High Accuracy of Common HIV-Related Oral Disease Diagnoses by Non-Oral Health Specialists in the AIDS Clinical Trial Group

Objective: Many studies include oral HIV-related endpoints that may be diagnosed by non-oral-health specialists (non-OHS) like nurses or physicians. Our objective was to assess the accuracy of clinical diagnoses of HIV-related oral lesions made by non-OHS compared to diagnoses made by OHS. Methods: A5254, a cross-sectional study conducted by the Oral HIV/AIDS Research Alliance within the AIDS Clinical Trial Group, enrolled HIV-1-infected adults participants from six clinical trial units (CTU) in the US (San Francisco, New York, Chapel Hill, Cleveland, Atlanta) and Haiti. CTU examiners (non-OHS) received standardized training on how to perform an oral examination and make clinical diagnoses of specific oral disease endpoints. Diagnoses by calibrated non-OHS were compared to those made by calibrated OHS, and sensitivity and specificity computed. Results: Among 324 participants, the majority were black (73%), men (66%), and the median CD4+ cell count 138 cells/mm3. The overall frequency of oral mucosal disease diagnosed by OHS was 43% in US sites, and 90% in Haiti. Oral candidiasis (OC) was detected in 153 (47%) by OHS, with erythematous candidiasis (EC) the most common type (39%) followed by pseudomembranous candidiasis (PC; 26%). The highest prevalence of OC (79%) was among participants in Haiti, and among those with CD4+ cell count ≤ 200 cells/mm3 and HIV-1 RNA > 1000 copies/mL (71%). The sensitivity and specificity of OC diagnoses by non-OHS were 90% and 92% (for EC: 81% and 94%; PC: 82% and 95%). Sensitivity and specificity were also high for KS (87% and 94%, respectively), but sensitivity was < 60% for HL and oral warts in all sites combined. The Candida culture confirmation of OC clinical diagnoses (as defined by ≥ 1 colony forming unit per mL of oral/throat rinse) was ≥ 93% for both PC and EC. Conclusion: Trained non-OHS showed high accuracy of clinical diagnoses of OC in comparison with OHS, suggesting their usefulness in studies in resource-poor settings, but detection of less common lesions may require OHS

Temporal dynamics of cortical and subcortical responses to apomorphine in Parkinson disease: an H2(15)O PET study

H2(15)O positron emission tomography (PET) was used to study the temporal course of central nervous system (CNS) responses to apomorphine in patients with idiopathic Parkinson disease (PD). Agonist-induced changes in regional cerebral blood flow (rCBF) were evaluated within corticostriatal-thalamocortical circuits as well as in regions that extend beyond the standard pathophysiological model for PD. Compared with controls, rCBF was increased in PD patients in subcortical regions including the basal ganglia and cerebellum and both increased and decreased in prefrontal, parietal, sensorimotor, and paralimbic cortical areas. Apomorphine reversed many of these effects and had widespread effects throughout the brain. We evaluated the effects of apomorphine as they changed over time, comparing rCBF before the motor response and at later times when the motor response was maximal. Apomorphine's effects on functional connectivity also changed over time; activity in the ventrolateral thalamus was coupled with that in the SMA and cerebellum at the time of maximum motor response, but not at 45 seconds. Apomorphine affected rCBF in regions commonly considered part of the pathophysiological model of PD (eg, basal ganglia, thalamus, SMA), and other effects were seen in regions outside of the model (eg, cerebellum and superior parietal lobule). Results are discussed in light of this mode

High Accuracy of Common HIV-Related Oral Disease Diagnoses by Non-Oral Health Specialists in the AIDS Clinical Trial Group

