bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP27 Patient Engagement At Scottish Medicines Consortium Committee Meetings
Authors: Lockhart Lindsay , Dickson Jennifer , Lee Anne , McGrath Peter , Hughes Yvonne 
Published: January 2019

Introduction:Since 2014 patient group representatives have been able to observe Scottish Medicines Consortium (SMC) committee meetings as members of the public. However, they have had no opportunity to participate in discussions on their submission on the patient experience of living with the condition under review. In 2017, to strengthen patient engagement, we revised our processes to enable representatives from all submitting patient groups to play a bigger part in the monthly meeting.Methods:The SMC Public Involvement Network (PIN) Advisory Group consulted on potential issues around patient group participation in committee meetings. Recommendations approved for implementation included (i) provision of comprehensive information and support to participating patient group representatives, and (ii) holding an educational session for SMC members on ‘What matters to the patient’. The process change was introduced in June 2017. Patient group representatives are invited to complete an online survey on their experience of taking part in the meeting and working with the public involvement team. Implementation is being monitored and will be evaluated in a commitment to continuous improvement.Results:Since June 2017, 14 patient group representatives have attended SMC meetings for the discussion of their submission. This has enabled them to answer questions from committee members and clarify points relating to their submission, if required. Early feedback has been positive with participants believing that patient engagement has been strengthened and that the patient voice was heard and valued. Patient groups expressed a willingness to participate again. The evaluation of their experience to date will be presented.Conclusions:SMC now involves patient group participation at committee meetings, demonstrating commitment to listening and responding to stakeholders on patient engagement. Early feedback has been positive and suggests that discussions relating to quality of life impact on patients and carers better reflect the lived experience. This ensures we are meeting our commitment to openness and transparency and strengthens patient engagement in our process.
OP28 Partnership Working To Inform Patient Engagement In Health Technology Assessment
Authors: Lockhart Lindsay , Dickson Jennifer , Lee Anne , Coombes Martin 
Published: January 2019

Introduction:The Scottish Medicines Consortium (SMC) works in partnership with patient groups and carers to capture their experiences to help inform decisions on new medicines. To better inform their participation in the SMC assessment process, patient groups highlighted a need for information from submitting pharmaceutical companies about the new medicine under review.Methods:We established a multi-stakeholder short life working group (SLWG) to explore how to meet these needs. The group comprised members of the SMC Public Involvement Network (PIN) Advisory Group, representatives of two pharmaceutical companies and the Association of British Pharmaceutical Industries, and the SMC public involvement team. The main outputs were the development of a new Summary Information for Submitting Patient Groups (SIP) form and supporting guidance document. The SIP form completed by the submitting pharmaceutical company is then shared by SMC's Public Involvement Team, to assist submitting patient groups.Results:The SIP form was implemented in June 2016, and following positive evaluation, became essential for inclusion with the pharmaceutical company's new medicine submission in June 2017. Feedback has been positive, with patient groups reporting that the form includes valuable information that they may not otherwise have been able to access including the positioning of the medicine in the treatment pathway, information on dosage, administration and side-effects. The form is also completed in plain English without overly technical or marketing information. Company representatives who have completed the form state that it provides clear information on the licensed indication, enables accessible scientific evidence for patients and families/carers, and allows them to give accurate and balanced information about the medicine.Conclusions:Partnership working with key stakeholders has enabled SMC to provide improved information to submitting patient groups. A better understanding of a new medicine may in turn allow patient groups to participate more effectively in the HTA.
OP35 Integrated Knowledge Translation In Policy Development
Authors: Laing Glenna , Djebah Rume , Hoff Judy , Shaffer Robert , Harding Sheila Rutledge , Moga Carmen , Kletke Stefanie , Scott Ann 
Published: January 2019

