To minimize the potential impact of conflicts of interest on health recommendations, several health institutions may be reluctant to recruit academic physicians due to their potential close relationship with industry. The present study aimed at evaluating the influence of academic physicians (AP) on the “rate of deport” due to financial support in the national commission of the HAS assessing medical devices.

After the renewal of this commission in November 2015, introducing patients representatives and more academic physicians, two periods of 12 months immediately before and after that date have been compared regarding the rate of deport during the sessions. Deport were decided by the legal section of our institution one week before each meeting according to a complete analysis of potential financial conflict of interest related to the medical device assessed. Only members without significant financial conflicts were allowed to participate to the discussion and the vote. The assessment of potential conflict of interest of all members followed the same criteria during the two periods.

The number of physicians increased in the second period (nineteen versus twenty-three) with a significant higher rate of academic physicians (63 percent versus 82 percent, p = .001). The mean attendance of physicians was significantly lower during the second period (80 percent versus 65 percent, p = .03). During the two periods, the number of meetings (n = 22) was similar and the number of dossiers assessing new products was comparable (96 versus 104, p = .872). The decision to reimburse the medical devices was similar in the two periods (78 percent versus 73 percent, p = .681). The number of cases when physicians’ members were deported for conflict of interest was similar during the two periods (30 versus 28, p = .482) with not any increase among academic physicians.

This study showed that it is possible to recruit several academic physicians without major financial conflicts of interest providing that their status could alter their assiduity.

China, with the largest aging population which is fast increasing, faces great challenges. Increasingly, researchers are looking at the relationship between whole life conditions from birth to death and health status in old age using a life-course approach. Few researchers have paid attention to developing countries like China where early life conditions were worse than those in western countries in the early twentieth century. China has had a complex social and political history in the twentieth century. This study investigates trajectories of aging and the effects of childhood and adulthood Socioeconomic Status (SES) encompassing education, job and family condition, on oldest-elders physical health in China.

The data used in this study was from all seven waves (1998-2014) of the Chinese Longitudinal Healthy Longevity Survey and covered 6,483 respondents aged 80 to105 years in baseline. Measuring the limitation in activities of daily living represents physical health. Group-based trajectory modeling is used to identify groups of individuals with statistically similar developmental characteristics or trajectories. Multinomial logistic regression is used to compare the differences among trajectory groups.

Three-group models best fit the data for males and females. Along with increasing age, there was an increase in the limitation in activities of daily living. Some groups changed gradually, while others rose rapidly. Some childhood and adulthood socioeconomic status characteristics influenced trajectory-group membership. For both genders, group one and two had similar childhood socioeconomic status, while higher adulthood socioeconomic status like jobs were associated with less favorable health status. For group three of males suffering the hardest childhood in regard to education, had stable health status instead.

Diversity exists among aging procedure. Childhood and adulthood socioeconomic status influence health conditions of the oldest-elders in complex ways. Education is a remarkably positive factor significantly contributing to better health status.

Health technology assessment (HTA) bodies often rely heavily upon evidence from peer-review publications to inform their recommendations. Since journal editors attitudes likely influence the types of study designs that are accepted through the peer-review process and on to publication, journal editors serve as gatekeepers to translation of evidence, including real word evidence (RWE), into practice. Given past skepticism of RWE study designs, journal editors perceptions of and possible biases toward RWE are important to understand as they may impact dissemination and, therefore, uptake of research findings. The objective of this study was to examine current views of journal editors regarding the: (i) value of RWE studies and (ii) challenges editors face in managing, reviewing, and publishing RWE manuscripts.

Journal editors representing general medicine (GM), specialty medicine (SM), health policy/services research (HSR) were invited to participate in a telephone interview, a survey, and an in-person, roundtable discussion.

In total, seventy-nine journals were approached, resulting in: 15 interviews (GM = 2; SM = 5; HSR = 8), 17 survey responses (GM = 2; SM = 6; HSR = 9) and 8 roundtable participants. RWE was viewed favorably by interviewed editors (n = 15). Characteristics of high-quality RWE manuscripts included: research question novelty/relevance, rigorous methodology, alignment of data with question, and the extent data-source advantages are optimized. Similar manuscript review processes and challenges were voiced for RWE and other study designs. HSR editors were more likely than SM or GM editors to participate, potentially indicating these researchers are more comfortable or interested in RWE. A possible study limitation was that editors favorable toward RWE may have been more likley to participate.

