bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluating Opportunities for Achieving Cost Efficiencies Through the Introduction of PrePex Device Male Circumcision in Adult VMMC Programs in Zambia and Zimbabwe
Authors: Vandament Lyndsey , Chintu Naminga , Yano Nanako , Mugurungi Owen , Tambatamba Bushimbwa , Ncube Gertrude , Xaba Sinokuthemba , Mpasela Felton , Muguza Edward , Mangono Tichakunda , Madidi Ngonidzashe , Samona Alick , Tagar Elva , Hatzold Karin 
Published: June 2016

Background:
Results from recent costing studies have put into question potential Voluntary Medical Male Circumcision (VMMC) cost savings with the introduction of the PrePex device.

Methods:
We evaluated the cost drivers and the overall unit cost of VMMC for a variety of service delivery models providing either surgical VMMC or both PrePex and surgery using current program data in Zimbabwe and Zambia. In Zimbabwe, 3 hypothetical PrePex only models were also included. For all models, clients aged 18 years and older were assumed to be medically eligible for PrePex and uptake was based on current program data from sites providing both methods. Direct costs included costs for consumables, including surgical VMMC kits for the forceps-guided method, device (US $12), human resources, demand creation, supply chain, waste management, training, and transport.

Results:
Results for both countries suggest limited potential for PrePex to generate cost savings when adding the device to current surgical service delivery models. However, results for the hypothetical rural Integrated PrePex model in Zimbabwe suggest the potential for material unit cost savings (US $35 per VMMC vs. US $65–69 for existing surgical models).

Conclusions:
This analysis illustrates that models designed to leverage PrePex's advantages, namely the potential for integrating services in rural clinics and less stringent infrastructure requirements, may present opportunities for improved cost efficiency and service integration. Countries seeking to scale up VMMC in rural settings might consider integrating PrePex only MC services at the primary health care level to reduce costs while also increasing VMMC access and coverage.
Safety and Efficacy of the PrePex Male Circumcision Device: Results From Pilot Implementation Studies in Mozambique, South Africa, and Zambia
Authors: Feldblum Paul , Martinson Neil , Bvulani Bruce , Taruberekera Noah , Mahomed Mehebub , Chintu Namwinga , Milovanovic Minja , Hart Catherine , Billy Scott , Necochea Edgar , Samona Alick , Mhazo Miriam , Bossemeyer Debora , Lai Jaim Jou , Lebinai Limakatso , Ashengo Tigistu A. , Macaringue Lucinda , Veena Valentine , Hatzold Karin 
Published: June 2016

Background:
Fourteen countries in East and Southern Africa have engaged in national programs to accelerate the provision of voluntary medical male circumcision (VMMC) since 2007. Devices have the potential to accelerate VMMC programs by making the procedure easier, quicker, more efficient, and widely accessible.

Methods:
Pilot Implementation studies were conducted in Mozambique, South Africa, and Zambia. The primary objective of the studies was to assess the safety of PrePex device procedures when conducted by nurses and clinical officers in adults and adolescent males (13–17 years, South Africa only) with the following end points: number and grade of adverse events (AEs); pain-related AEs measured using visual analog score; device displacements/self-removals; time to complete wound healing; and procedure times for device placement and removal.

Results:
A total of 1401 participants (1318 adult and 83 adolescent males) were circumcised using the PrePex device across the 3 studies. Rates of moderate/severe AEs were low (1.0%; 2.0%; and 2.8%) in the studies in Mozambique, Zambia, and South Africa, respectively. Eight early self-removals of 1401 (0.6%) were observed, all required corrective surgery. High rates of moderate/severe pain-related AEs were recorded especially at device removal in South Africa (34.9%) and Mozambique (59.5%). Ninety percent of participants were healed at day 56 postplacement.

Discussion:
The study results from the 3 countries suggest that the implementation of the PrePex device using nonphysician health care workers is both safe and feasible, but better pain control at device removal needs to be put in place to increase the comfort of VMMC clients using the PrePex device.
Surgical Outcomes of Newly Trained ShangRing Circumcision Providers
Authors: Awori Quentin D. , Lee Richard K. , Li Philip S. , Zulu Robert , Agot Kawango , Combes Stephanie , Simba Raymond O. , Hart Catherine , Lai Jaim Jou , Zyambo Zude , Goldstein Marc , Feldblum Paul J. , Barone Mark A. 
Published: June 2016

Background:
Devices can potentially accelerate scale-up of voluntary medical male circumcision in sub-Saharan Africa. Studies have demonstrated advantages of the ShangRing device over conventional circumcision. With the need to train providers rapidly for scale-up, concerns arise about the transferability of techniques and the expertise of new trainees.

