Category: Statistics

BMJ Open. 2021 Jun 16;11(6):e050541. doi: 10.1136/bmjopen-2021-050541.

ABSTRACT

INTRODUCTION: Approximately 7.2% of children in the world suffer from attention-deficit/hyperactivity disorder (ADHD). Due to the availability of the osmotic-release oral-system methylphenidate, ADHD currently has a remission rate of up to 30.72%. Nevertheless, it has been reported that patients with ADHD tend to exhibit vitamin A and vitamin D deficiency, which may aggravate the symptoms of ADHD. This study aims to determine the effect of vitamin A and vitamin D supplementation as adjunctive therapy to methylphenidate on the symptoms of ADHD.

METHODS AND ANALYSIS: This is a parallel, prospective, interventional multicentric study. Patients will be enrolled from the southern, central and northern parts of China. A target of 504 patients will be followed for 8 weeks. They will be allocated into three groups (vitamin AD, vitamin D and placebo) and administered the interventions accordingly. Data on changes in the symptoms of ADHD as well as changes in the serum concentrations of vitamin A and vitamin D will be recorded. Both responders and nonresponders based on the sociodemographic and clinical data will also be described to mitigate selection bias.

ETHICS AND DISSEMINATION: This study is performed in accordance with the Declaration of Helsinki and was approved by the Institutional Review Board of Children’s Hospital of Chongqing Medical University, China (approval number: (2019) IRB (STUDY) number 262). The results of the trial will be reported in peer-reviewed scientific journals and academic conferences regardless of the outcomes.

TRIAL REGISTRATION NUMBER: NCT04284059.

PMID:34135055 | DOI:10.1136/bmjopen-2021-050541

BMJ Open. 2021 Jun 16;11(6):e046438. doi: 10.1136/bmjopen-2020-046438.

ABSTRACT

INTRODUCTION: Therapeutic mammaplasty (TM) is an oncological procedure which combines tumour resection with breast reduction and mastopexy techniques. Previous systematic reviews have demonstrated oncological safety of TM, but poor and inconsistent reporting of quality-of-life, aesthetic and functional outcomes, often with non-validated measurement tools. Moreover, there is a paucity of patient-reported outcome measures. Standardisation of outcome reporting is required to enable study results to be compared and combined, for example, through core outcome set (COS) development. This systematic review aims to comprehensively describe the outcomes reported in clinical studies of TM, their respective outcome measures and the time points at which they were evaluated. The overall objective is to facilitate the development of a COS for TM.

METHODS AND ANALYSIS: A systematic review of clinical studies evaluating outcomes following TM will be completed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The following electronic databases have been searched from inception to 5 August 2020: Ovid MEDLINE, Embase, CINAHL and Web of Science. Primary outcomes will include the number of reported outcomes of various types (clinical, aesthetic, functional, quality-of-life and cost-effectiveness), whether these are patient-reported or clinician-reported, how outcomes are defined and the outcome measurement tool(s) used. The time point(s) at which outcomes were measured will be a secondary outcome. No studies will be excluded on the basis of methodological quality in order to generate a comprehensive list of reported outcomes and outcome measures; hence, risk of bias assessment is not required. The data will be described narratively. This protocol has been reported in line with PRISMA-Protocols.

ETHICS AND DISSEMINATION: This study does not involve human or animal participants, hence ethical approval is not required. The findings will be published in a peer-reviewed journal and presented at relevant conferences.

PROSPERO REGISTRATION NUMBER: CRD42020200365.

PMID:34135045 | DOI:10.1136/bmjopen-2020-046438

BMJ Open. 2021 Jun 16;11(6):e046904. doi: 10.1136/bmjopen-2020-046904.

ABSTRACT

OBJECTIVES: Though dissertation is mandatory for postgraduates (PG), it is unknown if adequate knowledge on plagiarism exists at that level. Thus, we intended to study the knowledge and attitude towards plagiarism among junior doctors in India.

DESIGN: Cross-sectional study SETTING: PG medical residents and Junior faculty from various teaching institutions across south India.

PARTICIPANTS: A total of N=786 doctors filled the questionnaires of which approximately 42.7% were from government medical colleges (GMCs) and the rest from private institutions.

METHODS: Participants were given a pretested semistructured questionnaire which contained: (1) demographic details; (2) a quiz developed by Indiana University, USA to assess knowledge and (3) Attitudes towards Plagiarism Questionnaire (ATPQ).

OUTCOME MEASURES: The Primary outcome measure was knowledge about plagiarism. The secondary outcome measure was ATPQ scores.

