Category: Statistics

BMJ Open. 2022 Jul 4;12(7):e058546. doi: 10.1136/bmjopen-2021-058546.

ABSTRACT

OBJECTIVES: Physical activity (PA) plays a significant role in the treatment of type two diabetes (T2D). This study evaluated the effectiveness of PA counselling in primary healthcare (PHC) on clinical outcome measures in patients with T2D, comparing them with a registry-based controls.

SETTING: The study was carried out in North Karelia, Finland, among PHC clients who have been diagnosed with T2D in 2016-2018.

PARTICIPANTS: The study population consisted of patients aged 19-87 years diagnosed with T2D (n=1803). Altogether 546 patients were referred to the PA educator of whom 521 participated the counselling. In totally 1382 sex, age, time of diagnosis and intervention time-matched controls were used to see the effect of intervention.

INTERVENTIONS: Patients with T2D followed up in PHC were offered to participate in PA counselling provided by trained PA educators. The number of counselling sessions and their content were tailored according to patients needs and willingness to participate. To assess the effects of PA to management of T2D clinical outcome measures such as weight and Haemoglobin A1c (HbA1c) and lipid levels were assessed using data from electronic patient records. Each patient was followed up from records at least for a year.

RESULTS: Weight and body mass index (BMI) decreased in both groups and mean yearly changes did not differ between the groups. HbA1c levels declined in the intervention and increased in the control group with statistically significant difference in the mean yearly change between the groups (p=0.001). The low-density lipoprotein declined in both groups. The decline was bigger in the intervention group, but the difference did not quite reach the statistical significance (p=0.096).

CONCLUSIONS: This study shows that PA counselling in PHC offers significant benefits in the treatment outcomes of T2D although no significant declines were not observed in the weight or BMI.

PMID:35788078 | DOI:10.1136/bmjopen-2021-058546

BMJ Open. 2022 Jul 4;12(7):e058770. doi: 10.1136/bmjopen-2021-058770.

ABSTRACT

OBJECTIVE: To explore the impact of the COVID-19 on the distribution, type and patterns of diseases in hospitalised children under local antiepidemic measures.

DESIGN: Retrospective chart review.

SETTING: Electronic medical records of patients hospitalised in the paediatric department of a tertiary hospital in South China from 21 January 2019 to 20 January 2021.

PARTICIPANTS: Records of 2139 patients.

OUTCOME MEASURES: Data were analysed before and during the COVID-19 pandemic. Disease characteristics were analysed based on the 10th revision of the International Statistical Classification of Diseases and Related Health Problems. Features of the length of hospital stay were investigated. Categorical variables involving more than three groups were analysed using an overall χ² test, followed by pairwise comparisons.

RESULTS: During the COVID-19 outbreak period, paediatric hospitalisation was reduced by 29.6%, from 1255 to 884. The proportions of infection-related diseases (36.3% (455 cases) vs 20.8% (184 cases)), respiratory system-related diseases (22.5% (283 cases) vs 9.4% (83 cases)); and endocrine, nutritional and metabolic diseases (17.1% (214 cases) vs 9.2% (81 cases)) decreased significantly, whereas that of musculoskeletal and connective tissue diseases increased from 11.0% (138 cases) to 20.1% (178 cases), thereby becoming the most common reason for hospitalisation. The proportions of diseases of the nervous system (12.4% (156 cases) to 18.8% (166 cases)) and mental and behavioural disorders (0.2% (3 cases) to 2.1% (19 cases)) increased significantly. The average length of hospital stay increased after the outbreak (7.57±6.53 vs 8.36±6.87).

CONCLUSION: The number of hospitalisation cases decreased during the COVID-19 period. The prominent decreases in hospitalisation associated with infections and respiratory system diseases were likely attributed to the improved epidemic prevention work, enhancement of people’s health awareness and fear of possible exposure to COVID-19. Describing the impact of COVID-19 on disease patterns may provide a reference for resource planning during the pandemic.

PMID:35788068 | DOI:10.1136/bmjopen-2021-058770

BMJ Open. 2022 Jul 4;12(7):e062572. doi: 10.1136/bmjopen-2022-062572.

