A Study to Compare a CHW-Led Versus Physician-Led Intervention for Prostate Cancer Screening Decision-Making among Black Men.

Introduction: Prostate cancer is the second leading cause of cancer deaths among men in the United States and harms Black men disproportionately. Most US men are uninformed about many key facts important to make an informed decision about prostate cancer. Most experts agree that it is important for men to learn about these problems as early as possible in their lifetime. Objectives: To compare the effect of a community health worker (CHW)-led educational session with a physician-led educational session that counsels Black men about the risks and benefits of prostate-specific antigen (PSA) screening. Methods: One hundred eighteen Black men recruited in 8 community-based settings attended a prostate cancer screening education session led by either a CHW or a physician. Participants completed surveys before and after the session to assess knowledge, decisional conflict, and perceptions about the intervention. Both arms used a decision aid that explains the benefits, risks, and controversies of PSA screening and decision coaching. Results: There was no significant difference in decisional conflict change by group: 24.31 physician led versus 30.64 CHW led (P=.31). The CHW-led group showed significantly greater improvement on knowledge after intervention, change (SD): 2.6 (2.81) versus 5.1 (3.19), P<.001). However, those in the physician-led group were more likely to agree that the speaker knew a lot about PSA testing (P<.001) and were more likely to trust the speaker (P<.001). Conclusions: CHW-led interventions can effectively assist Black men with complex health decision-making in community-based settings. This approach may improve prostate cancer knowledge and equally minimize decisional conflict compared with a physician-led intervention.

Safety, effectiveness and costs of percutaneous mitral valve repair: A real-world prospective study.

AIMS: Percutaneous mitral valve leaflet repair is a treatment option for some people with severe mitral valve regurgitation for whom conventional mitral valve surgery is clinically inappropriate. This study aimed to determine the safety, efficacy, and costs of percutaneous mitral valve leaflet repair, using the MitraClip device in a UK setting. METHODS AND RESULTS: This was a prospective, single-armed registry with a follow-up of 2 years that reported a range of procedural, clinical and patient-orientated outcomes. Registry data were linked to routine data sources to allow for more comprehensive follow up concerning mortality and healthcare resource use. The registry received data for 199 mainly elective patients with mixed mitral regurgitation aetiology. A MitraClip device was implanted in 187 patients (94%), with a procedural success rate of 86%, with 8% of patients having a serious in-hospital adverse event (including 5% mortality). Percutaneous mitral valve leaflet repair reduced mitral regurgitation from 100% MR grade ≥ 3+ to 7% at discharge. There were corresponding improvements in New York Heart Association functional class, reducing from 92% (class ≥ 3) at baseline to 18% at 6 weeks. There were significant improvements in generic and disease specific quality of life indicators up to 2 years. The all-cause mortality rate was estimated to be 12.7% (95% CI 7.5 to 17.7%) at 1 year. Percutaneous mitral valve leaflet repair was associated with reduced hospital readmissions and potential cost-savings in post-procedural care. CONCLUSION: This study shows that percutaneous mitral valve leaflet repair using MitraClip is a relatively safe and effective treatment in patients unable to tolerate surgery and has the potential to reduce ongoing healthcare costs in the UK.

Balloon dilatation for paediatric airway stenosis: Evidence from the UK Airway Intervention Registry.

OBJECTIVES: To assess the safety and efficacy in routine clinical practice of balloon dilatation procedures in the treatment of paediatric airway stenosis. DESIGN: Observational data collection in prospective online research database. SETTING: Acute NHS Trusts with ENT department undertaking complex paediatric airway work. PARTICIPANTS: Children (<18) undergoing balloon dilatation treatment for airway stenosis. MAIN OUTCOME MEASURES: Airway diameter, complications, hospital resource usage. RESULTS: Fifty-nine patients had 133 balloon procedures during 128 visits to 10 hospitals. Sixty-nine (52%) of balloon procedures were conducted with a tracheostomy. Intra-operative Cotton-Myer grade decreased in 43 (57%). The mean pre-balloon subglottic diameter was 4.2 [95% CI: 3.8 to 4.5] mm, and its rate of increase was 0.8 [0.5 to 1.2] mm per year modelled on 30 patients' long-term data. As the primary treatment of stenosis, the procedural success rate of balloon dilatation (n = 52) was 65% (22% with tracheostomy, 88% without tracheostomy), and 71% as an adjunct to open reconstructive surgery (n = 7). In the 64 hospital visits where a balloon procedure was conducted with a tracheostomy in place, only one in-hospital complication (lower respiratory tract infection) occurred. For those without a tracheostomy in place, in-hospital complications occurred in seven of 64 balloon hospital visits, all related to ongoing or worsening stenosis. Six out-of-hospital complications were deemed related to ongoing or worsening stenosis following the procedure, and two complications were a combination of lower respiratory infection and ongoing or worsening stenosis. CONCLUSIONS: Balloon dilation increases the size of the airway intraoperatively and is associated with long-term increase in airway diameter. Safety outcomes mostly relate to ongoing or worsening stenosis and are more common in patients without a tracheostomy.