RESULTS: A total of N=786 resident doctors and junior faculty from across 11 institutions participated in this study. Of this, 42.7% were from GMCs and 60.6% were women. The mean (SD) knowledge score was 4.43 (1.99) out of 10. The factors (adjusted OR; 95% CI; p value) that emerged as significant predictors of knowledge were number of years in profession (-0.181; -0.299 to -0.062; 0.003), no previous publication (0.298; 0.099 to 0.498; 0.003) and working in a GMC (0.400; 0.106 to 0.694; 0.008). The overall mean (SD) scores of the three attitude components were: Permissive attitudes-37.33 (5.33), critical attitudes -20.32 (4.82) and subjective norms-31.05 (4.58), all of which corresponded to the moderate category.

CONCLUSION: Participants lacked adequate knowledge on how to avoid plagiarism suggesting a need for a revamp in medical education curriculum in India by incorporating research and publication ethics.

PMID:34135051 | DOI:10.1136/bmjopen-2020-046904

BMJ Open. 2021 Jun 16;11(6):e048788. doi: 10.1136/bmjopen-2021-048788.

ABSTRACT

OBJECTIVES: To capture the complexities and unique experience of a newly formed multidisciplinary and multicentre research team developing and deploying a COVID-19 study and to identify lessons learnt.

DESIGN: Co-autoethnographic study.

SETTING: Staff at two UK academic institutions, a national charity and two major UK hospitals.

PARTICIPANTS: Researchers, clinicians, academics, statisticians and analysts, patient and public involvement representatives and national charity.

METHODS: The sampling frame was any content discussed or shared between research team members (emails, meeting minutes, etc), standard observational dimensions and reflective interviews with team members. Data were thematically analysed.

RESULTS: Data from 34 meetings and >50 emails between 17 March and 5 August 2020 were analysed. The analysis yielded seven themes with ‘Managing our stress’ as an overarching theme.

CONCLUSIONS: Mutual respect, flexibility and genuine belief that team members are doing the best they can under the circumstances are essential for completing a time-consuming study, requiring a rapid response during a pandemic. Acknowledging and managing stress and a shared purpose can moderate many barriers, such as the lack of face-to-face interactions, leading to effective team working.

PMID:34135052 | DOI:10.1136/bmjopen-2021-048788

BMJ Open. 2021 Jun 16;11(6):e045014. doi: 10.1136/bmjopen-2020-045014.

ABSTRACT

OBJECTIVE: To test if participation in the Health Start Programme, an Arizona statewide Community Health Worker (CHW) maternal and child health (MCH) home visiting programme, reduced rates of low birth weight (LBW), very LBW (VLBW), extremely LBW (ELBW) and preterm birth (PTB).

DESIGN: Quasi-experimental retrospective study using propensity score matching of Health Start Programme enrolment data to state birth certificate records for years 2006-2016.

SETTING: Arizona is uniquely racially and ethnically diverse with comparatively higher proportions of Latino and American Indian residents and a smaller proportion of African Americans.

PARTICIPANTS: 7212 Health Start Programme mothers matched to non-participants based on demographic, socioeconomic and geographic characteristics, health conditions and previous birth experiences.

INTERVENTION: A statewide CHW MCH home visiting programme.

PRIMARY AND SECONDARY OUTCOME MEASURES: LBW, VLBW, ELBW and PTB.

RESULTS: Using Health Start Programme’s administrative data and birth certificate data from 2006 to 2016, we identified 7212 Health Start Programme participants and 53 948 matches. Programme participation is associated with decreases in adverse birth outcomes for most subgroups. Health Start participation is associated with statistically significant lower rates of LBW among American Indian women (38%; average treatment-on-the-treated effect (ATT): 2.30; 95% CI -4.07 to -0.53) and mothers with a pre-existing health risk (25%; ATT: -3.06; 95% CI -5.82 to -0.30). Among Latina mothers, Health Start Programme participation is associated with statistically significant lower rates of VLBW (36%; ATT: 0.35; 95% CI -0.69 to -0.01) and ELBW (62%; ATT: 0.31; 95% CI (-0.52 to -0.10)). Finally, Health Start Programme participation is associated with a statistically significant lower rate of PTB for teen mothers (30%; ATT: 2.81; 95% CI -4.71 to -0.91). Other results were not statistically significant.

CONCLUSION: A state health department-operated MCH home visiting intervention that employs CHWs as the primary interventionist may contribute to the reduction of LBW, VLBW, ELBW and PTB and could improve birth outcomes statewide, especially among women and children at increased risk for MCH inequity.

PMID:34135037 | DOI:10.1136/bmjopen-2020-045014

BMJ Open. 2021 Jun 16;11(6):e045988. doi: 10.1136/bmjopen-2020-045988.