AbstractObjectiveMany studies include oral HIV-related endpoints that may be diagnosed by non-oral-healthspecialists (non-OHS) like nurses or physicians. Our objective was to assess the accuracyof clinical diagnoses of HIV-related oral lesions made by non-OHS compared to diagnosesmade by OHS.MethodsA5254, a cross-sectional study conducted by the Oral HIV/AIDS Research Alliance withinthe AIDS Clinical Trial Group, enrolled HIV-1-infected adults participants from six clinicaltrial units (CTU) in the US (San Francisco, New York, Chapel Hill, Cleveland, Atlanta) andHaiti. CTU examiners (non-OHS) received standardized training on how to perform an oralexamination and make clinical diagnoses of specific oral disease endpoints. Diagnoses bycalibrated non-OHS were compared to those made by calibrated OHS, and sensitivity andspecificity computed.ResultsAmong 324 participants, the majority were black (73%), men (66%), and the median CD4+cell count 138 cells/mm3. The overall frequency of oral mucosal disease diagnosed by OHSwas 43% in US sites, and 90% in Haiti. Oral candidiasis (OC) was detected in 153 (47%) byOHS, with erythematous candidiasis (EC) the most common type (39%) followed by pseudomembranouscandidiasis (PC; 26%). The highest prevalence of OC (79%) was amongparticipants in Haiti, and among those with CD4+ cell count 200 cells/mm3 and HIV-1RNA > 1000 copies/mL (71%). The sensitivity and specificity of OC diagnoses by non-OHSwere 90% and 92% (for EC: 81% and 94%; PC: 82% and 95%). Sensitivity and specificitywere also high for KS (87% and 94%, respectively), but sensitivity was < 60% for HL andoral warts in all sites combined. The Candida culture confirmation of OC clinical diagnoses(as defined by 1 colony forming unit per mL of oral/throat rinse) was 93% for both PCand EC.ConclusionTrained non-OHS showed high accuracy of clinical diagnoses of OC in comparison withOHS, suggesting their usefulness in studies in resource-poor settings, but detection of lesscommon lesions may require OHS

Proportion of participants with a positive oral rinse culture among 153 participants¹ with a clinical diagnosis of oral candidiasis in ACTG/OHARA² protocol 5254.

<p>¹ All participants in the study had an oral rinse culture, however we only report the proportion of positive cultures, defined as ≥ 1 CFU/mL, among those who had clinical features of oral candidiasis, as potential confirmation of the clinical diagnosis</p><p>² The Oral HIV/AIDS Research Alliance (OHARA) is a Collaborative Science Group within the AIDS Clinical Trial Group (ACTG)</p><p>³ Number of clinical diagnoses. Note: participants may have more than one type of oral candidiasis, so counts do not add up to 153</p><p>Proportion of participants with a positive oral rinse culture among 153 participants<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0131001#t005fn001" target="_blank">¹</a> with a clinical diagnosis of oral candidiasis in ACTG/OHARA<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0131001#t005fn002" target="_blank">²</a> protocol 5254.</p

Socio-demographic characteristics and CD4+ cell count at enrollment, by recruitment site among 324 participants in ACTG/OHARA¹ protocol 5254.

<p>¹ The Oral HIV/AIDS Research Alliance (OHARA) is a Collaborative Science Group within the AIDS Clinical Trial Group (ACTG)</p><p>²<b>US sites</b>: Case Western Reserve University (Cleveland); Emory University (Atlanta); New York University (New York City); University of California San Francisco (San Francisco); University of North Carolina at Chapel Hill (Chapel Hill). <b>Non-US site</b>: Centre GHESKIO (Port au Prince, Haiti)</p><p>Socio-demographic characteristics and CD4+ cell count at enrollment, by recruitment site among 324 participants in ACTG/OHARA<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0131001#t001fn001" target="_blank">¹</a> protocol 5254.</p

Sensitivity and specificity of HIV-related oral diagnoses made by ACTG Clinical Trial Unit non-dental examiners as compared to reference standard diagnoses made by oral health specialists among 324 participants in ACTG/OHARA¹ protocol 5254.

<p>¹ The Oral HIV/AIDS Research Alliance (OHARA) is a Collaborative Science Group within the AIDS Clinical Trial Group (ACTG)</p><p>²<b>US sites</b>: Case Western Reserve University (Cleveland); Emory University (Atlanta); New York University (New York City); University of California San Francisco (San Francisco); University of North Carolina (Chapel Hill). <b>Non-US site</b>: Centre GHESKIO (Port au Prince, Haiti)</p><p>³ Number of cases diagnosed by Oral Medicine specialist</p><p>⁴ Exact 95% confidence interval</p><p>Sensitivity and specificity of HIV-related oral diagnoses made by ACTG Clinical Trial Unit non-dental examiners as compared to reference standard diagnoses made by oral health specialists among 324 participants in ACTG/OHARA<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0131001#t004fn001" target="_blank">¹</a> protocol 5254.</p

Frequency of HIV-related oral lesions diagnosed by oral health specialists by site (US sites versus non-US site) among 324 participants in ACTG/OHARA¹ protocol 5254.

