Psychometric validation of the Self-Care Inventory-Revised (SCI-R) in UK adults with type 2 diabetes using data from the AT.LANTUS follow-on study.

Background: Achieving optimal outcomes in type 2 diabetes (T2DM) involves several demanding self-care&nbsp;behaviours, e.g. managing diet, activity, medications, monitoring glucose levels, footcare. The Self-Care Inventory-Revised (SCI-R) is valid for use in people with T2DM in the US. Our aim was to determine its suitability for use&nbsp;in the UK.Methods: 353 people with T2DM participated in the AT.LANTUS Follow-on study, completing measures of diabetes&nbsp;self-care (SCI-R), generic and diabetes-specific well-being (W- BQ28), and diabetes treatment satisfaction (DTSQ).&nbsp;Statistical analyses were conducted to explore structure, reliability, and validity of the SCI-R.Results: Principal components analysis indicated a 13-item scale (items loading &gt;0.39) with satisfactory internal&nbsp;consistency reliability (&alpha; = 0.77), although neither this model nor any alternatives were confirmed in the&nbsp;confirmatory factor analysis. Acceptability was high (&gt;95% completion for all but one item); ceiling effects were&nbsp;demonstrated for six items. As expected, convergent validity (correlations between self-care behaviours) was found&nbsp;for few items. Divergent validity was supported by expected low correlations between SCI-R total and well-being&nbsp;(rs = 0.02-0.21) and treatment satisfaction (rs = 0.29). Known-groups validity was partially supported with significant&nbsp;differences in SCI-R total by HbA1c (&le;7.5% (58 mmol/mol): 72 &plusmn; 11, &gt;7.5% (58 mmol/mol): 68 &plusmn; 14, p &lt; 0.05) and&nbsp;diabetes duration (&le;16 years: 67 &plusmn; 13, &gt;16 years: 71 &plusmn; 12, p &lt; 0.001) but not by presence/absence of complications&nbsp;or by insulin treatment algorithm.Conclusions: The SCI-R is a brief, valid and reliable measure of self-care in people with T2DM in the UK. However,&nbsp;ceiling effects raise concerns about its potential for responsiveness in clinical trials. Individual items may be more&nbsp;useful clinically than the total score.</div

Integrating family planning services into HIV care: use of a point-of-care electronic medical record system in Lilongwe, Malawi

Background: Integrating family planning (FP) services into human immunodeficiency virus (HIV) clinical care helps improve access to contraceptives for women living with HIV. However, high patient volumes may limit providers’ ability to counsel women about pregnancy risks and contraceptive options

Integrating reproductive health services into HIV care: strategies for successful implementation in a low-resource HIV clinic in Lilongwe, Malawi

BackgroundLighthouse Trust operates two public HIV testing, treatment and care clinics in Lilongwe, Malawi, caring for over 26 000 people living with HIV, 23 000 of whom are on antiretroviral treatment (ART). In August 2010, Lighthouse Trust piloted a step-wise integration of sexual and reproductive health (SRH) services into routine HIV care at its Lighthouse clinic site. The objectives were to increase uptake of family planning (FP), promote long-term reversible contraceptive methods, and increase access, screening and treatment for cervical cancer using visual inspection with acetic acid.Methods and resultsPatients found integrated SRH/ART services acceptable; service availability appeared to increase uptake. Between August 2010 and May 2014, over 6000 women at Lighthouse received FP education messages. Of 859 women who initiated FP, 55% chose depot medroxyprogesterone acetate, 19% chose an intrauterine contraceptive device, 14% chose oral contraceptive pills, and 12% chose an implant. By May 2014, 21% of eligible female patients received cervical cancer screening: 11% (166 women) had abnormal cervical findings during screening for cervical cancer and underwent further treatment.ConclusionsSeveral lessons were learned in overcoming initial concerns about integration. First, our integrated services required minimal additional resources over those needed for provision of HIV care alone. Second, patient flow improved during implementation, reducing a barrier for clients seeking multiple services. Lastly, analysis of routine data showed that the proportion of women using some form of modern contraception was 45% higher at Lighthouse than at Lighthouse's sister clinic where services were not integrated (42% vs 29%), providing further evidence for promotion of SRH/ART integration

A cross-sectional study to evaluate second line virological failure and elevated bilirubin as a surrogate for adherence to atazanavir/ritonavir in two urban HIV clinics in Lilongwe, Malawi

