An Award of Damages for Commercial Surrogacy Overseas?

This article examines the United Kingdom Supreme Court decision in Whittington Hospital NHS Trust v XX [2020] UKSC 14. The case centred on whether damages could be awarded for the cost of a commercial surrogacy arrangement in California, following clinical negligence by the hospital that left the plaintiff unable to carry her own children. After examination of this case, the article outlines and compares the United Kingdom and Australian surrogacy laws. It then discusses how a similar case would be decided in Australia and argues that the result would be the same in some Australian States. It also discusses the concept of reproductive autonomy and the importance of this concept when considering cases involving the loss of fertility.

Opioid Consumption Following Breast Surgery Decreases with a Brief Educational Intervention: A Randomized, Controlled Trial.

BACKGROUND: Current rates of opioid prescribing and consumption in the United States have resulted in deleterious consequences for both patients and society. There has been a focus on opioid consumption and overprescribing, but the utility of patient education in reducing opioid consumption has only recently been explored. This randomized trial aimed to evaluate the effectiveness of a brief patient educational intervention in reducing pain and opioid consumption in patients undergoing mastectomy and breast reconstruction. METHODS: A parallel, randomized, single-center trial of women undergoing mastectomy with immediate, implant-based breast reconstruction was completed to evaluate the utility of a patient educational instrument with information on multi-modal pain control. A questionnaire was administered postoperatively to collect data on pain control and opioid consumption. RESULTS: Fifty participants were randomized to each group preoperatively; 46 control (92%) and 39 intervention (78%) participants completed the postoperative questionnaire. Active tobacco use was more common in the control group (p = 0.04). There was a trend towards lower pain scores in the intervention group (3.0/10, SD 1.8 vs 3.6/10, SD 1.6, p = 0.06). Both groups were prescribed a median of 32.0 5-mg oxycodone tablets postoperatively. Participants in the intervention group consumed 33% fewer opioids than the control group (16.2 tablets, SD 16.4 vs 24.3 tablets, SD 21.8, p = 0.05). CONCLUSIONS: The use of a brief educational intervention provided at a preoperative appointment can reduce opioid consumption. We recommend the use of an educational intervention to decrease opioid consumption among breast surgery patients.

Perception of pain and influences on opioid use in implant-based breast reconstruction patients.

Although there has been a recent focus on decreasing opioid prescribing through alternative pain medication protocols, the patient's perception of pain related to breast reconstructive surgeries has not been well described. We sought to evaluate patient perception of pain control as it influences opioid use. We hypothesize that modifiable factors may influence patterns in pain perception and postoperative opioid use. Patients undergoing consultation for mastectomy with immediate, implant-based breast reconstruction were enrolled in a prospective, cohort survey study. A survey was administered at preoperative and postoperative appointments to collect data on pain expectations and pain control. Of 100 patients enrolled, 85% completed the postoperative survey. Over half of patients (52%) reported feeling anxious about pain control after surgery. Patients with preoperative opioid use were more likely to expect complete relief of pain postoperatively (P = .038). Patients with psychiatric comorbidity were more likely to report feeling anxious about postoperative pain (P = .012; 70% vs 42%; OR 3.0 CI 1.2-7.4). Patients who reported feeling anxious about pain control preoperatively were more likely to report trying opioids (P = .047; 67% vs 44%; OR 2.5 CI 1.0-6.1) and benzodiazepines (P = .020; 80% vs 56%; OR 3.0 CI 1.2-8.0) postoperatively. Anxiety related to pain control is common and results in an increased likelihood of trying opioid and benzodiazepine medications postoperatively. This presents an opportunity to educate patients preoperatively by addressing anxiety related to pain control to decrease controlled substance use.

Optimisation of umbu juice spray drying, and physicochemical, microbiological and sensory evaluation of atomised powder.

