Tag: statistics

CNS Neurosci Ther. 2023 Jan 4. doi: 10.1111/cns.14080. Online ahead of print.

ABSTRACT

AIMS: The aim of this study was to explore the interaction between reperfusion and treatment time on the outcomes of patients undergoing endovascular treatment presenting within 24 h of last known well, and to compare the predictive ability of different reperfusion measurements on outcomes.

METHODS: Eligible patients from a single-center cohort were enrolled in this study. Reperfusion was assessed using reperfusion index (decreased volume of hypoperfusion lesion compared with baseline) measured by repeated perfusion imaging, and modified treatment in cerebral ischemia score measured by digital subtraction angiography, respectively. The interactions between reperfusion measurements and treatment time on outcomes were explored using multivariate-adjusted logistic and linear regression models. The predictive abilities of reperfusion measurements on outcomes were compared using area under the receiver operating characteristic curve (ROC-AUC) and values of R-square.

RESULTS: Reperfusion index and treatment time had significant interactions on 3-month modified Rankin Scale (mRS) 0-2 and infarct growth (p for interaction <0.05). Although the AUCs were statistically similar (AUCs of mRS 0-2 prediction, mTICI≥2b:0.63, mTICI≥2c:0.59, reperfusion index≥0.5:0.66, reperfusion index ≥0.9:0.73, P value of any of the two AUCs >0.05), reperfusion index≥0.9 showed the highest R-square values in outcome prediction (R-square values of 3-month mRS 0-2 and infarct growth = 0.21) among all the reperfusion measurements.

CONCLUSION: Treatment time mitigated the effect of reperfusion on outcomes of patients receiving endovascular treatment within 24 h of last known well. Reperfusion index≥0.9 might serve as a better proxy of good outcomes compared with other reperfusion measurements.

PMID:36601659 | DOI:10.1111/cns.14080

BMJ Open Respir Res. 2022 Dec;9(1):e001355. doi: 10.1136/bmjresp-2022-001355.

ABSTRACT

BACKGROUND AND OBJECTIVE: Obesity and asthma impose a heavy health and economic burden on millions of people around the world. The complex interaction between genetic traits and phenotypes caused the mechanism between obesity and asthma is still vague. This study investigates the relationship among obesity-related polygenic risk score (PRS), obesity phenotypes and the risk of having asthma.

METHODS: This is a matched case-control study, with 4 controls (8288 non-asthmatic) for each case (2072 asthmatic). Data were obtained from the 2008-2015 Taiwan Biobank Database and linked to the 2000-2016 National Health Insurance Research Database. All participants were ≥30 years old with no history of cancer and had a complete questionnaire, as well as physical examination, genome-wide single nucleotide polymorphisms and clinical diagnosis data. Environmental exposure, PM_2.5, was also considered. Multivariate adjusted ORs and 95% CIs were calculated using conditional logistic regression stratified by age and sex. Mediation analysis was also assessed, using a generalised linear model.

RESULTS: We found that the obese phenotype was associated with significantly increased odds of asthma by approximately 26%. Four obesity-related PRS, including body mass index (OR=1.07 (1.01-1.13)), waist circumference (OR=1.10 (1.04-1.17)), central obesity as defined by waist-to-height ratio (OR=1.09 (1.03-1.15)) and general-central obesity (OR=1.06 (1.00-1.12)), were associated with increased odds of asthma. Additional independent risk factors for asthma included lower educational level, family history of asthma, certain chronic diseases and increased PM_2.5 exposure. Obesity-related PRS is an indirect risk factor for asthma, the link being fully mediated by the trait of obesity.

CONCLUSIONS: Obese phenotypes and obesity-related PRS are independent risk factors for having asthma in adults in the Taiwan Biobank. Overall, genetic risk for obesity increases the risk of asthma by affecting the obese phenotype.

PMID:36600406 | DOI:10.1136/bmjresp-2022-001355

BMJ Open. 2022 Dec 7;12(12):e056689. doi: 10.1136/bmjopen-2021-056689.

ABSTRACT

INTRODUCTION: Recent studies in animal models indicate that recombinant human erythropoietin (rHuEPO) is very effective in enhancing neurological recovery after spinal cord injury (SCI). We described a protocol aimed at evaluating the efficacy of rHuEPO plus methylprednisolone (MP) compared with MP alone in improving neurological function of patients with SCI in randomised controlled trials (RCTs).

