Since the adoption of electronic health record (EHR) systems, which contain large volumes of aggregated longitudinal clinical data, promises a number of substantial benefits including better care, improved safety issues and decreased healthcare costs (1). It is also associated with significant costs and large technical and organizational impacts, therefore it is important to conduct comprehensive evaluations of healthcare delivery outcomes. The purpose of the study is to gather evidence on safety and overall effectiveness of EHR implementation in Bambino Gesù Children's Hospital (OPBG).

Decision-oriented HTA (DoHTA) method (2) was applied to assess the technology on clinical, technical, organizational, economic, legal, ethical and safety domains. It's a new implementation of the European Network for Health Technology Assessment (EUnetHTA) CoreModel integrated with the Analytic Hierarchy Process. It allows defining an evaluation structure represented by a hierarchical decision tree filled by indicators of technology's performances, each of which was given a weight proportional to the impact that this criterion provides to achieve the purpose of the decision problem; finally, the alternatives’ ranking was defined.

The multidisciplinary assessment took into consideration all of the aspects and recommendations about the benefits and disadvantages of EHR (3). The synthesis of scientific evidence integrated with results of the specific context analysis, resulted in the definition of components of the decisional hierarchy structure. In particular, EHR seems to offer many benefits in terms of safety and clinical effectiveness such as improved continuity and quality of care, and increased accessibility of the data. The implementation of EHR resulted in important organizational outcome such as EHR configuration, learning curve and training. For these reasons, the usability was the main technical characteristics of the technology taken into account. Finally, legal aspects on privacy and security of data, covered a key role in the assessment.

A thorough evaluation of the EHR before its implementation has permitted hospital's decision makers to choose knowingly.

Cataract surgery is one of the most frequent ophthalmological surgical procedures performed in children. However, clinical outcomes in younger patients are generally unpredictable. Currently, cataract surgery can be performed through the traditional phacoemulsification ultrasound probe or Femtosecond Laser (1). The aim of this study is to describe the application of Decision-oriented Health Technology Assessment (HTA) (DoHTA) to assess the femtosecond laser-assisted cataract surgery (FLACS) compared to conventional cataract surgery (CCS).

To evaluate safety, costs, organizational aspects, effectiveness and technical characteristics of FLACS compared with CCS, a DoHTA method was applied (2). DoHTA is a new implementation of the European Network For HTA (EUnetHTA) Core Model®, which integrates the Multi-Criteria Decision Analysis (MCDA) using the Analytic Hierarchy Process (AHP). All the relevant assessment aspects of FLACS are summarized in a hierarchical decision tree by means of Key Performance Indicators (KPI), subsequently weighted through pairwise comparisons. Lastly, FLACS and CCS were ranked against lowest indicators of decision tree.

The multidisciplinary assessment took into consideration all the aspects and recommendations about the benefits and disadvantages of FLACS compared to CCS. DoHTA results showed that FLACS surgery is safe and effective for pediatric patients. Furthermore, FLACS seems to overcome CCS with several important developments such as increased precision of anterior capsulotomy, reduced ultrasound power requirement during phacoemulsification, decreased collateral tissue damage, increased accuracy and consistency in surgical results as well as better visual outcomes. Notwithstanding such clinical improvements, FLACS is more expensive than its comparator.

The DoHTA results integrated the evidence from the scientific literature (which is still limited) with experts judgments. Indeed, although FLACS had the highest purchase price, DoHTA results showed that FL improves the quality of cataract surgery. Based on our results and taking into consideration the positive safety and clinical effectiveness features, we conclude that FLACS may be a good alternative to CCS.

This rapid review aimed to determine the effectiveness of Sustained Low Efficiency Dialysis (SLED) when compared to Continuous Renal Replacement Therapy (CRRT) and Continuous Veno-Venous Hemofiltration (CVVH) in the treatment of acute renal failure (ARF) with a view to implementing SLED in a tertiary hospital in 2014.

A rapid review was performed on the effect of SLED for patients with ARF compared with CRRT or CVVH. The outcomes of interest were mortality, hemodynamic stability, reduced utilization of intensive care unit (ICU) and cost-effectiveness. The search terms ("sustained low-efficiency dialysis[MESH]”) were used to search PubMed, the Cochrane Library, UK NHS Centre for Reviews and Dissemination databases and the US National Guidelines Clearinghouse for relevant articles until 2014.