Aim: Optimum conditions of umbu juice spray drying were selected using inlet air temperature (T), feed flow rate (F) and 10-DE maltodextrin concentration (CMD) as independent variables, and water activity, moisture content, hygroscopicity and phenolic compounds retention as responses.Methods: Powders water activity was determined with a water activity metre, moisture content and hygroscopicity gravimetrically, total phenolics spectrophotometrically, apparent and absolute density, porosity and solubility by standard methods, particle size by laser diffraction, and morphology by Scanning Electron Microscopy. Nectars sensory analysis was based on acceptance, purchase intention and multiple comparison preference tests. Powder stability was checked at 25 °C varying water activity and storage time in the ranges 0.1-0.3 and 30-90 days, respectively.Results: Powders prepared at T = 110 °C, F = 0.84 L/h, CMD=10% and T = 140 °C, F = 0.60 L/h, CMD=10% gave the best microparticles and sensory results. The former showed properties suitable for industrial production.Conclusion: These findings may promote umbu powder industrial exploitation.

Oral health-related quality of life following dental treatment under general anaesthesia for early childhood caries - a UK-based study.

OBJECTIVE: To assess parental reports of changes in oral health-related quality of life (OHRQoL) of young children in the UK with early childhood caries (ECC) following dental treatment under general anaesthesia (DGA). To compare the impact of oral rehabilitation (OR) and extraction-only (Exo) treatment approaches on this. METHODS: Data were collected using the proxy reported components of the Child Oral Health-Related Quality of Life (COHRQoL® ) questionnaire: the Parent-Caregivers Perceptions questionnaire (P-CPQ) and Family Impact Scale (FIS), from a convenience sample of parents of children receiving DGA at a UK Paediatric Dental Department. Mean scores and prevalence impacts were compared pre- and postoperatively with mean change score and effect sizes calculations. RESULTS: Seventy-eight parents were recruited (51 children undergoing OR, 27 Exo) with 6 lost to follow-up (92.3%). Following treatment, changes in mean P-CPQ and FIS scores were statistically significant (P < 0.0001) with medium to large effect sizes (0.45-1.39). The differences in change scores between the two treatment approaches were not statistically different. CONCLUSION: DGA for young children with early childhood caries resulted in substantial improvements in parent's ratings of their child's OHRQoL and of the impact on their families. Larger cohort studies are needed to validate these preliminary findings.

Regulating preimplantation genetic diagnosis in Australia: Disability and parental choice.

Preimplantation genetic diagnosis (PGD) is the process by which an early in vitro embryo is screened for a genetic condition. As the name suggests, the procedure is undertaken prior to the embryo being implanted into a woman and therefore affected embryos can be discarded. This article argues that the objections previously put forward opposing the use of PGD to select against disability are flawed. It also argues that permitting parents to act in a procreatively beneficent manner and to preserve their child's right to an open future are good reasons for parents to have the freedom to select against disability. In light of this, are there any sound reasons to limit the use of PGD to selection against serious disabilities?

Case Report: Beware the Silver Nitrate Stick--A Risk Factor for Bisphosphonate-Related Osteonecrosis of the Jaw (BRONJ).

Topical silver nitrate may be used in oral and maxillofacial clinical settings owing to its astringent, caustic and disinfectant properties. Uses of the toughened silver nitrate pencil stick include haemostasis at bleeding points and for the management of aphthous ulcers, hypergranulation tissue, warts and verrucas. We present an interesting case of apparent silver nitrate-induced, bisphosphonate-related osteonecrosis of the hard palate following mucosal lesion biopsy in a multiple myeloma patient receiving zoledronic acid intravenous infusions. Our review of the literature indicates that this is the first report of such a scenario. CPD/Clinical Relevance: Clinicians must consider all potential sources of chemical and mechanical trauma to the bone and overlying mucosa when managing patients at risk of developing bisphosphonate-related osteonecrosis of the jaw.

Working at the interface: lessons from a joined-up approach between oral medicine and paediatric dentistry.

