was estimated using data reported in the literature. A systematic literature review was conducted to find country-specific parameter estimates for disability duration, risks of progression to bacteraemia and mortality.

Results

The annual excess burden of AMR E. coli UTI was estimated at 3.89 and 99.27 DALY/100 0000 population and 39 and 2786 excess deaths for the Netherlands and Italy, respectively.

Conclusions

For the first time, we use country-specific and pathogen-specific parameters to estimate the excess burden of resistant infections. Given the large difference in excess burden due to resistance estimated for Italy and for the Netherlands, we emphasise the importance of using country-specific parameters describing the incidence and disease progression following AMR and susceptible infections that are pathogen specific, and unfortunately currently difficult to locate.

Advanced Clinical Practitioners (ACPs) have a significant impact on patient outcomes and healthcare services

Por: Wood · A. F. · Hyde · R.

Commentary on: Mann C, Timmons S, Evans C, Pearce R, Overton C, Hinsliff-Smith K, Conway J. Exploring the role of advanced clinical practitioners (ACPs) and their contribution to health services in England: A qualitative exploratory study. Nurse Educ Pract. 2023 Feb;67:103546. doi: 10.1016/j.nepr.2023.103546. Epub 2023 Jan 24.

Implications for practice and research

  • Workforce planning needs focus on the level of practice required for service demand and not ‘what role is needed’. Planners must appreciate the contributions and limitations of practice different advanced clinical practitioners (ACPs) bring.

  • Research is needed to move beyond capturing the advancement of roles to exploring changes, in practice and education, and evaluating the improvements made, particularly with advanced practice (AP) regulation being reviewed by the Nursing and Midwifery Council (NMC).

  • Context

    Advanced Practice (AP) is a phenomenon which in the last century may be traced back to the post second...

    Methodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review protocol

    Por: De Oliveira Ascef · B. · Gabriel · F. C. · Suzumura · E. A. · Maia · F. H. d. A. · Bortoluzzi · A. F. R. · Farias · N. S. · Jahn · B. · Siebert · U. · De Soarez · P. C.
    Background

    Benefit–risk assessment (BRA) is used in multiple phases along the health technology’s life-cycle to evaluate the balance between the benefits and risks, as it is fundamental to all stakeholders. BRA and its methodological approaches have been applied primarily in the context of regulatory agencies. However, BRA’s application and extent in the context of health technology assessment (HTA) bodies remain less clear. Our goal is to perform a scoping review to identify and map methodological guidelines and publications on methods of BRA. This will be done considering the different phases of the life-cycle of health technologies to underline both the depth and extent of research concerning BRA, especially in the context of HTA.

    Methods and analysis

    This scoping review protocol was developed following the framework proposed by Arksey and O’Malley, and the updated guidelines by the Joanna Briggs Institute. We will include methodological publications that provide recommendations or guidelines on methods for BRA. We will conduct electronic searches on Medline (PubMed) and EMBASE (Ovid) databases; manual searches on the main websites of HTA bodies and drug regulatory organisations; and contact experts in the field. Systematic extraction forms will be used to screen and assess the identified publications by independent assessors. We will provide a qualitative synthesis using descriptive statistics and visual tools. Results will be summarised in systematic evidence tables and comparative evidence scoping charts.

    Ethics and dissemination

    This review will use data publicly available and does not require ethics approval. The results of this scoping review will contribute to scientific knowledge and act as a basis for methodologists, guideline developers and researchers for the development of BRA to inform regulatory decisions, reimbursement and coverage decision making. The results will be disseminated through peer-reviewed articles, conferences, policy briefs and workshops.

    Trial registration number

    Open Science Framework (https://doi.org/10.17605/OSF.IO/69T3V).

    Self-reported prevalence of asthma and its associated factors among adult rural population in Bangladesh: a cross-sectional study using WHO PEN protocol

    Por: Rakhshanda · S. · Abedin · M. · Wahab · A. · Barua · L. · Faruque · M. · Banik · P. C. · Shawon · R. A. · Rahman · A. F. · Mashreky · S. R.
    Objective

    For over a decade, the prevalence of asthma remained unchanged at around 7% in Bangladesh. Although asthma causes significant morbidity among both children and adults, updates on epidemiological data are limited on the prevalence in Bangladesh. This study attempted to determine the prevalence of asthma, and its modifiable and non-modifiable lifestyle predictors in a rural population of Bangladesh.

    Method

    This study was part of a cross-sectional study that applied the WHO Package of Essential Noncommunicable Disease Interventions via census in a rural area of Bangladesh, where self-reported data on asthma were recorded. Data on anthropometric measurement, sociodemographic characteristics and behavioural risk factors were collected following the standard protocol described in the WHO STEP-wise approach to surveillance (STEPS) questionnaire. Analysis included descriptive statistics to assess the prevalence of asthma and its risk factors, and binary logistic regression to determine contributing factors.