Four observational and two randomized controlled trial (RCT) studies were found. The results showed that 90-day mortality, was similar between groups (SLED: 49.6 percent versus CVVH: 55.6 percent, p = .43). Hemodynamic stability did not differ between SLED and CVVH and between SLED and CRRT. Patients in the SLED group had significantly fewer days of mechanical ventilation (17.7 ± 19.4 versus 20.9 ± 19.8, p = .047) and fewer days in the ICU (19.6 ± 20.1 versus 23.7 ± 21.9, p = .04). Patients treated with SLED needed fewer blood transfusions (1,375 ± 2,573 ml versus 1,976 ± 3,316 ml, p = .02) and had a substantial reduction in nursing time (p < .001). The hospital weekly costs were CAD1,431 for SLED, CAD2,607 for CRRT with heparin, and CAD 3,089 for CRRT with citrate. Dialysis using SLED was associated with higher first post-dialysis mean arterial pressure (p = .003) than those treated with CVVH, which led to lower mortality.

The evidence suggests that SLED can be used as an alternative to CRRT, as the outcomes were similar. SLED provides solute removal equivalent to CRRT at significantly lower cost.

Iron Deficiency Anemia (IDA), a common cause of anemia in the world, is a frequently neglected disease that represents the main extraintestinal manifestation affecting patients with inflammatory bowel disease (IBD) (1). The release of new intravenous (IV) iron compounds represents a great opportunity for both physicians and patients, but the higher costs might hold back their optimal diffusion. A Health Technology Assessment (HTA) approach was used to provide insights on the sustainability of the IV iron formulations in a hospital setting, with a special focus on ferric carboxymaltose.

Epidemiology of IBD, as well as IDA associated with these conditions, was assessed with a systematic appraisal of the published literature. Data on efficacy and safety of IV iron formulations currently used in Italy were retrieved from the available medical electronic databases. A hospital based cost-analysis of the outpatient delivery of IV iron treatments was performed. Organizational and ethical implications were discussed.

The reported prevalence of anemia in patients with IBD varies markedly from 10 to 73 percent for Crohn's Disease and from 9 to 67 percent for Ulcerative Colitis. Although there are no studies on direct comparison of different IV iron preparations, the literature indicates good efficacy and safety profiles of these formulations. However, ferric carboxymaltose seemed to provide a better and faster correction of hemoglobin and serum ferritin levels in iron-deficient patients (2,3). Our analyses indicated that ferric carboxymaltose, in spite of a greater price, would have positive benefits for the hospital, in terms of reduced costs related to individual patient management, and for the patients themselves, by reducing the number of infusions and accesses to health facilities.

This hospital-based HTA reports an overall positive organizational, economic and ethical evaluation for the sustainable introduction of ferric carboxymaltose in the Italian outpatient setting.

Minimizing the delay between regulatory approval and Health Technology Assessment (HTA) recommendation is critical to ensure patients access to medicines of therapeutic value. The aim of this study was to evaluate the level of synchronization between the regulatory decision and HTA recommendation.

Data were collected from the public domain for new active substances that were first appraised by the HTA agency in Scotland (SMC - Scottish Medicines Consortium), France (HAS - Haute Autorité de Santé), Germany (IQWIG - Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen), Australia (PBAC - Pharmaceutical Benefits Advisory Committee) and Canada (CADTH - Canadian Agency for Drugs and Technologies), and that reached an outcome in 2014 and 2015. The year the product was approved by the European Medicines Agency (EMA), Australian Therapeutic Goods Administration (TGA) and Health Canada were also assessed.

In 2014 and 2015, fifty-one products with HTA recommendations were identified for SMC and IQWIG, forty-two for HAS, forty for PBAC and thirty-eight for CADTH.

Of the HTA agencies studied, CADTH had the lowest percentage of HTA recommendations occurring the same year as jurisdictional regulatory approval. Of the products with CADTH recommendations in 2014, only 7 percent were approved by Health Canada in the same year. By comparison, all of the products with PBAC recommendations in 2015 were approved by TGA in the same year.

For 2014 and 2015, comparing the percentage of HTA recommendations with the jurisdictional regulatory agency approval the same year showed 7 percent (2014) versus 29 percent (2015) for CADTH: 35 percent versus 37 percent for SMC: 35 percent versus 44 percent for HAS; 56 percent versus 57 percent for IQWIG; and 91 percent versus 100 percent for PBAC.

