The efficiency of the EmERGE pathway of care for people living with HIV in England.

This study estimated the efficiency of implementing the EmERGE Pathway of Care for people living with medically stable HIV in Brighton, UK; an App enables individuals to communicate with caregivers via their smart-phone. Individual data on the use of HIV outpatient services were collected one-year pre- and post-implementation of EmERGE. Unit costs of HIV outpatient services were calculated and linked with mean use of services per patient year. Primary outcomes were CD4 count and viral load; patient activation and quality-of-life measures were secondary outcomes. 565 participants were followed up April 2017 - October 2018: 93% men, mean age at recruitment 47.0 years (95%CI:46.2-47.8). Outpatient visits decreased by 9% from 5.6 (95%CI:5.4-5.8) to 5.1 (95%CI:4.9-5.3). Face-to-face visits decreased and virtual visits increased. Annual costs decreased by 9% from £751 (95%CI: £722-£780) to £678 (95%CI: £653-£705). Including anti-retroviral drugs, total annual cost decreased from £7,343 (95%CI: £7,314-7,372) to £7,270 (95%CI: £7,245-7,297): ARVs costs comprised 90%. EmERGE was a cost-saving intervention, patients remained engaged and clinically stable. Annual costs were reduced, but ARVs continue to dominate costs. Extension of EmERGE to other people with chronic conditions, could produce greater efficiencies but these needs to be evaluated and monitored over time.

Efficiency of the EmERGE Pathway to provide continuity of care for Spanish people living with medically stable HIV.

OBJECTIVE: Calculate the efficiency of the EmERGE Pathway of Care for medically stable people living with HIV at the Hospital Clínic-IDIBAPS, Barcelona, Spain. METHODS: 546 study participants were followed between 1st July 2016 and 30th October 2019 across three HIV outpatient clinics, but the virtual clinic was closed during the second year. Unit costs were calculated, linked to mean use outpatient services per patient year, one-year before and after the implementation of EmERGE. Costs were combined with primary and secondary outcomes. RESULTS: Annual costs across HIV-outpatient services increased by 8%: €1073 (95%CI €999-€1157) to €1158 (95%CI €1084-€1238). Annual cost of ARVs was €7,557; total annual costs increased by 1% from €8430 (95%CI €8356-8514) to €8515 (95%CI €8441-8595). Annual cost for 433 participants managed in face-to-face (F2F) clinics decreased by 5% from €958 (95%CI 905-1018) to €904 (95%CI 863-945); participants transferred from virtual to F2F outpatient clinics (V2F) increased their annual cost by a factor of 2.2, from €115 (95%CI 94-139) to €251 (95%CI 219-290). No substantive changes were observed in primary and secondary outcomes. CONCLUSION: EmERGE Pathway is an efficient and acceptable intervention. Increases in costs were caused by internal structural changes. The cost reduction observed in F2F clinics were off-set by the transfer of participants from the virtual to the F2F clinics due to the closure of the virtual clinic during the second year of the Study. Greater efficiencies are likely to be achieved by extending the use of the Pathway to other PLHIV.

Efficiency of the EmERGE Pathway to provide continuity of care for Spanish people living with medically stable HIV.

OBJECTIVE: Calculate the efficiency of the EmERGE Pathway of Care for medically stable people living with HIV at the Hospital Clínic-IDIBAPS, Barcelona, Spain. METHODS: 546 study participants were followed between 1st July 2016 and 30th October 2019 across three HIV outpatient clinics, but the virtual clinic was closed during the second year. Unit costs were calculated, linked to mean use outpatient services per patient year, one-year before and after the implementation of EmERGE. Costs were combined with primary and secondary outcomes. RESULTS: Annual costs across HIV-outpatient services increased by 8%: €1073 (95%CI €999-€1157) to €1158 (95%CI €1084-€1238). Annual cost of ARVs was €7,557; total annual costs increased by 1% from €8430 (95%CI €8356-8514) to €8515 (95%CI €8441-8595). Annual cost for 433 participants managed in face-to-face (F2F) clinics decreased by 5% from €958 (95%CI 905-1018) to €904 (95%CI 863-945); participants transferred from virtual to F2F outpatient clinics (V2F) increased their annual cost by a factor of 2.2, from €115 (95%CI 94-139) to €251 (95%CI 219-290). No substantive changes were observed in primary and secondary outcomes. CONCLUSION: EmERGE Pathway is an efficient and acceptable intervention. Increases in costs were caused by internal structural changes. The cost reduction observed in F2F clinics were off-set by the transfer of participants from the virtual to the F2F clinics due to the closure of the virtual clinic during the second year of the Study. Greater efficiencies are likely to be achieved by extending the use of the Pathway to other PLHIV.

The development and cognitive testing of the positive outcomes HIV PROM: a brief novel patient-reported outcome measure for adults living with HIV.

