Is Health Literacy Associated With Surgical Outcomes? A Systematic Review.

INTRODUCTION: Low levels of health literacy have been shown to increase healthcare utilization and negatively affect health outcomes within medical specialties. However, the relationship of health literacy with clinical, patient-centered, and process-oriented surgical outcomes is not as well understood. MATERIALS AND METHODS: We sought to systematically review the current evidence base regarding the relationship between health literacy and a range of outcomes in patients experiencing surgical care. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we searched six databases and then identified and extracted data from 25 cross-sectional or cohort studies deemed eligible for a systematic review. RESULTS: Among included studies, strong evidence exists to support an association between low health literacy and worse patient-centered outcomes, as well as an association between low health literacy and poorer process-oriented surgical outcomes. However, the relationship between health literacy and clinical outcomes remains unclear. CONCLUSIONS: Substantial opportunities remain to improve our understanding of the impact of health literacy on surgical outcomes. Future work should expand the range of institutional and specialized surgical settings studied, implement a standardized set of validated health literacy assessment tools, include more diverse patient populations, and investigate a comprehensive range of patient-reported outcomes.

Incorporating patient-reported outcomes into shared decision-making in the management of patients with osteoarthritis of the knee: a hybrid effectiveness-implementation study protocol.

INTRODUCTION: Osteoarthritis (OA) is a major clinical and public health concern. The primary surgical treatment of knee OA is total knee replacement (TKR), a procedure that aims to alleviate pain and restore physical function. TKR is expensive, however, and based on professional guidelines, inappropriately performed in up to a third of patients. Patient-reported outcome measures (PROMs) help evaluate treatment options by quantifying health outcomes that matter to patients and can thus inform shared decision-making (SDM) between patients and health professionals. METHODS AND ANALYSIS: This is a US-based 2-year, two-site hybrid type 1 study to assess clinical effectiveness and implementation of a machine learning-based patient decision aid (PDA) integrating patient-reported outcomes and clinical variables to support SDM for patients with knee OA considering TKR. Substudy 1: At one study site, a randomised controlled trial is evaluating the clinical effectiveness of the PDA and SDM process on decision quality as measured after the baseline consultation and treatment choice measured 3 and 6 months after the baseline visit among 200 patients with knee OA. Substudy 2: At a second study site, a qualitative assessment using principles of behaviour design and intervention mapping is evaluating the feasibility and acceptability of the PROMs, PDA and SDM process by interviewing seven health professionals and 25 patients before and 25 patients after PDA implementation. ETHICS AND DISSEMINATION: Ethics approval has been obtained from The University of Texas at Austin Institutional Review Board (protocol number: 2018-11-0042). Informed consent will be obtained from all participants. Study results will be disseminated through conference presentations, publications and professional societies. TRIAL REGISTRATION NUMBER: NCT04805554.

Effect of a Question-Building Intervention on Patient Activation in Integrated Musculoskeletal Care.

Patient activation, the propensity for patients to engage in adaptive health behaviors, is a modifiable factor associated with health outcomes and treatment compliance. The authors evaluated the effect of a question-building intervention (QBI) on patient activation among patients with musculoskeletal symptoms and a low baseline level of activation. Patients seeking treatment for musculoskeletal pain were recruited at the beginning of their outpatient clinic appointment, and they completed the Patient Activation Measure 10-item version (PAM-10) and a demographic questionnaire. Those identified as low activating, based on the initial PAM-10 scores, completed a QBI protocol before their consultation with their provider. A follow-up PAM-10 survey was administered at the end of the visit. A paired sample Student's t test was used to evaluate preintervention and postintervention PAM-10 scores. Fisher's exact test and an unpaired t test were used to assess the association between demographic variables and achievement of minimal clinically important difference (MCID) for PAM-10. Of 194 patients who consented to participate, 60 were identified as low activating and completed the QBI. A paired Student's t test showed a statistically significant increase in mean PAM-10 scores from preintervention (47.3±7.4) to postintervention (54.8±16.8; P<.001). No statistically significant differences were shown in the likelihood of achieving MCID for PAM-10 scores for the sociodemographic variables that were tested. Low-activating patients may benefit from a simple question-formulating intervention before consultation with an orthopedic provider. [Orthopedics. 2021;44(5):e661-e667.].

