Category: Statistics

Int J Paediatr Dent. 2023 Oct 6. doi: 10.1111/ipd.13128. Online ahead of print.

ABSTRACT

BACKGROUND: Caries Impacts and Experiences Questionnaire for Children (CARIES-QC) has been developed to assess the oral health-related quality of life (OHRQoL) associated with caries.

AIM: This study aimed to evaluate the validity and reliability of the CARIES-QC in the Turkish-speaking population following its translation and adaptation into Turkish (CARIES-QC/T).

DESIGN: Two hundred and fifty children between the ages of 5 and 16 years who have active dental caries were included in the study and answered the Turkish-translated and cross-culturally adapted final version of CARIES-QC/T. Test-retest reliability and internal consistency were used to examine the reliability of the CARIES-QC/T. Factor structure of CARIES-QC/T was analyzed using exploratory factor analysis (EFA), and convergent validity was determined.

RESULTS: Cronbach’s alpha and McDonald’s ômega values were 0.907 and 0.908, respectively. For the CARIES-QC/T scale, the intraclass correlation coefficient (ICC) value was 0.933, and polychoric correlations ranged from 0.390 to 0.794. The convergent validity of the items revealed a statistically significant correlation with the global question (r_s = 0.821, p < .001). The EFA results of CARIES-QC/T suggested a one-factor solution and explained 59.7% of the total variance.

CONCLUSION: The findings provided supporting evidence that the CARIES-QC/T could be used as a tool for measuring OHRQoL in healthy Turkish-speaking children aged 5-16 years with active caries.

PMID:37803497 | DOI:10.1111/ipd.13128

Inj Prev. 2023 Oct 6:ip-2023-044948. doi: 10.1136/ip-2023-044948. Online ahead of print.

ABSTRACT

INTRODUCTION: Gun buyback programmes have been popular in the USA since the 1970s. Studies show that they have no effect on citywide gun crime rates, but more microlevel examinations around gun buyback locations have not been conducted. This study tests for local effects of 34 Philadelphia, PA buyback events at 30 locations between 2019 and 2021.

METHODS: We analysed all gun-related crime events and gun-related calls for service attended by the police from 2019 to 2021. Multilevel models with an autoregressive residual structure were estimated on weekly gun crime and call event intensity (inverse distance weighted) totals across a range of distances (4000-8000 feet). Impacts of a gun buyback event were estimated for 1-4 weeks postevent.

RESULTS: Statistically significant weekly increases in gun event intensity are associated with seasonality and after the murder of George Floyd. Gun event intensity was not significantly affected by gun buybacks. Across 20 sensitivity tests of different distances and time periods (4000-8000 feet and between 1 and 4 weeks), gun buybacks were not statistically associated with any localised reduction in the intensity of gun crimes and calls.

CONCLUSIONS: Extant research has failed to uncover any effect of gun buybacks on citywide gun crime rates. The current results now contribute a lack of evidence at the local level to this literature. While gun buybacks remain popular with politicians and the public, this study adds to the ongoing question of whether buyback funds could be better spent more effectively.

PMID:37802644 | DOI:10.1136/ip-2023-044948

BMJ Support Palliat Care. 2023 Oct 6:spcare-2023-004571. doi: 10.1136/spcare-2023-004571. Online ahead of print.

ABSTRACT

OBJECTIVES: Investigate trends in where patients died of anal cancer in the USA.

METHODS: Retrospective cohort study using the US National Center for Health Statistics Wide-Ranging ONline Data for Epidemiologic Research platform from 2003 to 2020; all patients with death certificates listing anal cancer as the underlying cause of death in the USA. Main outcome measure of location of patient death: inpatient facility, home, hospice, nursing home/long-term care facility and other.

RESULTS: There were a total of 16 296 deaths with anal cancer as the underlying diagnosis during the study period. The crude rate increased from 0.191 per 100 000 deaths in 2003 to 0.453 per 100 000 deaths in 2020. Over the study period, 22.4% of patient deaths occurred in inpatient facilities, 44.9% at home, 12.2% at hospice facilities and 13.1% at nursing homes/long-term care facilities. The percentage of deaths occurring in hospice facilities increased from 1.0% to 13.3% during the study period. Deaths at home also increased from 42.7% in 2003 to 55.8% in 2020. Meanwhile, inpatient deaths decreased from 33.5% in 2003 to 14.4% in 2020.

CONCLUSIONS: There has been a significant increase in the proportion of patients with anal cancer dying at home or hospice from 2003 to 2020.

PMID:37802636 | DOI:10.1136/spcare-2023-004571

BMJ Open. 2023 Oct 6;13(10):e077676. doi: 10.1136/bmjopen-2023-077676.