Peer-review journal editors appear to have favorable views regarding RWE studies and can be accelerators to dissemination of RWE findings. However, they do report that studies and processes could be improved. One suggested improvement included a checklist for editors to speed rejections and improve communications with authors.

Our cardiovascular evaluation unit is mandated to evaluate transcatheter aortic valve implantation (TAVI) in the province of Québec. In 2012, it was recommended that only patients at too high risk for surgery receive TAVI. In partnership with our six hospital TAVI programs, we have measured indicators of structure, process and outcomes since 2013. We are collaborating with multidisciplinary clinical experts to update recommendations for optimal use. Herein, we present the evolving portrait of TAVI in Québec and identify priority issues.

Clinical data were collected and analyzed for all TAVI performed from 1 April 2013 to 31 March 2016. Regular site feedback was provided. A systematic review of recent guidelines and randomized trials facilitated the interpretation of “real world” results and formulation of provincial quality standards.

Provincial TAVI volume increased from 294 in 2013–14 to 340 in 2014–15, and to 360 in 2015–16. Patient age and sex distribution remained relatively constant over time (median age 83 years; 47 percent female). However, the median predicted risk of operative mortality (STS score) decreased in the latest period [6 percent (Interquartile Range, IQR: 4–9) versus 7 percent (IQR: 4–9) versus 4 percent (IQR: 3–7)], suggesting TAVI is increasingly being performed in lower-risk patients. Clinical documentation and processes of care generally improved. Thirty-day mortality decreased (6.1 percent versus 4.1 percent versus 2.8 percent). The literature review identified two central issues: TAVI futility in patients who are too sick and apparent non-inferiority of TAVI compared with surgical valve replacement in medium-risk patients.

Our province-wide TAVI evaluation indicates improving processes and outcomes. Patient selection remains the key in our universal healthcare system, with the need to minimize futile and costly therapy and offer TAVI to those most likely to benefit. Continued monitoring of clinical practice and newly-established quality standards, in close collaboration with clinical teams, remains essential to promote optimal use of this evolving technology.

A conventional approach to communicating value is to model the budget impact of a medicine and the associated formulations in which it is available to be prescribed. However, such an approach does not demonstrate the actual realization of the proposed impact. This abstract outlines an approach to presenting retrospective data back to healthcare professionals (HCP) that blends assumptions and real-world data. For illustrative purposes, we present the results of an application of the model for subcutaneously delivered trastuzumab in an anonymized trust in Yorkshire and Humber.

The authors developed a model that examined one calendar year (from April 2014) of redistributed sales data for both the intravenous and subcutaneous formulations of trastuzumab for every National Health Service (NHS) trust in England. A series of baseline assumptions (1) were used to model the resource impact of different formulations such as chair time, HCP time, pharmacy preparation time, consumables, wastage, and other considerations. Impacts were estimated at the individual attendance level and scaled to the caseload. These baseline assumptions could then be overwritten by the individual trust using local data.

The site delivered approximately 985 doses of subcutaneous trastuzumab over a period of 12 months from April 2014, which represented about 76 percent of the total number of doses delivered. Chair time is estimated to have reduced by 22 minutes per attendance, resulting in a total saving of 361hours. HCP administration time is estimated to have reduced by 23 minutes per attendance, resulting in a total saving of 378 hours based on changing 985 IV doses to SC therapy.

Blending real data and assumptions to provide a retrospective assessment of actual benefits realized back to HCPs is a powerful tool for demonstrating real-world value at both an individual trust and system level.

Reimbursement decisions are usually based on evidence from randomized controlled trials (RCT) with high internal validity but lower external validity. Real-World Data (RWD) may provide complimentary evidence for relative effectiveness assessments (REA's) and cost-effectiveness assessments (CEA's) of treatments. This study explores to which extent RWD is incorporated in REA's and CEA's of drugs used to treat metastatic melanoma (MM) by five Health Technology Assessment (HTA) agencies.

Dossiers for MM drugs published between 1 January 2011 and 31 December 2016 were retrieved for HTA agencies in five countries: the United Kingdom (NICE), Scotland (SMC), France (HAS), Germany (IQWiG) and the Netherlands (ZIN). A standardized data-extraction form was used to extract data on RWD mentioned in the assessment and its impact on appraisal (for example, positive, negative, neutral or unknown) for both REA and CEA.

