Tag: nevin manimala

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

BMJ Open Qual. 2023 Oct;12(4):e002358. doi: 10.1136/bmjoq-2023-002358.

ABSTRACT

OBJECTIVES: There is little evidence to suggest the best model of palliative and end-of-life care (PEOLC) in an acute care hospital. We introduced a bundle of care to drive improvements in PEOLC; this bundle included three full-time nursing positions providing a palliative care clinical consult service with physician backup, as well as educating staff, using the NSW Resuscitation Plan and the Last-Days-of-Life Toolkit.

METHODS: Two audits were performed at John Hunter Hospital, a tertiary hospital in Newcastle, Australia, each sampling from all deaths in a 12-month period, one prior to and one after the bundle of care was introduced. Sampling was stratified into deaths that occurred within 4-48 hours of admission and after 48 hours. Key outcomes/data points were recorded and compared across the two time periods.

RESULTS: Statistically significant improvements noted included: lower mortality on the wards after 48 hours of admission, better recognition of the dying patient, increased referral to palliative care nurses and physicians, reduction in the number of medical emergency team calls and increase in the use of comfort care and resuscitation plans. Currently, 73% of patients have their end-of-life wishes observed as per their advance care directive.

CONCLUSION: A bundle of care involving dedicated nurses with physician backup providing a consult service and education is an effective method for driving improvements in PEOLC.

PMID:37802540 | DOI:10.1136/bmjoq-2023-002358

Zhongguo Zhen Jiu. 2023 Oct 12;43(10):1175-9. doi: 10.13703/j.0255-2930.20221204-0007.

ABSTRACT

Due to various constraints, such as clinical implementation conditions and unique characteristics of acupuncture-moxibustion, some randomized controlled trials (RCTs) of acupuncture-moxibustion still suffer from relatively low quality and limited applicability. The single-arm objective performance criteria/performance goal can be considered as an ideal supplementary and alternative research approach to RCTs. In this paper, the feasibility of applying the single-arm objective performance criteria/performance goal in acupuncture-moxibustion clinical research is explored from the limitations of conducting acupuncture-moxibustion RCTs, the principles, the essential design considerations and key statistical steps. In addition, illustrative examples are provided. The objective is to offer insights into resolving practical difficulties in acupuncture-moxibustion clinical research.

PMID:37802525 | DOI:10.13703/j.0255-2930.20221204-0007

Zhongguo Zhen Jiu. 2023 Oct 12;43(10):1151-6. doi: 10.13703/j.0255-2930.20221111-k0004.

ABSTRACT

OBJECTIVE: To observe the effect of electroacupuncture (EA) at “Neiguan” (PC 6) on myocardial fibrosis in spontaneously hypertensive rats (SHR), and explore preliminarily the mediating role of cholinergic anti-inflammatory pathway (CAP) and its downstream nuclear factor κB (NF-κB) signaling pathway.

METHODS: Six 12-week-old WKY male rats were employed as the normal group. Eighteen 12-week-old SHR were randomly divided into 3 groups, i.e. a model group, an EA group and a blocking group (EA after blocking α7 nicotinic acetylcholine receptor [α7nAchR]), with 6 rats in each one. In the EA group, EA was delivered at “Neiguan”(PC 6) and the site 0.5 cm from its left side, with disperse-dense wave, 2 Hz/15 Hz in frequency and 1 mA in current intensity. One intervention took 30 min and was given once every 2 days, lasting 8 weeks. In the blocking group, prior to each EA, the α7nAchR specific blocker, α-bungartoxin was injected intravenously in the tails of the rats. After EA intervention, the systolic blood pressure (SBP), the diastolic blood pressure (DBP) and the mean arterial pressure (MAP) were measured with non-invasive blood pressure monitor. Using echocardiogram, the left ventricular (LV) anterior wall end-diastolic thickness (LVAWd) , LV posterior wall end-diastolic thickness (LVPWd) and the LV end-diastolic internal diameter (LVIDd) were measured. The level of hydroxyproline (Hyp) in the myocardial tissue was determined by using alkaline hydrolysis, and that of acetylcholine (Ach) was detected by ELISA. With the real-time PCR adopted, the mRNA expression of NF-κB p65, tumor necrosis factor α (TNF-α), interleukin (IL)-1β and IL-6 were determined.

RESULTS: Compared with the normal group, SBP, DBP, MAP, LVAWd and LVPWd were increased (P<0.01), and LVIDd was decreased (P<0.01) in the rats of the model group. SBP, DBP, MAP and LVAWd were dropped (P<0.01, P<0.05), and LVIDd rose (P<0.01) in the EA group when compared with those in the model group. The differences in the above indexes were not statistically significant between the blocking group and the model group (P>0.05). Compared with the normal group, Hyp level and the mRNA expression of NF-κB p65, TNF-α, IL-1β and IL-6 in the myocardial tissue increased (P<0.01, P<0.05) and Ach level decreased (P<0.01) in the model group. Hyp level, the mRNA expression of NF-κB p65, TNF-α, IL-1β and IL-6 in the myocardial tissue were reduced (P<0.05, P<0.01) and Ach level rose (P<0.01) in the EA group when compared with those in the model group. These indexes were not different statistically between the blocking group and the model group (P>0.05).

CONCLUSION: CAP may be involved in ameliorating the pathological damage of myocardial fibrosis during EA at “Neiguan”(PC 6). The underlying effect mechanism is associated with up-regulating the neurotransmitter, Ach and down-regulating mRNA expression of NF-κB p65 and pro-inflammatory factors such as TNF-α, IL-1β and IL-6 in myocardial tissue.

PMID:37802521 | DOI:10.13703/j.0255-2930.20221111-k0004