<p>¹ The Oral HIV/AIDS Research Alliance (OHARA) is a Collaborative Science Group within the AIDS Clinical Trial Group (ACTG)</p><p>²<b>US sites</b>: Case Western Reserve University (Cleveland); Emory University (Atlanta); New York University (New York City); University of California San Francisco (San Francisco); University of North Carolina (Chapel Hill). <b>Non-US site</b>: Centre GHESKIO (Port au Prince, Haiti)</p><p>Frequency of HIV-related oral lesions diagnosed by oral health specialists by site (US sites versus non-US site) among 324 participants in ACTG/OHARA<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0131001#t003fn001" target="_blank">¹</a> protocol 5254.</p

Partner-based adherence intervention for second-line antiretroviral therapy (ACTG A5234): a multinational randomised trial

ACTG (AIDS Clinical Trials Group). The IPEC (INI - Fiocruz) site is one of the leading international sites in the ACTG network.Submitted by Fábio Marques ([email protected]) on 2018-10-15T14:55:36Z No. of bitstreams: 1 Partner-based Adherence Intervention for Second-line_Sandra_Cardoso_etal_INI_Lapclin-AIDS_2015.pdf: 528003 bytes, checksum: a3fe5499df665034615b85d576e29bc5 (MD5)Approved for entry into archive by Regina Costa ([email protected]) on 2018-10-17T15:24:34Z (GMT) No. of bitstreams: 1 Partner-based Adherence Intervention for Second-line_Sandra_Cardoso_etal_INI_Lapclin-AIDS_2015.pdf: 528003 bytes, checksum: a3fe5499df665034615b85d576e29bc5 (MD5)Made available in DSpace on 2018-10-17T15:24:34Z (GMT). No. of bitstreams: 1 Partner-based Adherence Intervention for Second-line_Sandra_Cardoso_etal_INI_Lapclin-AIDS_2015.pdf: 528003 bytes, checksum: a3fe5499df665034615b85d576e29bc5 (MD5) Previous issue date: 2015University of Pennsylvania Perelman School of Medicine, Medicine (Infectious Diseases) and Epidemiology. Philadelphia, PA, USA.Harvard School of Public Health. Biostatistics. Boston, MA, USA.Asociacion Civil IMPACTA Salud y Educacion. Lima, Peru.Harvard School of Public Health. Biostatistics. Boston, MA, USA.Harvard School of Public Health. Biostatistics. Boston, MA, USA.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.Joint Clinical Research Centre. Kampala, Uganda.EUPATI. Barcelona, Spain.National Institute of Allergy and Infectious Diseases. Bethesda, MD, USA.Northwestern University Feinberg School of Medicine. Chicago, IL, USA.Massachusetts General Hospital and Harvard Medical School. Boston, MA, USA.University of Zimbabwe. Harare, Zimbabwe.Lancet Laboratories. Johannesburg, South Africa.Yale University School of Nursing. New Haven, CT USA.Harvard School of Public Health. Biostatistics. Boston, MA, USA.Massachusetts General Hospital and Harvard Medical School. Boston, MA, USA.Social and Scientific Systems. Silver Spring, MD, USA.GHESKIO. Port au Prince, Haiti.University of Washington. Seattle, WA, USA.Adherence is key to the success of antiretroviral therapy. Enhanced partner support might benefit patients with previous treatment failure. We aimed to assess whether an enhanced partner-based support intervention with modified directly observed therapy would improve outcomes with second-line therapy in HIV-infected patients for whom first-line therapy had failed

Frequency of HIV-related oral lesions diagnosed by oral health specialists by CD4+ cell count and plasma HIV RNA viral load among 324 participants in ACTG/OHARA¹ protocol 5254.

<p>^<b>1</b> The Oral HIV/AIDS Research Alliance (OHARA) is a Collaborative Science Group within the AIDS Clinical Trial Group (ACTG)</p><p>^<b>2</b> CD4 cell count in cells/mm³</p><p>^<b>3</b> VL: Plasma HIV-1 viral load in copies/mL</p><p>^<b>4</b> Other oral lesions include recurrent oral herpes simplex infection, ulcerations not otherwise specified, and necrotizing ulcerative periodontitis and gingivitis</p><p>⁵ UWS: Unstimulated whole saliva</p><p>Frequency of HIV-related oral lesions diagnosed by oral health specialists by CD4+ cell count and plasma HIV RNA viral load among 324 participants in ACTG/OHARA<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0131001#t002fn001" target="_blank">¹</a> protocol 5254.</p