Evaluación del modelo de calidad de Donabedian en base a los criterios de Chinn y Kramer / Evaluation of the Donabedian quality model based on the Chinn and Kramer criteria

INTRODUCCIÓN: La evaluación de teorías es un proceso crucial para el desarrollo del conocimiento enfermero, permite seleccionar y utilizar la teoría en función de los problemas y fenómenos del cuidado, sin embargo, es escasamente realizada, especialmente en teorías de otras disciplinas. OBJETIVO: Analizar críticamente el modelo de calidad de la atención de salud de Donabedian, a través de la propuesta metodológica de Chinn y Kramer. DESARROLLO: Se realizó un estudio descriptivo-reflexivo del componente teórico y conceptual del modelo de Donabedian, se explica el propósito, conceptos, relaciones, estructura y supuestos. Se continua con la evaluación crítica del modelo, analizada bajo los criterios de claridad, sencillez, generalidad, accesibilidad e importancia, a través de una revisión narrativa de la literatura. CONCLUSIÓN: el modelo es útil para la gestión, los procesos de mejora, evaluación de estrategias y programas. Con valor para enfermería, puesto que coinciden en el significado e importancia otorgada a la calidad de la atención, reconociendo su contribución en la implementación, desarrollo de intervenciones y mejoramiento de la salud.

NTRODUCTION: The evaluation of theories is a crucial process for the development of nursing knowledge, as it allows the selection and use of such theories to address the problems of patient care. However, it is scarcely performed, especially with theoriesfrom disciplines other than nursing. OBJECTIVE: To critically analyze the Donabedian model of health care quality, through the methodological approach of Chinn and Kramer (1999). METHODOLOGY: A descriptive-reflexive study of the theoretical and conceptualcomponent of the Donabedian model was carried out, explaining its purpose, concepts, relationships, structure, and assumptions. A critical evaluation of the model was then conducted, using the criteria of clarity, simplicity, generality, accessibility, and importance, through a narrative review of the literature. CONCLUSIONS: The model is useful for management, improvement processes, and the evaluation of strategies and programs. It is especially valuable for nursing, since it coincides with the meaning and importance given to the quality of nursing care, recognizing its contribution in the development and implementation of interventions and improvement of health.

Validação do modelo lógico operacional de uma rede nacional de bancos de alimentos: contribuição para avaliação em segurança alimentar e nutricional / Validation of the logical operational model of a national network of food banks: contribution to evaluation in food and nutritional security

Resumo Objetivo: Descrever o processo de validação do modelo lógico operacional (MLO) do Programa Mesa Brasil Sesc (MBS) para a promoção da SAN. Métodos: Trata-se de um estudo transversal e de validação de instrumento, baseado em documentos legais de SAN, por meio da técnica de consenso Delphi com painel de especialistas. Resultados: O painel para validação foi formado por 12 participantes, atores em SAN das cinco macrorregiões geográficas do país, que analisaram a pertinência e relevância das atividades, produtos, resultados e impactos dos seis componentes técnicos do MBS. Os 103 itens, distribuídos nos componentes técnicos, foram consensuados quando alcançaram mais de 85% de concordância entre os participantes, confirmados pelas análises da mediana e intervalo interquartílico. Conclusão: Esse processo proporcionou um espaço rico e horizontal de discussão sobre teoria, prática e resultados, trouxe reflexões e novas percepções sobre o MBS, e o MLO resultante é valiosa ferramenta para o desenvolvimento de estratégias de M&A, tomada de decisões e governança sobre o programa.

Objective: To describe the validation process of the logical operational model (LOM) of Mesa Brasil Sesc Program (MBS) for the promotion of FNS. Methods: This is a cross-sectional study and instrument validation, based on FNS legal documents, using the Delphi consensus technique with a team of experts. Results: The validation team was made up of 12 participants, FNS important players from the country's five geographical macro-regions, who analyzed the pertinence and relevance of the activities, products, results and impacts of the six technical components of MBS. The 103 items, distributed in the technical components, reached consensus when they reached more than 85% agreement among the participants, confirmed by the analysis of the median and interquartile range. Conclusion: This process provided a rich and horizontal discussion on theory, practice and results, brought reflections and new perceptions about MBS and the resulting LOM is a valuable tool for developing M&E strategies, decision-making and governance of the Program.

