Psychometric validation of the cross-culturally adapted traditional Chinese version of the Back Beliefs Questionnaire (BBQ) and Fear-Avoidance Beliefs Questionnaire (FABQ)

Purpose: To translate and cross-culturally adapt the Back Beliefs Questionnaire (BBQ) and Fear-Avoidance Beliefs Questionnaire (FABQ) into traditional Chinese for their use in patients experiencing low back pain (LBP). Methods: This was a prospective questionnaire translation and psychometric validation of the BBQ and FABQ in Chinese patients with back pain. Patients also completed the Traditional Chinese (Hong Kong) versions of the Oswestry Disability Index (ODI), the Short Form-12 version 2 (SF-12v2) questionnaires and the visual analogue scale (VAS) for LBP. Construct validity was assessed using Spearman’s correlation test against the subscales and domains with similar constructs. Internal consistency was assessed by Cronbach’s alpha (α). Sensitivity was determined by known-group comparisons. Results: A total of 100 patients were recruited. Both BBQ (α = 0.810) and FABQ (α = 0.859) demonstrated excellent overall internal consistency. BBQ scores significantly correlated with ODI scores, VAS-LBP and all domains of SF-12v2 (p < 0.01–0.05), whereas only FABQ Work subscale correlated with ODI scores (p < 0.01) and VAS-LBP (p < 0.05). Both FABQ subscales correlated with only specific domains of SF-12v2 (p < 0.01–0.05). FABQ-W was sensitive to difference between patients with acute versus chronic back pain. Conclusions: Both the adapted BBQ and FABQ (Traditional Chinese-Hong Kong) were demonstrated to have satisfactory psychometric properties, with adequate internal consistencies, construct validity and sensitivity to certain clinical parameters. Our findings were based on a clinically relevant patient group and provides insight into patients’ own perception of back pain which may often be different from that of surgeons. This is a platform for future cross-cultural comparisons

Traditional growing rod versus magnetically controlled growing rod for treatment of early onset scoliosis: Cost analysis from implantation till skeletal maturity

Purpose: To compare the yearly cost involved per patient in the use of magnetically controlled growing rod (MCGR) and traditional growing rods (TGRs) in the treatment of early onset scoliosis (EOS) and to assess the overall cost burden of MCGR with reference to patient and health-care infrastructure. Methods: For a hypothetical case of a 5-year-old girl with a diagnosis of EOS, a decision-tree model using TreeAge Software was developed to simulate annual health state transitions and compare the 8-year accumulative direct, indirect, and total cost among the four groups: (1) dual MCGRs with exchange every 2 years, (2) dual MCGRs with exchange every 3 years, (3) TGR with surgical distraction every year, and (4) TGR with surgical distraction every 6 months. Base-case values and ranges of clinical parameters reflecting complication rate after each type of surgical distraction were determined from a review of literature and expert opinion. Government gazette and expert opinion provided cost estimation of growing rods, surgeries, surgical complications, and routine follow-up. Microsimulation of 1000 individuals was conducted to test the variation in total direct costs (in 2016 Hong Kong dollars (HKD)) between individuals, and estimated the standard deviations of total direct costs for each group. Results: Over the projected treatment period, indirect costs incurred by patients and family were higher for the MCGR as compared to the TGR. However, the total costs incurred by MCGR groups (group 1: HKD164k; group 2: HKD138k) were lower than those incurred by TGR groups (group 3: HKD191k; group 4: HKD290k). Although the accumulative costs of three groups (TGR with distraction every year and MCGR replacing every 2 and 3 years) were approaching each other in the first 2 years after initial implantation, at year 3 the accumulative cost of MCGR exchange every 2 years was HKD36k more than the yearly TGR surgery due to the cost of implant exchange. The cost incurred by both the MCGR groups was less than that incurred by the TGR groups from year 4 to skeletal maturity. Conclusions: The use of dual MCGRs, regardless of its 2- or 3-year exchange, was only cost saving and less expensive than the dual TGRs for EOS treatment from the fourth year of continuous treatment. Despite higher patient-related costs during MCGR treatment, it is important to consider the reduced risks and mental burden suffered by these children during repeat surgeries. With improved knowledge of the costs associated with long-term MCGR use, better constructed cost-effectiveness studies can be performed in the future.published_or_final_versio

Psychometric validation of the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) in Chinese patients with adolescent idiopathic scoliosis