Oral mucosal and other head and neck conditions in children have a variety of presentations. The joint oral medicine and paediatric (JOMP) dental clinic is a specialised unit within a London teaching hospital, developed to manage a wide range of oral conditions with an absolute commitment to a child-centred care approach. The authors present eight cases from the JOMP clinic experience at Guy's and St Thomas' NHS Foundation trust, over a nine-year period. Each case is unique in its presentation, diagnosis and bespoke management, tailored to the nuance of each individual patient and their unique position. The eight clinical cases demonstrate the success of the JOMP team in achieving good patient outcomes, in terms of providing accurate diagnoses for their oral conditions and for appropriately tailored management/ treatment. The cases also serve to raise awareness of some of the more unusual oral conditions affecting paediatric patients among our professional colleagues.

Impact of HIV pre-exposure prophylaxis (PREP) on health-related quality of life (QOL) of patients followed up at a reference center in São Paulo, Brazil.

BACKGROUND: HIV Pre-Exposure Pophylaxis (PrEP) is provided free of charge by the Brazilian national health system. Though effective in preventing HIV infection, little is known about its impact on the health-related Quality of Life (QoL) of users. OBJECTIVE: The present study aimed at assessing the impact of PrEP on the QoL of its users. METHODS: Prospective cohort study with 114 HIV-negative participants aged 18 years or older. Participants' QoL was assessed before starting PrEP and after 7 months of use, using the self-responsive WHOQOL-bref questionnaire. Sociodemographic and behavioral aspects were described and the Wilcoxon signed-rank test with p ≤ 0.05 was considered statistically significant. RESULTS: Improvement was seen in QoL scores for the environment domain (p = 0.02), which addresses feeling of physical safety, access to information and health services, and participation in leisure activities. Furthermore, participants reported improved satisfaction with their sex life, when questioned about the social relationships domain. There was no statistically significant change in the global QoL score, in the global health score, in the physical and psychological domains, nor in the total score for the social relationships domain. As for their socio-demographic profile, most participants were white and highly educated young cisgender men who have sex with men. 76.3% had unprotected sex in the 3 months before starting PrEP. 60.5% had reported substance use: marijuana (42.1%), club drugs (35.1%), and poppers (20.2%). CONCLUSIONS: This study unveiled that PrEP benefited our cohort beyond its effectiveness in preventing HIV infection, having improved environmental aspects of QoL and self-satisfaction with sex life.

Cultural Beliefs Regarding Breast Reconstruction in a Minority Group.

Background: The diagnosis and treatment of breast cancer can significantly affect a woman's health and well-being. Several studies have identified factors contributing to disparities in breast reconstruction among ethnic groups, but few have examined the experience of Hispanic women. Methods: Hispanic women who had undergone breast reconstruction were interviewed in retrospective focus groups. Data were collected to identify themes that affected decision-making regarding the type and timing of reconstruction. Results: Most participants chose to undergo reconstruction to regain normalcy and maintain their previous "feminine" appearance. Most (75%) received silicone breast implants, and 25% received autologous reconstruction. Safety was the most important consideration when choosing the type of reconstruction. All but 1 participant relied on a spouse or other family member for support during recovery. Although most found the experience overwhelming, they felt their community was supportive and encouraging throughout the process. Conclusions: Several themes underlying the decision to undergo reconstruction were identified, including maintaining femininity and choosing the safest procedure. Overall, participants described the experience as overwhelming but found support from community and family. These findings, which could be applied broadly to women regardless of ethnicity, can be used to improve communication between surgeon and patient throughout the reconstruction process.

The regulation of preimplantation genetic diagnosis: is there anything the United Kingdom can learn from the Australian experience?

