Category: Statistics

Nurs Health Sci. 2024 Sep;26(3):e13136. doi: 10.1111/nhs.13136.

ABSTRACT

Postpartum depression is one of the most common mental health disorders in women after giving birth. This study was conducted to examine the effect of telecounseling support on depression in primiparous mothers. This study was conducted as a randomized controlled trial with a parallel group pretest-posttest design. The study comprised 50 participants each in the intervention and control groups. Face-to-face interviews were conducted with all participants, and the Maternal Information Form and the Edinburgh Postpartum Depression Scale (EPDS) were administered. The intervention group received telecounseling for 6 weeks, while the control group received routine postnatal care. After the 6-week period, EPDS was re-administered to both groups. In the intervention group, the EPDS mean score decreased from 7.12 ± 3.96 to 6.34 ± 3.73 after telecounseling (p < 0.001). Conversely, in the control group, the EPDS mean score increased from 6.62 ± 3.55 to 7.90 ± 4.65 without any intervention (p = 0.002). The results indicate that telecounseling is an effective method for reducing the risk of depression among mothers during the postpartum period. It is recommended that healthcare professionals extend their support by providing telecounseling for mothers.

PMID:38960587 | DOI:10.1111/nhs.13136

J Neurol Neurosurg Psychiatry. 2024 Jul 2:jnnp-2023-333296. doi: 10.1136/jnnp-2023-333296. Online ahead of print.

ABSTRACT

BACKGROUND: The pathogenesis of multiple sclerosis (MS) requires both genetic factors and environmental events. The question remains, however, whether these factors and events completely describe the MS disease process. This question was addressed using the Canadian MS data, which includes 29 478 individuals, estimated to represent 65-83% of all Canadian patients with MS.

METHOD: The ‘genetically-susceptible’ subset of the population, (G), includes everyone who has any non-zero life-time chance of developing MS, under some environmental conditions. A ‘sufficient’ environmental exposure, for any genetically-susceptible individual, includes every set of environmental conditions, each of which is ‘sufficient’, by itself, to cause MS in that person. This analysis incorporates many epidemiological parameters, involved in MS pathogenesis, only some of which are directly observable, and establishes ‘plausible’ value ranges for each parameter. Those parameter value combinations (ie, solutions) that fall within these plausible ranges are then determined.

RESULTS: Only a small proportion of the population (≤52%) has any possibility of developing MS, regardless of any environmental conditions that they could experience. Moreover, some of these genetically-susceptible individuals, despite their experiencing a ‘sufficient’ environmental exposure, will still not develop disease.

CONCLUSIONS: This analysis explicitly includes all of those genetic factors and environmental events (including their interactions), which are necessary for MS pathogenesis, regardless of whether these factors, events and interactions are known, suspected or as yet unrecognised. Nevertheless, in addition, a ‘truly’ random mechanism also seems to play a critical role in disease pathogenesis. This observation provides empirical evidence, which undermines the widely-held deterministic view of nature. Moreover, both sexes seem to share a similar genetic and environmental disease basis. If so, then it is this random mechanism, which is primarily responsible for the currently-observed differences in MS disease expression between susceptible women and susceptible men.

PMID:38960584 | DOI:10.1136/jnnp-2023-333296

Mayo Clin Proc. 2024 Jul;99(7):1058-1077. doi: 10.1016/j.mayocp.2023.11.023.

ABSTRACT

OBJECTIVE: To conduct a randomized controlled trial examining the effects of a social network intervention on health.

PARTICIPANTS AND METHODS: The Microclinic Social Network Program randomized controlled trial (implemented from June 1, 2011, through December 31, 2014) delivered weekly social-health classroom interventions for 9 to 10 months vs standard of care. Longitudinal multilevel analyses examined end-of-trial and 6-month post-intervention outcomes. Social network effects were estimated via a novel social induction ratio.