Methods:
We compared outcomes of ShangRing circumcisions conducted in Kenya by experienced providers (experience with more than 100 ShangRing circumcisions) and newly trained providers (trained in Kenya by the experienced providers before the study began). During training, trainees performed at least 7 ShangRing circumcisions and 3 removals. Newly trained providers received intermittent clinical mentoring initially during the study but otherwise conducted circumcisions on their own.

Results:
Four hundred six and 115 ShangRing procedures were performed by the new trainees and the experienced providers, respectively. The mean duration of circumcisions was 6.2 minutes for both trained and experienced provider groups (P = 0.45), whereas the mean pain score (on an 11-point scale) was 2.5 and 3.2, respectively (P = 0.65). There was no difference in the proportion of participants healed by the day 42 visit (P = 0.13) nor in the incidence of moderate and severe adverse events observed (P = 0.16). Participants in both groups were equally satisfied with final wound cosmesis.

Discussion:
Results demonstrate that the ShangRing circumcision technique is easy to learn and master. Newly trained providers can safely conduct ShangRing circumcisions in routine service settings. The ShangRing can facilitate rapid rollout of voluntary medical male circumcision for HIV prevention in sub-Saharan Africa.
Acceptability and Satisfaction Associated With the Introduction of the PrePex Circumcision Device in Maputo, Mozambique
Authors: Cummings Beverley , Necochea Edgar , Ferreira Thais , Soares Benilde , Mahomed Mehebub , Muquingue Humberto , Nhambi Leonel , Bossemeyer Debora , Ashengo Tigistu A. 
Published: June 2016

Background:
Adult device circumcision may potentially reach more men in Sub-Saharan Africa, with fewer human resource and capacity needs than surgical procedures. Despite these advantages, little is known about device acceptability, including pain and maintaining the device in situ.

Methods:
Healthy, HIV-negative men, between 18 and 49 years, in a Maputo clinic, were consecutively asked to participate in a circumcision device study that included assessing acceptability. Clinical forms and self-administered surveys were used to collect data at various times during the circumcision process for consenting men. Data were entered into a central database and analyzed using statistical software.

Results:
Between May and July, 2013, 504 men received device circumcision. Placement was painless for 98.2% of the male population, but the pain was more common during removal with 38.3% reporting severe or unbearable and 21.5% moderate pain. Satisfaction was high at both time points with 88.8% and 92.6% of men being very or somewhat satisfied at placement and removal, respectively. Half of the male population (50.2%) was very or somewhat comfortable with the device in situ; whereas, 36.8% were somewhat or very uncomfortable. Common device difficulties experienced were painful erections (38.5%) and difficult urination (21.8%) and hygiene (21.4%). By the final clinic visit at day 49, 90.4% of them were very or somewhat satisfied with the procedure.

Discussion:
High levels of satisfaction were reported for device circumcision, despite the pain noted during removal and some challenges with the device in situ. Given the advantages and acceptability among Mozambican men in this study, device circumcision could be offered, when clinically appropriate, as an alternative to surgery.
Participant Experiences and Views of Odor and PrePex Device Removal Pain in a VMMC Pilot Study in Botswana
Authors: Musiige Adrian M. , Ashengo Tigistu A. , Stolarsky Galina , Dialwa Rosinah T. , Manda Robert , Ntsuape Conrad O. , Mafeni Jerome , Busang Lesego , Curran Kelly , Motlhoiwa Kenanao , Mwangemi Frank J. , Lukobo-Durrell Mainza , Glenshaw Mary T. 
Published: June 2016

Objective:
To assess participant experiences and perceptions of removal pain and odor associated with the PrePex device procedure.