The United Kingdom fertility regulator, the Human Fertilisation and Embryology Authority (HFEA), is set to be abolished and its functions transferred to the Care Quality Commission. Together with the Human Fertilisation and Embryology Act 1990 (UK), the HFEA has played a central role in the regulation of preimplantation genetic diagnosis (PGD) and human leukocyte antigen tissue typing (HLA typing). Australia, on the other hand, does not have a national regulatory body for assisted reproductive technologies, which are instead regulated by a series of national guidelines, State legislation and State regulators. Using PGD and HLA typing as a focal point, this article asks, is there anything the United Kingdom can learn from Australia?

Predictors of Opioid Consumption in Immediate, Implant-Based Breast Reconstruction.

BACKGROUND: Current rates of opioid prescribing have deleterious consequences on both patient and societal levels. This study aims to evaluate responsible opioid prescribing and predictors of opioid consumption in immediate implant-based breast reconstruction. METHODS: Patients undergoing consultation for immediate, implant-based breast reconstruction were enrolled in a prospective, cohort survey study. A survey was administered at the preoperative and postoperative appointment to collect data on pain expectations and opioid use. A medical record review was performed. RESULTS: Of 100 enrolled patients, 97 (97.0 percent) underwent surgery and 85 (85.0 percent) completed the postoperative survey. Preoperatively, 27 patients (27.0 percent) had a history of a chronic pain syndrome, 34 (34.0 percent) had a history of a mental health comorbidity, and nine (9.0 percent) had a history of active preoperative opioid use. A total of 85 tissue expander (87.6 percent) and 12 direct-to-implant (12.4 percent) reconstructions were completed. Patients were prescribed an average of 36.0 5-mg oxycodone tablets postoperatively. Patients reported consuming an average of 20.6 tablets, or 57.0 percent of the average prescription amount. The majority of patients (75.3 percent) reported taking an opioid less than once per day at the time of survey completion, and 24 patients (28.2 percent) reported that they did not use any opioids postoperatively. Preoperative opioid use (p = 0.004), inpatient opioid consumption (p < 0.0001), and patient-reported anxiety related to pain control (p < 0.05) were predictors of opioid consumption. CONCLUSIONS: Patients undergoing mastectomy and implant-based breast reconstruction are prescribed nearly twice as many opioid tablets as consumed, and one in three patients report not using any opioids postoperatively. Clinical factors may help guide prescribing practices. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Plastic Surgery for Women.

Plastic surgery is a broad field, including maxillofacial surgery, reconstruction after injuries, hand surgery, and skin flaps and grafts, but the most common procedures for women are liposuction and body contouring, breast surgery, and facial cosmetic procedures. Techniques of face and brow lifts, blepharoplasty, and rhinoplasty are discussed as well as botulinum toxin and filler injections, and laser and pulsed light techniques that may delay or eliminate the need for surgery. Comparison of the surgeries for breast reconstruction, reduction, augmentation, and mastopexy is discussed. New surgeries for enhancement of female genitalia are also examined.

Nonoperative management of epidural hematomas and subdural hematomas: is it safe in lesions measuring one centimeter or less?

BACKGROUND: Management of a patient with a closed head injury is based on neurologic status and computerized tomography scan results. We hypothesized that those patients with an epidural hematoma (EDH) or subdural hematoma (SDH) <1 cm in thickness could safely be treated nonoperatively. METHODS: We retrospectively reviewed charts of 204 consecutive patients with either an EDH or SDH. RESULTS: There were 122 lesions < or =1 cm and 82 lesions >1 cm. In the first group, 115 were managed nonoperatively, with 111 good outcomes (minimal deficit with a Rancho Los Amigos score [RLAS] > or =3), two poor outcomes (severely disabled with RLAS <3), and two deaths. Twenty-eight patients with lesions greater than 1 cm had concomitant cerebral edema (CE) with an 89% mortality rate. The mortality rate in this group without CE was 20%, demonstrating the presence of CE in this group may have adversely affected the mortality rate, regardless of intervention. CONCLUSIONS: This data suggests that EDH or SDH <1 cm thick can be safely managed nonoperatively unless there is concomitant CE.

The costs of reducing loss to follow-up in South African cervical cancer screening.