RESULTS: We randomized 494 participants, comprising 27 classroom clusters from five neighborhood cohorts. Compared with controls, the intervention showed decreased body weight ^–6.32 pounds (95% CI, ^–8.65 to ^–3.98; overall P<.001), waist circumference ^–1.21 inches (95% CI, ^–1.84 to ^–0.58; overall P<.001), hemoglobin A_1c % change ^–1.60 (95% CI, ^–1.88 to ^–1.33; overall P<.001), mean arterial blood pressure ^–1.83 mm Hg (95% CI, ^–3.79 to 0.32; overall P<.01), borderline-increased high-density lipoprotein cholesterol 1.09 (95% CI, 0.01-2.17; P=.05; overall P=.01). At 6 months post-intervention, net improvements were: weight change 97% sustained (P<.001), waist circumference change 92% sustained (P<.001), hemoglobin A_1c change 82.5% sustained (P<.001), high-density lipoprotein change 79% sustained (overall P=.01), and mean arterial blood pressure change greater than 100% sustained improvement of ^–4.21 mm Hg (P<.001). Mediation analysis found that diet and exercise did not substantially explain improvements. In the intent-to-treat analysis of social causal induction, the weight-change social induction ratio (SIR) was 1.80 for social-network weight change-meaning that social networks explained the greater weight loss in the intervention than controls. Furthermore, we observed an even stronger weight-loss SIR of 2.83 at 6 months post-intervention.

CONCLUSION: Results show intervention effectiveness for improving health in resource-limited communities, with SIR demonstrating that social-network effects helped induce such improvements.

TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT01651065.

PMID:38960495 | DOI:10.1016/j.mayocp.2023.11.023

BMJ Open. 2024 Jul 3;14(7):e080855. doi: 10.1136/bmjopen-2023-080855.

ABSTRACT

OBJECTIVES: In this study, we evaluated the amount of public funds spent on the operative treatment of carpal tunnel syndrome (CTS) in Finland in 2011-2015.

DESIGN: A registry-based cost burden study.

SETTING: The data were collected in primary and secondary care in both private and public hospitals, covering the whole population of Finland.

PARTICIPANTS: We collected the total number of patients with new CTS diagnoses and the total number of patients undergoing surgery from the Care Register for Health Care, Finland’s national register.

INTERVENTIONS: Open carpal tunnel release (OCTR).

OUTCOME MEASURES: We collected the costs of the OCTR procedure from diagnosis-related group prices. The Social Insurance Institution of Finland provided the total amount of euros reimbursed for sick leaves. We then combined the average amount of reimbursed sick leave with our estimated cost of the treatment chain to approximate the average cost per patient.

RESULTS: The average amount of public funds used for diagnosing and surgically treating new CTS in 2011-2015 in Finland, including reimbursements for sick leaves, was €2759 per patient in 2015 currency. The average direct procedure cost was €1020. We found no clear trend in total cost per patient, but the proportion of surgically treated patients rose from 63.14% to 73.09%. The total annual cost of these treatments was between €18 128 420 and €22 569 973.

CONCLUSIONS: The average amount of public funds used to surgically treat one patient with new CTS in 2011-2015 in Finland was €2759, making the total annual burden €20.7 million.

PMID:38960470 | DOI:10.1136/bmjopen-2023-080855

BMJ Open. 2024 Jul 2;14(7):e076934. doi: 10.1136/bmjopen-2023-076934.

ABSTRACT

INTRODUCTION: Almonds have prebiotic potential to maintain gut health and regulate glycaemia. Western studies have shown their positive effects on preventing non-communicable diseases like diabetes and cardiovascular diseases. However, there is a lack of research involving Asian Indians, who have a higher predisposition to diabetes due to their unique ‘Asian phenotype’. Therefore, this study aims to evaluate the impact of almond supplementation on glycaemic control and gut health in adults with pre-diabetes in rural India through a randomised clinical trial.

METHODS AND ANALYSIS: A parallel cluster randomised controlled trial with 178 participants with pre-diabetes (assigned 1:1) aged 20-50 years, of both genders, with a body mass index of 18.9-25 kg/m², will be conducted in rural areas of Chikkaballapur, Kolar and Rural Bangalore districts in India. The intervention group will receive 56 g of almonds as mid-morning snacks for 16 weeks, while the control group will receive cereal/pulse-based traditional isocaloric snacks under the closed supervision of the study investigators. The primary outcome of the study is HbA1c measured at the 16th week. The secondary outcomes-anthropometry, clinical and other biochemical parameters-will be measured at 0th, 8th and 16th weeks, and a subgroup of 120 participants will undergo gut health analysis. Glucagon-like peptide 1 analysis will be conducted on 30 participants at 0th and 16th weeks. Statistical analysis will be performed using SPSS for Windows V.27.0, and both intention-to-treat and per-protocol analyses will be conducted.