Comparison of an Artificial Intelligence-Enabled Patient Decision Aid vs Educational Material on Decision Quality, Shared Decision-Making, Patient Experience, and Functional Outcomes in Adults With Knee Osteoarthritis: A Randomized Clinical Trial.

Importance: Decision aids can help inform appropriate selection of total knee replacement (TKR) for advanced knee osteoarthritis (OA). However, few decision aids combine patient education, preference assessment, and artificial intelligence (AI) using patient-reported outcome measurement data to generate personalized estimations of outcomes to augment shared decision-making (SDM). Objective: To assess the effect of an AI-enabled patient decision aid that includes education, preference assessment, and personalized outcome estimations (using patient-reported outcome measurements) on decision quality, patient experience, functional outcomes, and process-level outcomes among individuals with advanced knee OA considering TKR in comparison with education only. Design, Setting, and Participants: This randomized clinical trial at a single US academic orthopedic practice included 129 new adult patients presenting for OA-related knee pain from March 2019 to January 2020. Data were analyzed from April to May 2020. Intervention: Patients were randomized into a group that received a decision aid including patient education, preference assessment, and personalized outcome estimations (intervention group) or a group receiving educational material only (control group) alongside usual care. Main Outcomes and Measures: The primary outcome was decision quality, measured using the Knee OA Decision Quality Instrument (K-DQI). Secondary outcomes were collaborative decision-making (assessed using the CollaboRATE survey), patient satisfaction with consultation (using a numerical rating scale), Knee Injury and Osteoarthritis Outcome Score Joint Replacement (KOOS JR) score, consultation time, TKR rate, and treatment concordance. Results: A total of 69 patients in the intervention group (46 [67%] women) and 60 patients in the control group (37 [62%] women) were included in the analysis. The intervention group showed better decisional quality (K-DQI mean difference, 20.0%; SE, 3.02; 95% CI, 14.2%-26.1%; P < .001), collaborative decision-making (CollaboRATE, 8 of 69 [12%] vs 28 of 60 [47%] patients below median; P < .001), satisfaction (numerical rating scale, 9 of 65 [14%] vs 19 of 58 [33%] patients below median; P = .01), and improved functional outcomes at 4 to 6 months (mean [SE] KOOS JR, 4.9 [2.24] points higher in intervention group; 95% CI, 0.8-9.0 points; P = .02). The intervention did not significantly affect consultation time (mean [SE] difference, 2.23 [2.18] minutes; P = .31), TKR rates (16 of 69 [23%] vs 7 of 60 [12%] patients; P = .11), or treatment concordance (58 of 69 [84%] vs 44 of 60 [73%] patients; P = .19). Conclusions and Relevance: In this randomized clinical trial, an AI-enabled decision aid significantly improved decision quality, level of SDM, satisfaction, and physical limitations without significantly impacting consultation times, TKR rates, or treatment concordance in patients with knee OA considering TKR. Decision aids using a personalized, data-driven approach can enhance SDM in the management of knee OA. Trial Registration: ClinicalTrials.gov Identifier: NCT03956004.

Centers for Medicare & Medicaid Services' Comprehensive Care for Joint Replacement: The Present and Future for Orthopedic Surgeons.

The primary aim of this article is to describe the structure and challenges of Medicare and Medicaid reimbursement for a total hip or knee arthroplasty within the context of the Comprehensive Care for Joint Replacement model. The secondary aims are to identify potential challenges for reimbursement and solutions to overcome challenges for the orthopedic surgeon, and to describe and compare the current and projected reimbursement structures for total arthroplasty procedures. Final decisions on reimbursement for total arthroplasty as outlined by the Centers for Medicare & Medicaid Services are reviewed. The impact of these decisions and the effect of the Centers for Medicare & Medicaid Services' payment structure on reimbursement for surgeons and organizations and the effect on patient care are highlighted. [Orthopedics. 2017; 40(2):77-80.].

Health Utility of Early Hemiarthroplasty vs Delayed Total Hip Arthroplasty for Displaced Femoral Neck Fracture in Elderly Patients: A Markov Model.