Acceptability and implementation challenges of smartphone-based training of community health nurses for visual inspection with acetic acid in Ghana: mHealth and cervical cancer screening.

OBJECTIVE: To explore acceptability and feasibility of smartphone-based training of low-level to mid-level health professionals in cervical cancer screening using visual inspection with acetic acid (VIA)/cervicography. DESIGN: In 2015, we applied a qualitative descriptive approach and conducted semi-structured interviews and focus groups to assess the perceptions and experiences of community health nurses (CHNs) (n=15) who performed smartphone-based VIA, patients undergoing VIA/cryotherapy (n=21) and nurse supervisor and the expert reviewer (n=2). SETTING: Community health centres (CHCs) in Accra, Ghana. RESULTS: The 3-month smartphone-based training and mentorship was perceived as an important and essential complementary process to further develop diagnostic and management competencies. Cervical imaging provided peer-to-peer learning opportunities, and helped better communicate the procedure to and gain trust of patients, provide targeted education, improve adherence and implement quality control. None of the patients had prior screening; they overwhelmingly accepted smartphone-based VIA, expressing no significant privacy issues. Neither group cited significant barriers to performing or receiving VIA at CHCs, the incorporation of smartphone imaging and mentorship via text messaging. CHNs were able to leverage their existing community relationships to address a lack of knowledge and misperceptions. Patients largely expressed decision-making autonomy regarding screening. Negative views and stigma were present but not significantly limiting, and the majority felt that screening strategies were acceptable and effective. CONCLUSIONS: Our findings suggest the overall acceptability of this approach from the perspectives of all stakeholders with important promises for smartphone-based VIA implementation. Larger-scale health services research could further provide important lessons for addressing this burden in low-income and middle-income countries.

Community-Based, Preclinical Patient Navigation for Colorectal Cancer Screening Among Older Black Men Recruited From Barbershops: The MISTER B Trial.

OBJECTIVES: To test the effectiveness of a preclinical, telephone-based patient navigation intervention to encourage colorectal cancer (CRC) screening among older Black men. METHODS: We conducted a 3-parallel-arm, randomized trial among 731 self-identified Black men recruited at barbershops between 2010 and 2013 in New York City. Participants had to be aged 50 years or older, not be up-to-date on CRC screening, have uncontrolled high blood pressure, and have a working telephone. We randomized participants to 1 of 3 groups: (1) patient navigation by a community health worker for CRC screening (PN), (2) motivational interviewing for blood pressure control by a trained counselor (MINT), or (3) both interventions (PLUS). We assessed CRC screening completion at 6-month follow-up. RESULTS: Intent-to-treat analysis revealed that participants in the navigation interventions were significantly more likely than those in the MINT-only group to be screened for CRC during the 6-month study period (17.5% of participants in PN, 17.8% in PLUS, 8.4% in MINT; P < .01). CONCLUSIONS: Telephone-based preclinical patient navigation has the potential to be effective for older Black men. Our results indicate the importance of community-based health interventions for improving health among minority men.

The XprESS Multi-Sinus Dilation System for the Treatment of Chronic Sinusitis: A NICE Medical Technology Guidance.

The XprESS multi-sinus dilation system (XprESS) is a minimally invasive alternative to functional endoscopic sinus surgery (FESS) used in the treatment of people with chronic or recurrent acute sinusitis refractory to medical treatment. The manufacturer of XprESS, Entellus Medical, claims the technology is as effective as FESS in improving quality of life and is associated with quicker recovery times and reduced costs. The Medical Technologies Advisory Committee (MTAC) at the National Institute for Health and Care Excellence (NICE) selected XprESS for evaluation. Nine trials published in 13 papers were correctly identified by the company as relevant to the decision problem, including one randomised controlled trial (REMODEL study). From this evidence, the company concluded that XprESS is as beneficial as FESS for a range of clinical endpoints. The External Assessment Centre (EAC) agreed with the company's conclusion in a subgroup of patients, but judged that the evidence did not generalise to patients within the NHS fully. The company constructed a de novo costing model. XprESS generated cost-savings of £1302 per patient compared with FESS. The EAC critiqued and updated the model's inputs, with differences in results driven by changes in assumptions on procedure duration, length of hospital stay and the proportion of procedures undertaken in an outpatient setting under local anaesthetic. Although cost-incurring in the base case, XprESS generated cost savings under certain scenarios. The MTAC reviewed the evidence and supported the case for adoption, issuing positive draft recommendations. After public consultation NICE published this as Medical Technologies Guidance 30.