ETHICS AND DISSEMINATION: Ethics approval was obtained from the Institutional Ethics Committee at Ramaiah Medical College, Bangalore, Karnataka, India (DRPEFP7672021). We will obtain the informed written consent of the participants prior to screening and enrolling them in the study. Results from this trial will be disseminated through publication in peer-reviewed journals and scientific gatherings.

TRIAL REGISTRATION NUMBER: Clinical Trial Registry of India (CTRI/2023/03/050421).

PMID:38960469 | DOI:10.1136/bmjopen-2023-076934

BMJ Open. 2024 Jul 3;14(7):e078632. doi: 10.1136/bmjopen-2023-078632.

ABSTRACT

OBJECTIVES: The objectives are to assess smoking abstinence and its effects on vascular risk and to report tobacco-cessation counselling and pharmacotherapy use in patients who had a recent minor stroke or transient ischaemic attack (TIA).

DESIGN AND SETTING: The TIA registry.org project is a prospective, observational registry of patients with TIA and minor stroke that occurred in the previous 7 days with a 5-year follow-up, involving 61 sites with stroke specialists in 21 countries (Europe, Asia, Latin America and Middle East). Of those, 42 sites had 5-year follow-up data on more than 50% of their patients and were included in the present study.

PARTICIPANTS: From June 2009 through December 2011, 3847 patients were eligible for the study (80% of the initial cohort).

OUTCOMES: Tobacco counselling and smoking-cessation pharmacotherapy use in smoking patients were reported at discharge. Association between 3-month smoking status and risk of a major cardiovascular event (MACE) was analysed with multivariable Cox regression model.

RESULTS: Among 3801 patients included, 835 (22%) were smokers. At discharge, only 35.2% have been advised to quit and 12.5% had smoking-cessation pharmacotherapy prescription. At 3 months, 383/835 (46.9%) baseline smokers were continuers. Living alone and alcohol abuse were associated with persistent smoking; high level of education, aphasia and dyslipidaemia with quitting. The adjusted HRs for MACE at 5 years were 1.13 (95% CI 0.90 to 1.43) in former smokers, 1.31 (95% CI 0.93 to 1.84) in quitters and 1.31 (95% CI 0.94 to 1.83) in continuers. Using time-varying analysis, current smoking at the time of MACE non-significantly increased the risk of MACE (HR 1.31 (95% CI 0.97 to 1.78); p=0.080).

CONCLUSION: In the TIAregistry.org, smoking-cessation intervention was used in a minority of patients. Surprisingly, in this population in which, at 5 years, other vascular risk factors were well controlled and antithrombotic treatment maintained, smoking cessation non-significantly decreased the risk of MACE.

PMID:38960468 | DOI:10.1136/bmjopen-2023-078632

BMJ Open. 2024 Jul 2;14(7):e081791. doi: 10.1136/bmjopen-2023-081791.

ABSTRACT

OBJECTIVES: Globally, one in six older adults in the community will be a victim of abuse (elder abuse; EA). Despite these horrific statistics, EA remains largely undetected and under-reported. Available screening methods and tools fail to accurately identify the phenomenon’s true prevalence. We aimed to test assessment capture rates by altering the criteria for suspicion of EA in the interRAI-HC (International Resident Assessment Instrument-Home Care) in a large national dataset.

DESIGN: We employed secondary analyses of existing data to test a methodology to improve the detection of older adults at risk of EA using the interRAI-HC, which currently underestimates the extent of abuse.

SETTING: The interRAI is a suite of clinical assessment instruments. In Aotearoa New Zealand, interRAI is mandatory in aged residential care and home and community services for older people living in the community. They are designed to show the assessor opportunities for improvement and any risks to the person’s health.