ABSTRACT

INTRODUCTION: Time-varying exposure is an important issue that should be addressed in longitudinal observational studies using routinely collected data (RCD) for drug treatment effects. How well investigators designed, analysed and reported time-varying exposure, and to what extent the divergence that can be observed between different methods used for handling time-varying exposure in these studies remains uncertain. We will conduct a cross-sectional study to comprehensively address this question.

METHODS AND ANALYSIS: We have developed a comprehensive search strategy to identify all studies exploring drug treatment effects including both effectiveness and safety that used RCD and were published in core journals between 2018 and 2020. We will collect information regarding general study characteristics, data source profile, methods for handling time-varying exposure, results and the interpretation of findings from each eligibility. Paired reviewers will screen and extract data, resolving disagreements through discussion. We will describe the characteristics of included studies, and summarise the method used for handling time-varying exposure in primary analysis and sensitivity analysis. We will also compare the divergence between different approaches for handling time-varying exposure using ratio of risk ratios.

ETHICS AND DISSEMINATION: No ethical approval is required because the data we will use do not include individual patient data. Findings will be disseminated through peer-reviewed publications.

PMID:35788067 | DOI:10.1136/bmjopen-2022-062572

J Acad Nutr Diet. 2022 Mar 25:S2212-2672(22)00170-8. doi: 10.1016/j.jand.2022.03.014. Online ahead of print.

ABSTRACT

BACKGROUND: Obesity is associated with a multitude of comorbidities and considerable healthcare costs.

OBJECTIVE: The objective was to examine the efficacy of weight management interventions provided by a registered dietitian or international equivalent (referred to as “dietitian”).

METHODS: This systematic review and meta-analysis of randomized controlled trials (RCTs) compared weight management interventions provided by a dietitian to usual care or no intervention on several cardiometabolic outcomes and quality of life in adults with overweight or obesity. MEDLINE, Embase, PsycINFO, Cochrane CENTRAL, Cochrane Database of Systematic Reviews and CINAHL databases were searched for eligible RCTs published between January 2008 and January 2021 in the English language. Meta-analyses were conducted using a random-effects model, publication bias was assessed using funnel plots and Egger’s statistics and heterogeneity was assessed by interpreting I² values. Efficacy of intervention components, such as telehealth or group contacts, were explored in sub-group analyses. The revised risk of bias tool for RCTs (ROB 2.0) tool was used to assess risk of bias. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) method was used to determine certainty of evidence.

RESULTS: This systematic review included 62 RCTs. Compared to control conditions, weight management interventions provided by a dietitian resulted in improved body mass index [Mean Difference (95% CI): -1.5 kg/m² (-1.74, -1.26); moderate evidence certainty]; percent weight loss [-4.01% (-5.26, -2.75); high evidence certainty]; waist circumference [-3.45 cm (-4.39, -2.51); high evidence certainty]; blood pressure [-3.04 mmHg (-5.10, -0.98) and -1.99 mmHg (-3.02, -0.96) for systolic and diastolic, respectively; moderate and low evidence certainty] and quality of life using the SF-36 tool [5.84 (2.27, 9.41) and 2.39 (1.55, 3.23) for physical and mental quality of life, respectively; low and moderate evidence certainty].

CONCLUSION: For adults with overweight or obesity, weight management interventions provided by a dietitian are efficacious for improving several examined cardiometabolic outcomes and quality of life.

PMID:35788061 | DOI:10.1016/j.jand.2022.03.014

Clin Microbiol Infect. 2022 Jul 1:S1198-743X(22)00330-5. doi: 10.1016/j.cmi.2022.06.017. Online ahead of print.

ABSTRACT

BACKGROUND: Randomised controlled trials (RCTs) investigated analgesics, herbal formulations, delayed prescription of antibiotics and placebo to prevent overprescription of antibiotics in women with uncomplicated urinary tract infections (uUTI).

OBJECTIVES: To estimate the effect of these strategies and to identify symptoms, signs or other factors that indicate a benefit from these strategies.

DATA SOURCES: MEDLINE, EMBASE, Web of Science, LILACS, Cochrane Database of Systematic Reviews and of Controlled Trials, and ClinicalTrials.

STUDY ELIGIBILITY CRITERIA, PARTICIPANTS AND INTERVENTIONS: RCTs investigating any strategies to reduce antibiotics versus immediate antibiotics in adult women with uUTI in primary care.