BACKGROUND: Treatment for femoral neck fracture among patients aged 65 years or older varies, with many surgeons preferring hemiarthroplasty (HA) over total hip arthroplasty (THA). There is evidence that THA may lead to better functional outcomes, although it also carries greater risk of mortality and dislocation rates. METHODS: We created a Markov decision model to examine the expected health utility for older patients with femoral neck fracture treated with early HA (performed within 48 hours) vs delayed THA (performed after 48 hours). Model inputs were derived from the literature. Health utilities were derived from previously fit patients aged more than 60 years. Sensitivity analyses on mortality and dislocation rates were conducted to examine the effect of uncertainty in the model parameters. RESULTS: In the base case, the average cumulative utility over 2 years was 0.895 for HA and 0.994 for THA. In sensitivity analyses, THA was preferred over HA until THA 30-day and 1-year mortality rates were increased to 1.3× the base case rates. THA was preferred over HA until the health utility for HA reached 98% that of THA. THA remained the preferred strategy when increasing the cumulative incidence of dislocation among THA patients from a base case of 4.4% up to 26.1%. CONCLUSION: We found that delayed THA provides greater health utility than early HA for older patients with femoral neck fracture, despite the increased 30-day and 1-year mortality associated with delayed surgery. Future studies should examine the cost-effectiveness of THA for femoral neck fracture.

What Quality Metrics Is My Hospital Being Evaluated on and What Are the Consequences?

Quality, experience, and cost are important indicators of value to patients. However, stakeholders have yet to reach agreement on how to define quality and which measures should be used to assess quality. Measures that have been used to assess quality in health care include structural, process, patient experience, efficiency, and outcomes measures. Payers and other quality rating organizations use a combination of measures to rate or rank hospitals on the quality of care they provide. These ratings can be strictly informational or can be used to steer patients, for contracting between payers and providers, and more recently, for adjustments to reimbursements. Physicians and hospitals have a crucial role to play in the development of quality measures that are used to measure and improve value. Consensus on quality measures will facilitate meaningful comparisons across providers and insights that will enable improvements in the value of care we deliver to our patients.

InformedTogether: Usability Evaluation of a Web-Based Decision Aid to Facilitate Shared Advance Care Planning for Severe Chronic Obstructive Pulmonary Disease.

BACKGROUND: Advance care planning may help patients receive treatments that better align with their goals for care. We developed a Web-based decision aid called InformedTogether to facilitate shared advance care planning between chronic obstructive pulmonary disease (COPD) patients and their doctors. OBJECTIVE: Our objective was to assess the usability of the InformedTogether decision aid, including whether users could interact with the decision aid to engage in tasks required for shared decision making, whether users found the decision aid acceptable, and implications for redesign. METHODS: We conducted an observational study with 15 patients and 8 doctors at two ethnically and socioeconomically diverse outpatient clinics. Data included quantitative and qualitative observations of patients and doctors using the decision aid on tablet or laptop computers and data from semistructured interviews. Patients were shown the decision aid by a researcher acting as the doctor. Pulmonary doctors were observed using the decision aid independently and asked to think aloud (ie, verbalize their thoughts). A thematic analysis was implemented to explore key issues related to decision aid usability. RESULTS: Although patients and doctors found InformedTogether acceptable and would recommend that doctors use the decision aid with COPD patients, many patients had difficulty understanding the icon arrays that were used to communicate estimated prognoses and could not articulate the definitions of the two treatment choices-Full Code and Do Not Resuscitate (DNR). Minor usability problems regarding content, links, layout, and consistency were also identified and corresponding recommendations were outlined. In particular, participants suggested including more information about potential changes in quality of life resulting from the alternative advance directives. Some doctor participants thought the decision aid was too long and some thought it may cause nervousness among patients due to the topic area. CONCLUSIONS: A decision aid for shared advance care planning for severe COPD was found acceptable to most COPD patients and their doctors. However, many patient participants did not demonstrate understanding of the treatment options or prognostic estimates. Many participants endorsed the use of the decision aid between doctors and their patients with COPD, although they desired more information about quality of life. The design must optimize comprehensibility, including revising the presentation of statistical information in the icon array, and feasibility of integration into clinical workflow, including shortening the decision aid.