METHODS AND ANALYSIS: This study aims to explore the effect of rHuEPO combined with MP on neurological function in patients with SCI through a meta-analysis. To this end, the authors will search eight research databases for data retrieval: MEDLINE, China National Knowledge Infrastructure, Wan Fang, China Biology Medicine dis, Web of Science, PubMed, Cochrane and Embase for RCTs on SCI in any language. The primary outcome will be the American Spinal Injury Association score at the time of follow-up. The secondary outcomes will be the WHOQOL-100 instrument score, neurophysiological state and related factors. Two authors will independently search literature records, scan titles, abstracts and full texts, collect data, and assess materials for risk of bias. Stata V.14.0 will be used for statistical analysis.

ETHICS AND DISSEMINATION: This research is exempt from ethics approval because the work is carried out on published documents. We will disseminate this protocol in scientific conferences and a peer-reviewed journal.

PROSPERO REGISTRATION NUMBER: CRD42021260688.

PMID:36600375 | DOI:10.1136/bmjopen-2021-056689

BMJ Open. 2022 Dec 7;12(12):e062278. doi: 10.1136/bmjopen-2022-062278.

ABSTRACT

INTRODUCTION: Anterior shoulder dislocation is a common reason for consultation at the emergency department (ED). Hypnosis could be a safe and effective alternative therapy for pain relief during shoulder dislocation reduction but nowadays, evidence is not sufficient. The main objective of this study is to show that reduction under hypnosis is associated with a decrease in the use of analgesic compared with usual care.

METHODS AND ANALYSIS: We will conduct an interventional, controlled, multicentre, randomised study. A total of 44 patients with shoulder dislocation will be randomised in two groups: the hypnosis group (N=22) and the usual care group (N=22). The primary endpoint will be the comparison of morphine equivalent analgesic consumption during a shoulder dislocation reduction manoeuvre. Secondary endpoints will include haemodynamic parameters monitoring, patient and practitioner satisfaction using a Likert scale, use of coanalgesic or sedative drugs, number of reduction attempts and time spent at ED. Adverse events will be recorded. Statistical analysis will include parametric tests, multivariate linear regression and descriptive statistics.

ETHICS AND DISSEMINATION: This study has received ethics approval from the Comité de Protection des Personnes of Sud-Est IV on 03/11/2021 (ANSM informed on 19 November 2021). The results will be published in scientific articles and communicated in national and international conferences.

TRIAL REGISTRATION NUMBER: ClinicalTrial.gov: NCT04992598; National Clinical trial no ID RCB : 2021-A01382-39.

PMID:36600368 | DOI:10.1136/bmjopen-2022-062278

BMJ Open. 2022 Dec 7;12(12):e063617. doi: 10.1136/bmjopen-2022-063617.

ABSTRACT

OBJECTIVES: Current research on trafficking in persons (TIP) relies heavily on legal and prosecutorial definitions. A public health approach has called for population-level assessment; however, identification of TIP victims lacks a standardised operational definition. This study applied the Prevalence Reduction Innovation Forum (PRIF) statistical definitions, developed by the US Department of State, to a community survey in Cape Town, South Africa.

DESIGNS: A high-risk sampling strategy was used. TIP screening questions from two instruments were matched with PRIF domain indicators to generate prevalence estimates. Sensitivity, specificity and receiver operating characteristics analyses were conducted to assess the performance of the two screeners.

SETTING: Cross-sectional survey conducted in Cape Town, South Africa, from January to October 2021.

PARTICIPANTS: South Africans and immigrants from other nations residing in Cape Town and its surrounding areas, aged 18 or older, who met the study inclusion criteria for a set of experiences that were identified as TIP risk factors.

PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome measures were PRIF lifetime and past 12-month TIP positivity. Secondary outcome measures included individual and summary measures from the two screeners.

RESULTS: Our PRIF algorithm yielded a TIP lifetime prevalence rate of 17.0% and past 12-month rate of 2.9%. Summary measures from each TIP screener showed an excellent range of predictive utility. The summary screener measures yielded statistically significant differences among some demographic and background categories. Several screener items were shown less predictive of the PRIF statistical definition criteria than others.

CONCLUSIONS: Prevalence estimates of probable TIP were higher than those reported elsewhere. Our TIP screeners yielded an excellent range of predictive utility for the statistical definitions, promising the potential for wider applications in global and regional TIP research and policymaking. A more systematic sampling strategy is needed even if statistical definitions become widely used.

PMID:36600367 | DOI:10.1136/bmjopen-2022-063617

BMJ Open. 2022 Dec 6;12(12):e065653. doi: 10.1136/bmjopen-2022-065653.