This study shows that the parallel submission mechanism to enable synchronizing HTA and regulatory decision making is effective in Australia, whilst there remains a synchronization disconnect in other countries; although this may be improving. The extent of decision timing disconnect, influence of company strategy and type of HTA outcome were also studied. This initial analysis suggests gaps between the timing of regulatory approval and HTA recommendation for HTA agencies outside of Australia.

Immunotherapies are a relatively new innovative class of drug that have garnered excitement in the fight against cancer. In 2011, the immunotherapy drug, ipilimumab, was approved. Since then, four additional drugs have gained approval. This analysis evaluates the initial reception of immunotherapies by Health Technology Assessment (HTA) agencies.

The Context Matters Data Model was used to evaluate the regulatory and HTA agency decisions surrounding the five approved immunotherapies through November 2016: atezolizumab, elotuzumab, ipilimumab, nivolumab, and pembrolizumab. Thirty-three labels from Australia, Canada, Europe, and the United States, and ninety-two assessments from Agenzia Italiana del Farmaco (AIFA), Gemeinsamer Bundesausschuss (Federal Joint Committee; G-BA), Haute Autorité de Santé (French National Authority for Health; HAS), Institute for Clinical and Economic Review (ICER), Institute for Quality and Efficiency in Health Care (IQWiG), National Institute for Health and Care Excellence (NICE), Pharmaceutical Benefits Advisory Committee (PBAC), pan-Canadian Oncology Drug Review (pCODR), and Scottish Medicines Consortium (SMC) were found. Using a sample t-test and a chi-squared test, reimbursement agencies’ decisions were evaluated, and the clinical and economic factors that went into these decisions were examined.

Of the evaluated reviews: sixty-four were for melanoma indications, fourteen were for non-small-cell lung cancer (NSCLC) indications, and seven were for kidney cancer indications. Many of the reviews did not reach any decision, but 75 percent of HTA decisions (n = 72; p = .0000) reached were positive. Elotuzumab, approved for multiple myeloma, received a positive decision from G-BA and a negative one from SMC. There was an association between different disease conditions or drugs and the rate of positive decisions.

For reviews that had clinical reasons for their decisions, 72.9 percent (n = 59; p = .0000) had positive clinical rationales that were associated with positive decisions (p = .000). Economic rationales for decisions were more mixed, with only 48.4 percent (n = 31; p = .0000) receiving positive decisions. Positive economic evaluations were also associated with positive decisions (p = .000). Atezolizumab, approved only in the United States at the time of this writing, has yet to be reviewed by any of the HTA agencies.

Immunotherapies are promising new options for the treatment of cancer. Thus far, reception by HTA agencies has generally been positive.

The Health system in Nigeria is structured into three tiers which include tertiary health care, secondary health care and primary health care (PHC). The latter forms the grassroots system of delivering basic health services to communities in both rural and urban centers. However PHC in Nigeria have been affected by poor service delivery. This has resulted in underuse of PHC due to the acceptance and utilization of health services delivered through this system. This research seek to bridge the gap of inequality, reaffirm that implementing PHC is a human right/duty and fosters patient and consumer involvement for economic, social and environmental sustainability of PHC.

A qualitative method of research was adopted using a participatory research model. The relative data was sourced secondarily from recent findings (July 2015) carried out in seventy-three primary health centers across Anambra State, Benue State, Kaduna State, Plateau State and Federal Capital Territory (FCT) of Nigeria. Issues that were examined included: client perspective and community involvement, status of available services, utilization and service delivery, and infrastructure and human resource capacities. The respondent of 294 client/service user population from interview were recorded and analyzed.

The assessment showed client dissatisfaction to services being provided. In most centers, National Primary Health Care Development Agency (NPHCDA) requirements like availability of basic functional equipment, well trained health workers, patient record system, and access to water and sanitation were not met. Most of the facilities visited reported to be disconnected from the health system due to supportive supervision.

Conclusively, the interest of the underserved Nigerian could be advocated for through local committees of consumer organizations. Their involvement will have an impact in PHC evaluation, policy making, and implementation of action plans aimed at improving PHC services.