BACKGROUND: People living with HIV experience burdensome multidimensional symptoms and concerns requiring person-centred care. Routine use of patient reported outcome measures can improve outcomes. There is no brief patient reported outcome measure (PROM) that currently reflects the breadth of concerns for people living with HIV. This study aimed to develop and cognitively test a brief novel patient reported outcome measure for use within routine adult HIV care- the "Positive Outcomes" HIV PROM. METHODS: Development followed the COSMIN taxonomy and guidance for relevance and comprehensiveness, and Rothrock guidance on development of valid patient reported outcome measures. The Positive Outcomes HIV PROM was developed by a steering group (people living with HIV, HIV professionals and health services researchers) using findings from a previously reported qualitative study of priority outcomes for people living with HIV. The prototype measure was cognitively tested with a purposive sample of people living with HIV. RESULTS: The Positive Outcomes HIV PROM consists of 23 questions (22 structured, and one open question) informed by the priorities of key stakeholders (n = 28 people living with HIV, n = 21 HIV professionals and n = 8 HIV commissioners) to ensure face and content validity, and refined through cognitive testing (n = 6 people living with HIV). Cognitive testing demonstrated high levels of acceptability and accessibility. CONCLUSIONS: The Positive Outcomes HIV PROM is the first brief patient reported outcome measure reflecting the diverse needs of people living with HIV designed specifically for use in the clinical setting to support patient assessment and care, and drive service quality improvement. It is derived from primary data on the priority outcomes for people living with HIV and is comprehensive and acceptable. Further psychometric testing is required to ensure reliability and responsiveness.

Towards person-centred care for people living with HIV: what core outcomes matter, and how might we assess them? A cross-national multi-centre qualitative study with key stakeholders.

OBJECTIVES: People living with HIV (PLWH) have multidimensional concerns requiring person-centred care. Routine use of patient-reported outcome measures (PROMs) improves outcomes. No brief PROM currently reflects the breadth of concerns for PLWH. This study sought to identify priority outcomes for PLWH, model current practice, explore views on introducing PROMs into routine care, and devise a model for person-centred care incorporating the PROM. METHODS: A cross-national multi-centre study (London, Brighton and Dublin) was carried out. Semi-structured qualitative interviews with adult PLWH, HIV health care professionals and HIV commissioners (responsible for planning and commissioning services) were performed. Interviews were analysed using thematic and framework analysis. RESULTS: PLWH (n = 28), professionals (n = 21) and commissioners (n = 8) described concerns related to living with HIV across six domains: physical (e.g. pain and gastrointestinal symptoms), cognitive (e.g. memory and sleep), psychological (e.g. anxiety and depression), social (e.g. isolation and intimacy), welfare (e.g. finances and fears regarding change of immigration status), and information (e.g. long-term outcomes) needs. Themes were highly inter-related, impacting across domains of need (e.g. physical and cognitive problems impacting on psychological and social wellbeing). Perceived benefits of using PROMs in routine HIV care included improved person-centredness, patient empowerment, fewer missed concerns, increased engagement with services, and informed planning of services. Potential challenges included heterogeneity of PLWH, literacy, and utility for those who struggle to engage with care. CONCLUSIONS: This study presents a novel model of person-centred care incorporating an HIV-specific PROM. The model reflects priorities of key stakeholders. Explicit use of PROMs in routine HIV care could afford benefits for PLWH, clinical teams and commissioners.

Pre-exposure prophylaxis for conception (PrEP-C) as a risk reduction strategy in HIV-positive men and HIV-negative women in the UK.

Couples wishing to have biological children when one partner is HIV positive and the other is HIV negative present clinicians with complex clinical, social and ethical considerations. We established two multidisciplinary pre-conception services for HIV-positive individuals and their partners. We report the first UK use of pre-exposure prophylaxis for conception (PrEP-C) as part of an overall risk reduction strategy. Couples were counselled and written informed consent for PrEP-C was obtained. Patient demographics, HIV and medical histories were recorded. Males underwent baseline semen analysis and seminal HIV viral load testing. Females had full fertility screens. Both partners were screened for sexually transmitted infections. All couples used timed ovulatory intercourse (TOI). Tenofovir±emtricitabine was taken by the female at protocol designated times before±after TOI. Thirty-two male positive/female negative couples used the services. Thirteen couples have used PrEP-C (median age of male 41 years (range 32-56), female 31 (28-43); median CD4 533 (236-1194); all male plasma and seminal HIV viral loads were undetectable). Eleven pregnancies in 10 couples have resulted in 7 live births, 1 ongoing pregnancy and 4 miscarriages (5/40, 6/40, 10/40 and 1 twin 17/40) after a median of 2.5 attempts (range 1-5). PrEP-C was well tolerated with no discontinuations and no HIV transmissions. These data suggest that PrEP-C is a safe and effective option for serodiscordant couples wishing to conceive; a standardised protocol has been developed; data collection via a central database is under way.