ABSTRACT

INTRODUCTION: Ankyloglossia is a situation where the tongue tip cannot go beyond the mandibular incisor because the frenulum linguae is short. It could affect children’s health by interfering with their ability to talk, breast feeding and dental development. The most effective measure to control ankyloglossia is the surgical method. However, which surgical procedure is the best one is still controversial. Thus, this protocol aims to assess the effectiveness of different surgical interventions in children with ankyloglossia.

METHODS AND ANALYSIS: PubMed, EMBASE, Cochrane Library, Web of Science and OVID will be searched for relevant information from inception to 31 May 2022. Observational studies in English that investigate the association between surgical methods and ankyloglossia will be included in this protocol. This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. The Critical Appraisal Checklist for Analytical Cross-Sectional Studies and the Newcastle-Ottawa Quality Assessment Scale for longitudinal studies will be used to assess the included studies. The improvement of breast feeding and nipple pain will be the primary outcome. STATA V.15.1 will do the statistical analysis in the meta-analysis. Subgroup and meta-regression will be carried out based on the characteristics of included studies.

ETHICS AND DISSEMINATION: This systematic review and meta-analysis will summarise relevant information on the effects of different surgical treatments on patients with ankyloglossia. The results will be disseminated through peer-reviewed publications. The data included in this study will be extracted from the published original studies. Thus, ethical approval and informed consent will not be required.

PROSPERO REGISTRATION NUMBER: CRD42022323350.

PMID:36600360 | DOI:10.1136/bmjopen-2022-065653

BMJ Open. 2022 Dec 6;12(12):e059463. doi: 10.1136/bmjopen-2021-059463.

ABSTRACT

INTRODUCTION: Incisional hernia has an incidence of up to 20% following laparotomy and is associated with significant morbidity and impairment of quality of life. A variety of surgical strategies including techniques and mesh types are available to manage patients with incisional hernia. Previous works have reported significant heterogeneity in outcome reporting for abdominal wall herniae, including ventral and inguinal hernia. This is coupled with under-reporting of important clinical and patient-reported outcomes. The lack of standardisation in outcome reporting contributes to reporting bias, hinders evidence synthesis and adequate data comparison between studies. This project aims to develop a core outcome set (COS) of clinically important, patient-oriented outcomes to be used to guide reporting of future research in incisional hernia.

METHODS: This project has been designed as an international, multicentre, mixed-methods project. Phase I will be a systematic review of current literature to examine the current clinical and patient-reported outcomes for incisional hernia and abdominal wall reconstruction. Phase II will identify the outcomes of importance to all key stakeholders through in depth qualitative interviews. Phase III will achieve consensus on outcomes of most importance and for inclusion into a COS through a Delphi process. Phase IV will achieve consensus on the outcomes that should be included in a final COS.

ETHICS AND DISSEMINATION: The adoption of this COS into clinical and academic practice will be endorsed by the American, British and European Hernia Societies. Its utilisation in future clinical research will enable appropriate data synthesis and comparison and will enable better clinical interpretation and application of the current evidence base. This study has been registered with the Core Outcome Measures in Effectiveness Trials initiative.

PROSPERO REGISTRATION NUMBER: CRD42018090084.

PMID:36600359 | DOI:10.1136/bmjopen-2021-059463

BMJ Open. 2022 Dec 6;12(12):e066814. doi: 10.1136/bmjopen-2022-066814.

ABSTRACT

OBJECTIVES: To examine how drug shop clients’ expenditures are affected by subsidies for malaria diagnostic testing and for malaria treatment, and also to examine how expenditures vary by clients’ malaria test result and by the number of medications they purchased.

DESIGN: Secondary cross-sectional analysis of survey responses from a randomised controlled trial.

SETTING: The study was conducted in twelve private drug shops in Western Kenya.

PARTICIPANTS: We surveyed 836 clients who visited the drug shops between March 2018 and October 2019 for a malaria-like illness. This included children >1 year of age if they were physically present and accompanied by a parent or legal guardian.

INTERVENTIONS: Subsidies for malaria diagnostic testing and for malaria treatment (conditional on a positive malaria test result).

PRIMARY AND SECONDARY OUTCOME MEASURES: Expenditures at the drug shop in Kenya shillings (Ksh).

RESULTS: Clients who were randomised to a 50% subsidy for malaria rapid diagnostic tests (RDTs) spent approximately Ksh23 less than those who were randomised to no RDT subsidy (95% CI (-34.6 to -10.7), p=0.002), which corresponds approximately to the value of the subsidy (Ksh20). However, clients randomised to receive free treatment (artemisinin combination therapies (ACTs)) if they tested positive for malaria had similar spending levels as those randomised to a 67% ACT subsidy conditional on a positive test. Expenditures were also similar by test result, however, those who tested positive for malaria bought more medications than those who tested negative for malaria while spending approximately Ksh15 less per medication (95% CI (-34.7 to 3.6), p=0.102).