In total, fourty-nine dossiers were retrieved: NICE = 10, SMC = 13, IQWiG = 16, HAS = 8 and ZIN = 2. Nine dossiers (18.4 percent) included RWD in REA's for several parameters: to describe effectiveness (n = 5) and/or the safety (n = 2) of the drug, and/or the prevalence of MM (n = 4). CEA's were included in 25/49 dossiers (IQWiG and HAS did not perform CEA's). Of the twenty-five CEA's, twenty (80 percent) included RWD to extrapolate long-term effectiveness (n = 19), and/or identify costs associated with treatments (n = 7). When RWD was included in REA's (n = 9), its impact on the appraisal was negative (n = 4), neutral (n = 2), unknown (n = 1) or was not discussed in the appraisal (n = 2). When RWD was included in CEA's (n = 11), its impact on the appraisal varied between positive (n = 2), negative (n = 5) and unknown (n = 4).

Generally, RWD is more often included in CEA's than REA's (80 percent versus 18.4 percent, respectively). When included, RWD was mostly used to describe the effectiveness of the drug (REA) or to predict long-term effectiveness (CEA). The impact of RWD on the appraisal varied greatly within both REA's and CEA's.

Our purpose is to present the potential for health technology assessment that arthroplasty registers may offer.

A revision of the health assessment uses and information collected by arthroplasty registers was made. The information provided from international networks like NORE, ISAR and ICOR was also considered. Arthroplasty registers collect data of patients undergoing joint replacement surgery (mainly hip and knee) along with implant information. They provide longitudinal information useful to assess implant survival (expressed as revision rate and calculated from the primary surgery to implant revision). They also data from the surgical procedure and, more recently, a number of registries incorporate patient reported outcomes (PROMs) information.

Arthroplasty registers provide information from multiple perspectives:

1. (i) Decision-makers and healthcare providers/authorities: the comparison of revision rates by using funnel plots is a useful methodology to benchmark implants and to identify outliers, or models with significantly different revision rate in comparison to their peers. Besides, data available in registers has proven to be useful to define sets of indicators related to safety, effectiveness, efficiency, patient-centered healthcare and perceived health outcomes.

2. (ii) Surgeons: Some ongoing initiatives, like ODEP, aiming at providing a benchmark rating for implant survivorship, are gaining interest by professionals promoting an evidence-based clinical practice.

3. (iii) Industry: the large amount of data recorded so far may allow obtaining robust information of prosthesis behavior.

4. (iv) Patients: there is an increasing number of registers that incorporate PROMs. Moreover, a growing interest to promote patient engagement in arthroplasty decision making has been observed.

Long-standing arthroplasty registries have untapped potential. Beyond the assessment of implant survival, they have been consolidated as a useful tool for decision-makers, professionals, and patients. Next steps will be to promote joint analysis of national/regional registries to explore uncommon practices or new medical devices, and also to adapt to future regulations on implant traceability.

A high degree of geographic variation in the use of medical interventions is usually considered as a sign for inappropriate use. However, the plain geographic variation has the disadvantage that the variation might also be appropriate due to differences in the regions. Hence, we conducted a more comprehensive analysis on Magnetic Resonance Imaging (MRI) use and the relationship to hip or knee replacements. We evaluated whether there is evidence that guideline recommendations regarding hip replacements and total knee replacements are being followed. Additionally, we tried to assess whether the use of MRI is related to subsequent interventions.

We extracted recommendations of the American College of Radiology (ACR) on the use of MRI relevant to hip replacements and total knee replacements. Subsequently, we created three hypotheses on MRI for hip or total knee replacements on what to expect from the data when these recommendations are being followed.

For each hypothesis we calculated a multiple linear regression to analyze Organisation for Economic Co-operation and Development (OECD) data. This was necessary to control for other important variables that might have had an influence on the number of interventions despite the MRI use (for example, healthcare spending, or Computed Tomography (CT) use).

The initial results on (primary) hip replacement and secondary hip replacement were heavily influenced by outliers. After the exclusion of the outliers (Turkey and Belgium), (primary) hip replacements were related to MRI use but not secondary hip replacements. The results on MRI and (primary) hip replacement suggest that the relationship between MRI and hip replacement in Turkey is lower than in the other OECD nations.