Pigmented villonodular synovitis (PVNS) is a very rare, benign proliferative tumor affecting the inner lining of synovial joints and tendon sheets. Information on treatment needs of PVNS patients to inform drug development is currently scarce, hence we conducted qualitative research with patients using an online bulletin board (OBB) methodology to generate insights on objective and emotional aspects related to the medical journey and living with this disease.

OBB is an asynchronous, online qualitative market research tool that allows participants to comprehensively answer pre-defined questions in a comprehensive manner. Patients were recruited via physician referral and underwent screening questions to ensure eligibility for the study and willingness to participate. The discussion was moderated, structured, and allowed open answers and in response to other participants posts. Analysis was conducted using a combination of different qualitative analytical tools.

The patient OBB ran for 4 days with eleven participants (n = 3 Canada, n = 4 United Kingdom, n = 4 United States of America) aged 28–57 years, suffering from PVNS for 2–27 years. The key patient insights were: (i) pain is the primary factor, constituting a significant emotional and psychological burden; (ii) surgery (arthroscopy) does not get rid of PVNS, relapse rate was high in these patients; and (iii) PVNS has a big financial impact on patients, their families, and the healthcare system, due in particular to time off work/lost wages (patient & caretaker), for healthcare system it is repeat costs for surgeries/hospital stays plus other medical expenses. We also identified orthopedic specialists/surgeons are the physicians who predominantly manage PVNS at this point, as surgery is the only option.

This study shows the suitability of the OBB for uncovering qualitative patient insights to inform decision making and strategy in early pharmaceutical drug development. OBB lends itself very well to uncovering patient insights which might not be revealed in focus group or telephone interviews, particularly in a rare disease like this. PVNS patients are in need of a medical drug treatment which can reduce pain, relapses and provide an alternative to surgery, the current standard of care.

Healthcare organizations should assess the relevance of both existing and new practices. Involving patients in decisions regarding which health technologies and interventions should be prioritized could favor a better fit between strategic choices and patients needs.

Following a systematic review of existing multi-criteria decision support tools and a consultation with hospital clinicians and managers, a set of potentially relevant criteria was identified. A three-round modified Delphi study was then conducted among four groups (hospital managers, heads of department, clinicians, and patient representatives) in order to reach consensus on criteria that should be considered in the tool.

In total, seventy-four participants completed the third round of the Delphi study. Consensus was obtained on twelve criteria. There were some significant differences between groups in priority scores given to criteria. Patient representatives differed significantly from other groups on two criteria. Their ranking of the accessibility criteria was higher, and their ranking of the organizational aspect criteria was lower than for the other groups.

Patient representatives can be involved in the development of a multi-criteria decision support tool to identify, evaluate and prioritize high value-added health technologies and interventions in order to enhancing clinical appropriateness The fact that accessibility aspects were more important for patient representatives calls for specific attention to these criteria when prioritizing health technologies or interventions. Furthermore, we need to ensure that the decisions made regarding the relevance of these technologies and interventions also reflect patients’ preferences.

There is a lack of Health-Technology-Assessment (HTA) tools in pharmacy practice and the collection of real-world-evidence (RWE) in community pharmacy to populate longer-term-disease-progression-modelling (1). This project is looking at the development and application of a novel Patient-Reported-Outcome- Measure (PROM) in community pharmacy that can enable: the evaluation of the quality of care delivered from the patient perspective in terms of economic impact, patient health outcomes and ‘utilities’; the collection of RWE and evaluate long-term effect of care; to provide different stakeholders with unique evidence-based information that help formulate health policies in community pharmacy that are safe, effective, patient-focused and cost-effective, balancing access to innovation and cost containment.

Evidence from the Italian-Medicine-Use-Review (I-MUR) trial (2) showed that the I-MUR intervention provided by community pharmacists to asthma patients is effective, cost-saving and cost-effective (3). The trial allowed to model a framework (I-MUR-HTA) that would enable to routinely deliver the intervention, but also collect and analyse PROM data on its clinical-effectiveness, quality-of-life and cost-effectiveness. I-MUR-HTA was discussed within three expert-panel discussions including policy-makers, commissioners, academics, healthcare-professionals and patient-representatives in Italy, United Kingdom and Europe. Current plan include testing the use of the tool in the real world environment.