    Result

    The overall prevalence of asthma was 4.2%. Asthma was predominant among people above 60 years (8.4%). Higher asthma was noted among males (4.6%), self-employed (5.1%), with a family history of asthma (9.1%), with comorbidities besides asthma (7.8%) and underweight (6.0%) compared with their counterparts. The OR of having asthma was 1.89, 1.93, 1.32, 1.50, 2.60, 0.67, 0.67 and 0.78 if a respondent was 45 years old or more, married, underweight, ever smoker, with a family history of asthma, housewife, employed and consumed red meat, respectively, while considering all other variables constant, compared with their counterparts.

    Conclusion

    The study emphasised asthma to be a public health concern in Bangladesh, although it seems to have decreased over the last decade. Among others, red meat intake and nutritional status were strongly associated with asthma, and the linkage among these is still a grey area that needs further exploration.

    Patients perspectives on tapering programmes for prescription opioid use disorder: a qualitative study

    Por: Davies · L. E. M. · Koster · E. S. · Damen · K. F. · Beurmanjer · H. · van Dam · V. W. · Bouvy · M. L. · Schellekens · A. F.
    Objectives

    Approximately 10% of chronic pain patients who receive opioids develop an opioid use disorder (OUD). Tapering programmes for these patients show high drop-out rates. Insight into chronic pain patients’ experiences with tapering programmes for prescription OUD could help improve such programmes. Therefore, we investigated the perspectives of chronic pain patients with prescription OUD to identify facilitators and barriers to initiate and complete a specialised OUD tapering programme.

    Design

    A qualitative study using semi-structured interviews on experiences with initiation and completion of opioid tapering was audio recorded, transcribed and subject to directed content analysis.

    Setting

    This study was conducted in two facilities with specialised opioid tapering programmes in the Netherlands.

    Participants

    Twenty-five adults with chronic pain undergoing treatment for prescription OUD participated.

    Results

    Participants indicated that tapering is a personal process, where willingness and motivation to taper, perceived (medical) support and pain coping strategies have an impact on the tapering outcome. The opportunity to join a medical-assisted tapering programme, shared decision-making regarding tapering pace, tapering location, and receiving medical and psychological support facilitated completion of an opioid tapering programme.

    Conclusions

    According to patients, a successful treatment of prescription OUD requires a patient-centred approach that combines personal treatment goals with shared decision-making on opioid tapering. Referral to a specialised tapering programme that incorporates opioid rotation, non-judgmental attitudes, and psychological support can create a safe and supportive environment, fostering successful tapering and recovery.

    Baduanjin exercise for chronic non-specific low back pain: protocol for a series of N-of-1 trials

    Por: Zhai · J. · Liu · A. F. · Yu · W. · Guo · T.
    Introduction

    Chronic non-specific low back pain (CNLBP) is one of the most common health problems worldwide. According to the clinical guideline released by the American College of Physicians, exercise has been recommended for the treatment of chronic LBP. In recent years, traditional Chinese medicine (TCM) is becoming increasingly popular for the management of chronic LBP. Baduanjin exercise is one of the exercise therapies in TCM. N-of-1 trial is a randomised cross-over self-controlled trial suitable for patients with this chronic disease. A series of similar N-of-1 trials can be pooled to estimate the overall and individual therapeutic effects synchronously by hierarchical Bayesian analysis. And N-of-1 trials are considered as a good tool for evaluating the therapeutic effect of TCM. Therefore, this study aims to conduct a series of N-of-1 trials with hierarchical Bayesian analysis for assessing whether Baduanjin exercise is effective and safe for CNLBP.

    Methods and analysis

    This study conducts a series of N-of-1 trials on Baduanjin exercise for the management of CNLBP. Fifty participants will receive 1–3 treatment cycles. They will be randomised into a Baduanjin exercise or waiting list group for a week during the two periods of each treatment cycle. The primary outcome is the 10-point Visual Analogue Scale. The secondary outcomes include the Oswestry Disability Index, the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and the Short Form Health Survey 12. Statistical analysis will be conducted with WinBUGS V.1.4.3 software. Overall and individual therapeutic effects will be estimated synchronously by hierarchical Bayesian analysis.

    Ethics and dissemination

    This study is approved by the Medical Ethics Committee of Tianjin University of TCM (reference number TJUTCM-EC20220005). Our findings will be published in a peer-reviewed journal or international conference.

    Trial registration number

    ChiCTR2200063307.

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