Regarding knee replacements, we detected a relationship between the MRI use and total knee replacement. An increase of 10 MRI examinations per 1,000 population would, according to our model, result in 9.8 additional total knee replacements per 100,000 population.

The relationship of MRI and (primary) hip replacement hints to inappropriate use of MRI in Turkey since the data shows a substantial deviation in the relationship compared to the other OECD nations. Apart from this, we found no evidence for inappropriate use of MRI in connection with hip replacements.

However, our results suggest that MRI is inappropriately used in relation to total knee replacements. This might contribute to potentially unnecessary total knee replacements.

In 2015, 18.3 percent of the Austrian population were at risk of poverty and social exclusion - about 211,000 (20 percent) women aged 20–39 years were affected. International studies report that poverty may lead to an increased risk of complications and pathologies during pregnancy. Further, children who grow up in poverty often have poorer long-term health outcomes.

In order to identify recent guidelines (2011-2016) a comprehensive handsearch was conducted in the guideline databases National Guideline Clearinghouse (NGC) and Guidelines International Network (GIN). Moreover, a handsearch for systematic reviews and primary studies was conducted in PubMed.

Two guidelines, the British National Institute for Health and Clinical Excellence (NICE) Guideline “Pregnancy and Complex Social Factors”, as well as the Australian Health Ministers' Advisory Council (AHMAC) Guideline “Antenatal Care”, address socioeconomic disadvantages of women during antenatal care. The recommendation of the AHMAC is that pregnancy care should be offered to all pregnant women. In addition, an individual approach will help to pay particular attention to socioeconomic factors and to incorporate them in routine examinations. NICE recommends in its guideline, affected women should be supported in order to ensure adequate prenatal care. NICE also defines criteria which are used to identify pregnant women who are in greater need of support. The only identified study developed and tested a tool for the identification of patients affected by poverty. The authors of this Canadian pilot study concluded that the defined questions helped to identify socioeconomically disadvantaged persons during anamnesis without stigmatizing.

Due to the proven link between poverty and health risks, special attention must be paid to socioeconomically disadvantaged pregnant women. Research on non-stigmatizing instruments, which can identify vulnerable women, is of great importance. In addition to social policy measures, it is necessary to ensure that low-threshold services are available for socioeconomic disadvantaged women and their children.

A recent study claimed that increasing numbers of reviews are being published and many are poorly conducted and reported (1). The aim of the present study was to assess how well reporting standards in systematic reviews published in 2014 in the United Kingdom Health Technology Assessment (UK HTA) monograph series compared with the reporting in Cochrane and other “non-Cochrane” systematic reviews from the same year, as reported by Page et al. (1).

All relevant UK HTA programme systematic reviews published in 2014 were identified. After piloting of the form, two reviewers each extracted relevant data on conduct and reporting from these reviews. These data were compared with data for Cochrane and “non-Cochrane" systematic reviews from 2014, as published by Page et al. (1). All data were tabulated and summarized.

There were 30 UK HTA programme systematic reviews and 300 other systematic reviews, including Cochrane reviews (n = 45). Fewer UK HTA reviews covered therapeutic and pharmaceutical topics (53 percent and 20 percent respectively) than Cochrane (100 percent and 51 percent). The percentage of HTA reviews with required elements of conduct and reporting was frequently very similar to Cochrane and much higher than all other systematic reviews: for example, availability of protocols (90 percent, 98 percent and 16 percent respectively); the specification of study design criteria (100 percent, 100 percent, 79 percent); the reporting of outcomes (100 percent, 100 percent, 78 percent), quality assessment (100 percent, 100 percent, 70 percent) and other processes; the searching of trial registries for unpublished data (70 percent, 62 percent, 19 percent); reporting of reasons for excluding studies (91 percent, 91 percent and 70 percent) and reporting of authors' conflicts of interest (100 percent, 100 percent, 87 percent). However, HTA reviews compare less favourably with Cochrane and other reviews in the assessment of publication bias and reporting overall numbers of patients in the review.

UK HTA systematic reviews are often produced within a specific policy-making context and cover a greater variety of topics than Cochrane reviews. This has implications for timelines, tools and resources. However, they still tend to present standards of conduct and reporting equivalent to “gold standard” Cochrane reviews and are superior to systematic reviews more generally.