Background: Scoliosis is a common spinal deformity that occurs often during adolescence. Previous studies suggested that adolescent idiopathic scoliosis (AIS) patients can have various aspects of their lives being affected, due to disease presentation and/or treatment received. It is important to define a reliable instrument based on which the affected patients’ health-related quality of life can be assessed. This study aims to assess the validity, reliability and sensitivity of the EuroQoL 5-dimension 5-level (EQ-5D-5L) in Chinese patients with AIS. Methods: Adolescent idiopathic scoliosis patients of Chinese descent were prospectively recruited to complete both the traditional Chinese versions of the EQ-5D-5L and the refined Scoliosis Research Society-22 (SRS-22r) questionnaires. Patients’ demographic profiles and corresponding clinical parameters including treatment modalities, spinal curve pattern and magnitude, and duration of bracing were recorded. Telephone interviews were then conducted at least two weeks later for the assessment of test-retest reliability. Statistical analysis was performed: construct validity of the EQ-5D-5L domains were assessed using Spearman’s correlation test against the SRS-22r; whereas intra-class correlation coefficient (ICC) was used to assess the test-retest reliability, and agreement over the test-retest period was expressed in percentages. Also, the sensitivity of the EQ-5D-5L in differentiating various clinical known groups was determined by effect size, independent t-test and analysis of variance. Results: A total of 227 AIS patients were recruited. Scores of domains of the EQ-5D-5L correlated significantly (r: 0.57-0.74) with the scores of the SRS-22r domains that were intended to measure similar constructs, supporting construct validity. The EQ-5D-5L domain responses and utility scores showed good test-retest reliability (ICC: 0.777; agreement: 76.4 -98.1 %). Internal consistency was good (Cronbach’s α: 0.78) for the EQ-5D-5L utility score. The EQ-5D-5L utility score was sensitive in detecting differences between subjects who had different treatment modalities and bracing duration, but not for curve pattern and its magnitude. Conclusions: The EQ-5D-5L is found to be a valid, reliable and sensitive measure to assess the health-related quality of life in Chinese AIS patients. This potentiates the possibility of utilizing the EQ-5D-5L to estimate AIS patients’ health-related quality of life, based on which the outcome of various treatment options can eventually be evaluated.published_or_final_versio

Mapping the SRS-22r questionnaire onto the EQ-5D-5L utility score in patients with adolescent idiopathic scoliosis

This is a prospective study to establish prediction models that map the refined Scoliosis Research Society 22-item (SRS-22r) onto EuroQoL-5 dimension 5-level (EQ-5D-5L) utility scores in adolescent idiopathic scoliosis (AIS) patients. Comparison of treatment outcomes in AIS can be determined by cost-utility analysis. However, the mainstay spine-specific health-related quality of life outcome measure, the SRS-22r questionnaire does not provide utility assessment. In this study, AIS patients were prospectively recruited to complete both the EQ-5D-5L and SRS-22r questionnaires by trained interviewers. Ordinary least squares regression was undertaken to develop mapping models, which the validity and robustness were assessed by using the 10-fold cross-validation procedure. EQ-5D-5L utility scores were regressed on demographics, Cobb angle, curve types, treatment modalities, and five domains of the SRS-22r questionnaire. Three models were developed using stepwise selection method. EQ-5D-5L scores were regressed on 1) main effects of SRS-22r subscale scores, 2) as per 1 plus squared and interaction terms, and 3) as per 2 plus demographic and clinical characteristics. Model goodness-of-fit was assessed using R-square, adjusted R-square, and information criteria; whereas the predictive performance was evaluated using root mean square error (RMSE), mean absolute error (MAE), and the proportion of absolute error within the threshold of 0.05 and 0.10. A total of 227 AIS patients with mean age of 15.6 years were recruited. The EQ-5D-5L scores were predicted by four domains of SRS-22r (main effects of ‘Function’, ‘Pain’, ‘Appearance’ and ‘Mental Health’, and squared term of ‘Function’ and ‘Pain’), and Cobb angle in Model 3 with the best goodness-of-fit (R-square/adjusted R-square: 62.1%/60.9%). Three models demonstrated an acceptance predictive performance in error analysis applying 10-fold cross-validation to three models where RMSE and MAE were between 0.063–0.065 and between 0.039–0.044, respectively. Model 3 was therefore recommended out of three mapping models established in this paper. To our knowledge, this is the first study to map a spine-specific health-related quality of life measure onto EQ-5D-5L for AIS patients. With the consideration and incorporation of demographic and clinical characteristics, over 60% variance explained by mapping model 3 enabled the satisfactory prediction of EQ-5D-5L utility scores from existing SRS-22r data for health economic appraisal of different treatment options.published_or_final_versio