BACKGROUND: This study was designed to quantify the resources used in reestablishing contact with women who missed their scheduled cervical cancer screening visits and to assess the success of this effort in reducing loss to follow-up in a developing country setting. METHODS: Women were enrolled in this Cape Town, South Africa-based screening study between 2000 and 2003, and all had scheduled follow-up visits in 2003. Community health worker (CHW) time, vehicle use, maintenance, and depreciation were estimated from weekly logs and cost accounting systems. The percentage of women who attended their scheduled visit, those who attended after CHW contact(s), and those who never returned despite attempted contact(s) were determined. The number of CHW visits per woman was also estimated. RESULTS: 3,711 visits were scheduled in 2003. Of these, 2,321 (62.5%) occurred without CHW contact, 918 (24.8%) occurred after contact(s), and 472 (12.7%) did not occur despite contact(s). Loss to follow-up was reduced from 21% to 6%, 39% to 10%, and 50% to 24% for 6, 12, and 24-month visits. CHWs attempted 3,200 contacts in 530 trips. On average, 3 CHWs attempted to contact 6 participants over each 111 minute trip. The per-person cost (2003 Rand) for these activities was 12.75, 24.92, and 40.50 for 6, 12, and 24-month visits. CONCLUSION: CHW contact with women who missed scheduled visits increased their return rate. Cost-effectiveness analyses aimed at policy decisions about cervical cancer screening in developing countries should incorporate these findings.

Screen-and-treat approaches for cervical cancer prevention in low-resource settings: a randomized controlled trial.

CONTEXT: Non-cytology-based screen-and-treat approaches for cervical cancer prevention have been developed for low-resource settings, but few have directly addressed efficacy. OBJECTIVE: To determine the safety and efficacy of 2 screen-and-treat approaches for cervical cancer prevention that were designed to be more resource-appropriate than conventional cytology-based screening programs. DESIGN, SETTING, AND PATIENTS: Randomized clinical trial of 6555 nonpregnant women, aged 35 to 65 years, recruited through community outreach and conducted between June 2000 and December 2002 at ambulatory women's health clinics in Khayelitsha, South Africa. INTERVENTIONS: All patients were screened using human papillomavirus (HPV) DNA testing and visual inspection with acetic acid (VIA). Women were subsequently randomized to 1 of 3 groups: cryotherapy if she had a positive HPV DNA test result; cryotherapy if she had a positive VIA test result; or to delayed evaluation. MAIN OUTCOME MEASURES: Biopsy-confirmed high-grade cervical cancer precursor lesions and cancer at 6 and 12 months in the HPV DNA and VIA groups compared with the delayed evaluation (control) group; complications after cryotherapy. RESULTS: The prevalence of high-grade cervical intraepithelial neoplasia and cancer (CIN 2+) was significantly lower in the 2 screen-and-treat groups at 6 months after randomization than in the delayed evaluation group. At 6 months, CIN 2+ was diagnosed in 0.80% (95% confidence interval [CI], 0.40%-1.20%) of the women in the HPV DNA group and 2.23% (95% CI, 1.57%-2.89%) in the VIA group compared with 3.55% (95% CI, 2.71%-4.39%) in the delayed evaluation group (P<.001 and P = .02 for the HPV DNA and VIA groups, respectively). A subset of women underwent a second colposcopy 12 months after enrollment. At 12 months the cumulative detection of CIN 2+ among women in the HPV DNA group was 1.42% (95% CI, 0.88%-1.97%), 2.91% (95% CI, 2.12%-3.69%) in the VIA group, and 5.41% (95% CI, 4.32%-6.50%) in the delayed evaluation group. Although minor complaints, such as discharge and bleeding, were common after cryotherapy, major complications were rare. CONCLUSION: Both screen-and-treat approaches are safe and result in a lower prevalence of high-grade cervical cancer precursor lesions compared with delayed evaluation at both 6 and 12 months. Trial Registration http://clinicaltrials.gov Identifier: NCT00233727.