BACKGROUND: Malawi's national antiretroviral therapy program provides atazanavir/ritonavir-based second line regimens which cause concentration-dependent rise in indirect bilirubin. We sought to determine if elevated bilirubin, as a surrogate of atazanavir/ritonavir adherence, can aid in the evaluation of second line virological failure in Malawi. METHODS: We conducted a cross-sectional study of HIV-infected patients ≥15 years who were on boosted protease inhibitor-based second line antiretroviral therapy for at least 6 months in two urban HIV clinics in Lilongwe, Malawi. Antiretroviral therapy history and adherence data were extracted from the electronic medical records and blood was drawn for viral load, complete blood count, total bilirubin, and CD4 cell count at a clinic visit. Factors associated with virological failure were assessed using multivariate logistic regression model. RESULTS: Out of 376 patients on second line antiretroviral therapy evaluated, 372 (98.9%) were on atazanavir/ritonavir-based therapy and 142 (37.8%) were male. Mean age was 40.9 years (SD ± 10.1), mean duration on second line antiretroviral therapy was 41.9 months (SD ± 27.6) and 256 patients (68.1%) had elevated bilirubin >1.3 mg/dL. Overall, 35 (9.3%) patients had viral load >1000 copies/ml (virological failure). Among the virologically failing vs. non-failing patients, bilirubin was elevated in 34.3% vs. 72.0% respectively (p < 0.001), although adherence by pill count was similar (62.9% vs. 60.7%, p = 0.804). The odds of virological failure were higher for adults aged 25-40 years (adjusted odds ratio (aOR) 2.5, p = 0.048), those with CD4 cell count <100 (aOR 17.5, p < 0.001), and those with normal bilirubin levels (aOR 5.4, p < 0.001); but were lower for the overweight/obese patients (aOR 0.3, p = 0.026). Poor pill count adherence (aOR 0.7, p = 0.4) and male gender (aOR 1.2, p = 0.698) were not associated with second line virological failure. CONCLUSIONS: Among patients receiving atazanavir/ritonavir-based second line antiretroviral therapy, bilirubin levels better predicted virological failure than pill count adherence. Therefore, strategic use of bilirubin and viral load testing to target adherence counseling and support may be cost-effective in monitoring second line antiretroviral therapy adherence and virological failure. Drug resistance testing targeted for patients with virological failure despite elevated bilirubin levels would facilitate timely switch to third line antiretroviral regimens whenever available

Anemia in people on second line antiretroviral treatment in Lilongwe, Malawi: a cross-sectional study

Abstract Background Anemia is common among people living with HIV infection and is frequently associated with poor quality of life and poor prognosis. It has been well described in antiretroviral naïve individuals and those on non-nucleoside reverse transcriptase inhibitor-based first line antiretroviral therapy (ART) regimens. However there is limited information on anemia for ART experienced individuals on protease inhibitor-based second line ART regimens in resource limited settings. Our objective was to describe the prevalence and risk factors of anemia in this ART experienced population in Malawi. Methods We conducted a cross-sectional study using routine facility data at two HIV clinics in Lilongwe, Malawi. The analysis included individuals receiving protease inhibitor-based second line ART. Clinical and laboratory data were collected at routine clinic visits. We used descriptive statistics, two-sample t-tests and multivariate logistic regression for data analysis. Results Three hundred seventy-seven records were included in this analysis (37% male, median age 41 years, median CD4 count 415 cells/μL). The prevalence of anemia was 125/377 (33.2%) − mild, moderate and severe anemia was 17.5%, 13.8%, and 1.9% respectively. Female participants had a higher prevalence than male participants (43.6% vs. 15.7%, p < 0.001). In multivariate logistic regression, female sex (adjusted odds ratio (aOR) 5.3; 95% CI 2.9–9.5) and a CD4 count <200 cell/ul (aOR 3.1; 95%CI 1.6–6.0) were associated with increased risk of having anemia while a BMI ≥30 kg/m2 (aOR 0.8; 95% CI 0.6–1.0) and being on ART for more than 10 years (aOR 0.4; 95% CI 0.2–0.9) were associated with reduced risk of anemia. Being on a zidovudine- containing ART regimen was not associated with anemia. Conclusion Anemia is common in people on second line ART in Lilongwe, Malawi. Screening for anemia in this population would be a useful strategy; especially for female patients, those who are underweight and have a low CD4 cell counts

The British Army, information management and the First World War revolution in military affairs

Information Management (IM) – the systematic ordering, processing and channelling of information within organisations – forms a critical component of modern military command and control systems. As a subject of scholarly enquiry, however, the history of military IM has been relatively poorly served. Employing new and under-utilised archival sources, this article takes the British Expeditionary Force (BEF) of the First World War as its case study and assesses the extent to which its IM system contributed to the emergence of the modern battlefield in 1918. It argues that the demands of fighting a modern war resulted in a general, but not universal, improvement in the BEF’s IM techniques, which in turn laid the groundwork, albeit in embryonic form, for the IM systems of modern armies. KEY WORDS: British Army, Information Management, First World War, Revolution in Military Affairs, Adaptatio

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Missing Data - implications for outcomes research and strategies to maximise data integrity

he workshop will firstly provide an overview of the problems associated with missing data within the context of clinical trials and how to minimise these. Missing data will be explored by modeling the impact on a number of datasets. This approach will be invaluable in highlighting how alternative methods for controlling for missing data impact differentially on the interpretation of study findings. Popular strategies involve options based on an assessment of the percentage of missing data. More innovative approaches to the management of missing data (e.g. based upon reliability analyses) will be explored and evaluated and the role of the most popular methods of data management explored in several study designs beyond those of the classic randomised controlled trial. Participants will have the opportunity to appraise and debate existing methods of missing data handling.<br /