Evidence collected from the panel discussions confirmed that I-MUR-HTA evidence-based information is relevant to meet current National-Health-Care-System plans and this is what is needed to support the evaluation of innovative effective and cost-effective health policies and promote their implementation across nations. Current Italian law on pharmacy services provides the appropriate institutional framework to regulate the introduction of I-MUR-HTA across the territory. Its implementation is underway and a real-world pilot is planned to take place in Italy.

I-MUR-HTA appears to be an innovative tool to promote active patient involvement into policy-decision-making and pharmacy-service.

Understanding the current landscape of patient engagement across value decision-making bodies internationally is a critical first step toward improving the patient centricity of Health Technology Assessment (HTA). This study assessed: (i) Terms and definitions used; (ii) Patient engagement opportunities; (iii) Evidence of patient engagement.

A sample of country-specific HTA's (HTA; n = 6), professional organizations (PO; n = 4), and collaborations/independent organizations (CO; n = 3) was selected for representativeness. Information was gathered through: (i) targeted web search and (ii) emailing organizations directly. Definitions, HTA methods documents, and the three most recent evaluations were identified, abstracted, and compared. Data were collected between September-October 2016.

Numerous terms are used to describe patient engagement: patient input (HTA = 1, PO = 1), patient-group submitted information (HTA = 1), cooperation with patients/users (HTA = 1), public consultation (HTA = 1), patient perspectives (HTA = 1, PO = 1), involvement of people affected (HTA = 1), patient involvement (HTA = 2), patient and public involvement (HTA = 1), lay involvement (HTA = 1), inclusion of patient representative (PO = 3), patient reports (PO = 1), patient preference (PO = 2), public consultation (CO = 1), stakeholder consultation (CO = 1), open input (CO = 1), stakeholder engagement (CO = 1), and patient participation (CO = 1). Opportunities for patient engagement were described as: patient questionnaire (HTA = 2); comment period (HTA = 1; CO = 1); committee participation (HTA = 3; PO = 3); propose topics (HTA = 1); draft guidance (HTA = 1); general stakeholder forum (CO = 1). While organizations outline opportunities for patient engagement, not all organizations have clear evidence the practices are used or have impact. Recent evaluations demonstrate clear evidence of engagement (HTA = 2); Unclear or mixed evidence (HTA = 1; PO = 1; CO = 2); No evidence (HTA = 3; PO = 3; CO = 1).

There is substantial heterogeneity in the terms used to describe patient engagement activities across organizations. While a variety of opportunities for patient engagement are described, lack of clear evidence to how patient engagement practices are consistently used may contribute to the perception that engagement by HTAs.

Rapid reviews are of increasing importance within Health Technology Assessment (HTA) due to the need for timely evidence to underpin the assessment of new technologies as well as financial constraints. There are many rapid review methods available (1) although there is little guidance as to the most suitable methods (2). A recent paper outlines issues to consider when selecting rapid review methods (3). The aim of this presentation is to present key aspects to consider when selecting rapid review methods.

We searched the evidence base for guidance on the selection of rapid review methods. We also examined three recently completed systematic reviews to identify rapid review methods used, the reasons for selection and the strengths and weaknesses of each method. Finally we identified key aspects to consider when selecting rapid review methods.

The evidence on guidance identified for the selection of rapid review methods was very limited. The analysis of the three reviews found that each review had distinctly different challenges, such as large numbers of relevant trials and heterogeneity in terms of populations, interventions, comparators and outcomes. All reviews included at least ten randomized controlled trials and numerous outcome measures. Three different approaches to the rapid review of the evidence were used in the three reviews. Key themes to consider when selecting rapid review methods were identified. These include: the size and nature of the evidence base, the characteristics of included studies and the expectations of those commissioning the review.

Rapid review methods need to be chosen to fit the needs of the review, each of which may have different challenges. Collaboration between those producing rapid reviews and commissioners is crucial when choosing methods to ensure that the needs of commissioners are met and limitations associated with the chosen methods are understood.

The expanding range of disease modifying therapies (DMT) for relapsing-remitting multiple sclerosis (RRMS) has led to increased interest in the relative effects of different DMTs. Previous mixed treatment comparisons (MTCs) have used different methods to address similar questions highlighting the need for a consistent approach to the assessment of treatments in RRMS.

We compared the methodology of six published MTCs of DMTs for RRMS identified by a systematic search of the literature. We assessed sources of evidence, DMTs included, outcomes reported and methods of data synthesis.