Hyperhidrosis is characterized by uncontrollable excessive sweating, which occurs at rest, regardless of temperature, and can significantly affect quality of life. There is substantial variation in the availability of treatments in secondary care and uncertainty regarding optimal patient management. A systematic review was undertaken to assess the clinical effectiveness of treatments prescribed by dermatologists (iontophoresis, anticholinergic medications, botulinum toxin injections) and minor surgical treatments (curettage and newer energy based technologies) for primary hyperhidrosis and identify areas for further research.

Fifteen databases and trial registers were searched to July 2016. Pairwise meta-analyses were conducted for comparisons between botulinum toxin injections and placebo for axillary hyperhidrosis. For other treatments data were synthesised narratively due to limited and heterogeneous data.

Fifty studies were included in the review; thirty-two randomized controlled trials (RCTs), seventeen non-RCTs and one case series. There was substantial variation between the studies in terms of country of origin (indicating climate and population differences), interventions and methods of outcome assessment. Most studies were small, at high risk of bias and poorly reported. There was moderate quality evidence of a large statistically significant effect of botulinum toxin injections on axillary hyperhidrosis symptoms in the short to medium term (up to 16 weeks), compared with placebo. There was weak but consistent evidence for iontophoresis for palmar hyperhidrosis. Evidence for other interventions was low or very low quality. Combining the evidence and patient advisor input, we established that further research on the clinical and cost-effectiveness of botulinum toxin injections (with anesthesia) versus iontophoresis for palmar hyperhidrosis would be useful.

The evidence for the effectiveness and safety of treatments for primary hyperhidrosis is limited overall and few firm conclusions can be drawn. However, there is moderate quality evidence to support the use of botulinum toxin injections for axillary hyperhidrosis. A trial comparing botulinum toxin injections with iontophoresis for palmar hyperhidrosis is warranted.

Over the past decades, early awareness and alert (EAA) activities and systems have gained importance and become a key early Health Technology Assessment (HTA) tool. While a pioneer in HTA, Sweden had no national level EAA activities until recently. We describe the evolution and current status of the Swedish EAA System.

This was a historical analysis based on the knowledge and experience of the authors supplemented by a targeted review of published and grey literature, as well as documents produced by or relating to the Swedish EAA System. Key milestones and a description of the current state of the Swedish EAA System are presented.

Initiatives to establish a system for the identification and assessment of emerging health technologies in Sweden date back to the 1980s. Since the 1990s, the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) supported the development of EuroScan and was one of its founding members. In the mid-2000s, an independent regional initiative, driven by the Stockholm Drug and Therapeutics Committee, resulted in the establishment of a regional horizon scanning unit. By 2009, this work had expanded to a collaboration between the four biggest regions in Sweden. The following year it was further expanded to the national level. Today, the Swedish EAA System carries out identification, filtration and prioritization of new drugs, early assessment of the prioritized drugs, and dissemination of the information. Its outputs are used to select new drugs for inclusion in the Swedish national process for managed introduction and follow-up.

The Swedish EAA System started as a regional initiative and rapidly grew to become a national level activity. An important feature of the system today is its complete integration into the national process for managed introduction and follow-up of new drugs. The system will continue to evolve as a response both to the changing landscape of health innovations and to new policy initiatives at the regional, national and international levels.

The telediagnostic systems can achieve relevant epidemiological information from local community needs to global countrywide opportunities. In this context the telemedicine applications should be directed to gain the prevalence of pathologies towards developing better equity in the provision of services (1), and greater concern for the effectiveness and usefulness of health technologies in remote locations without access to specialists (2). This study, has evaluated the results of a telemedicine system in remote public regional and district hospitals in Paraguay (3), in order to show the epidemiological trends in communities of a low income country.

This prospective study used the results of telemedicine for diagnosis in remote regional and district hospitals to evaluate a as tool to determine the prevalence of pathologies countrywide over three years (2014-16). For these purposes, type and frequency of pathology diagnosed was determined. Sampling was non-probabilistic of convenience.