Unilateral parotid mass as an unusual presentation of lupus erythematosus profundus.

Unilateral parotid swelling or mass in the lupus erythematosus profundus person is a rare or under reported clinical scenario in existing literature. This is a case of a 49-year-old man with such presentation for whom medical management of the underlying condition led to the resolution of the swelling. Lupus erythematosus profundus must be considered as a differential diagnosis of unexplained parotid swelling to prevent incorrect diagnosis, unnecessary surgical intervention (eg, parotidectomy) and the morbidity that comes with it (eg, facial nerve weakness, Frey's syndrome etc).

Efeitos de um programa de exercícios em um adulto com acidente vascular encefálico após transplante cardíaco / Efectos de un programa de ejercicios en un adulto con accidente cerebrovascular después de trasplante cardíaco / Effects of an exercise program in an adult with stroke after cardiac transplantation

Introdução. O transplante do coração (TC) é a técnica de escolha para indivíduos com insuficiência cardíaca grave. Dentre as complicações relacionadas com a cirurgia está o acidente vascular encefálico (AVE), condição que torna o processo de reabilitação pós transplante ainda mais delicado. Relato de caso. Trata-se de uma voluntária de 38 anos com diagnóstico de AVE isquêmico após cirurgia de TC. Foi submetida a um programa de reabilitação cardíaco (PRC) por oito semanas, constituído por um protocolo de exercícios contendo três fases com atividades variadas. Teste de força muscular, capacidade de exercício, mobilidade funcional e questionários foram aplicados para avaliação das variáveis de desfecho. Resultados. Houve um aumento da força muscular isométrica dos flexores e extensores do joelho. Observouse uma redução no tempo para realizar o timed up and go. Melhora da capacidade funcional. Observou-se uma correlação linear entre a pressão arterial sistólica e o tempo de tratamento. No questionário de qualidade de vida WHOQOL-Bref, a voluntária apresentou um ganho em quase todos os domínios. No WHODAS 2.0 houve uma melhora da funcionalidade. Conclusão. Um protocolo específico de oito semanas direcionado à reabilitação de uma voluntária com sequelas de AVE após TC, foi de grande importância para melhora da capacidade de exercício, mobilidade, funcionalidade e melhora na qualidade de vida.

Introduction. Heart transplantation (HT) is the technique of choice for individuals with severe heart failure (HF). Among the complications related to surgery the stroke is a condition that makes the post-transplant rehabilitation process more delicate. Report case. A 38-year-old volunteer with a diagnosis of ischemic stroke after HT surgery. She was submitted to a cardiac rehabilitation program (CRP) for eight weeks, consisting of protocol containing three exercises phases with varied activities. Muscle strength test, exercise capacity, functional mobility and questionnaires were applied to evaluate the outcome variables. Results. There was an increase in the isometric muscle strength of the knee flexors and extensors. There was a reduction in time to perform Timed Up and Go test. Moreover, there was an improvement of the functional capacity. A linear correlation between systolic blood pressure and rehabilitation time was observed. In the WHOQOL-Bref quality of life questionnaire, the volunteer presented a gain in almost all domains. In WHODAS 2.0 there was an improvement in functionality. Conclusion. A specific 8-week protocol aimed at the rehabilitation of a volunteer with sequelae of stroke after CT for improvement of exercise capacity, mobility, functionality and improvement in quality of life was of great importance.