CONCLUSIONS: Our results suggest that subsidies for diagnostic health products may result in larger household savings than subsidies on curative health products. A better understanding of how people adjust their behaviours and expenditures in response to subsidies could improve the design and implementation of subsidies for health products.

TRIAL REGISTRATION NUMBER: NCT03810014.

PMID:36600353 | DOI:10.1136/bmjopen-2022-066814

BMJ Open. 2022 Dec 6;12(12):e065234. doi: 10.1136/bmjopen-2022-065234.

ABSTRACT

INTRODUCTION: A proportion of those who survive the acute phase of COVID-19 experience prolonged symptoms, commonly known as long COVID-19. Given that healthcare workers (HCWs) face an elevated risk of acute COVID-19 compared with the general population, the global burden of long COVID-19 in HCWs is likely to be large; however, there is limited understanding of the prevalence of long COVID-19 in HCWs, or its symptoms and their clustering. This review will aim to estimate the pooled prevalence and the symptoms of long COVID-19 among HCWs infected with SARS-CoV-2 globally, and investigate differences by country, age, sex, ethnicity, vaccination status and occupation.

METHODS AND ANALYSIS: A systematic review and meta-analysis will be conducted. Medline (via Ovid), CINAHL (via EBSCO), Embase (via Ovid), PsycINFO (via EBSCO), OpenGrey (grey literature) and medRxiv (preprint server) will be searched from the 31 December 2019 onward. All research studies and preprint articles reporting any primary data on the prevalence and/or the symptoms of long COVID-19 among adult HCWs will be included. Methodological quality will be assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Studies Reporting Prevalence Data. Outcomes are anticipated to be the prevalence of long COVID-19 among HCWs around the world and trajectory of symptoms. Data synthesis will include random-effect meta-analysis for studies reporting prevalence data of long COVID-19 following SARS-CoV-2 infection among HCWs. The results will be presented with a 95% CI as an estimated effect across studies. Heterogeneity will be assessed using I² statistic. Where meta-analysis is inappropriate, a narrative synthesis of the evidence will be conducted.

ETHICS AND DISSEMINATION: Ethical approval is not needed as data will be obtained from published articles. We will publish our findings in a peer-reviewed journal and disseminate the results of our review at conferences.

PROSPERO REGISTRATION NUMBER: CRD42022312781.

PMID:36600349 | DOI:10.1136/bmjopen-2022-065234

BMJ Open. 2022 Dec 9;12(12):e067656. doi: 10.1136/bmjopen-2022-067656.

ABSTRACT

OBJECTIVES: To describe the extent to which pragmatic trials underachieved or overachieved their target sample sizes, examine explanations and identify characteristics associated with under-recruitment and over-recruitment.

STUDY DESIGN AND SETTING: Secondary analysis of an existing database of primary trial reports published during 2014-2019, registered in ClinicalTrials.gov, self-labelled as pragmatic and with target and achieved sample sizes available.

RESULTS: Of 372 eligible trials, the prevalence of under-recruitment (achieving <90% of target sample size) was 71 (19.1%) and of over-recruitment (>110% of target) was 87 (23.4%). Under-recruiting trials commonly acknowledged that they did not achieve their targets (51, 71.8%), with the majority providing an explanation, but only 11 (12.6%) over-recruiting trials acknowledged recruitment excess. The prevalence of under-recruitment in individually randomised versus cluster randomised trials was 41 (17.0%) and 30 (22.9%), respectively; prevalence of over-recruitment was 39 (16.2%) vs 48 (36.7%), respectively. Overall, 101 025 participants were recruited to trials that did not achieve at least 90% of their target sample size. When considering trials with over-recruitment, the total number of participants recruited in excess of the target was a median (Q1-Q3) 319 (75-1478) per trial for an overall total of 555 309 more participants than targeted. In multinomial logistic regression, cluster randomisation and lower journal impact factor were significantly associated with both under-recruitment and over-recruitment, while using exclusively routinely collected data and educational/behavioural interventions were significantly associated with over-recruitment; we were unable to detect significant associations with obtaining consent, publication year, country of recruitment or public engagement.

CONCLUSIONS: A clear explanation for under-recruitment or over-recruitment in pragmatic trials should be provided to encourage transparency in research, and to inform recruitment to future trials with comparable designs. The issues and ethical implications of over-recruitment should be more widely recognised by trialists, particularly when designing cluster randomised trials.

PMID:36600344 | DOI:10.1136/bmjopen-2022-067656