Understanding Barriers and Facilitators to Breast and Cervical Cancer Screening among Muslim Women in New York City: Perspectives from Key Informants.

BACKGROUND: Muslims are one of the fastest growing religious groups in the US. However, little is known about their health disparities, and how their unique cultural, religious, and social beliefs and practices affect health behaviors and outcomes. Studies demonstrate Muslim women may have lower rates of breast and cervical cancer screening compared to the overall population. METHODS: The purpose of this study was to: 1) conduct key-informant interviews with Muslim community leaders in New York City (NYC), to understand contextual factors that impact Muslim women's beliefs and practices regarding breast and cervical cancer screening; and 2) inform the development and implementation of a research study on breast and cervical cancer screening among Muslims. Twelve key-informant interviews were conducted. The sample included imams, female religious leaders, physicians, community-based organization leaders, and social service representatives. The interview guide assessed: 1) unique healthcare barriers faced by Muslim women; 2) cultural and social considerations in conducting research; 3) potential strategies for increasing screening in this population; and 4) content and venues for culturally tailored programming and messaging. RESULTS: Key informants noted structure and culture as barriers and religion as a facilitator to breast and cervical cancer screening. Themes regarding the development of targeted health campaigns to increase screening included the importance of educational and in-language materials and messaging, and engaging mosques and religious leaders for dissemination. CONCLUSION: Although Muslim women face a number of barriers to screening, religious beliefs and support structures can be leveraged to facilitate screening and enhance the dissemination and promotion of screening.

mHealth to Train Community Health Nurses in Visual Inspection With Acetic Acid for Cervical Cancer Screening in Ghana.

OBJECTIVE: There is a shortage of trained health care personnel for cervical cancer screening in low-/middle-income countries. We evaluated the feasibility and limited efficacy of a smartphone-based training of community health nurses in visual inspection of the cervix under acetic acid (VIA). MATERIALS AND METHODS: During April to July 2015 in urban Ghana, we designed and developed a study to determine the feasibility and efficacy of an mHealth-supported training of community health nurses (CHNs, n = 15) to perform VIA and to use smartphone images to obtain expert feedback on their diagnoses within 24 hours and to improve VIA skills retention. The CHNs completed a 2-week on-site introductory training in VIA performance and interpretation, followed by an ongoing 3-month text messaging-supported VIA training by an expert VIA reviewer. RESULTS: Community health nurses screened 169 women at their respective community health centers while receiving real-time feedback from the reviewer. The total agreement rate between all VIA diagnoses made by all CHNs and the expert reviewer was 95%. The mean (SD) rate of agreement between each CHN and the expert reviewer was 89.6% (12.8%). The agreement rates for positive and negative cases were 61.5% and 98.0%, respectively. Cohen κ statistic was 0.67 (95% CI = 0.45-0.88). Around 7.7% of women tested VIA positive and received cryotherapy or further services. CONCLUSIONS: Our findings demonstrate the feasibility and efficacy of mHealth-supported VIA training of CHNs and have the potential to improve cervical cancer screening coverage in Ghana.

Factors Associated With Waiting Time for Breast Cancer Treatment in a Teaching Hospital in Ghana.

Background Breast cancer is the leading cause of cancer-related mortality among women in Ghana. Data are limited on the predictors of poor outcomes in breast cancer patients in low-income countries; however, prolonged waiting time has been implicated. Among breast cancer patients who received treatment at Korle Bu Teaching Hospital, this study evaluated duration and factors that influenced waiting time from first presentation to start of definitive treatment. Method We conducted a hospital-based retrospective study of 205 breast cancer patients starting definitive treatment at Korle Bu Teaching Hospital between May and December 2013. We used descriptive statistics to summarize patient characteristics. Mann-Whitney U and Kruskal-Wallis tests and Spearman rank correlation were performed to examine the patients, health system, and health worker factors associated with median waiting time. Poisson regression was used to examine the determinants of waiting time. Results The mean age of the patients was 51.1 ± 11.8 years. The median waiting time was 5 weeks. The determinants of waiting time were level of education, age, income, marital status, ethnicity, disease stage, health insurance status, study sites, time interval between when biopsy was requested and when results were received and receipt of adequate information from health workers. Conclusion A prolonged waiting time to treatment occurs for breast cancer patients in Ghana, particularly for older patients, those with minimal or no education, with lower income, single patients, those with late disease, those who are insured, and who did not receive adequate information from the health workers. Time to obtain biopsy reports should be shortened. Patients and providers need education on timely treatment to improve prognosis.