ABSTRACT

OBJECTIVES: Compassion is a key indicator of quality care that is reportedly eroding from patients’ care experience. While the need to assess compassion is recognised, valid and reliable measures are lacking. This study developed and validated a clinically informed, psychometrically rigorous, patient-reported compassion measure.

DESIGN: Data were collected from participants living with life-limiting illnesses over two study phases across four care settings (acute care, hospice, long term care (LTC) and homecare). In phase 1, data were analysed through exploratory factor analysis (EFA), with the final items analysed via confirmatory factor analysis (CFA) in phase 2. The Schwartz Center Compassionate Care Scale (SCCCS), the revised Edmonton Symptom Assessment Scale (ESAS-r) and Picker Patient Experience Questionnaire (PPEQ) were also administered in phase 2 to assess convergent and divergent validity.

SETTING AND PARTICIPANTS: 633 participants were recruited over two study phases. In the EFA phase, a 54-item version of the measure was administered to 303 participants, with 330 participants being administered the final 15-item measure in the CFA phase.

RESULTS: Both EFA and CFA confirmed compassion as a single factor construct with factor loadings for the 15-item measure ranging from 0.76 to 0.86, with excellent test-retest reliability (intraclass correlation coefficient range: 0.74-0.89) and excellent internal reliability (Cronbach’s alpha of 0.96). The measure was positively correlated with the SCCCS (r=0.75, p<0.001) and PPEQ (r=0.60, p<0.001). Participants reporting higher experiences of compassion had significantly greater well-being and lower depression on the ESAS-r. Patients in acute care and hospice reported significantly greater experiences of compassion than LTC residents.

CONCLUSIONS: There is strong initial psychometric evidence for the Sinclair Compassion Questionnaire (SCQ) as a valid and reliable patient-reported compassion measure. The SCQ provides healthcare providers, settings and administrators the means to routinely measure patients experiences of compassion, while providing researchers a robust measure to conduct high-quality research.

PMID:34135041 | DOI:10.1136/bmjopen-2020-045988

BMJ Open. 2021 Jun 16;11(6):e042066. doi: 10.1136/bmjopen-2020-042066.

ABSTRACT

OBJECTIVES: Systematic evaluation of the influence of occupation type on the association between sleep-glucose metabolism DESIGN: A cross-sectional study.

SETTING: The Nantong Metabolic Syndrome Study is a Chinese population-based study.

PARTICIPANTS: 20 502 participants aged 18-74 years old.

INTERVENTION: No intervention.

PRIMARY AND SECONDARY OUTCOME MEASURES: Impaired fasting glucose (IFG).

RESULTS: A total of 1503 participants (7.33%) with a slightly longer sleep duration had IFG. After being stratified according to occupation, a sleep duration of ≥10 hours daily corresponded to a 1.321-fold risk of IFG (95% CI 1.071 to 1.628, p=0.0092) among moderate and heavy physical workers compared with those with a daily sleep duration of 7-9 hours. There was no significant relationship between sleep and IFG among other types of workers. Moreover, we discovered a gender difference in the influence of occupation on the sleep-IFG. A positive association among moderate and heavy physical men and a negative association among light or sedentary men were established, but not in unemployed men. However, a positive association was evident only in unemployed women; there was no significant association among other occupations.

CONCLUSION: This study highlights the role of occupation in the relationship of sleep-glucose metabolism. A gender difference was found to have been influenced by occupational types on the sleep-metabolic association.

PMID:34135029 | DOI:10.1136/bmjopen-2020-042066

BMJ Open. 2021 Jun 16;11(6):e043906. doi: 10.1136/bmjopen-2020-043906.

ABSTRACT

RATIONALE: Clinical trials are the gold standard for testing interventions. COVID-19 has further raised their public profile and emphasised the need to deliver better, faster, more efficient trials for patient benefit. Considerable overlap exists between data required for trials and data already collected routinely in electronic healthcare records (EHRs). Opportunities exist to use these in innovative ways to decrease duplication of effort and speed trial recruitment, conduct and follow-up.

APPROACH: The National Institute of Health Research (NIHR), Health Data Research UK and Clinical Practice Research Datalink co-organised a national workshop to accelerate the agenda for ‘data-enabled clinical trials’. Showcasing successful examples and imagining future possibilities, the plenary talks, panel discussions, group discussions and case studies covered: design/feasibility; recruitment; conduct/follow-up; collecting benefits/harms; and analysis/interpretation.