Understanding patients' and doctors' attitudes about shared decision making for advance care planning.

BACKGROUND: Although shared decision making (SDM) is the preferred model of making complex treatment decisions with patients, patients' and doctors' attitudes towards SDM for advance care planning are unknown. OBJECTIVE: We sought to: (i) gain general insights into the current practice of SDM and attitudes about patient involvement, and (ii) gain specific insights into experience with, and attitudes about, SDM for advance care planning. DESIGN: Qualitative analysis of face-to-face semi-structured interviews. SETTING AND PARTICIPANTS: Patients with chronic lung disease and their doctors at a New York City public hospital. RESULTS: Although patients described participation in decision making, many deferred the final decision to their doctors. Doctors indicated a preference for SDM but expressed barriers including perceived lack of patient understanding and lack of patient empowerment. With regard to end-of-life discussions, patients were generally open to having these discussions with their doctors, although their openness sometimes depended on the circumstance (i.e. end-of-life discussions may be more acceptable to patients for whom the chance of dying is high). Doctors reported engaging in end-of-life treatment decisions with their patients, although expressed the need for conversations to take place earlier, in advance of acute illness, and identified a lack of prognostic estimates as one barrier to engaging in this discussion. CONCLUSIONS: Doctors should explore their patients' attitudes regarding end-of-life discussions and preferences for decision-making styles. There is a need for tools such as decision aids which can empower patients to participate in decision making and can support doctors with prognostic estimates pertinent to individual patients.

Impact of interventions targeting unhealthy alcohol use in Kenya on HIV transmission and AIDS-related deaths.

BACKGROUND: HIV remains a major cause of preventable morbidity and mortality in Kenya. The effects of behaviors that accompany unhealthy alcohol consumption are a pervasive risk factor for HIV transmission and progression. Our objective was to estimate the portion of HIV infections attributable to unhealthy alcohol use and to evaluate the impact of hypothetical interventions directed at unhealthy alcohol use on HIV infections and deaths. METHODS: We estimated outcomes over a time horizon of 20 years using a computer simulation of the Kenyan population. This computer simulation integrates a compartmental model of HIV transmission with a mechanistic model of HIV progression that was previously validated in sub-Saharan Africa. Integration of the transmission and progression models allows simultaneous consideration of alcohol's effects on HIV transmission and progression (e.g., lowering antiretroviral adherence may increase transmission risk by elevating viral load, and may simultaneously increase progression by increasing the likelihood of AIDS). The simulation considers important aspects of heterogeneous sexual mixing patterns, including assortativeness of partners by age and activity level, age-discordant relationships, and high activity subgroups. Outcomes included number of new HIV infections, number of AIDS deaths, and infectivity (number of new infections per infected person per year). RESULTS: Our model estimated that the effects of behaviors accompanying unhealthy alcohol consumption are responsible for 13.0% of new HIV infections in Kenya. An alcohol intervention with effectiveness similar to that observed in a published randomized controlled trial of a cognitive-behavioral therapy-based intervention in Kenya (45% reduction in unhealthy alcohol consumption) could prevent nearly half of these infections, reducing their number by 69,858 and reducing AIDS deaths by 17,824 over 20 years. Estimates were sensitive to assumptions with respect to the magnitude of alcohol's underlying effects on condom use, antiretroviral therapy adherence, and sexually transmitted infection prevalence. CONCLUSIONS: A substantial number of new HIV infections in Kenya are attributable to unhealthy alcohol use. An alcohol intervention with the effectiveness observed in a published randomized controlled trial has the potential to reduce infections over 20 years by nearly 5% and avert nearly 18,000 deaths related to HIV.

How do different eligibility guidelines for antiretroviral therapy affect the cost-effectiveness of routine viral load testing in sub-Saharan Africa?