New world mucosal and cutaneous leishmaniasis: an emerging health problem among British travellers.

BACKGROUND: Mucosal leishmaniasis (ML) is an important complication of new world cutaneous leishmaniasis (CL) caused by species of the Leishmania Viannia subgenus. Previous reports of ML among travellers to Latin America are few. AIMS: To determine the annual number of cases of CL due to L. Viannia species diagnosed at this institution and to correlate this with changing patterns of travel. Secondly, to document the clinical presentation, diagnosis, treatment and outcome of ML at this institution. DESIGN: Retrospective observational study. METHODS: Data were collected from a clinical database, laboratory records, patient case notes and an international passenger survey. RESULTS: Between 1995 and 2003, the annual number of cases of CL (total 79) steadily increased from 4 per year to 18 per year; the estimated number of travellers from the UK to Latin America increased 3.5-fold. Six cases of ML were diagnosed among British travellers in 1995 (1), 1997 (1) and 2002 (4). These infections were acquired in Bolivia (3), Colombia (2) and Belize (1). Nasopharyngeal symptoms developed 0-15 months after returning to the UK. Four patients had concurrent CL at diagnosis. Diagnosis of ML was delayed up to 6 months from the onset of symptoms. Mucosal biopsies from all 6 patients were PCR-positive for L. (Viannia) DNA; microscopy and culture were less sensitive. ML relapsed in one patient following treatment. DISCUSSION: Increasing travel to Latin America from the UK was associated with an increasing number of diagnoses of L. Viannia CL. ML is likely to emerge as a more frequently imported infection among such travellers. Familiarity with these diseases is important for prompt diagnosis and optimal management.

Investigation of tropical eosinophilia; assessing a strategy based on geographical area.

OBJECTIVES: Patients with eosinophilia are an important clinical problem. This study aimed to assess the most efficient manner of investigating patients with peripheral eosinophilia (eosinophil count >0.5x10(9)ml(-1)) presenting from the tropics. METHODS: Patients attending the Hospital for Tropical Diseases, London, from October 1997 to March 2002 for investigation of eosinophilia were identified prospectively. Laboratory, clinical and demographic data were recorded from laboratory and clinical records. An investigation set was proposed prospectively and assessed for all geographical areas (stool microscopy, strongyloides culture and serology), all of Africa (additional schistosomal serology, terminal urine microscopy and filarial serology) and West Africa (additional day-bloods for microfilaria). RESULTS: Data was analysed for 261 patients. At least one helminthic cause for eosinophilia was found in 64% of patients (median eosinophilia 1.2x10(9)ml(-1)). Seventeen per cent of patients had more than one helminth species found. Median eosinophilia increased with number of diagnoses per patient. The proposed investigation sets were validated, with high yield for all proposed tests apart from filarial serology outside West Africa, and good sensitivity. CONCLUSIONS: Initial investigation of eosinophilia in patients presenting from the tropics may be guided by a simple investigation set depending on broad area of travel which has high sensitivity and yield. Patients frequently have more than one helminthic cause of eosinophilia.

Ursodeoxycholic acid for the treatment of intrahepatic cholestasis of pregnancy.

OBJECTIVE: To report our experience in managing intrahepatic cholestasis of pregnancy with ursodeoxycholic acid. METHODS: All cases of intrahepatic cholestasis of pregnancy that were diagnosed at Bridgeport Hospital from January 1997 to August 1999 were identified. Information was abstracted on demographics, medical and obstetric history, symptoms, laboratory data, therapy and pregnancy outcome. Statistical analysis was primarily descriptive; continuous variables were analyzed with t tests. RESULTS: A total of 20 cases of intrahepatic cholestasis of pregnancy were identified (0.32% of live births). All patients presented with pruritus. The mean gestational age at onset of symptoms was 31.1 weeks (range 13-38.4, median 32.4). Bile acids were measured in 18 cases and were elevated in all. The mean gestational age at delivery was 36.4 weeks (32.3-39.9). Eight patients were treated with ursodeoxycholic acid (600-1200 mg). All eight patients experienced subjective improvement in pruritus after initiation of treatment with ursodeoxycholic acid. Ursodeoxycholic acid was associated with a decrease in bile acids in most patients (p = 0.16) and with a significant decrease in serum transaminases (p = 0.03). CONCLUSIONS: Ursodeoxycholic acid is an effective therapy for relief of pruritus and improvement of the liver dysfunction that occurs with intrahepatic cholestasis of pregnancy.

Indicated preterm birth: a possible contribution to group B streptococcal sepsis prophylaxis protocol failures. A case report.