Responsiveness of the EuroQoL 5-dimension (EQ-5D) in adolescent idiopathic scoliosis

Purpose: To test the responsiveness of the EuroQoL 5-dimension (EQ-5D) utility scores for adolescent idiopathic scoliosis (AIS). Methods:A baseline sample of 227 AIS patients was recruited between August and October 2015, and was surveyed prospectively to 9–12 months follow-up. EQ-5D-5L utility scores were derived using a two-step approach: (1) cross-walking from five-level responses to three-level responses and (2) applying the EQ-5D-3L Chinese population value set. An anchor approach was adopted to assess the responsiveness of EQ-5D. Effect size statistics (standardized effect size and standardized response mean) and independent t test were used to assess the responsiveness, as well as to analyze the ability of measures to detect score changes with global health condition changes or discriminate between the worsened and unchanged/improved groups. Results: Approximately two-thirds of follow-up patients (64.2%) reported no change in global health condition based on the self-reported health anchor, whilst 4.6 and 31.3% of patients rated worse and better in current health condition compared to baseline, respectively. In the subgroup where health worsened, EQ-5D utility scores were responsive to detect negative changes. EQ-5D utility scores had slight improvement in the group where health improved, despite a high mean score of 0.92 at baseline. Neither statistical significance nor moderate–large effect size was observed in mean changes among unchanged group. Responsiveness property of the EQ-5D utility score was generally satisfactory with respect to each health condition group. Conclusions: EQ-5D is found to be able to capture positive changes, and responsive in detecting important clinical changes in the improved group of this AIS population

Psychometric Validation of the Traditional Chinese Version of the Early Onset Scoliosis-24 Item Questionnaire (EOSQ-24)

Study Design. Questionnaire translation and validation. Objective. To translate and cross-culturally adapt the Early Onset Scoliosis-24 item Questionnaire (EOSQ-24) into traditional Chinese, and to assess its validity, reliability and sensitivity in Southern-Chinese patients diagnosed with early onset scoliosis (EOS). Summary of Background Data. Relying on radiographs alone for assessing treatment outcomes in EOS patients is inadequate. To properly gauge health-related quality of life, a disease-specific instrument that assesses patient quality of life and the burden of primary caregivers is necessary. The EOSQ-24 was created for this purpose but it has not been adapted to the Chinese language. Methods. The translation and cross-cultural adaptation of the original English EOSQ-24 were performed using the method of double forward and single backward translations, followed by a panel review. EOS patients of Southern-Chinese descent were recruited, via convenience sampling from a scoliosis specialty clinic. These patients' parents/caretakers were then administered the traditional Chinese EOSQ-24, Likert Scale regarding the understanding of completed EOSQ-24, and the Child Health Questionnaire Parent Form 50 (CHQ-PF50) (Traditional Chinese). Reliability was analysed using Cronbach's alpha. Construct validity of domains and sub-domains were assessed using Spearman's correlation test against CHQ-PF50 domains with similar constructs. Sensitivity of the EOSQ-24 scores was determined by performing known group comparisons. Results. A total of 100 EOS patients were recruited. A very good reliability was demonstrated (Cronbach's [alpha]: 0.896) and internal consistency of all domains was excellent (Cronbach's [alpha]: 0.829-0.919). Sub-domain scores of EOSQ-24 and CHQ-PF50 had significant correlations (p < 0.001), indicating a good construct validity. Conclusions. This is the first psychometric study to translate and adapt the EOSQ-24 questionnaire for Chinese EOS patients and it has been found to have satisfactory validity, reliability and sensitivity. It is a useful disease-specific instrument for assessing patients' quality of life and the burden of caregivers.postprin

Effectiveness of BNT162b2 after extending the primary series dosing interval in children and adolescents aged 5–17