What proportions of focal liver lesions detected by unenhanced ultrasound are inconclusive?

In August 2012, the National Institute for Health and Care Excellence produced positive diagnostics guidance on the ultrasound contrast agent SonoVue®, but recommended further research involving an estimation of the proportion of unenhanced ultrasound scans reporting, but not characterising, focal liver lesions, particularly in cirrhotic livers. Patient records from the Radiology Information System of an acute hospital trust were progressively filtered based on categorical fields and keywords in the free text reports, to obtain ultrasound records including the liver that were appropriate for manual analysis. In total, 21,731 records referred from general practice or out-patient clinics were analysed. Patients described as having cirrhosis were analysed as a subgroup. After automatic exclusion of records considered likely to be negative, 5812 records were manually read and categorised as focal liver lesion inconclusive, benign or malignant. In the general practice cohort of 9175 records, 746 reported the presence of one or more focal liver lesions, with 18.4% (95% CI 15.7% to 21.3%) of these records mentioning an inconclusive focal liver lesion. In the out-patient cohort of 12,556 records, 1437 reported one or more focal liver lesions, and 29.4% (95% CI 26.9% to 32.0%) of these were inconclusive. Cirrhosis was reported in 10.8% of the out-patient scans that also reported a focal liver lesion, and 47.4% (95% CI 39.3% to 55.6%) of these scans had an inconclusive focal liver lesion, compared with 27.3% (95% CI 24.9% to 29.8%) that were inconclusive in non-cirrhotic livers (odds ratio 2.4; 95% CI 1.7 to 3.4). This retrospective study indicates that unenhanced ultrasound scans, in which a focal liver lesion is detected, are frequently inconclusive, with the probability of an inconclusive scan being greater in out-patient than general practice referrals. Inconclusive focal liver lesions were also reported in greater proportions of cirrhotic than non-cirrhotic livers. The results of this research will inform future updates of National Institute for Health and Care Excellence diagnostics guidance.

Identifying complications of interventional procedures from UK routine healthcare databases: a systematic search for methods using clinical codes.

BACKGROUND: Several authors have developed and applied methods to routine data sets to identify the nature and rate of complications following interventional procedures. But, to date, there has been no systematic search for such methods. The objective of this article was to find, classify and appraise published methods, based on analysis of clinical codes, which used routine healthcare databases in a United Kingdom setting to identify complications resulting from interventional procedures. METHODS: A literature search strategy was developed to identify published studies that referred, in the title or abstract, to the name or acronym of a known routine healthcare database and to complications from procedures or devices. The following data sources were searched in February and March 2013: Cochrane Methods Register, Conference Proceedings Citation Index - Science, Econlit, EMBASE, Health Management Information Consortium, Health Technology Assessment database, MathSciNet, MEDLINE, MEDLINE in-process, OAIster, OpenGrey, Science Citation Index Expanded and ScienceDirect. Of the eligible papers, those which reported methods using clinical coding were classified and summarised in tabular form using the following headings: routine healthcare database; medical speciality; method for identifying complications; length of follow-up; method of recording comorbidity. The benefits and limitations of each approach were assessed. RESULTS: From 3688 papers identified from the literature search, 44 reported the use of clinical codes to identify complications, from which four distinct methods were identified: 1) searching the index admission for specified clinical codes, 2) searching a sequence of admissions for specified clinical codes, 3) searching for specified clinical codes for complications from procedures and devices within the International Classification of Diseases 10th revision (ICD-10) coding scheme which is the methodology recommended by NHS Classification Service, and 4) conducting manual clinical review of diagnostic and procedure codes. CONCLUSIONS: The four distinct methods identifying complication from codified data offer great potential in generating new evidence on the quality and safety of new procedures using routine data. However the most robust method, using the methodology recommended by the NHS Classification Service, was the least frequently used, highlighting that much valuable observational data is being ignored.