DATA SYNTHESIS: We extracted individual participant data (IPD) if available, otherwise aggregate data (AD). Bayesian random-effects meta-analysis of the AD was used for pairwise comparisons. Candidate moderators and prognostic indicators of treatment effects were investigated using generalised linear mixed models based on IPD.

RESULTS: We analysed IPD of 3524 patients from eight RCTs and AD of 78 patients. Non-antibiotic strategies increased the rates of incomplete recovery (odds ratio [OR] 3.0; 95% credible interval [CI] 1.7-5.5; Bayesian p-value p_B=0.0017; τ=0.6), subsequent antibiotic treatment (OR 3.5 [95% CI 2.1, 5.8; p_B=0.0003) and pyelonephritis (OR 5.6; 95% CI 2.3, 13.9; p_B=0.0003). Conversely, they decreased overall antibiotic use by 63%. In patients positive for urinary erythrocytes and urine culture were at increased risk for incomplete recovery (OR 4.7; 95% CI 2.1-10.8; p_B =0.0010), but no difference was apparent where both were negative (OR 0.8; 95% CI 0.3-2.0; p_B =0.667). In patients treated with using non-antibiotic strategies, urinary erythrocytes and positive urine culture were independent prognostic indicators for subsequent antibiotic treatment and pyelonephritis.

CONCLUSIONS AND RELEVANCE: Compared to immediate antibiotics, non-antibiotic strategies reduce overall antibiotic use but result in poorer clinical outcomes. The presence of erythrocytes and tests to confirm bacteria in urine could be used to target antibiotic prescribing.

PMID:35788049 | DOI:10.1016/j.cmi.2022.06.017

J Shoulder Elbow Surg. 2022 Jul 1:S1058-2746(22)00548-1. doi: 10.1016/j.jse.2022.05.024. Online ahead of print.

ABSTRACT

BACKGROUND: Women surgeons receive lower compensation, hold fewer academic positions, and hold fewer leadership positions than men, particularly in orthopedic surgery. Gender bias at the trainee level has been demonstrated in various surgical subspecialties, but there is a lack of information on gender bias within the orthopedic training environment. This study investigated whether implicit gender bias is present in the subjective evaluation of orthopedic trainee arthroscopic skills.

METHODS: After institutional review board (IRB) approval, a web-based survey was sent to American Shoulder and Elbow Surgeons (ASES) members via the society’s email listserv. Study participants were informed that the study was being done to develop a systematic evaluation method for trainees. The survey randomized participants to view and evaluate a pre-fellowship and a post-fellowship video of “Rachel” (she/her) or “Charles” (he/him) performing a 15-point diagnostic shoulder arthroscopy. The videos for Rachel and Charles were identical except for the pronouns used in the video. Participants evaluated the trainee’s skill level using questions from the Arthroscopic Surgical Skill Evaluation Tool (ASSET). Blinded and de-identified additional comments regarding the trainee’s skill were classified as positive, negative, or neutral. Statistical analyses were used to compare scores and comments between Rachel and Charles.

RESULTS: Of 1115 active ASES members, 181 ASES members started the survey and 106 watched both videos and were included in the analysis. Of the 106 participants completing the survey, 96 (91%) were men and 10 (9%) were women with median [IQR] age of 44 [38-51]. A teaching role was reported by 84 of 106 participants (79%). There was no significant difference between pre-fellowship scores (p = 0.87) or between post-fellowship scores (p = 0.84) for the woman and man fellow. The numbers of comments classified as positive, negative, or neutral were not significantly different between the man and woman fellow (p = 0.19). Participants in teaching roles gave significantly lower scores to both fellows at both timepoints (p=0.04), and participants who had fellow trainees were more likely to give negative comments to both fellows (p = 0.02).

DISCUSSION: Trainee gender did not influence the ratings and comments participants gave for trainee arthroscopic skills, suggesting that gender bias may not play a major role in the evaluation of arthroscopic skill during orthopedic training.

PMID:35788056 | DOI:10.1016/j.jse.2022.05.024

BMJ. 2022 Jul 4;378:e070022. doi: 10.1136/bmj-2022-070022.

ABSTRACT

OBJECTIVE: To assess the benefits and harms of different types and doses of anticoagulant drugs for the prevention of venous thromboembolism in patients who are acutely ill and admitted to hospital.