All six MTCs were based on systematic reviews that included randomized controlled trials (RCTs). MS relapse was reported as the rate ratio based on annualised relapse rates (four MTCs) and as odds ratios or relative risk (one MTC each) based on the proportion with relapse. The analysis of relapse included between sixteen and twenty-seven RCTs and seven to twenty DMTs in different MTCs. One MTC reported both disability progression confirmed after three months (CDP3M) and disability progression confirmed after six months (CDP6M) as hazard ratios. One MTC combined CDP3M and CDP6M as a single outcome. One MTC reported only CDP3M based on hazard ratios. Two MTCs reported only CDP6M as either odds ratios or risk ratios (one MTC each). In one MTC the definition of disability progression was not reported. The analysis of disability included between seven and twenty-six RCTs and between six and nineteen DMTs in different MTCs. All six MTCs fitted a random effects MTC model using either Bayesian (four MTCs) or frequentist (two MTCs) methods.

There is substantial heterogeneity between published MTCs in RRMS with regard to inclusion criteria, outcome definitions, effect measures and statistical methods. There is a clear requirement for a consistent approach to health technology assessment of DMTs for RRMS.

Alzheimer's disease (AD) is the most common type of dementia. Plasmapheresis is a procedure consisting of removing the plasma, or specific elements which are considered to be involved in pathological processes. Plasmapheresis could reduce the A beta peptides load in the brain. The objective is to study the safety and efficacy of plasmapheresis for AD.

Systematic review, with all studies published before April 2016 reviewed. Selected studies included patients with AD treated with plasmapheresis. GRADE was used to assess quality. Efficacy outcomes include: (i) Cognitive, functional and behavior status, through Mini Mental State Examination, and Alzheimer Disease Assessment Scale-Cognitive test; (ii) Plasma and cerebrospinal fluid A beta levels; (iii) Brain-imaging and functional neuroimaging studies. Safety outcomes included side effects related to the treatment.

Two papers reporting results from three studies were selected: (i) pilot study (n = 10), (ii) its extended study (12 months more of follow-up) (n = 7), and (iii) clinical trial (n = 39). The quality of evidence was very low. About efficacy, the studies didn't report quantitative results and were inconclusive. The pilot study and its extended study reported (1): a tendency towards stabilization in cognitive status; the plasma levels of A beta peptides didn't show a clear pattern; and the brain-imaging assessment suggested a progressive volume increase in the hippocampus. The clinical trial reported in the experimental group vs control (2): a better score for the cognitive status; an increase of plasma A beta peptides; and did not find significant differences between groups for cerebrospinal fluid A beta peptides. The brain-imaging assessment showed a progressive loss of hippocampus volume in both groups. Regarding safety, the studies didn't report quantitative data. We didn't find economic evaluation studies.

The included studies had very high risk of bias and very low quality. We found no evidence on efficacy and safety of plasmapheresis treating AD. Plasmapheresis isn't a priority line in research of AD treatment.

A Health Technology Assessment (HTA) systematic review was undertaken in rheumatoid arthritis (RA) of treat-to-target (TTT) studies (n = 16) in which studies were grouped according to: TTT versus usual care, trials comparing different targets, or trials comparing different treatment protocols. To our knowledge, this was the first RA TTT review where studies were grouped in this way. We wanted to compare if our approach had been adopted in reviews of hypertension, hyperlipidemia or diabetes.

We searched MEDLINE for systematic reviews (SRs) of TTT studies in hypertension, hyperlipidaemia or diabetes.

Eleven SRs were included; eight were in diabetes, and four were in hypertension, while none were in hyperlipidaemia. The diabetes SRs evaluated different insulin regimens (n = 3), non-insulin medications (n = 1), any antidiabetic treatment (n = 2), metformin monotherapy versus combination therapy (n = 1), and tight versus conventional glucose control (n = 1). The metformin review grouped studies by outcome whereas all other diabetes SRs grouped studies by treatment. Two hypertension SRs evaluated the effects of any treatment on two blood pressure targets, whereas one evaluated two different treatment regimen effects on the same blood pressure target. No SR in hypertension or diabetes included a mix of TTT versus usual care, and/or same treatment protocol different targets, and/or different treatment protocols same target study designs.