Introduction:Immune globulin (IG) is a publicly funded blood product with high utilization rates and rapidly rising costs. Inappropriate use of IG, particularly in dose and treatment duration, is observed in about 10 percent of cases, and the national guidelines for IG treatment are outdated. To develop a utilization management policy for IG, the Alberta, Manitoba and Saskatchewan Ministries of Health collaborated with health technology assessment (HTA) researchers and clinicians to develop evidence-based guideline recommendations for IG treatment to inform an authorization policy for IG utilization in the provinces.Methods:A multidisciplinary committee comprising HTA researchers and 22 physicians from seven medical specialties adapted recommendations from 43 “seed” guidelines into one locally contextualized IG guideline. HTA methods and rapid review products were used extensively to update gaps in the evidence base. The guideline recommendation document was used to develop a provincial IG utilization management policy. The challenges of achieving a methodologically rigorous guideline development process will be discussed.Results:The guideline contained over 60 recommendations for IG use in different medical specialties. The health ministries used the guideline recommendations to develop an IG authorization policy. The clinician-sanctioned review criteria were used to construct a conditional reimbursement system for generating outcome data from controlled off-label IG use for conditions where evidence gaps existed, and were built into policies for benchmarking compliance.Conclusions:Three provinces successfully collaborated to develop an IG utilization management policy. The unique approach involved a credible and transparent process that incorporated key review elements for compliance benchmarking and reimbursement, promoted clinician buy-in, and created a cadre of clinical champions willing to assist in policy development and implementation. The proactive, rather than retroactive, incorporation of clinician-sanctioned benchmarking and review criteria into policy will help bridge the know-do gap and foster a stronger, more direct link between health policy and evidence.
OP39 Evaluation Of Discharge Planning And Transitional Care For The Elderly
Authors: Wassef Maggy , Trepanier Marc-Olivier , Beauchamp Sylvie 
Published: January 2019

Introduction:According to our local data, elderly patients accounted for 14 percent of the population yet, represent 58 percent of hospitalization and, they are more likely to return after discharge. These patients are more likely to return to the hospital following discharge. In order to meet ministerial target for length of stay of patient on a stretcher, the UETMIS-SS was requested to evaluate interventions aiming to improve the fluidity of patient trajectories in the acute care services. The objective of this health technology assessment is to evaluate the effectiveness of discharge planning and transitional care interventions aiming at reducing the readmission rate of the elderly.Methods:An umbrella review was conducted following the PRISMA statement to summarize the scientific evidence. The search was conducted in five databases along with the grey literature search. Two reviewers independently performed the study selection, the quality assessment and the data extraction. To better illustrate the activities and the healthcare professionals (HCP) involved in the interventions, an analytical framework was developed. Results were summarized in a narrative synthesis. The contextual and experiential data were collected through interviews with HCP and directorates from different settings. The level of evidence was and a committee was then held to elaborate the recommendations.Results:In the nine systematic reviews included in the narrative synthesis, three models were identified: Post-discharge planning and follow-up by the same HCP was established to be effective in reducing the readmission rate. Discharge planning interventions with follow-up by non-specific HCP have been shown to be promising, while discharge planning without follow-up after the hospital discharge has shown to be ineffective in reducing the readmission rate.Conclusions:An individualized discharge plan, coordination of services and follow-up performed by the same HCP is established to be effective in reducing readmission rate.
OP43 Robotic Or Conventional Gait Training Rehabilitation? A Health Technology Assessment Study
Authors: Andellini Martina , Faggiano Francesco , di Mauro Roxana , Derrico Pietro , Ritrovato Matteo 
Published: January 2019

Introduction:The purpose of this study is to gather evidence on safety and overall effectiveness of three alternative technologies for gait rehabilitation in diplegic children with Cerebral Palsy: robotic, conventional and joint conventional and robotic gait training.Methods:A new methodology, decision-oriented health technology assessment (DoHTA), was applied to assess the technology on clinical, technical, organizational, economic, social and ethical, legal and safety domains. This method, conceived as a hospital-based HTA tool for supporting the introduction of innovative technologies, has been implemented merging the EUnetHTA Core Model® with the Multi-Criteria Decision Analysis. In particular, the general items of the EUnetHTA Core Model® are re-formulated as performance indicators and re-placed along a decision tree structure that, from the one hand, respects the original top-down design of the EUnetHTA model (growing level of detail from domains to issues) and, from the other hand, allows obtaining a quantitative evaluation of each identified performance indicator.Results:The multiple indicators, which have been identified for the seven domains, play important and different roles in the alternative technologies evaluation. DoHTA results showed that robotic system offers the possibility to control more accurately the exerted forces and movement trajectories than the traditional therapy. It gives the possibility to measure the task performances parameters and to receive the patient feedback simultaneously. To carry out robotic gait rehabilitation fewer therapists are required compared with the conventional therapy, resulting in lower therapists’ physical workload.Conclusions:Despite the great perspectives that robotics offer to motor rehabilitation, it seems that robotic gait training could not provide greater benefits in terms of motor and functional recovery compared to the conventional therapy. Preliminary results, supported by most recent literature evidence, lead to the hypothesis that joint use of robotic and conventional therapy can produce better clinical outcomes than the separate use of the two rehabilitation techniques.
OP44 HTA Of 3D Videolaparoscopy: Follow-up 12 Months After Introduction
Authors: di Mauro Roxana , Andellini Martina , Faggiano Francesco , Derrico Pietro , Ritrovato Matteo 
Published: January 2019