ABSTRACT

INTRODUCTION: Young adults with HIV (YWH) experience worse clinical outcomes than adults and have high rates of substance use (SU) and mental illness that impact their engagement in care and adherence to antiretroviral therapy (ART). The intervention for Virologic Suppression in Youth (iVY) aims to address treatment engagement/adherence, mental health (MH) and SU in a tailored manner using a differentiated care approach that is youth friendly. Findings will provide information about the impact of iVY on HIV virological suppression, MH and SU among YWH who are disproportionately impacted by HIV and at elevated risk for poor health outcomes.

METHODS AND ANALYSIS: The iVY study will test the effect of a technology-based intervention with differing levels of resource requirements (ie, financial and personnel time) in a randomised clinical trial with an adaptive treatment strategy among 200 YWH (18-29 years old). The primary outcome is HIV virological suppression measured via dried blood spot. This piloted and protocolised intervention combines: (1) brief weekly sessions with a counsellor via a video-chat platform (video-counselling) to discuss MH, SU, HIV care engagement/adherence and other barriers to care; and (2) a mobile health app to address barriers such as ART forgetfulness, and social isolation. iVY has the potential to address important, distinct and changing barriers to HIV care engagement (eg, MH, SU) to increase virological suppression among YWH at elevated risk for poor health outcomes.

ETHICS AND DISSEMINATION: This study and its protocols have been approved by the University of California, San Francisco Institutional Review Board. Study staff will work with a Youth Advisory Panel to disseminate results to YWH, participants and the academic community.

TRIAL REGISTRATION NUMBER: NCT05877729.

PMID:37802624 | DOI:10.1136/bmjopen-2023-077676

BMJ Open. 2023 Oct 6;13(10):e075946. doi: 10.1136/bmjopen-2023-075946.

ABSTRACT

OBJECTIVES: Determine community needs and perspectives as part of planning health service incorporation into Wanang Conservation Area, in support of locally driven sustainable development.

DESIGN: Clinical and rapid anthropological assessment (individual primary care assessments, key informant (KI) interviews, focus groups (FGs), ethnography) with treatment of urgent cases.

SETTING: Wanang (pop. c189), a rainforest community in Madang province, Papua New Guinea.

PARTICIPANTS: 129 villagers provided medical histories (54 females (f), 75 males (m); median 19 years, range 1 month to 73 years), 113 had clinical assessments (51f, 62m; median 18 years, range 1 month to 73 years). 26 ≥18 years participated in sex-stratified and age-stratified FGs (f<40 years; m<40 years; f>40 years; m>40 years). Five KIs were interviewed (1f, 4m). Daily ethnographic fieldnotes were recorded.

RESULTS: Of 113 examined, 11 were ‘well’ (a clinical impression based on declarations of no current illness, medical histories, conversation, no observed disease signs), 62 (30f, 32m) were treated urgently, 31 referred (15f, 16m), indicating considerable unmet need. FGs top-4 ranked health issues concorded with KI views, medical histories and clinical examinations. For example, ethnoclassifications of three ((A) ‘malaria‘, (B) ‘sotwin‘, (C) ‘grile‘) translated to the five biomedical conditions diagnosed most ((A) malaria, 9 villagers; (B) upper respiratory infection, 25; lower respiratory infection, 10; tuberculosis, 9; (C) tinea imbricata, 15) and were highly represented in declared medical histories ((A) 75 participants, (B) 23, (C) 35). However, 29.2% of diagnoses (49/168) were limited to one or two people. Treatment approaches included plant medicines, stored pharmaceuticals, occasionally rituals. Travel to hospital/pharmacy was sometimes undertaken for severe/refractory disease. Service barriers included: no health patrols/accessible aid post, remote hospital, unfamiliarity with institutions and medicine costs. Service introduction priorities were: aid post, vaccinations, transport, perinatal/birth care and family planning.

CONCLUSIONS: This study enabled service planning and demonstrated a need sufficient to acquire funding to establish primary care. In doing so, it aided Wanang’s community to develop sustainably, without sacrificing their forest home.

PMID:37802618 | DOI:10.1136/bmjopen-2023-075946

BMJ Open. 2023 Oct 6;13(10):e072115. doi: 10.1136/bmjopen-2023-072115.

ABSTRACT

OBJECTIVE: To assess prevalence and correlation of factors of family burden associated with mental and physical disorders in the general population of Saudi Arabia.

SETTING AND PARTICIPANTS: A secondary analysis of data from the Saudi National Mental Health Survey (SNMHS).

OUTCOME MEASURES: Mental and physical health disorders of first-degree relatives and objective (time, financial) and subjective (distress, embarrassment) family burden.

RESULTS: We found significant caregiver burden for family members with mental health disorders. Around one-third of the sample was providing care for a family member with a health issue. Within this group, 40% had a mental health diagnosis. 73% of the study population reported experiencing some form of burden as a result of the care they are obligated to provide for their family members. We found the highest burden on male caregivers, in providing care for family members with serious memory disorders, mental retardation, schizophrenia or psychosis, followed by, alcohol and drug disorders, anxiety, depression or manic depression.