BACKGROUND: Increased eligibility guidelines of antiretroviral therapy (ART) may lead to greater routine viral load monitoring. However, in resource-constrained settings, the additional resources required by greater routine viral load monitoring may impair ability to comply with expanded eligibility guidelines for ART. OBJECTIVE: We use a published validated computer simulation of the HIV epidemic in East African countries (expanded to include transmission as well as disease progression) to evaluate the cost-effectiveness of routine viral load monitoring. METHODS: We explored alternative scenarios regarding cost, frequency, and switching threshold of routine viral load monitoring (including every 6 or every 12 months; and switching thresholds of 1000, or 10 000 copies/ml), as well as alternative scenarios regarding ART initiation (200, 350, 500  cells/µl, and no CD4 cell threshold). For each ART initiation strategy, we sought to identify the viral load monitoring strategy at which the incremental cost-effectiveness ratio (ICER) of more frequent routine viral load testing became more favorable than the ICER of more expansive ART eligibility. Cost inputs were based on data provided by the Academic Model Providing Access to Healthcare (AMPATH), and disease progression inputs were based on prior published work. We used a discount rate of 3%, a time horizon of 20 years, and a payer perspective. RESULTS: Across a wide range of scenarios, and even when considering the beneficial effect of virological monitoring at reducing HIV transmission, earlier ART initiation conferred far greater health benefits for resources spent than routine virological testing, with ICERs of approximately $1000 to $2000 for earlier ART initiation, versus ICERs of approximately $5000 to $25 000 for routine virological monitoring. ICERs of viral load testing were insensitive to the cost of the viral load test, because most of the costs originated from the downstream higher costs of later regimens. ICERs of viral load testing were very sensitive to the relative cost of second-line compared with first-line regimens, assuming favorable value when the costs of these regimens were equal. CONCLUSION: If all HIV patients are not yet treated with ART starting at 500  cells/µl and costs of second regimens remain substantially more expensive than first-line regimens, resources would buy more population health if they are spent on earlier ART rather than being spent on routine virological testing.

Identifying design considerations for a shared decision aid for use at the point of outpatient clinical care: An ethnographic study at an inner city clinic.

BACKGROUND AND OBJECTIVE: Computerized decision aids could facilitate shared decision-making at the point of outpatient clinical care. The objective of this study was to investigate whether a computerized shared decision aid would be feasible to implement in an inner-city clinic by evaluating the current practices in shared decision-making, clinicians' use of computers, patient and clinicians' attitudes and beliefs toward computerized decision aids, and the influence of time on shared decision-making. METHODS: Qualitative data analysis of observations and semi-structured interviews with patients and clinicians at an inner-city outpatient clinic. FINDINGS: The findings provided an exploratory look at the prevalence of shared decision-making and attitudes about health information technology and decision aids. A prominent barrier to clinicians engaging in shared decision-making was a lack of perceived patient understanding of medical information. Some patients preferred their clinicians make recommendations for them rather than engage in formal shared decision-making. Health information technology was an integral part of the clinic visit and welcomed by most clinicians and patients. Some patients expressed the desire to engage with health information technology such as viewing their medical information on the computer screen with their clinicians. All participants were receptive to the idea of a decision aid integrated within the clinic visit although some clinicians were concerned about the accuracy of prognostic estimates for complex medical problems. IMPLICATIONS: We identified several important considerations for the design and implementation of a computerized decision aid including opportunities to: bridge clinician-patient communication about medical information while taking into account individual patients' decision-making preferences, complement expert clinician judgment with prognostic estimates, take advantage of patient waiting times, and make tasks involved during the clinic visit more efficient. These findings should be incorporated into the design and implementation of a computerized shared decision aid at an inner-city hospital.

The cost-effectiveness of tuberculosis preventive therapy for HIV-infected individuals in southern India: a trial-based analysis.