DESIGN: Systematic review and network meta-analysis.

DATA SOURCES: Cochrane CENTRAL, PubMed/Medline, Embase, Web of Science, clinical trial registries, and national health authority databases. The search was last updated on 16 November 2021.

ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Published and unpublished randomised controlled trials that evaluated low or intermediate dose low-molecular-weight heparin, low or intermediate dose unfractionated heparin, direct oral anticoagulants, pentasaccharides, placebo, or no intervention for the prevention of venous thromboembolism in acutely ill adult patients in hospital.

MAIN OUTCOME MEASURES: Random effects, bayesian network meta-analyses used four co-primary outcomes: all cause mortality, symptomatic venous thromboembolism, major bleeding, and serious adverse events at or closest timing to 90 days. Risk of bias was also assessed using the Cochrane risk-of-bias 2.0 tool. The quality of evidence was graded using the Confidence in Network Meta-Analysis framework.

RESULTS: 44 randomised controlled trials that randomly assigned 90 095 participants were included in the main analysis. Evidence of low to moderate quality suggested none of the interventions reduced all cause mortality compared with placebo. Pentasaccharides (odds ratio 0.32, 95% credible interval 0.08 to 1.07), intermediate dose low-molecular-weight heparin (0.66, 0.46 to 0.93), direct oral anticoagulants (0.68, 0.33 to 1.34), and intermediate dose unfractionated heparin (0.71, 0.43 to 1.19) were most likely to reduce symptomatic venous thromboembolism (very low to low quality evidence). Intermediate dose unfractionated heparin (2.63, 1.00 to 6.21) and direct oral anticoagulants (2.31, 0.82 to 6.47) were most likely to increase major bleeding (low to moderate quality evidence). No conclusive differences were noted between interventions regarding serious adverse events (very low to low quality evidence). When compared with no intervention instead of placebo, all active interventions did more favourably with regard to risk of venous thromboembolism and mortality, and less favourably with regard to risk of major bleeding. The results were robust in prespecified sensitivity and subgroup analyses.

CONCLUSIONS: Low-molecular-weight heparin in an intermediate dose appears to confer the best balance of benefits and harms for prevention of venous thromboembolism. Unfractionated heparin, in particular the intermediate dose, and direct oral anticoagulants had the least favourable profile. A systematic discrepancy was noted in intervention effects that depended on whether placebo or no intervention was the reference treatment. Main limitations of this study include the quality of the evidence, which was generally low to moderate due to imprecision and within-study bias, and statistical inconsistency, which was addressed post hoc.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020173088.

PMID:35788047 | DOI:10.1136/bmj-2022-070022

Neuroimage. 2022 Jul 1:119439. doi: 10.1016/j.neuroimage.2022.119439. Online ahead of print.

ABSTRACT

Quantification methods based on the acquisition of diffusion magnetic resonance imaging (dMRI) with multiple diffusion weightings (e.g., multi-shell) are becoming increasingly applied to study the in-vivo brain. Compared to single-shell data for diffusion tensor imaging (DTI), multi-shell data allows to apply more complex models such as diffusion kurtosis imaging (DKI), which attempts to capture both diffusion hindrance and restriction effects, or biophysical models such as NODDI, which attempt to increase specificity by separating biophysical components. Because of the strong dependence of the dMRI signal on the measurement hardware, DKI and NODDI metrics show scanner and site differences, much like other dMRI metrics. These effects limit the implementation of multi-shell approaches in multicenter studies, which are needed to collect large sample sizes for robust analyses. Recently, a post-processing technique based on rotation invariant spherical harmonics (RISH) features was introduced to mitigate cross-scanner differences in DTI metrics. Unlike statistical harmonization methods, which require repeated application to every dMRI metric of choice, RISH harmonization is applied once on the raw data, and can be followed by any analysis. RISH features harmonization has been tested on DTI features but not its generalizability to harmonize multi-shell dMRI. In this work, we investigated whether performing the RISH features harmonization of multi-shell dMRI data removes cross-site differences in DKI and NODDI metrics while retaining longitudinal effects. To this end, 46 subjects underwent a longitudinal (up to 3 time points) two-shell dMRI protocol at 3 imaging sites. DKI and NODDI metrics were derived before and after harmonization and compared both at the whole brain level and at the voxel level. Then, the harmonization effects on cross-sectional and on longitudinal group differences were evaluated. RISH features averaged for each of the 3 sites exhibited prominent between-site differences in the frontal and posterior part of the brain. Statistically significant differences in fractional anisotropy, mean diffusivity and mean kurtosis were observed both at the whole brain and voxel level between all the acquisition sites before harmonization, but not after. The RISH method also proved effective to harmonize NODDI metrics, particularly in white matter. The RISH based harmonization maintained the magnitude and variance of longitudinal changes as compared to the non-harmonized data of all considered metrics. In conclusion, the application of RISH feature based harmonization to multi-shell dMRI data can be used to remove cross-site differences in DKI metrics and NODDI analyses, while retaining inherent relations between longitudinal acquisitions.