Introduction:In 2016, a health technology assessment (HTA) was conducted to gather evidence on the safety and overall effectiveness of performing laparoscopic surgery by using 3D videolaparoscopy (3DVL) versus 2D videolaparoscopy (2DVL) display systems in a variety of pediatric surgical procedures in order to efficiently support the final investment decision on video system to be acquired. Results showed that 3DVL might be a good alternative to 2DVL. Moreover, sensitivity analysis has also confirmed that the results associated to the best technology (3DVL) are robust; this has led to a confident decision for recommending it in Bambino Gesù Children's Hospital (OPBG). The objective of this work is to evaluate the impact of 3DVL within the hospital setting after 12 months its introduction in clinical practice.Methods:After 12 months since the technology's introduction, clinical data, identified in previous HTA study, were extracted from surgery registries; data concerning the number of surgeries, duration of intervention, blood loss and surgery complications were analyzed. Statistical analyses on these data, between pre and post 3D system implementation period were carried out.Results:Results confirmed the 2016 HTA results, highlighting clinical advantages identified a priori. The percentage of the number of laparoscopic procedures significantly increased from 12 percent in pre-3D system installation period to the 20 percent in post 3D system installation (p=7,35E-6). No statistical differences in length of hospital stay, operative time, incidence of perioperative blood loss and surgery complication, between pre- and post- 3D installation period were identified.Conclusions:This study highlighted the importance of a HTA process before the acquisition of a technology for which the investment decision is not obvious, because benefits and drawbacks of the new technology are unclear. Preliminary results showed that 3D video laparoscopy system seems to be better than the 2D laparoscopy system. However, more data has to be examined to be able to establish the final judgement.
OP48 A Contextual Model For Evaluating The Value Of Multi-Indication Drugs
Authors: Wu Elise , Pellissier James , Bellanca Leana , Normand Raphael , Hughes Robert , Ratciffe Aran 
Published: January 2019

Introduction:An increasing number of anti-cancer medications are indicated for multiple tumors. Existing pharmacoeconomic evaluations routinely examine the cost-effectiveness (CE) and budget impact (BI) of such drugs by indication, as and when each indication is reviewed. The impact of indication-specific conclusions on the holistic value of such medications across all indicated patients is not currently evaluated, yet is important to stakeholders including health technology assessment (HTA) agencies, payers and patients. We introduce a holistic framework that considers the value of multiple indications together at a product level. Application of this approach is illustrated via an example across multiple indications for a novel, targeted anti-cancer therapy (pembrolizumab) in Canada.Methods:Previously-HTA-evaluated indication-specific CE and BI models serve as the foundation for this multi-indication model. Comparing to standard of care (SoC) per indication, the model evaluates the potential BI, clinical outcomes and CE of pembrolizumab among the individual indications along with the overall multi-indication patient population from the perspective of a third-party payer. For the contextual model, incremental costs and quality-adjusted life years (QALYs) were weighted using indication populations derived from national incidence rates.Results:The indication-specific incremental cost-effectiveness ratios (ICER) from CE analyses of ipilimumab-treated advanced melanoma, ipilimumab-naïve advanced melanoma, second-line non-small cell lung cancer (NSCLC), first-line NSCLC and fourth-line classical Hodgkin lymphoma range from USD 52 K to USD 163 K per QALY. Accounting for the relative contributions of the various sizes of indication-specific patient populations results in an overall ICER for pembrolizumab vs. SoC of USD 100 K.Conclusions:A holistic model can provide stakeholders with a tool to evaluate the overall value of multi-indication drugs. Results enable an understanding of the outcomes and economic consequences of treatment with pembrolizumab versus SoC by both individual indications and across all indications. Insights from this contextual approach will enable data from less-developed clinical trials to be considered when previously they might have gone unevaluated by decision-makers.
OP79 A Meta-Framework To Inform Health Inequalities In Systematic Reviews
Authors: Maden Michelle 
Published: January 2019