In RA TTT does not refer to a single concept but a range of different approaches to the treatment of patients and the evidence reflects this. Whilst our approach to grouping RA TTT studies in a review was novel, this made it complex for us to synthesize evidence and draw general conclusions. We did not identify any TTT reviews in hypertension or diabetes including a mix of the TTT approaches we identified in RA. At present, a comparison of the strengths and limitations of our TTT review study grouping with reviews of hypertension, hyperlipidemia or diabetes cannot be made.

Knotless barbed sutures can eliminate knot tying when patients are undergoing cosmetic surgery (CS). Although benefits reported on clinical outcomes are obvious, many studies have failed to demonstrate the potential for barbed sutures to mitigate adverse events. Thus, this study aimed to determine the safety of knotless barbed suture in CS.

PubMed, EMBASE, Cochrane Register of Clinical Studies, and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) and cohort studies comparing barbed sutures with conventional sutures in CS (until 30 June 2016). Quality assessment was conducted using Cochrane recommendations. Review Manager was applied to analyze the data, and we sequentially omitted each study to perform sensitivity analyses.

A total of five RCTs (low to moderate risk of bias) and six cohort studies (low to moderate risk of bias), proved eligible (3,481 patients). The CS included body contouring operations, breast reconstruction, lipoabdominoplasty, abdominoplasty and wound closure of cesarean delivery. Comparing to conventional sutures, pooling data showed that general adverse events of barbed sutures were not significantly different (Odds Ratio, OR = .6, 95 percent Confidence Interval, CI .24 to 1.52, P = .28), while the subgroup analysis showed that fewer adverse events occurred in cohort studies, though with high heterogeneity (I2 = 87 percent). Specifically, no significant differences were shown between barbed and traditional sutures in wound dehiscence (OR = .55, 95 percent CI .29 to 1.03, P = .06), incisional infection (OR = .56, 95 percent CI .22 to 1.48, P = .25), seroma (OR = .87, 95 percent CI .42 to 1.79, P = .70) and hematoma (OR = 1.52, 95 percent CI .29 to 7.99, P = .62).

No differences were found between knotless barbed sutures and conventional sutures generally, but the cohort studies suggested barbed sutures resulted in fewer adverse events with longer follow-up. Thus barbed sutures are considered a safe surgical technique in CS. More evidence with larger sample sizes and longer follow up are needed to confirm the advantages of this technique in the future.

New approaches are needed to safely reduce emergency admissions to hospital by targeting interventions effectively in primary care. A predictive risk stratification tool (PRISM) identifies each registered patient's risk of an emergency admission in the following year, allowing practitioners to identify and manage those at higher risk. We evaluated the introduction of PRISM in primary care in one area of the United Kingdom, assessing its impact on emergency admissions and other service use.

We conducted a randomized stepped wedge trial with cluster-defined control and intervention phases, and participant-level anonymized linked outcomes. PRISM was implemented in eleven primary care practice clusters (total thirty-two practices) over a year from March 2013. We analyzed routine linked data outcomes for 18 months.

We included outcomes for 230,099 registered patients, assigned to ranked risk groups.

Overall, the rate of emergency admissions was higher in the intervention phase than in the control phase: adjusted difference in number of emergency admissions per participant per year at risk, delta = .011 (95 percent Confidence Interval, CI .010, .013). Patients in the intervention phase spent more days in hospital per year: adjusted delta = .029 (95 percent CI .026, .031). Both effects were consistent across risk groups.

Primary care activity increased in the intervention phase overall delta = .011 (95 percent CI .007, .014), except for the two highest risk groups which showed a decrease in the number of days with recorded activity.

Introduction of a predictive risk model in primary care was associated with increased emergency episodes across the general practice population and at each risk level, in contrast to the intended purpose of the model. Future evaluation work could assess the impact of targeting of different services to patients across different levels of risk, rather than the current policy focus on those at highest risk.

This study examined the technical efficiency determinants of each Organisation for Economic Co-operation and Development (OECD) country's behavioral health system (BHS).

The technical efficiency of each OECD country's BHS was analyzed through data envelopment analysis with model combinations ranging from 1–11 models, with each model constructed with different BHS input and output variable combinations. A decision tree was generated from the efficiency scores of the model with the highest mean technical efficiency score as a predictor variable. Data was obtained from 2013 OECD and Eurostat statistics.