OUTCOME MEASURE: Capture rates of individuals at risk of EA when the interRAI Abuse-Clinical Assessment Protocol (A-CAP) is changed to include the unable to determine abuse (UDA) group shown in a pilot study to increase capture rates of individuals at risk of EA.

RESULTS: Analysis of 9 years of interRAI-HC data (July 2013-June 2022) was undertaken, encompassing 186 713 individual assessments consisting of 108 992 women (58.4%) and 77 469 men (41.5%). The mean age was 82.1 years (range: 65-109); the majority 161 378 were European New Zealanders (86.4%) and the most common minority ethnicity was Māori (6.1%). Those at high risk of abuse (A-CAP) tended to be male (2402; 51.0%), were 79.2 years old on average (range 65-105), with 49.6% (2335) living alone, 39.4% (1858) suffering from depression and a majority were assessed as not having independent decision making (2942; 62.5%). In comparison, the UDA group showed similar characteristics to the A-CAP group on some measures. They were slightly younger than the general sample, with a mean age 80.1 years (range 65-107), they had higher rates of depression (2123; 33.5%) compared with the general sample (25 936; 14.8%) and a majority were assessed as not having independent decision-making (3855; 60.9%). The UDA group is distinct from the general sample and the UDA group broadly has similar but less extreme characteristics to the A-CAP group. Through altering the criteria for suspicion of EA, capture rates of at-risk individuals could be more than doubled from 2.5% to 5.9%.

CONCLUSIONS: We propose that via adapting the interRAI-HC criteria to include the UDA category, the identification of older adults at risk of EA could be substantially improved, facilitating enhanced protection of this vulnerable population.

PMID:38960466 | DOI:10.1136/bmjopen-2023-081791

BMJ Open. 2024 Jul 3;14(7):e081751. doi: 10.1136/bmjopen-2023-081751.

ABSTRACT

INTRODUCTION: Post-traumatic stress disorder (PTSD) is a prevalent and severe psychiatric disorder. Repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex provides limited relief for symptoms of PTSD. This study will be conducted to validate the efficacy of MRI-guided rTMS in targeting the sites most closely associated with the amygdala for patients with PTSD. We hypothesise that the intervention will improve clinical symptoms by decreasing amygdala activity in patients.

METHODS AND ANALYSIS: A randomised, double-blind, sham-controlled trial will be conducted. Forty-eight eligible patients with PTSD will be randomly assigned to receive either active or sham MRI-guided rTMS for 10 consecutive days after the initial MRI scans. MRI scans will be recollected at the end of the intervention. Clinical assessments will be performed at baseline, treatment day 5, treatment day 10, and 2 weeks, 4 weeks, 8 weeks after completion of the intervention to monitor changes in clinical symptoms. The primary assessment outcome is the change in PTSD symptoms between baseline and treatment day 10, as measured by the PTSD Checklist for DSM-5. Repeated measures analysis of variance will be performed using statistical software SPSS V.26.0. The significance level will be set at 0.05.

ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Ethics Committee of Xijing Hospital in Xi’an, China (KY20222176-X-1), and the trial has been registered on ClinicalTrials.gov. The findings of this trial will be disseminated at academic conferences or published in peer-reviewed scientific journals.

TRIAL REGISTRATION NUMBER: NCT05544110.

PMID:38960463 | DOI:10.1136/bmjopen-2023-081751

BMJ Open. 2024 Jul 3;14(7):e080600. doi: 10.1136/bmjopen-2023-080600.

ABSTRACT

OBJECTIVES: Long-term sickness absence from employment has negative consequences for the economy and can lead to widened health inequalities. Sick notes (also called ‘fit notes’) are issued by general practitioners when a person cannot work for health reasons for more than 7 days. We quantified the sick note rate in people with evidence of COVID-19 in 2020, 2021 and 2022, as an indication of the burden for people recovering from COVID-19.

DESIGN: Cohort study.

SETTING: With National Health Service (NHS) England approval, we used routine clinical data (primary care, hospital and COVID-19 testing records) within the OpenSAFELY-TPP database.