Methods:
We analyzed data from a PrePex device pilot implementation study of 802 male participants aged 18–49 years at 2 clinics in Botswana, 2013. Study staff administered survey questions on device-related odor and assessed pain using visual analog scale scores categorized as no pain (0), mild (1–4), moderate (5–7), or severe pain (8–10).

Results:
Mean participant age was 27.7 (range = 18–48) years. Of the 802 participants, 751 (94%) reported to have noticed an unusual or unpleasant odor while wearing the device. Of these, 193 (26%) participants tried something to combat the odor. A total of 84 (10%) participants reported no pain, 655 (82%) mild pain, 48 (6%) moderate pain, and 15 (2%) severe pain at 2 minutes after device removal. Pain reports at 15 minutes after removal were 553 (69%) no pain, 247 (31%) mild pain, and 2 (0.25%) moderate pain, with no report of severe pain at this time point. Of 740 participants interviewed on day 42 after device placement, 678 (92%) were satisfied with the procedure and 681 (92%) would recommend it to another man considering circumcision, including 488 (66%) who would recommend it strongly.

Conclusions:
An unusual or unpleasant odor while wearing the PrePex device and mild self-limiting pain at device removal were common, but overall, these did neither seem to impair satisfaction nor deter participants from recommending PrePex to others, which could suggest good prospects for uptake of the device in this setting.
Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes
Authors: Feldblum Paul J. , Zulu Robert , Linyama David , Long Sarah , Nonde Thikazi Jere , Lai Jaim Jou , Kashitala Joshua , Veena Valentine , Kasonde Prisca 
Published: June 2016

Objectives:To assess the safety, effectiveness, and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia.Methods:We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18–49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40–26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing.Results:Four hundred and ninety-six men comprised the analysis population, with 255 in the Standard Sizing arm and 241 in the Modified Sizing arm. Three men experienced a moderate or severe AEs (0.6%), including 2 in the Standard Sizing arm (0.8%) and 1 in the Modified Sizing arm (0.4%). 73.2% of participants were completely healed at the scheduled day 42 healing check visit, with similar percentages across study arms. Virtually all (99.6%) men, regardless of study arm, stated that they were very satisfied or satisfied with the appearance of their circumcised penis, and 98.6% stated that they would recommend ShangRing circumcision to family/friends.Conclusions:The moderate/severe AE rate was low and similar in the 2 study arms, suggesting that provision of one-half the number of adult device sizes is sufficient for safe service delivery. Effectiveness, time to healing, and acceptability were similar in the study arms. The simplicity of the ShangRing technique, and its relative speed, could facilitate VMMC program goals. In addition, sufficiency of fewer device sizes would simplify logistics and inventory.
Implementation and Operational Research: Clinical Impact of the Xpert MTB/RIF Assay in Patients With Multidrug-Resistant Tuberculosis
Authors: Padayatchi Nesri , Naidu Naressa , Yende-Zuma Nonhlanhla , O'Donnell Max Roe , Naidoo Kogieleum , Augustine Stanton , Zumla Alimuddin , Loveday Marian 
Published: June 2016

Background:
The Xpert MTB/RIF assay has been widely implemented in South Africa for rapid tuberculosis (TB) screening. However, its usefulness in management and improving treatment outcomes in patients with multidrug-resistant TB (MDR-TB) remains undefined. The aim of this study was to evaluate the clinical impact of introduction of the Xpert MTB/RIF assay in patients with MDR-TB.

Methods:
We enrolled 921 patients with MDR-TB, who presented to a specialist drug-resistant TB facility in KwaZulu-Natal, South Africa, pre- and post-rollout and implementation of the Xpert MTB/RIF assay. Clinical, laboratory, chest radiograph, and follow-up data from 108 patients with MDR-TB, post-introduction of the Xpert MTB/RIF assay (Xpert group) in November 2010, were analyzed and compared with data from 813 MDR-TB patients from the pre-MTB/RIF assay period (Conventional group), July 2008–2010. Primary impact measure was “treatment success” (World Health Organization definition) at 24 months. Secondary outcomes were time to treatment initiation and disease morbidity.

Results:
There were no significant differences in treatment success rates between the pre-Xpert MTB/RIF and post-Xpert MTB/RIF groups (54% versus 56.5%, P = 0.681). Median time to treatment initiation was 20 days (interquartile range, 13–31) in the Xpert group versus 92 days (interquartile range, 69–120) in the Conventional group (P < 0.001).

