The disadvantage of robotic surgery is its higher costs related to purchase and maintenance of technology and its longer operating room time. However, emerging evidence shows that operating room time decreases with experience using the robot. From the HTA viewpoint, the result of this review is that the jury still is out on the HTA of da Vinci-assisted robotic surgery.
BackgroundMale involvement (MI) along the continuum of HIV healthcare services has been promoted as a critical intervention in low-income countries and represents one of the reasons for dropout and low retention of women along the cascade of care. The present review aims to identify interventions adopted to improve MI across Antenatal Clinics (ANCs).MethodsFor this systematic review, we searched electronic databases, including Scopus, PubMed, Web of Science (from 2008 to 2018) in English language. We included all interventions explicitly aimed at involving partners in pregnant women’s HIV continuum of care and we excluded studies performed in developed countries, not involving pregnant women. We followed the PRISMA checklist.ResultsWe identified a total of 1694 records and excluded 1651 after duplicates were removed and abstract eligibility assessments were performed. Forty-three full-text articles were screened, but only 12 studies were included. Recurrent intermediate outcomes were antenatal partner attendance rate and male HIV testing. We subdivided articles according to the type of intervention: single intervention (7) and multiple interventions (5). Among single interventions, two studies evaluated the use of an invitation letter sent via women to encourage male attendance to the ANC. Four Randomized Controlled Trials (RCTs) compared the invitation card (standard of care, SC) to word of mouth, information letter, home visit and invitation card plus partner tracing. The partner attendance rate was lower in SC than in the intervention arm in three RCTs: information letter (14.2% vs 16.2%), home-visit (39% vs 87%) and invitation card plus partner tracing (52% vs 74%). Home visit strategies seemed the most effective. One study evaluated words of encouragement adopted to trigger women to invite their partners.Among multiple interventions, the most effective strategies in terms of male attendance included health promotion through education and healthcare worker development. These interventions were more likely to be effective in promoting MI than single interventions.ConclusionsFrom the review emerges the importance of male involvement in HIV cascade for pregnant women in countries with a significant HIV incidence and the need to define more precise indicators for measuring MI.
Objective. Systemic lupus erythematosus (SLE) is treated with anti-inflammatory and immunosuppressive drugs and off-label biologics. Belimumab is the first biologic approved after 50 years as an add-on therapy for active disease. This paper summarizes a health technology assessment performed in Italy. Methods. SLE epidemiology and burden were assessed using the best published international and national evidences and efficacy and safety of belimumab were synthesized using clinical data. A cost-effectiveness analysis was performed by a lifetime microsimulation model comparing belimumab to standard of care (SoC). Organizational and ethical implications were discussed. Results. Literature review showed that SLE affects 47 per 100,000 people for a total of 28,500 patients in Italy, 50% of whom are affected by active form of the disease despite SoC. These patients, if autoantibodies and anti-dsDNA positive with low complement, are eligible for belimumab. SLE determines work disability and a 2–5-fold increase in mortality. Belimumab with SoC may prevent 4,742 flares in three years being cost-effective with an incremental cost-effectiveness ratio of €32,859 per quality adjusted life year gained. From the organizational perspective, the development of clear and comprehensive clinical pathways is crucial. Conclusions. The assessment supports the use of belimumab into the SLE treatment paradigm in Italy.
Rare diseases imply clinical and economic burden as well as a significant challenge for health systems. One relevant objective of the activities planned within the European Reference Network on Rare and Complex Connective Tissue and Musculoskeletal Diseases (ERN ReCONNET) is to address the economic dimensions of rare diseases to identify, develop and suggest strategies to improve research and patients’ access to orphan drugs (ODs) and highly specialised health technologies. This paper presents a preliminary review of the existing policies on rare diseases in the countries of the Network members. It also introduces and discusses the theme of how to perform health economic evaluations of rare diseases and of existing or new treatments for rare diseases. To obtain a preliminary overview aiming at defining the state of the art of rare diseases policies and initiatives in ERN ReCONNET countries, we collected and analysed the rare diseases national plans of all the eight countries of the ERN ReCONNET participants. The preliminary overview that has been performed showed that in all the ERN ReCONNET countries are in place national plans for rare diseases; however, heterogeneity exists in the reimbursement of ODs, direct provision by the healthcare system, involvement of patients’ associations in decision making and implementation of clinical practice guidelines.