Community-based settings and sampling strategies: implications for reducing racial health disparities among black men, New York City, 2010-2013.

INTRODUCTION: Rates of screening colonoscopies, an effective method of preventing colorectal cancer, have increased in New York City over the past decade, and racial disparities in screening have declined. However, vulnerable subsets of the population may not be reached by traditional surveillance and intervention efforts to improve colorectal cancer screening rates. METHODS: We compared rates of screening colonoscopies among black men aged 50 or older from a citywide random-digit-dial sample and a location-based sample focused on hard-to-reach populations to evaluate the representativeness of the random-digit-dial sample. The location-based sample (N = 5,568) was recruited from 2010 through 2013 from community-based organizations in New York City. Descriptive statistics were used to compare these data with data for all black men aged 50 or older from the 2011 cohort of the Community Health Survey (weighted, N = 334) and to compare rates by community-based setting. RESULTS: Significant differences in screening colonoscopy history were observed between the location-based and random-digit-dial samples (49.1% vs 62.8%, P < .001). We observed significant differences between participants with and without a working telephone among the location-based sample and between community-based settings. CONCLUSIONS: Vulnerable subsets of the population such as those with inconsistent telephone access are excluded from random-digit-dial samples. Practitioners and researchers should consider the target population of proposed interventions to address disparities, and whether the type of setting reaches those most in need of services.

Rationale and design of Faith-based Approaches in the Treatment of Hypertension (FAITH), a lifestyle intervention targeting blood pressure control among black church members.

BACKGROUND: Uncontrolled hypertension (HTN) is a significant public health problem among blacks in the United States. Despite the proven efficacy of therapeutic lifestyle change (TLC) on blood pressure (BP) reduction in clinical trials, few studies have examined their effectiveness in church-based settings-an influential institution for health promotion in black communities. METHODS: Using a cluster-randomized, 2-arm trial design, this study evaluates the effectiveness of a faith-based TLC intervention vs health education (HE) control on BP reduction among hypertensive black adults. The intervention is delivered by trained lay health advisors through group TLC sessions plus motivational interviewing in 32 black churches. Participants in the intervention group receive 11 weekly TLC sessions targeting weight loss, increasing physical activity, fruit, vegetable and low-fat dairy intake, and decreasing fat and sodium intake, plus 3 monthly individual motivational interviewing sessions. Participants in the control group attend 11 weekly classes on HTN and other health topics delivered by health care experts. The primary outcome is change in BP from baseline to 6 months. Secondary outcomes include level of physical activity, percent change in weight, and fruit and vegetable consumption at 6 months, and BP control at 9 months. CONCLUSION: If successful, this trial will provide an alternative and culturally appropriate model for HTN control through evidence-based lifestyle modification delivered in churches by lay health advisors.

A novel community-based study to address disparities in hypertension and colorectal cancer: a study protocol for a randomized control trial.

BACKGROUND: Black men have the greatest burden of premature death and disability from hypertension (HTN) in the United States, and the highest incidence and mortality from colorectal cancer (CRC). While several clinical trials have reported beneficial effects of lifestyle changes on blood pressure (BP) reduction, and improved CRC screening with patient navigation (PN), the effectiveness of these approaches in community-based settings remains understudied, particularly among Black men. METHODS/DESIGN: MISTER B is a two-parallel-arm randomized controlled trial that will compare the effect of a motivational interviewing tailored lifestyle intervention (MINT) versus a culturally targeted PN intervention on improvement of BP and CRC screening among black men aged ≥50 with uncontrolled HTN who are eligible for CRC screening. Approximately 480 self-identified black men will be randomly assigned to one of the two study conditions. This innovative research design allows each intervention to serve as the control for the other. Specifically, the MINT arm is the control condition for the PN arm, and vice-versa. This novel, simultaneous testing of two community-based interventions in a randomized fashion is an economical and yet rigorous strategy that also enhances the acceptability of the project. Participants will be recruited during scheduled screening events at barbershops in New York City. Trained research assistants will conduct the lifestyle intervention, while trained community health workers will deliver the PN intervention. The primary outcomes will be 1) within-patient change in systolic and diastolic BP from baseline to six months and 2) CRC screening rates at six months. DISCUSSION: This innovative study will provide a unique opportunity to test two interventions for two health disparities simultaneously in community-based settings. Our study is one of the first to test culturally targeted patient navigation for CRC screening among black men in barbershops. Thus, our study has the potential to improve the reach of hypertension control and cancer prevention efforts within a high-risk population that is under-represented in primary care settings. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01092078.