Conclusions:
Although use of Xpert MTB/RIF assay significantly reduces the time to initiation of MDR-TB treatment, it had no significant impact on treatment outcomes of patients with MDR-TB. Studies on the impact of the Xpert MTB/RIF assay usage on transmission of MDR-TB are required.
Brief Report: Association of Adipokines With Bone Mineral Density in HIV-Infected and HIV-Uninfected Women
Authors: Sharma Anjali , Ma Yifei , Scherzer Rebecca , Wheeler Amber L. , Cohen Mardge , Gustafson Deborah R. , Keating Sheila M. , Yin Michael T. , Tien Phyllis C. 
Published: June 2016

Background:
HIV infection is associated with low bone mineral density (BMD) and alterations in adipokines, which may mediate the relationship between fat and bone.

Objective:
To evaluate the relationship of adiponectin and leptin with BMD in HIV-infected and uninfected women.

Methods:
We measured BMD over 5 years at the lumbar spine, total hip (TH), and femoral neck (FN) using dual-energy X-ray absorptiometry in 318 HIV-infected and 122 HIV-uninfected participants of the multicenter Women's Interagency HIV Study (WIHS). Total adiponectin and leptin were assayed on stored sera. Multivariable linear mixed models assessed the effects of adipokines and HIV status on BMD.

Results:
HIV-infected women had higher adiponectin (median 6.2 vs. 5.6 μg/mL,) but lower leptin (11.7 vs. 19.8 ng/mL) levels at baseline (both P < 0.05) compared with HIV-uninfected women. HIV infection was associated with lower BMD at the lumbar spine (−0.074 g/cm2), FN (−0.049 g/cm2), and TH (−0.047 g/cm2) (all P < 0.05) after adjusting for demographic, behavioral, and metabolic factors. HIV infection remained associated with lower BMD at each site, with little change in the effect sizes after additional adjustment for adiponectin or leptin. Among HIV-infected women, higher adiponectin was associated with lower TH BMD (−0.025 g/cm2 per 10-fold increase, P = 0.035), whereas higher leptin was associated with higher BMD at FN (+0.027 g/cm2 per 10-fold increase, P = 0.005) and TH (+0.019 g/cm2, P = 0.028). After multivariable adjustment, the adipokines showed little association with BMD at any site (P > 0.8 for adiponectin; P > 0.2 for leptin).

Conclusions:
Alterations in serum adiponectin and leptin do not explain low BMD in HIV-infected women.
Ultrasonographic Morphologic Changes of the Central Aponeurosis of the Rectus Femoris Muscle in Individuals With Knee Osteoarthritis
Authors: Takahashi Yusuke , Okada Kyoji , Saito Akira , Saito Isao , Kinoshita Kazuo , Wakasa Masahiko , Sato Hiromichi , Shibata Kazuyuki 
Published: June 2016

AbstractThe aim of this study was to clarify the morphologic characteristics of central aponeurosis (CA) of the rectus femoris (RF) muscle in individuals with medial knee osteoarthritis (OA). Forty legs in 26 individuals with medial knee OA (OA group), 41 legs in 21 elderly individuals (elderly group), and 40 legs in 20 young individuals (young group) were investigated. We measured the following 4 parameters: (1) ratio of CA length, expressed as the percentage of RF length; (2) CA morphologic type (curved, straight, S-shaped, or irregular); (3) CA direction, defined as the direction of the line from the anterior to posterior ends of the CA (lateral or medial); and (4) intercondylar distance (ICD). Ratio of CA length in the OA group was significantly smaller than that in the other 2 groups. The curved CA type was significantly more frequent in the young group than in the other 2 groups. The irregular type was observed in only 7 legs in the OA group. In the young group, CA direction was classified as medial in all cases. Laterally directed CA was observed only in the OA and elderly groups. Within the OA group, ICD in laterally directed CA was significantly larger than that in medially directed CA. Central aponeurosis observed in the RF muscle in individuals with medial knee OA is shorter and sometimes shows an irregular shape. Laterally directed CA is associated with increased ICD in knee OA. Attention should be given to the tendon-aponeurosis complex in individuals with medial knee OA.
Increased Frequency of Encopresis in a Child Diagnosed With Attention Deficit/Hyperactivity Disorder and Encopresis After Atomoxetine Use: A Case Report
Authors: Yektaş Çiğdem , Cansiz Mehmet Akif , Tufan Ali Evren 
Published: June 2016