A total of 182,406 telediagnoses were performed in 54 hospitals. The electrocardiography (ECG) diagnosis performed in the 52 hospitals were normal (62.1 percent), unspecified arrhythmias (12.5 percent), sinus bradycardia (10.4 percent), left ventricular hypertrophy (4.1 percent), sinus tachycardia (4.4 percent), right bundle branch block (3.5 percent), ischemia (1.4 percent), atrial fibrillation (1.0 percent) and left bundle branch block (0.6 percent). Teletomography was performed in twelve hospitals, where 54.4 percent corresponded to skull as a consequence of accidents (motorcycles) and cerebrovascular diseases, 13.8 percent chest, 6.2 percent dorsal spine, 5.4 percent abdominal and the rest the other anatomical regions. Regarding electroencephalography (EEG), antecedents of seizure (54.3 percent), evolutionary control (14.0 percent), headache (11.5 percent), cognitive impairment (2.0 percent), attention deficit in children (learning) (2.0 percent), brain death (1.0 percent), abnormal movements (0.8 percent), and sleep disturbances (0.3 percent) were diagnosed. The nineteen ultrasound studies corresponded to prenatal controls.

Despite the results of the telediagnosis implemented in the public health system to determine the prevalence of pathologies countrywide, a widespread use-assessment should be analyzed before deciding a large diffusion as a tool for public health planning.

As of July 2016, funding from England's Cancer Drugs Fund (CDF) is dispensed based on the results of National Institute for Health and Care Excellence (NICE) technology appraisal guidances instead of independent CDF appraisals (1). NICE can recommend providing temporary CDF funding for drugs that have potential to demonstrate cost-effectiveness after further data collection (2). This analysis examines drugs considered for temporary CDF funding since the start of this new process in July 2016.

We collected all final NICE oncology technology appraisal guidances completed before the end of 2016 and noted whether each drug was considered for or awarded CDF funding and which factors impacted the decision to give or withhold CDF funding (3).

We identified twenty-one NICE oncology reviews completed between July 2016 and the end of 2016. Of these reviews, only one was recommended for temporary funding under the CDF because further data collection had the potential to significantly reduce incremental cost-effectiveness ratios (ICERs). Three further reviews were considered for temporary CDF funding but ultimately received negative decisions. In all three cases, NICE found no potential for further data collection to sufficiently improve ICERs. The evaluations also noted that the manufacturers either did not intend or did not have sufficient time to prepare a case for CDF funding.

NICE focused strongly on evidence maturity in making CDF funding decisions. The only drug recommended for CDF funding had immature trial data with uncertainties that could be resolved by further data collection. The three drugs that did not receive CDF funding had relatively mature evidence that would not be improved through further data collection. Timing was also an issue: two reviews specifically noted that the manufacturers had insufficient time to prepare strong cases for CDF funding. The CDF historically had significant budget issues, so NICE may be trying to be more judicious in allocating CDF funding.

The Spanish National Network (REDETS) is a group of eight agencies, units and services, depending on National and Regional Governments that coordinate their work within a common methodological framework, guided by the principles of mutual recognition and cooperation. The necessity of considering a Quality Management System has been detected and, consequently, a common tool for all the members needs to be developed. We describe in this study the process to achieve that goal.

Based on both a review of previous literature and the proposal for a self-evaluating tool, a group of experts from each agency through consensus have developed a tool for self-evaluation in Health Technology Assessment (HTA) agencies. Through the structure described in the handbook of the Andalusian Agency for Healthcare Quality (ACSA), each standard should have a statement or proposal that needs to also include evidence or good practices, and the corresponding evaluation questions. In separate workgroups, the definition of these proposals, evidence and evaluation questions were developed. One face-to-face meeting and two meetings via teleconference were necessary to achieve a final document with all the quality standards.

From a proposed structure of sixty-six standards, the titles, definitions, statements and evidence as well as good practices and evaluation questions were established in workgroups with consensus among all of the members (1 - 3). The final version of the self-assessment tool was composed of sixty-eight standards, grouped in twelve quality criteria structured in four dimensions: I Responsibility, II Clients and Stakeholders, III Production Process, and IV Resources.

Quality management requires an evaluation tool and this version, based on a systematic review and consensus, is a useful and practical instrument for developing a handbook by each member of REDETS. An online version of the tool is in process of development.