BACKGROUND: Regimens for isoniazid-based preventive therapy (IPT) for tuberculosis (TB) in HIV-infected individuals have not been widely adopted given concerns regarding efficacy, adherence and drug resistance. Further, the cost-effectiveness of IPT has not been studied in India. METHODS: We used an HIV/TB model to project TB incidence, life expectancy, cost and incremental cost-effectiveness of six months of isoniazid plus ethambutol (6EH), thirty-six months of isoniazid (36H) and no IPT for HIV-infected patients in India. Model input parameters included a median CD4 count of 324 cells/mm(3), and a rate ratio of developing TB of 0.35 for 6EH and 0.22 for 36H at three years as compared to no IPT. Results of 6EH and 36H were also compared to six months of isoniazid (6H), three months of isoniazid plus rifampin (3RH) and three months of isoniazid plus rifapentine (3RPTH). RESULTS: Projected TB incidence decreased in the 6EH and 36H regimens by 51% and 62% respectively at three-year follow-up compared to no IPT. Without IPT, projected life expectancy was 136.1 months at a lifetime per person cost of $5,630. 6EH increased life expectancy by 0.8 months at an additional per person cost of $100 (incremental cost-effectiveness ratio (ICER) of $1,490/year of life saved (YLS)). 36H further increased life expectancy by 0.2 months with an additional per person cost of $55 (ICER of $3,120/YLS). The projected clinical impact of 6EH was comparable to 6H and 3RH; however when compared to these other options, 6EH was no longer cost-effective given the high cost of ethambutol. Results were sensitive to baseline CD4 count and adherence. CONCLUSIONS: Three, six and thirty-six-month regimens of isoniazid-based therapy are effective in preventing TB. Three months of isoniazid plus rifampin and six-months of isoniazid are similarly cost-effective in India, and should be considered part of HIV care.

Cost-effectiveness of HIV testing referral strategies among tuberculosis patients in India.

BACKGROUND: Indian guidelines recommend routine referral for HIV testing of all tuberculosis (TB) patients in the nine states with the highest HIV prevalence, and selective referral for testing elsewhere. We assessed the clinical impact and cost-effectiveness of alternative HIV testing referral strategies among TB patients in India. METHODS AND FINDINGS: We utilized a computer model of HIV and TB disease to project outcomes for patients with active TB in India. We compared life expectancy, cost, and cost-effectiveness for three HIV testing referral strategies: 1) selective referral for HIV testing of those with increased HIV risk, 2) routine referral of patients in the nine highest HIV prevalence states with selective referral elsewhere (current standard), and 3) routine referral of all patients for HIV testing. TB-related data were from the World Health Organization. HIV prevalence among TB patients was 9.0% in the highest prevalence states, 2.9% in the other states, and 4.9% overall. The selective referral strategy, beginning from age 33.50 years, had a projected discounted life expectancy of 16.88 years and a mean lifetime HIV/TB treatment cost of US$100. The current standard increased mean life expectancy to 16.90 years with additional per-person cost of US$10; the incremental cost-effectiveness ratio was US$650/year of life saved (YLS) compared to selective referral. Routine referral of all patients for HIV testing increased life expectancy to 16.91 years, with an incremental cost-effectiveness ratio of US$730/YLS compared to the current standard. For HIV-infected patients cured of TB, receiving antiretroviral therapy increased survival from 4.71 to 13.87 years. Results were most sensitive to the HIV prevalence and the cost of second-line antiretroviral therapy. CONCLUSIONS: Referral of all patients with active TB in India for HIV testing will be both effective and cost-effective. While effective implementation of this strategy would require investment, routine, voluntary HIV testing of TB patients in India should be recommended.

The "ART" of linkage: pre-treatment loss to care after HIV diagnosis at two PEPFAR sites in Durban, South Africa.

BACKGROUND: Although loss to follow-up after antiretroviral therapy (ART) initiation is increasingly recognized, little is known about pre-treatment losses to care (PTLC) after an initial positive HIV test. Our objective was to determine PTLC in newly identified HIV-infected individuals in South Africa. METHODOLOGY/PRINCIPAL FINDINGS: We assembled the South African Test, Identify and Link (STIAL) Cohort of persons presenting for HIV testing at two sites offering HIV and CD4 count testing and HIV care in Durban, South Africa. We defined PTLC as failure to have a CD4 count within 8 weeks of HIV diagnosis. We performed multivariate analysis to identify factors associated with PTLC. From November 2006 to May 2007, of 712 persons who underwent HIV testing and received their test result, 454 (64%) were HIV-positive. Of those, 206 (45%) had PTLC. Infected patients were significantly more likely to have PTLC if they lived > or = 10 kilometers from the testing center (RR = 1.37; 95% CI: 1.11-1.71), had a history of tuberculosis treatment (RR = 1.26; 95% CI: 1.00-1.58), or were referred for testing by a health care provider rather than self-referred (RR = 1.61; 95% CI: 1.22-2.13). Patients with one, two or three of these risks for PTLC were 1.88, 2.50 and 3.84 times more likely to have PTLC compared to those with no risk factors. CONCLUSIONS/SIGNIFICANCE: Nearly half of HIV-infected persons at two high prevalence sites in Durban, South Africa, failed to have CD4 counts following HIV diagnosis. These high rates of pre-treatment loss to care highlight the urgent need to improve rates of linkage to HIV care after an initial positive HIV test.