Abstract
Attention deficit hyperactivity disorder (ADHD) is among the most frequently reported coexisting psychiatric conditions in children with encopresis. Some case reports state that atomoxetine—a selective presynaptic norepinephrine reuptake inhibitor—approved for treatment of ADHD is also effective in the treatment of coexisting encopresis. Contrasting those reports, here we present a case diagnosed with ADHD and secondary encopresis without constipation whose encopretic symptoms increased after atomoxetine treatment and discuss possible mechanisms.
Effects of Noise Level and Cognitive Function on Speech Perception in Normal Elderly and Elderly with Amnestic Mild Cognitive Impairment
Authors: Lee Soo Jung , Park Kyung Won , Kim Lee-Suk , Kim HyangHee 
Published: June 2016

Objective and Background:
Along with auditory function, cognitive function contributes to speech perception in the presence of background noise. Older adults with cognitive impairment might, therefore, have more difficulty perceiving speech-in-noise than their peers who have normal cognitive function. We compared the effects of noise level and cognitive function on speech perception in patients with amnestic mild cognitive impairment (aMCI), cognitively normal older adults, and cognitively normal younger adults.

Methods:
We studied 14 patients with aMCI and 14 age-, education-, and hearing threshold-matched cognitively intact older adults as experimental groups, and 14 younger adults as a control group. We assessed speech perception with monosyllabic word and sentence recognition tests at four noise levels: quiet condition and signal-to-noise ratio +5 dB, 0 dB, and −5 dB. We also evaluated the aMCI group with a neuropsychological assessment.

Results:
Controlling for hearing thresholds, we found that the aMCI group scored significantly lower than both the older adults and the younger adults only when the noise level was high (signal-to-noise ratio −5 dB). At signal-to-noise ratio −5 dB, both older groups had significantly lower scores than the younger adults on the sentence recognition test. The aMCI group’s sentence recognition performance was related to their executive function scores.

Conclusions:
Our findings suggest that patients with aMCI have more problems communicating in noisy situations in daily life than do their cognitively healthy peers and that older listeners with more difficulties understanding speech in noise should be considered for testing of neuropsychological function as well as hearing.
Association of Depression, Anxiety, and Type D Personality with Cognitive Function in Patients with Coronary Artery Disease
Authors: Burkauskas Julius , Brozaitiene Julija , Bunevicius Adomas , Neverauskas Julius , Zaliunaite Violeta , Bunevicius Robertas 
Published: June 2016

Background and Objective:
Cognitive impairment predicts poor outcomes in patients with coronary artery disease (CAD), but much remains to be learned about these patients’ cognitive function. We investigated how depression, anxiety, and Type D personality relate to cognitive function in patients with CAD, adjusting for sociodemographic factors and clinical markers of CAD severity.

Methods:
We evaluated 510 consecutive patients with CAD (364 men, 146 women; mean age 58±9 years) but no history of coronary artery bypass graft surgery or cognitive impairment who were attending a cardiac rehabilitation program. We assessed the patients’ cognitive function (Mini-Mental State Examination, Digit Span Test, Digit Symbol Test, and Trail Making Test Part A), depressive symptoms (Beck Depression Inventory-II), anxiety (State-Trait Anxiety Inventory), Type D personality (14-item Type D Scale), and clinical markers of CAD severity.

Results:
After adjusting for sex, age, education, New York Heart Association functional class, and left ventricular ejection fraction, we found that higher depression symptom scores correlated with longer Digit Symbol Test completion time (β=0.158, P<0.004). Higher state anxiety scores correlated with worse Digit Span Test backward recall (β=−0.117, P<0.008) and Trail Making Test Part A scores (β=0.182, P<0.004). Type D personality correlated with lower Mini-Mental State Examination scores (β=−0.148, P=0.001).

Conclusions:
For patients with CAD undergoing a cardiac rehabilitation program, depression, anxiety, and Type D personality were associated with worse cognitive performance independent of clinical CAD severity and sociodemographic characteristics.