The socioeconomic burden of diseases is increasing in Africa. For instance in 2011, 70 percent of the world's human immunodeficiency virus (HIV) population resided in sub-Sahara Africa. There are also growing rates of Antimicrobial Resistance (AMR), which necessitates newer more expensive antibiotics adding to costs. There is also a growing burden of non-communicable diseases (NCDs), three out of four patients with hypertension currently live in low and middle income countries (LMICs), with prevalence rates up to 30 to 45 percent among adults in Africa. Alongside this, up to 70 percent of total healthcare expenditure is spent on medicines in LMICs; much of this out-of-pocket. Consequently, there is an urgent need to strengthen collaborative research to improve medicine use.

Summary of groups working together in Africa including the Medicines Utilisation Research in Africa (MURIA) group.

African Strategies for Health identifies and advocates best practices, as well as works with others to develop sustainable solutions. Pharmacology for Africa (PharfA) organises and promotes pharmacology on the African continent, including research in clinical pharmacology, alongside the International Union of Basic and Clinical Pharmacology (IUPHAR) sub-division. International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Africa co-ordinates activities from the different African country chapters. The South African Health Technology Assessment Society (SAHTAS) is a scientific and professional society for all those who produce, use, or encounter Health Technology Assessment (HTA) in Southern Africa, and the World Health Organization (WHO) International and Regional groups are improving antibiotic drug utilization capabilities in Africa. The MURIA group was established in 2015 (1). Ongoing collaborative research includes (i) initiatives to optimize antibiotic use; (ii) methods to enhance adherence to anti-infective prescribing guidance, (iii) approaches to improve adherence to HIV and NCDs; (iv) researching current anti-hypertensive utilization patterns and knowledge; (v) approaches to enhance Drugs and Therapeutic Committees (DTC) activities, and (vi) strengthening medicine utilization capabilities (2,3). These activities have already strengthened research ties across Africa.

A number of groups are already working across Africa to enhance appropriate medicine use, and should continue. Ongoing MURIA activities include antibiotic point-prevalence studies, ongoing research into infectious diseases, NCDs and DTCs including adherence as well as the third workshop and symposium in Namibia in 2017.

We aimed to identify the validity and robustness of effect estimates for serious rare adverse events in clinical study reports of antidepressant trials, across different meta-analysis methods for rare binary events data (1,2).

Four serious rare adverse events (all-cause mortality, suicidality, aggressive behaviour and akathisia) were meta-analyzed using different methods (3). The Yusuf-Peto odds ratio (OR), which ignores studies with no events in the treatment arms, was compared with the alternative approaches of generalized linear mixed models (GLMM), conditional logistic regression, a Bayesian approach using Markov Chain Monte Carlo (MCMC) and a beta-binomial regression model.

Though the estimates for the four outcomes did not change substantially across the different analysis methods, the Yusuf-Peto method underestimated the treatment harm and overstimated its precision, especially when the estimated odds ratio (OR) deviated greatly from 1. For example the OR for suicidality for children and adolescents was 2.39 (95 percent Confidence Interval, CI 1.32 to 4.33, using the Yusuf-Peto method), but increased to 2.64 (95 percent CI 1.33 to 5.26) using conditional logistic regression, to 2.69 (95 percent CI 1.19 to 6.09) using beta-binomial, to 2.73 (95 percent CI 1.37 to 5.42) using the GLMM and finally to 2.87 (95 percent CI 1.42 to 5.98) using the MCMC approach.

The method used for meta-analysis of rare events data influences the estimates obtained and the exclusion of double zero-event studies can give misleading results. To ensure reduction of bias and erroneous inferences, sensitivity analyses should be performed using different methods and we recommend that the Yusuf-Peto approach should no longer be used. Other methods, in particular the beta-binomial method that was shown to be superior, should be considered instead.

The aim of the study was to introduce ethnographic fieldwork (1), including participant-observation and ethnographic interviews. Ethnographic fieldwork is a robust research methodology to study patients experiences and perspectives and, therefore, particularly valuable for Health Technology Assessment (HTA). Conducting ethnographic fieldwork requires that the researcher joins the people under study where they live or work for a period of time to observe and experience their everyday life and grasp their point of view in relation to the assessment of a health technology.

The presentation focuses on ethnographic fieldwork with participant-observation and ethnographic interviews. In relation to HTA, fieldwork can be highly relevant in order to understand the social world of the patients, for instance how they perceive and act in relation to a health technology. Furthermore fieldnotes, considerations on the analytic process and the production of knowledge will be a focus in the presentation.