Different model combinations indicated that the model with the highest mean technical efficiency score (.9214) for OECD countries included (i) input variables for smoking, alcohol consumption, daily fruit consumption, the number of psychiatrists, the percentage of live births of young mothers first children, and the time devoted to leisure and personal care and (ii) output variables for death rate by mental and behavioral disorders, diabetes hospital admissions in adults, and suicide rates. Among all model combinations, >45 percent of OECD countries have an efficient BHS. The decision tree graph shows that daily fruit consumption, smoking, and suicide rates are predictor variables of the technical efficiency of an OECD country's BHS.

The study results offer important insights regarding the development of BHS in OECD countries. Health policymakers must develop collaborative activities and implement comprehensive policies promoting internationally-oriented BHS in order to improve the health status of people worldwide and reduce health inequality.

The Comprehensive Public Healthcare System of Catalonia (SISCAT) Atlases of Quality aim to evaluate the quality of care in relation to specific diseases or procedures in the Catalan territory with a focus on outcomes of care in order to promote best practices. The first Atlas of Quality aimed to assess the quality of integrated care for chronic patients.

Methodology was articulated in four stages:(i) Establishment of a conceptual framework of reference specific for each intervention/technology being assessed, (ii) Definition and consensus of the assessment indicators, and (iii) Implementation of indicators using the Basic Health Areas (ABS) of Catalonia as a unit of analysis, comparing ABS with vs without the intervention (such as integrated care for chronicity). Indicators were obtained from the SISCAT databases and implemented through risk adjustment models. For performance assessment, we calculated the observed and expected indicator rates for each ABS, and for the benchmarking analysis, these ratios were represented in funnel plots (Confidence Interval, CI 95 percent and 99.8 percent for exclusion zones). (iv) Evaluation of the intervention and identification of specific success factors.

For the assessment of integrated care interventions for chronicity, the defined framework in stage 1 was base on the Kaiser Pyramid (population distribution), and the Porter and the Donabedian's approaches (structure, processes, outcomes) (1). In stage 2 more than 500 experts, using several qualitative techniques, considered 18 indicators as relevants and feasibles for the assessment (2). Ten of them were implemented in stage 3 for congestive heart failure and pulmonary obstructive chronic disease. Significant values were found both in ABS with and without chronicity care programms (phase 3).

The subsequent analysis (phase 4) will allow identification of practices of each ABS that best explain these results. Some limitations must be considered such as the availability of the consensued indicators in the SISCAT databases.

Ceroid lipofuscinosis neuronal 2 (CLN2) disease, a form of Batten disease, is a rare, degenerative neurometabolic disorder. Disease onset around 2–4 years is followed by rapid decline in motor and neurologic function and mortality in early teenage years (1). Disease burden is best captured using observer-reported outcomes. However, validation is challenging in ultra-orphan diseases, requiring flexible methods and reasonable acceptance of limitations related to participant access.

The study aim was to assess content validation of clinical trial measures (i) CLN2 Disease Based Quality of Life Assessment (Sponsor-developed), (ii) EQ-5D-5L, (iii) Pediatric Quality of Life Inventory (PedsQL); and (iv) PedsQL Family Impact Module.

The Batten Disease Family Association recruited United Kingdom caregivers of a child with CLN2 disease (aged 3–7 years, non-participants in any CLN2 trial), to:

1. 1. Focus groups with symptom elicitation

2. 2. Cognitive interviews to assess measures.

The Focus group comprised eleven caregivers (eight female, three male) from six families. Three families were current caregivers and remainders bereaved. Symptom and disease impact elicited showed the majority of measures domains were relevant.

The interview sample comprised sixteen current caregivers (twelve female, four male) from ten families (caring for eleven children). Overall measures were relevant, easy to understand and answer. However several items were difficult to apply to children with advanced disease (for example, Euroqol, EQ-5D-5L “overall health”), when ability is lost (for example, PedsQL walking), with misinterpretation of “no difficulties” with eating where child feeds using gastrostomy (CLN2 QoL). Caregivers found it difficult to know how their uncommunicative child was feeling (PedsQL worrying, EQ-5D-5L depression). Some symptoms and impacts were missing (for example, constipation, working life).

The mixed-methods approach enabled content validity assessment of multiple measures. While these measures were largely relevant, adjustments could strengthen these for use in this fatal pediatric condition population and increase their acceptance within health technology assessment (HTA).