Extended intervals between the first and second doses of mRNA Covid-19 vaccines may reduce the risk of myocarditis in children and adolescents. However, vaccine effectiveness after this extension remains unclear. To examine this potential variable effectiveness, we conducted a population-based nested case-control study of children and adolescents aged 5–17 years who had received two doses of BNT162b2 in Hong Kong. From January 1 to August 15, 2022, 5396 Covid-19 cases and 202 Covid-19 related hospitalizations were identified and matched with 21,577 and 808 controls, respectively. For vaccine recipients with extended intervals [≥28 days, adjusted odds ratio 0.718, 95% Confidence Interval: 0.619, 0.833] there was a 29.2%-reduced risk of Covid-19 infection compared to those with regular intervals (21–27 days). If the threshold was set at eight weeks, the risk reduction was estimated at 43.5% (aOR 0.565, 95% CI: 0.456, 0.700). In conclusion, longer dosing intervals for children and adolescents should be considered

Effectiveness of routine measurement of health-related quality of life in improving the outcomes of patients with musculoskeletal problems—a cluster randomised controlled trial: protocol paper

Introduction: Managing chronic musculoskeletal problems usually focuses on pain control using medications, but outcomes are often unsatisfactory and sometimes harmful. Information on a patient’s health-related quality of life (HRQOL) may trigger a doctor to tailor management improving quality of life. The aim of this trial is to find out whether routine measurement and reporting of a patient’s EuroQoL 5-Dimension 5-Level (EQ-5D-5L) HRQOL data using an electronic platform can improve HRQOL and pain in patients with chronic knee or back problems in primary care. We will also assess the acceptability of routine electronic measurements and reporting of the EQ-5D-5L in primary care settings. Methods: This is a multicentre, prospective, cluster randomised controlled trial set in six public primary care clinics in Hong Kong. At the intervention clinics, subjects will complete an electronic EQ-5D-5L form at recruitment and at each clinic follow-up over 12 months. A report of the patient’s longitudinal EQ-5D-5L data will be provided to the doctor. Subjects in the control clinics will receive care as usual. All subjects will complete the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a 10-point Pain Rating Scale and a structured questionnaire to collect sociodemographic information and data on morbidity and service utilisation at recruitment at baseline, 3, 6 and 12 months. Primary outcome is the change in WOMAC total score. Secondary outcomes are change in pain, other patient-reported outcome scores and doctor-rated severity of disease. Group differences in the changes in WOMAC and other outcome scores over time will be analysed using generalised estimating equation model with an intention-to-treat principle. Ethics and dissemination: Ethics approval has been obtained from The University of Hong Kong/Hospital Authority Hong Kong West Cluster (IRB reference number: UW 18-270). The results of the trial will be submitted for publication in a peer-reviewed journal. Trial registration number: NCT03609762

Self-reported reactogenicity of CoronaVac (Sinovac) compared with Comirnaty (Pfizer-BioNTech): A prospective cohort study with intensive monitoring

OBJECTIVE: CoronaVac (Sinovac) Covid-19 vaccine has recently been approved for emergency use by the World Health Organization. However, data on its reactogenicity in real-world settings is scant. This study aimed to compare self-reported post-vaccination adverse reactions between CoronaVac and Comirnaty (Pfizer-BioNTech). METHODS: We adopted a prospective cohort study design using online surveys from the day of first-dose vaccination with intensive follow-up through two weeks after the second dose (11 time points). The primary outcome was adverse reactions (any versus none) and secondary outcomes were the sub-categories of adverse reactions (local, systemic, and severe allergic reactions). Potential effect modification across multimorbidity status, older age, and sex was examined. RESULTS: In total, 2,098 participants who were scheduled to complete the 14th-day survey were included, with 46.2% receiving Comirnaty. Retention rate two weeks after the second dose was 81.0% for the CoronaVac group and 83.6% for the Comirnaty group. Throughout the follow-up period, 801 (82.7%) of those receiving Comirnaty and 543 (48.1%) of those receiving CoronaVac reported adverse reactions. Adjusted analysis suggested that compared with Comirnaty, CoronaVac was associated with 83%-reduced odds of any adverse reactions [adjusted odds ratio (AOR) = 0.17, 95% confidence interval (CI) 0.15–0.20], 92%-reduced odds of local adverse reactions (AOR = 0.08, 95% CI 0.06–0.09), and 76%-reduced odds of systemic adverse reactions (AOR = 0.24, 95% CI 0.16–0.28). No significant effect modification was identified. CONCLUSION: This post-marketing study comparing the reactogenicity of Covid-19 vaccines suggests a lower risk of self-reported adverse reactions following vaccination with CoronaVac compared with Comirnaty