We argue, that a small fieldwork study based on participant-observation can do much more than just act as supplements to differents forms of interviews. We demonstrate that in the production of an HTA, patient knowledge should not depend on or prioritize one method like interviews or recorded talks. We show the importance of good fieldnotes in the process of analysis together with a discussion of the production of knowledge.

To explore patients perspectives is thus not to identify one ’true’ perspective through an individual interview. Patients perspectives and experiences are emerging, relational and shifting. Therefore, there is a need for enhancing methodological and epistemological reflections and discussions about future development of ethnographic fieldwork in relation to HTA and patient involvement. The potential use of ethnographic fieldwork including participant-observation and ethnographic interviews will be highly relevant in relation to the assessment of new screening procedures, tele-health solutions, and collaboration between different sectors such as hospitals, municipalities and general practice. Furthermore, ethnographic fieldwork would be of importance for exploring how technology is working in local settings.

Organizational aspects influence the behavior of healthcare professionals and managers, and may help to overcome the barriers in the implementation of new health technologies. However, the organizational domain is often under-represented or absent when Health Technology Assessment (HTA) reports are built. The objective of this study was to to explore the organizational assessment in HTA and build a new framework for applicative experience after the comparison with the European Network for HTA (EUnetHTA's) CoreModel 3.0.

A literature review was performed by extracting full HTA reports through INAHTA (International Network of Agencies for Health Technology Assessment) members websites, HTA agencies and snowball search, and the aspects relating to the organizational assessment were analyzed. A quantitative and qualitative analysis was performed on the retrieved reports and the results were compared with a framework of five domains and fifteen subdomains from EUnetHTA's CoreModel 3.0. A Multiple Correspondence Analysis was carried out in order to evaluate the power of CoreModel and identify new common domains to guide the organizational assessments in HTA reports.

The assessments of organizational issues in the reports were significantly heterogeneous and less common than inclusion of other classic assessments. When included, domains and subdomains of the CoreModel were not covered homogeneously by the organizational assessments (representation level varied from 19 percent to 62 percent). The statistical analysis performed on the current data and the subsequent clustering of items offered the possibility to develop a new methodology based on three new composite indicators.

This ongoing study analyzed the relevance of organizational assessments in current literature and the challenges of promoting an international approach to the matter. In this sense, according to the current state of the research, we proposed a new methodology to cover the most relevant aspects of organizational appraisal according to new, more homogeneous domains and a less context-oriented approach to encourage health professionals to perform organizational analysis and better fulfill the needs of future HTA research.

As part of the European Network for Health Technology Assessment (EUnetHTA) Joint Action 3, the National Institute for Health and Care Excellence (NICE) in collaboration with forty-nine Health Technology Assessment (HTA) agencies and payer organizations, is leading on research to gain a high level understanding of HTA processes across Europe. This will help to facilitate improved collaboration and use of EUnetHTA HTA reports and tools across member states and decrease the duplication of work.

To analyze the similarities and differences in HTA processes and decision making on the reimbursement of pharmaceuticals and medical devices across Europe.

National agencies involved in the HTA and reimbursement processes shared data on HTA and decision-making processes. Data provided was extracted into an excel workbook including information relating to pharmaceuticals, medical devices, inpatient and outpatient care and assessments that inform reimbursement, pricing and other processes.

Thirty-one countries provided fifty-eight sets of HTA process and procedural documents for both medical devices and pharmaceuticals. This information was translated into the workbook which consisted of eleven sections (general information, capacity, overview of the process, topic selection, assessment process, advice and decision making, legal and procedural issues, reassessment, stakeholders engagement, HTA information used and HTA information held).

The first stage of data analysis is a descriptive write up of existing processes from horizon scanning and topic selection up to decision making. The second stage is an analysis showing how collaboration and use of EUnetHTA outputs can be implemented into existing processes. An additional questionnaire will be developed to gain further understanding of EUnetHTA partners views on national engagement in the EUnetHTA procedures, implications of joint production, what EUnetHTA products are most valued and what mechanism might support better information sharing and more efficient use of HTA reports between jurisdictions.

The analysis of the above data will provide detailed information on how EUnetHTA products or HTA products from other jurisdictions could be introduced into HTA and reimbursement processes across member states and at what point could EUnetHTA partners best engage in joint and cooperative work.