PMID:35788044 | DOI:10.1016/j.neuroimage.2022.119439

BJGP Open. 2022 Jul 4:BJGPO.2022.0060. doi: 10.3399/BJGPO.2022.0060. Online ahead of print.

ABSTRACT

BACKGROUND: The British Lung Foundation previously estimated that 2.2 million symptomatic but undiagnosed people with COPD live in the UK.

AIM: This study investigates the proportion of patients with a missed COPD diagnosis among those with COPD as the cause of death on their death certificate and how this has changed over the past 17 years.

DESIGN & SETTING: We linked Clinical Practice Research Datalink Aurum and GOLD primary care data with Office for National Statistics mortality data and Hospital Episode Statistics data. We included adults who died between 2000 and 2017 with COPD as their main cause of death.

METHOD: Using a range of diagnostic COPD criteria, we estimated the proportion of patients with a missed COPD diagnosis, and described the demographic and clinical characteristics of patients with and without prior COPD diagnosis using a mixed effect logistic regression model.

RESULTS: Depending on the COPD definition used, between 96% and 27% of the 78,621 patients included received a diagnosis of COPD prior to death. Using presence of a COPD Read or SNOMED CT code and performed spirometry as a main definition, just over half of the patients (52%) had received a COPD diagnosis overall, with a proportion of those who did not decreasing from 91% in 2000 to 31% in 2017 (p-trend <0.001).

CONCLUSION: The proportion of people with COPD-recorded death who had received a diagnosis of COPD has improved over time and currently represents the majority of them, suggesting that few patients are being missed.

PMID:35788026 | DOI:10.3399/BJGPO.2022.0060

Exp Gerontol. 2022 Jul 1:111884. doi: 10.1016/j.exger.2022.111884. Online ahead of print.

ABSTRACT

INTRODUCTION: Sarcopenia, the age-related loss of skeletal muscle strength and mass, carries a significant burden for affected individuals. There has been little investigation of sarcopenia using experimental medicine techniques to study human muscle tissue in detail. The aim of the Muscle Ageing Sarcopenia Studies Lifecourse (MASS_Lifecourse) study is to recruit up to 160 participants, equally divided between females and males between ages 45 and 85 years for detailed phenotyping of skeletal muscle health. Here we describe the protocol for the study and the characteristics of the first 80 participants.

METHODS: We are recruiting participants from three sources in the north-east of England. Study fieldwork comprises a home visit (or videocall) for consent and assessment of health, cognition, lifestyle, and wellbeing. This is followed by a visit to a clinical research facility for assessment of sarcopenia status and collection of samples including a vastus lateralis muscle biopsy. We produced descriptive statistics for the first 80 participants, including expressing their grip strength relative to normative data in the form of Z-scores.

RESULTS: The first 80 participants (53.8 % female) covered the target ages, ranging from 48 to 84 years. They were regularly physically active, reported good physical function and had a prevalence of sarcopenia (including probable sarcopenia) of 11.3 % based on the revised European consensus. Their grip strength was similar to that in the general population, with a mean Z-score of 0.09 standard deviations (95 % CI: -1.64, 1.83) above that expected.

CONCLUSIONS: The MASS_Lifecourse study combines comprehensive health and lifestyle data with a range of biological samples including skeletal muscle. The findings from planned analyses should contribute to improvements in the diagnosis, treatment, and prevention of sarcopenia.

PMID:35788023 | DOI:10.1016/j.exger.2022.111884