CONCLUSION: Our findings for family burden were statistically significant, indicating potential negative impact on caregiver coping ability with the demands of caring for family members with health issues. A comprehensive review of national mental health policies is required to integrate aspects of community mental health promotion, scale-up prevention, screening interventions and social support to protect against the difficulties of mental illness and reduce the burden on caregivers, the family, society, health system and the economy.

PMID:37802615 | DOI:10.1136/bmjopen-2023-072115

Lupus Sci Med. 2023 Oct;10(2):e000961. doi: 10.1136/lupus-2023-000961.

ABSTRACT

OBJECTIVE: An important clinical question is whether the use of immunosuppressants or corticosteroids increases the risk of incident COVID-19 disease among patients with SLE. To address this question, we examined the incidence of COVID-19 infection in a large SLE cohort.

METHODS: This study was based on a single-centre cohort of patients with SLE seen quarterly from March 2020 to August 2022. Clinical information from these visits was augmented with information on COVID-19 infections and vaccinations obtained from the electronic medical records and by patient self-report. We compared treated and untreated patients with respect to the incidence of COVID-19 infection per person month. Statistical significance was assessed based on logistic regression models.

RESULTS: We observed 339 incident cases of COVID-19 experienced over 24 614 person-months of follow-up from 1052 different patients. The risk of infection per person-month of follow-up was similar among those not on prednisone (1.37%), on moderate doses of prednisone (<7 mg/day) (1.44%) and those on higher doses (1.52%) (p=0.87 for difference). We observed an elevated risk among those taking belimumab, however, after adjustment for potential confounding variables, the increased risk was not statistically significant (rate ratio 1.4, 95% CI 0.88 to 2.24, p=0.16) There was no evidence of an increased risk among those taking mycophenolate, methotrexate or azathioprine.

CONCLUSION: It is reassuring that there was not strong evidence of an increased risk of infection among those taking prednisone or other immunosuppressants. However, given the range of our CIs, moderate effects of these medications on COVID-19 risk cannot be completely ruled out.

PMID:37802601 | DOI:10.1136/lupus-2023-000961

RMD Open. 2023 Oct;9(4):e003396. doi: 10.1136/rmdopen-2023-003396.

ABSTRACT

OBJECTIVES: Treatment response is worse in obese patients with rheumatoid arthritis (RA), including patients on weight-adjusted therapies like infliximab. We aimed to assess the association between body mass index (BMI) and changes in RA disease activity and radiographic progression over time.

METHODS: We included infliximab users with an RA diagnosis in the Swiss Clinical Quality Management in Rheumatic Diseases registry (1997-2020). Two cohorts were defined: (1) starting from their first BMI measurement or disease activity score (DAS28-esr), and (2) from their first BMI measurement or radiographic assessment (Rau score). We evaluated the coefficient and 95% CI of BMI with changes in mean DAS28-esr (cohort 1) and mean Rau scores (a structural joint damage score, cohort 2) using generalised estimation equations, overall and stratified by BMI categories.

RESULTS: Cohort 1 comprised 412 patients (74% women, mean age 53 years, mean BMI 25). We observed no change in mean DAS28-esr with increasing BMI overall (adjusted coefficient: 0.00, 95% CI -0.02 to 0.02), or in BMI categories. Cohort 2 comprised 187 patients highly alike to those in cohort 1. We observed a significant decrease of 1.05 in mean Rau scores for every increase in BMI unit (adjusted coefficient: -1.05, 95% CI -1.92 to -0.19). Results remained statistically non-significant across BMI categories.

CONCLUSIONS: Our longitudinal investigation suggests that BMI increase may not lead to changes in DAS28-esr in patients receiving infliximab, despite the weight-adapted dose. Yet, there may be a decrease in erosions with increasing weight non-limited to obese patients.

PMID:37802600 | DOI:10.1136/rmdopen-2023-003396

Lancet HIV. 2023 Oct;10(10):e653-e662. doi: 10.1016/S2352-3018(23)00140-6.

ABSTRACT

BACKGROUND: Preclinical and clinical studies suggest that combinations of broadly neutralising antibodies (bnAbs) targeting different HIV envelope epitopes might be required for sufficient prevention of infection. We aimed to evaluate the dual and triple anti-HIV bnAb combinations of PGDM1400 (V2 Apex), PGT121 (V3 glycan), 10-1074 (V3 glycan), and VRC07-523LS (CD4 binding site).