PARTICIPANTS: People 18-64 years with a recorded positive test or diagnosis of COVID-19 in 2020 (n=365 421), 2021 (n=1 206 555) or 2022 (n=1 321 313); general population matched in age, sex and region in 2019 (n=3 140 326), 2020 (n=3 439 534), 2021 (n=4 571 469) and 2022 (n=4 818 870); people hospitalised with pneumonia in 2019 (n=29 673).

PRIMARY OUTCOME MEASURE: Receipt of a sick note in primary care.

RESULTS: Among people with a positive SARS-CoV-2 test or COVID-19 diagnosis, the sick note rate was 4.88 per 100 person-months (95% CI 4.83 to 4.93) in 2020, 2.66 (95% CI 2.64 to 2.67) in 2021 and 1.73 (95% CI 1.72 to 1.73) in 2022. Compared with the age, sex and region-matched general population, the adjusted HR for receipt of a sick note over the entire follow-up period (up to 10 months) was 4.07 (95% CI 4.02 to 4.12) in 2020 decreasing to 1.57 (95% CI 1.56 to 1.58) in 2022. The HR was highest in the first 30 days postdiagnosis in all years. Among people hospitalised with COVID-19, after adjustment, the sick note rate was lower than in people hospitalised with pneumonia.

CONCLUSIONS: Given the under-recording of postacute COVID-19-related symptoms, these findings contribute a valuable perspective on the long-term effects of COVID-19. Despite likely underestimation of the sick note rate, sick notes were issued more frequently to people with COVID-19 compared with those without, even in an era when most people are vaccinated. Most sick notes occurred in the first 30 days postdiagnosis, but the increased risk several months postdiagnosis may provide further evidence of the long-term impact.

PMID:38960458 | DOI:10.1136/bmjopen-2023-080600

BMJ Open. 2024 Jul 3;14(7):e084581. doi: 10.1136/bmjopen-2024-084581.

ABSTRACT

OBJECTIVES: Develop and validate short and rapid forms of the 36-item Menstrual Practice Needs Scale (MPNS-36).

DESIGN: Item reduction prioritised content validity and was informed by cognitive interviews with schoolgirls in Bangladesh, performance of scale items in past research and stakeholder feedback. The original MPNS-36 was revalidated, and short and rapid forms tested in a cross-sectional survey. This was followed by further tests of dimensionality, internal consistency and validity in multiple cross-sectional surveys.

SETTING AND PARTICIPANTS: Short form (MPNS-SF) and rapid form (MPNS-R) measures were developed in a survey of 313 menstruating girls (mean age=13.51) in Khulna, Bangladesh. They were further tested in the baseline survey of the Adolescent Menstrual Experiences and Health Cohort, in Khulna, Bangladesh (891 menstruating girls, mean age=12.40); and the dataset from the MPNS-36 development in Soroti, Uganda (538 menstruating girls, mean age=14.49).

RESULTS: The 18-item short form reflects the six original subscales, with the four core subscales demonstrating good fit in all three samples (Khulna pilot: root mean square error of approximation (RMSEA)=0.064, 90% CI 0.043 to 0.084, Comparative Fit Index (CFI)=0.94, Tucker-Lewis Index (TLI)=0.92. Cohort baseline: RMSEA=0.050, 90% CI 0.039 to 0.062, CFI=0.96, TLI=0.95. Uganda: RMSEA=0.039, 90% CI 0.028 to 0.050, CFI=0.95, TLI=0.94). The 9-item rapid form captures diverse needs. A two-factor structure was the most appropriate but fell short of adequate fit (Khulna pilot: RMSEA=0.092, 90% CI 0.000 to 0.158, CFI=0.93, TLI=0.89). Hypothesised associations between the MPNS scores and other constructs were comparable between the MPNS-36 and MPNS-SF in all populations, and replicated, with attenuation, in the MPNS-R. Internal consistency remained acceptable.

CONCLUSIONS: The MPNS-SF offers a reliable and valid measure of adolescent girls’ menstrual hygiene experience while reducing participant burden, to support implementation and improve measurement in menstrual health research. The MPNS-R provides a brief measure with poorer structural validity, suited to short surveys and including menstrual health within broader research topics.

PMID:38960457 | DOI:10.1136/bmjopen-2024-084581