Introduction:Recent equity review guidance encourages reviewers to consider whether it is likely that their findings may impact on health inequalities. Much of the guidance assumes that health inequalities have either already been identified as the focus of the review, or that reviewers are able to recognize if and how health inequalities matter. However, our experience is that this is not necessarily true. Furthermore, theorizing if and how health inequalities matter is not normally integrated into the HTA review process. This presentation describes a novel approach to the development of a theory-led meta-framework to inform health inequality considerations in systematic reviews. The meta-framework aims to increase the usefulness of systematic reviews in informing and implementing changes to practice.Methods:Following the best-fit framework synthesis approach, a meta-framework was generated by ‘deconstituting’ concepts from theories relating to complex interventions and socio-economic health inequalities into a single framework. Feedback was sought from health inequality experts and reviewers.Results:Complex intervention theories identify four domains and key factors that may influence effectiveness; intervention design, implementation, context and participant response. Applying an equity lens, socio-economic health inequality theories identify key factors and mechanisms associated with these domains that may lead to differential effects across disadvantaged populations.Conclusions:The meta-framework has the potential to i) facilitate the identification and understanding of when, why and how interventions may impact on socio-economic health inequalities, ii) promote a theory-led approach to incorporating health inequalities in systematic reviews iii) help reviewers identify data to extract and inform a priori analysis on what factors are associated with differential effects, iv) help reviewers to decide whether it is likely that their review findings may have the potential for an intervention to indirectly widen or narrow socio-economic health inequalities, even when evidence of an impact in the primary research is lacking.
OP83 Thinking Explicitly About Ethical Issues In Health Technology Assessment: Lessons From The Canadian Agency For Drugs And Technologies In Health
Authors: Bond Ken , Duthie Katherine 
Published: January 2019

Introduction:While methods for ethics analysis in health technology assessment (HTA) exist, there have been relatively few applications and assessments of these methods. The Canadian Agency for Drugs and Technologies in Health (CADTH) began to include an explicit analysis of ethical issues within its HTAs in 2015. To examine some of the differences among ethics analyses, we critically compared the conduct and contribution of the analysis of ethical issues for four CADTH HTAs.Methods:Two experts in ethics in HTA examined ethics analyses conducted by CADTH for four technologies: DNA mismatch repair testing for colorectal cancer, treatments for obstructive sleep apnea, dialysis for end-stage liver disease, and human papillomavirus screening for cervical cancer. The methods of analysis and presentation of results, extent to which the ethics analysis was used in committee deliberations was gathered via meeting notes, recommendation documents, and discussion, and were summarized narratively.Results:The amount of literature explicitly discussing ethical issues pertaining to particular technologies varied and was not predicted by the age and maturity of a technology. The axiological approach proved a helpful starting point for ethical reflection, but other methods were used for analysis and presentation. Explicit discussion of ethical issues identified the need for additional information to ensure robust deliberation. Committee members expressed the belief that ethics analysis “brought together” individual sections of the HTA.Conclusions:While many methods exist for ethics analysis, ethics expertise is required to identify and explicitly discuss the complete range of ethical issues relevant to a particular HTA. Ethics analyses create space to challenge assumptions underlying the clinical and economic evidence, raise issues about the value of technologies, and help to integrate the HTA results.
OP95 Are Patient-Reported Outcome Measures Meeting Today's Standards?
Authors: Oehrlein Elisabeth , Perfetto Eleanor , Rose Love T. , Chung Yujin , Ghafoori Parima 
Published: January 2019

Introduction:Over the past decade, health technology assessment (HTA) agencies have become interested in improving the patient-centeredness of their assessments. A common approach has been to prioritize patient-reported outcomes (PROs), often describing PROs as patient-relevant or patient-oriented. However, it is often unclear whether and to what degree PRO measures (PROMs) truly reflect what is important to patients. This review examined the pedigree of a sample of measures used as primary or secondary endpoints in trials and discussed in Food and Drug Administration (FDA) approved product labels between 2003 and 2014.Methods:We examined all 26 PROs included in chapters 1 (Office of Microbial Products) and 2 (Office of Drug Evaluation I) of the FDA's Pilot Clinical Outcome Assessment (COA) Compendium. Three reviewers independently searched PubMed and Google to identify publications or other relevant materials related to method and stage of measure development where patient engagement took place.Results:Among 26 evaluated PROMs, we were unable to locate any information on development or validation for 12 (patient diary=9; rating scale=3). Among the remaining 14 PROMs, 5 did not include any evidence of patient engagement (questionnaire=1; patient diary=2; rating scale=2); 3 engaged patients during concept elicitation or psychometric validation only (disease-specific questionnaires=3); and 6 engaged patients during both concept elicitation and cognitive interviewing (disease-specific questionnaires=6). PROMs either previously qualified or submitted for qualification by FDA were more likely to include patient engagement.Conclusions:PROs can provide patient-centered data useful for HTA; however, patient-reported information is not inherently patient-centered. This study found that only a minority of sampled PROMs engaged patients during both concept elicitation and cognitive interviewing. To facilitate patient-centered HTA, manufacturers should ensure that PROMs incorporated into clinical trials measure concepts important to patients. Similarly, HTAs should request data on development and validation of all outcome measures incorporated into trials.