BACKGROUND: Despite the acceptance of protocols for the prevention of group B streptococcal (GBS) sepsis for the newborn, protocol violations, with subsequent failure to initiate intrapartum antibiotic therapy, occur at many institutions. The causes for GBS prophylaxis protocol violations are not well understood. CASES: We report two cases of indicated preterm birth in which appropriate antibiotic prophylaxis for GBS sepsis was not initiated. CONCLUSION: In the setting of indicated preterm birth, GBS prophylaxis may be overlooked. We suspect that the attention given to the medical or fetal complications of indicated preterm birth may contribute to the omission of GBS sepsis prophylaxis in these situations.

Successful pregnancy after suspected anaphylactoid syndrome of pregnancy (amniotic fluid embolus). A case report.

BACKGROUND: Limited information is available on the recurrence risk of anaphylactoid syndrome of pregnancy. CASE: A successful pregnancy followed suspected anaphylactoid syndrome of pregnancy. CONCLUSION: A review of the literature revealed five cases of successful subsequent pregnancies following anaphylactoid syndrome of pregnancy. No instances of recurrent anaphylactoid syndrome of pregnancy have been reported.

The association of increased fetal nuchal translucency and spinal muscular atrophy type I.

We report a fetus with spinal muscular atrophy type I, who presented with an increased nuchal translucency at 13 weeks' gestation. A review of the literature reveals additional cases of spinal muscular atrophy type I associated with increased nuchal translucency and suggests increased nuchal translucency may be an early finding in this disorder.

Fetal ascites associated with ABO incompatibility: case report and review of the literature.

We report a pregnancy complicated by anti-B isoimmunization that resulted in fetal ascites, anemia, hepatomegaly, and polyhydramnios. A previous pregnancy in the same patient was complicated by neonatal ABO incompatibility. A review of the obstetric literature suggests that ABO incompatibility may cause severe fetal anemia, especially in patients with type O blood or a previous history of ABO incompatibility of the newborn.

Gaining access to the embryonic-fetal circulation via first-trimester endoscopy: a step into the future.

OBJECTIVE: To assess the feasibility of gaining access to the embryonic-fetal circulation via first-trimester transcervical embryoscopy. METHODS: A fiberoptic endoscope with a 3.5-mm, wide-angle lens was passed transcervically through the chorion and into the exocoelomic cavity of women undergoing pregnancy termination. A 26-gauge heparinized needle was passed through the sideport of the endoscope and inserted into the blood vessels of the chorionic plate or umbilical cord to obtain blood samples. RESULTS: With a modified endoscope, we have been able to gain access into the embryonic-fetal circulation and obtain a small aliquot of blood in five of eight cases. CONCLUSIONS: Our experience establishes the feasibility of gaining access to the human embryonic-fetal circulation. This work is expected to serve as a basis for further studies of the diagnosis and treatment of congenital diseases in early pregnancy.

Pregnancy in patients with cyclic neutropenia.

Cyclic neutropenia is characterized by periodic episodes of neutropenia that are often associated with infectious complications. A patient with cyclic neutropenia experienced two pregnancies with an amelioration of her infectious complications and an increase in neutrophil count. Cyclic neutropenia may follow a benign course during pregnancy.

Embryoscopy: a closer look at first-trimester diagnosis and treatment.

Advancing technology has made the fetus and its environment even more accessible to prenatal diagnosis and treatment. The current approach to prenatal diagnosis relies mainly on the use of high-resolution ultrasonography. However, as attempts are made to conduct antenatal diagnoses earlier in gestation, the limits of ultrasonography are approached. Embryoscopy allows for direct visualization of the first-trimester fetus with a fiberoptic endoscope. A customized side channel enables the operator to pass a variety of diagnostic tools and gain access into the fetal circulation. The further development and refinement of this technology are expected to change early prenatal diagnosis and treatment considerably. The potential contribution of this technique to perinatal medicine is readily apparent when it is placed in historic context. Undoubtedly, many ethical, legal, and regulatory questions will have to be addressed before the full potential of embryoscopy is realized. The responsibility for the judicious use of this powerful technology for prenatal intervention will have to be shared by the scientific community and a well-informed public.

Transcervical endoscopic verification of congenital anomalies in the second trimester of pregnancy.

Transcervical endoscopy was used to confirm prenatally diagnosed anomalies before elective termination of pregnancy. A complete anatomic survey was accomplished in 10 (70%) of 14 cases studied. Information was added to the ultrasonographic diagnosis in two cases, which changed the diagnosis in one fetus.

Transvaginal ultrasonographic detection of congenital anomalies in the first trimester.

Transvaginal ultrasonography enables detailed visualization of the first-trimester pregnancy. Thirty-three structural anomalies have been diagnosed in the first trimester of pregnancy during a 2-year study period. An understanding of normal embryonic development is essential before attempting diagnosis in this gestational period.