METHODS: In this phase 1 trial (HVTN 130/HPTN 089), adults without HIV were randomly assigned (1:1:1) to three dual-bnAb treatment groups simultaneously, or the triple-bnAb group, receiving 20 mg/kg of each antibody administered intravenously at four centres in the USA. Participants received a single dose of PGT121 + VRC07-523LS (treatment one; n=6), PGDM1400 + VRC07-523LS (treatment two; n=6), or 10-1074 + VRC07-523LS (treatment three; n=6), and two doses of PGDM1400 + PGT121 + VRC07-523LS (treatment four; n=9). Primary outcomes were safety, pharmacokinetics, and neutralising activity. Safety was determined by monitoring for 60 min after infusions and throughout the study by collecting laboratory assessments (ie, blood count, chemistry, urinalysis, and HIV), and solicited and unsolicited adverse events (via case report forms and participant diaries). Serum concentrations of each bnAb were measured by binding antibody assays on days 0, 3, 6, 14, 28, 56, 112, 168, 224, 280, and 336, and by serum neutralisation titres against Env-pseudotyped viruses on days 0, 3, 28, 56, and 112. Pharmacokinetic parameters were estimated by use of two-compartment population pharmacokinetic models; combination bnAb neutralisation titres were directly measured and assessed with different interaction models. This trial is registered with ClinicalTrials.gov, NCT03928821, and has been completed.

FINDINGS: 27 participants were enrolled from July 31, to Dec 20, 2019. The median age was 26 years (range 19-50), 16 (58%) of 27 participants were assigned female sex at birth, and 24 (89%) participants were non-Hispanic White. Infusions were safe and well tolerated. There were no statistically significant differences in pharmacokinetic patterns between the dual and triple combinations of PGT121, PGDM1400, and VRC07-523LS. The median estimated elimination half-lives of PGT121, PGDM1400, 10-1074, and VRC07-523LS were 32·2, 25·4, 27·5, and 52·9 days, respectively. Neutralisation coverage against a panel of 12 viruses was greater in the triple-bnAb versus dual-bnAb groups: area under the magnitude-breadth curve at day 28 was 3·1, 2·9, 3·0, and 3·4 for treatments one to four, respectively. The Bliss-Hill multiplicative interaction model, which assumes complementary neutralisation with no antagonism or synergism among the bnAbs, best described combination bnAb titres in the dual-bnAb and triple-bnAb groups.

INTERPRETATION: No pharmacokinetic interactions among the bnAbs and no loss of complementary neutralisation were observed in the dual and triple combinations. This study lays the foundation for designing future combination bnAb HIV prevention efficacy trials.

FUNDING: US National Institute of Allergy and Infectious Diseases, US National Institute on Drug Abuse, US National Institute of Mental Health, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

PMID:37802566 | DOI:10.1016/S2352-3018(23)00140-6

Neurologia (Engl Ed). 2023 Oct;38(8):541-549. doi: 10.1016/j.nrleng.2021.02.009.

ABSTRACT

BACKGROUND: Migraine attacks have a high impact on daily activities. There is limited research on the burden of migraine on sexual functioning.

OBJECTIVE: To determine the prevalence of sexual dysfunction in patients with migraine and its relationship with migraine features and comorbidities.

METHOD: This is a cross-sectional study. We included migraine patients between 18 and 60 years-old from 8 Headache Clinics in Spain. We recorded demographic data and migraine features. Patients fulfilled a survey including comorbidities, Arizona Sexual Experiences Scale, Hospital Anxiety and Depression Scale and a questionnaire about migraine impact on sexual activity. A K-nearest neighbor supervised learning algorithm was used to identify differences between migraine patients with and without sexual dysfunction.

RESULTS: We included 306 patients (85.6% women, mean age 42.3±11.1 years). A 41.8% of participants had sexual dysfunction. Sexual dysfunction was associated with being female (OR [95% CI]: 2.42 [1.17-5.00]; p<0.001), being older than 46.5 years (4.04 [2.48-6.59]; p<0.001), having chronic migraine (2.31 [1.41-3.77]; p=0.001), using preventive medication (2.45 [1.35-4.45]; p=0.004), analgesic overusing (3.51 [2.03-6.07]; p<0.001), menopause (4.18 [2.43-7.17]; p<0.001) and anxiety (2.90 [1.80-4.67]; p<0.001) and depression (6.14 [3.18-11.83]; p<0.001). However, only female gender, age, menopause and depression were the statistically significant variables selected in the model to classify migraine patients with or without sexual dysfunction (Accuracy [95% CI]: 0.75 (0.62-0.85), Kappa: 0.48, p=0.005).

CONCLUSIONS: Sexual dysfunction is frequent in migraine patients visited in a headache clinic. However, migraine characteristics or use of preventive medication are not directly associated with sexual dysfunction. Instead, risk factors for sexual dysfunction were female gender, higher age, menopause and depression.

PMID:37802552 | DOI:10.1016/j.nrleng.2021.02.009