BackgroundTuberculosis (TB) represents the ninth leading cause of death worldwide. In 2016 are estimated 1.3 million TB deaths among HIV negative people and an additional 374,000 deaths among HIV positive people. In 2016 are estimated 1.4 million new cases of TB in people living with HIV (PLHIV), 74% of whom were living in Africa. In light of these data, the reduction of mortality caused by TB in PLHIV is strongly required specially in low-income countries as Mozambique. According to international guidelines, the initial TB screening in HIV+ patients should be done with the four symptoms screening (4SS: fever, current cough, night sweats and weight loss). The diagnostic test more used in resource-limited countries is smear microscopy (SMEAR). World Health Organization (WHO) recommended Lateral Flow urine LipoArabinoMannan assay (LF-LAM) in immunocompromised patients; in 2010 WHO endorsed the use of Xpert Mycobacterium Tuberculosis/Rifampicin (MTB/RIF) test for rapid TB diagnosis but the assay is not used as screening test in all HIV+ patients irrespectively of symptoms due to cost and logistical barriers. The paper aims to evaluate the cost-effectiveness of three screening protocols: standard (4SS and SMEAR in positive patients to 4SS); MTB/RIF; LF-LAM / MTB/RIF.MethodsWe developed a model to assess the cost-effectiveness of the MTB/RIF protocol versus the common standard and LF-LAM / MTB/RIF protocol. The model considered a sample of 1,000 HIV+ antiretroviral treatment naïve patients in Mozambique. We evaluated disability-adjusted life year (DALY) averted for each protocol, cost per DALY, and incremental cost-effectiveness ratio (ICER), over 1-year, assuming a national healthcare system perspective. The model considered the delayed diagnosis as the time elapsed between a false negative test and the diagnosis and treatment of TB. Additional health system organization delay is defined as the time interval between positive test and treatment initiation caused by a delay in the delivery of results due organization of services. We conducted a sensitivity analysis on more relevant variables.ResultsThe MTB/RIF protocol was cost-effective as compared to the standard protocol with an ICER of $56.54 per DALY saved. In a cohort of 1,000 patients MTB/RIF and LF-LAM / MTB/RIF protocol generated 1,281 and 1,254 DALY’s saved respectively, with a difference of 174 and 147 DALY respect to the standard protocol. The total cost of MTB/RIF protocol was lower ($92,263) than the standard ($147,226) and the LF-LAM / MTB/RIF ($113,196). Therefore, the cost per DALY saved including new infections due to delayed diagnosis with the standard protocol was $79.06, about 5 fold higher than MTB/RIF and LF-LAM / MTB/RIF protocols. The cost of additional TB infections due to delays in diagnosis plus health system delay seemed the more relevant costs. The low sensibility and sensitivity of the standard protocol led to a high number of false negatives, thus delayed TB diagnoses and treatment lead to the development of newly transmitted TB infectio...
Background According to the World Health Organization, in 2018, 37.9 million people were living with HIV globally. More than two-thirds were residing in sub-Saharan Africa, where the HIV prevalence in the adult population (aged 15-49 years) was 3.9%. This population included 1.3 million pregnant women, of whom 82% had received antiretroviral therapy (ART) for the prevention of HIV mother-to-child transmission. In these countries, one challenge is an insufficient level of treatment adherence, particularly in HIV-positive pregnant women. Among the causes, the lack of involvement from a male partner is a significant contributor to the problem. This issue has strongly emerged in Malawi, one of the countries with the highest HIV prevalence in the world: 9.2% of its adult population were living with HIV in 2018. Objective This study aims to assess 3 interventions that are aimed at improving ART adherence and retention among HIV-positive women through engagement with their male partners in 4 Malawian health care centers. Methods The prospective, controlled before-and-after study is conducted in 3 phases (total duration: 24 months): preintervention, intervention, and postintervention analyses. The number of selected clusters (clinical centers) is limited to 4: one for each intervention, plus a cluster where no intervention is performed (control arm). The interventions are as follows: opening the facility on one Saturday per month only for men, defined as a special day; testing peer-to-peer counseling among men, male champions; and providing a noneconomic incentive to all women who are accompanied by their partners to the facility, nudge. The primary outcome of the study is to evaluate the differences in retention in care and adherence to therapeutic protocols among women; the intermediate outcome is the assessment of differences in male involvement. The level of male involvement in the health of their partners (intermediate outcome) will be evaluated through a dedicated questionnaire administered at baseline and in the postintervention phase. Data will be collected at the clinical centers and stored in 2 electronic databases managed using 2 different types of software. Results The analysis of data collected in the 4 centers during the preintervention phase is ongoing, as enrollment ended on March 31, 2020. The total number of patients enrolled was 452 (Namandanje: 133; Kapeni: 78; Kapire: 75; and Balaka: 166). Meanwhile, several meetings have been conducted to organize the intervention phase. Conclusions The study will identify the best intervention that enhances the involvement of male partners in women’s health, using an approach that considers a broad spectrum of behaviors. An important aspect is the use of educational tools focused on messages, thereby initiating a reflective discussion of stereotypes and false beliefs related to the idea of masculinity present in the Malawian culture. International Registered Report Identifier (IRRID) DERR1-10.2196/19384
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