REFLECTION: Some notable studies have successfully accessed and used EHR to identify potential recruits, support randomised trials, deliver interventions and supplement/replace trial-specific follow-up. Some outcome measures are already reliably collected; others, like safety, need detailed work to meet regulatory reporting requirements. There is a clear need for system interoperability and a ‘route map’ to identify and access the necessary datasets. Researchers running regulatory-facing trials must carefully consider how data quality and integrity would be assessed. An experience-sharing forum could stimulate wider adoption of EHR-based methods in trial design and execution.

DISCUSSION: EHR offer opportunities to better plan clinical trials, assess patients and capture data more efficiently, reducing research waste and increasing focus on each trial’s specific challenges. The short-term emphasis should be on facilitating patient recruitment and for postmarketing authorisation trials where research-relevant outcome measures are readily collectable. Sharing of case studies is encouraged. The workshop directly informed NIHR’s funding call for ambitious data-enabled trials at scale. There is the opportunity for the UK to build upon existing data science capabilities to identify, recruit and monitor patients in trials at scale.

PMID:34135032 | DOI:10.1136/bmjopen-2020-043906

BMJ Open. 2021 Jun 16;11(6):e033935. doi: 10.1136/bmjopen-2019-033935.

ABSTRACT

OBJECTIVES: The aim of this study is to quantify societal preferences for, and assess trade-offs between characteristics of treatment programmes for impulsive-violent offenders.

SETTING: The study was conducted in New South Wales, Australia’s largest state.

PARTICIPANTS: The study participants were income tax payers, aged over 18 and who were able to provide informed consent.

METHODS: A discrete choice experiment was used to assess the preferences for treatment programmes for impulsive violent offenders. The survey presented participants with six choice sets in which they chose between two unlabelled treatment scenarios and a ‘no treatment’ choice. A random parameters logistic (RPL) model and a latent class (LC) model were used to analyse the societal preferences for treatment and estimate willingness to pay values based on marginal rates of substitution. Respondents were asked to self-identify if they ever had experiences with violence and subgroup analysis was done.

RESULTS: The survey was completed by 1021 highly engaged participants. The RPL model showed that society had a preference for more effective programmes, programmes that provided full as opposed to partial treatment of all co-occurring health conditions, compulsory over voluntary programmes, those with flexibility in appointments and programmes that are provided with continuity of care postprison. Respondents were willing to pay an additional annual tax contribution for all significant attributes, particularly compulsory programmes, continuity of treatment and effectiveness.The LC model identified two classes of respondents with some differences in preferences which could be largely identified by whether they had experiences with violence or not.

CONCLUSION: The results are important for future programme design and implementation. Programmes for impulsive violent offenders that are designed to encompass societal preferences are likely to be supported by public and tax payers.

PMID:34135027 | DOI:10.1136/bmjopen-2019-033935

Int J Clin Pract. 2021 Jun 16:e14539. doi: 10.1111/ijcp.14539. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Breast cancer is one of the most common malignant tumors among women. In this study, we compared the analgesic efficacy of ultrasound (US)-guided rhomboid intercostal nerve block, erector spinae plane (ESP) block, and serratus plane block (SAB) after modified radical mastectomy (MRM) of unilateral breast cancer.

METHODS: This study involved a double-blind clinical trial that was carried out in the Affiliated Hospital of Jiaxing University on September 23, 2020. The inclusion criteria were the following: the American Society of Anesthesiologists (ASA) grade needed to be 1-2, the patients needed to be between 18 and 80 years old, and MRM needed to be proposed in our hospital. The exclusion criteria were patients with contraindications related to nerve block. Ninety patients were randomly divided into three groups receiving US-guided SAB, ESP block, and rhomboid intercostal block (RIB). All groups received 20 mL 0.5% ropivacaine. Within 24 hours after the operation, the patients received an intravenous injection of tramadol 1-2 mg/kg in the surgical ward for pain relief.

RESULTS: The dosage of tramadol 24 hours after the operation in the RIB (269.67 ± 48.75 mg) and ESP block groups (273.67 ± 36.90 mg) was significantly lower than that in the SAB group (314.33 ± 18.88 mg) (P < 0.001). There was no statistical difference in tramadol consumption between the ESP block and RIB groups within 24 hours (P = 0.676). The numerical rating scale (NRS) scores in the ESP block and RIB groups at 0.5, 1, 3, 6, 12, 18, and 24 hours after the operation once patients were active were significantly lower than that in the SAB group (P < 0.05 for all comparisons); however, the NRS scores of the RIB and ESP block groups did not differ significantly within 24 hours after surgery when patients were active.

CONCLUSIONS: US-guided rhomboid intercostal block (US-RIB) and ESP block can effectively reduce the dosage of tramadol within 24 hours after MRM, and they can effectively relieve pain within 24 hours after MRM compared with SAB.

PMID:34133831 | DOI:10.1111/ijcp.14539