Introducción. El trasplante cardíaco (TC) es la técnica de elección para los pacientes con insuficiencia cardíaca grave. Entre las complicaciones relacionadas con la cirugía se encuentra el accidente cerebrovascular (ACV), una condición que produce al proceso de rehabilitación post-trasplante más delicado. Caso clínico. Se trata de una paciente de 38 años con un diagnóstico de ACV isquémico después de la cirugía TC. Se sometió a un programa de rehabilitación cardiaca (PRC) durante ocho semanas, que consiste en un protocolo de ejercicio que contiene tres etapas con diversas actividades. Prueba de fuerza muscular, capacidad de ejercicio, movilidad funcional y cuestionarios para evaluar las variables de interés. Resultados. Luego del PRC se produjo un aumento de la fuerza muscular isométrica de los flexores y extensores de la rodilla. Hubo una reducción en el tiempo para realizar la prueba timed up and go, mejoría de la capacidad funcional. Observándose una correlación lineal entre la presión arterial sistólica y el tiempo de tratamiento. En el cuestionario de calidad de vida WHOQOL-Bref, la paciente presentó una mejoría en casi todas las áreas. En el WHODAS 2.0 hubo una mejoría de la funcionalidad. Conclusión. Un protocolo específico de ocho semanas, destinadas a la rehabilitación de una paciente con secuelas de ACV después del TC, fue de gran importancia para mejorar la capacidad de ejercicio, la movilidad, la funcionalidad y una mejor calidad de vida.

Program spending to increase adherence: South African cervical cancer screening.

BACKGROUND: Adherence is crucial for public health program effectiveness, though the benefits of increasing adherence must ultimately be weighed against the associated costs. We sought to determine the relationship between investment in community health worker (CHW) home visits and increased attendance at cervical cancer screening appointments in Cape Town, South Africa. METHODOLOGY/PRINCIPAL FINDINGS: We conducted an observational study of 5,258 CHW home visits made in 2003-4 as part of a community-based screening program. We estimated the functional relationship between spending on these visits and increased appointment attendance (adherence). Increased adherence was noted after each subsequent CHW visit. The costs of making the CHW visits was based on resource use including both personnel time and vehicle-related expenses valued in 2004 Rand. The CHW program cost R194,018, with 1,576 additional appointments attended. Adherence increased from 74% to 90%; 55% to 87%; 48% to 77%; and 56% to 80% for 6-, 12-, 24-, and 36-month appointments. Average per-woman costs increased by R14-R47. The majority of this increase occurred with the first 2 CHW visits (90%, 83%, 74%, and 77%; additional cost: R12-R26). CONCLUSIONS/SIGNIFICANCE: We found that study data can be used for program planning, identifying spending levels that achieve adherence targets given budgetary constraints. The results, derived from a single disease program, are retrospective, and should be prospectively replicated.

Impact of utilizing p16INK4A immunohistochemistry on estimated performance of three cervical cancer screening tests.

The histopathological diagnosis of cervical intraepithelial neoplasia grade 2,3 (CIN 2,3) is subjective and prone to variability. In our study, we analyzed the impact of utilizing a biomarker (p16(INK4A)) together with histopathology to refine the "gold standard" utilized for evaluating the performance of 3 different cervical cancer screening tests: cervical cytology, human papillomavirus (HPV) DNA testing and visual inspection with acetic acid (VIA). Cervical biopsies from 2 South African cervical cancer screening studies originally diagnosed by a single pathologist were reevaluated by a second pathologist and a consensus pathology diagnosis obtained. Immunohistochemical staining for p16(INK4A) was then performed. The estimated sensitivity of some cervical cancer screening tests was markedly impacted by the criteria utilized to define CIN 2,3. Use of routine histopathology markedly underestimated the sensitivity of both conventional cytology and HPV DNA testing compared to an improved gold standard of consensus pathology and p16(INK4A) positivity. In contrast, routine histopathology overestimated the sensitivity of VIA. Our results demonstrate that refining the diagnosis of CIN 2,3 through the use of consensus pathology and immunohistochemical staining for p16(INK4A) has an important impact on measurement of the performance of cervical cancer screening tests. The sensitivity of screening tests such as HPV DNA testing and conventional cytology may be underestimated when an imperfect gold standard (routine histopathology) is used. In contrast, the sensitivity of other tests, such as VIA, may be overestimated with an imperfect gold standard.