Who starts antiretroviral therapy in Durban, South Africa?... not everyone who should.

OBJECTIVE: To evaluate rates of antiretroviral therapy (ART) initiation within 12 months of a new HIV diagnosis in Durban, South Africa. DESIGN: Prospective observational cohort. METHODS: Adults (>or=18 years) were enrolled before HIV testing at two outpatient clinics into the South African Test, Identify and Link cohort. Both sites offer comprehensive HIV care. HIV test results, CD4 cell counts, dates of ART initiation and dates of death were collected from medical records and 12-month patient/family interviews were conducted. ART eligibility was defined as a CD4 cell count less than 200 cells/microl within 90 days of HIV diagnosis. The primary endpoint was ART initiation within 12 months for ART-eligible subjects. RESULTS: From November 2006 to October 2008, 1474 newly diagnosed HIV-infected outpatients were enrolled, 1012 (69%) of whom underwent CD4 cell count testing within 90 days. The median CD4 cell count was 159 cells/microl (interquartile range 65-299). Of those who underwent CD4 cell count testing, 538 (53%) were ART-eligible. Only 210 (39%) eligible enrollees were known to have initiated ART within 12 months. Among ART-eligible subjects, there were 108 known deaths; 82% occurred before ART initiation or with unknown ART initiation status. Men [rate ratio (RR) 1.3, 95% confidence interval (CI) 1.1-1.5] and subjects without an HIV-infected family member/friend (RR 1.3, 95% CI 1.1-1.7) were more likely not to start ART. CONCLUSION: Less than half of ART-eligible subjects started ART within 12 months. Substantial attrition and mortality follow HIV diagnosis before ART initiation in Durban, South Africa. Major efforts directed towards earlier HIV diagnosis, effective linkage to care and timely ART initiation are urgently needed.

Cost-effectiveness of preventing loss to follow-up in HIV treatment programs: a Côte d'Ivoire appraisal.

BACKGROUND: Data from HIV treatment programs in resource-limited settings show extensive rates of loss to follow-up (LTFU) ranging from 5% to 40% within 6 mo of antiretroviral therapy (ART) initiation. Our objective was to project the clinical impact and cost-effectiveness of interventions to prevent LTFU from HIV care in West Africa. METHODS AND FINDINGS: We used the Cost-Effectiveness of Preventing AIDS Complications (CEPAC) International model to project the clinical benefits and cost-effectiveness of LTFU-prevention programs from a payer perspective. These programs include components such as eliminating ART co-payments, eliminating charges to patients for opportunistic infection-related drugs, improving personnel training, and providing meals and reimbursing for transportation for participants. The efficacies and costs of these interventions were extensively varied in sensitivity analyses. We used World Health Organization criteria of <3x gross domestic product per capita (3x GDP per capita = US$2,823 for Côte d'Ivoire) as a plausible threshold for "cost-effectiveness." The main results are based on a reported 18% 1-y LTFU rate. With full retention in care, projected per-person discounted life expectancy starting from age 37 y was 144.7 mo (12.1 y). Survival losses from LTFU within 1 y of ART initiation ranged from 73.9 to 80.7 mo. The intervention costing US$22/person/year (e.g., eliminating ART co-payment) would be cost-effective with an efficacy of at least 12%. An intervention costing US$77/person/year (inclusive of all the components described above) would be cost-effective with an efficacy of at least 41%. CONCLUSIONS: Interventions that prevent LTFU in resource-limited settings would substantially improve survival and would be cost-effective by international criteria with efficacy of at least 12%-41%, depending on the cost of intervention, based on a reported 18% cumulative incidence of LTFU at 1 y after ART initiation. The commitment to start ART and treat HIV in these settings should include interventions to prevent LTFU.