Towards a Core Outcome Set for Abdominal Aortic Aneurysm: Systematic Review of Outcomes Reported Following Intact and Ruptured Abdominal Aortic Aneurysm Repair.

OBJECTIVE: To encompass the needs of all stakeholders and allow effective data synthesis from trials, registries, and other studies; a core outcome set for infrarenal abdominal aortic aneurysm (AAA) repair is needed. In this first stage, the aim was to report the range, frequency, and time of pre-specified outcomes reported following AAA repair. DATA SOURCES: Medline, Embase, and CENTRAL databases 2010 - 2019 were searched using ProQuest Dialog™. REVIEW METHODS: The systematic review was reported to Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines (PRISMA), PROSPERO registration CRD42019130119. Outcomes were coded using Core Outcome Measures in Effectiveness Trials (COMET) taxonomy and presented separately for intact and rupture repairs, endovascular aneurysm repair (EVAR) and open repair, and time from repair (acute < 90 days vs. ≥ 1 year) (COMET Initiative 1582). RESULTS: For intact AAA and rupture repair, a total of 231 and 70 reports with 589 255 and 177 465 patients respectively were included: only 98 and 19 respectively provided ≥ 1 year outcomes. Most studies were retrospective, with 13 randomised trials of intact AAA repair and five randomised trials of ruptured AAA repair. For intact AAA, the most common pre-specified COMET taxonomy outcomes were mortality (181), vascular complications (137), and re-intervention (52). EVAR studies dominated the vascular outcomes in acute and later time periods: excluding 47 reports from device registries, reduced vascular outcomes to 83. For ruptured AAA, the three most common outcomes were mortality (64), vascular (11), and hospital stay (10). The range of outcomes reported was wide with functioning outcomes reported from most randomised trials but few retrospective studies. CONCLUSION: This review identifies the paucity of long term data and the disproportionate attention paid to vascular complications vs. patient functioning outcomes, this skew being accentuated by reporting from EVAR device registries. These data will inform focus groups, prior to a pan-European Delphi consensus, involving clinicians, patients, carers and providers, for developing core outcomes for repair of intact and ruptured AAA.

Women's Health Initiative Strong and Healthy Pragmatic Physical Activity Intervention Trial for Cardiovascular Disease Prevention: Design and Baseline Characteristics.

BACKGROUND: National guidelines promote physical activity to prevent cardiovascular disease (CVD), yet no randomized controlled trial has tested whether physical activity reduces CVD. METHODS: The Women's Health Initiative (WHI) Strong and Healthy (WHISH) pragmatic trial used a randomized consent design to assign women for whom cardiovascular outcomes were available through WHI data collection (N = 18 985) or linkage to the Centers for Medicare and Medicaid Services (N30 346), to a physical activity intervention or "usual activity" comparison, stratified by ages 68-99 years (in tertiles), U.S. geographic region, and outcomes data source. Women assigned to the intervention could "opt out" after receiving initial physical activity materials. Intervention materials applied evidence-based behavioral science principles to promote current national recommendations for older Americans. The intervention was adapted to participant input regarding preferences, resources, barriers, and motivational drivers and was targeted for 3 categories of women at lower, middle, or higher levels of self-reported physical functioning and physical activity. Physical activity was assessed in both arms through annual questionnaires. The primary outcome is major cardiovascular events, specifically myocardial infarction, stroke, or CVD death; primary safety outcomes are hip fracture and non-CVD death. The trial is monitored annually by an independent Data Safety and Monitoring Board. Final analyses will be based on intention to treat in all randomized participants, regardless of intervention engagement. RESULTS: The 49 331 randomized participants had a mean baseline age of 79.7 years; 84.3% were White, 9.2% Black, 3.3% Hispanic, 1.9% Asian/Pacific Islander, 0.3% Native American, and 1% were of unknown race/ethnicity. The mean baseline RAND-36 physical function score was 71.6 (± 25.2 SD). There were no differences between Intervention (N = 24 657) and Control (N = 24 674) at baseline for age, race/ethnicity, current smoking (2.5%), use of blood pressure or lipid-lowering medications, body mass index, physical function, physical activity, or prior CVD (10.1%). CONCLUSION: The WHISH trial is rigorously testing whether a physical activity intervention reduces major CV events in a large, diverse cohort of older women. Clinical Trials Registration Number: NCT02425345.

Effectiveness of Menghini-Type Needles for Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Pancreatic Masses.

BACKGROUND: Cutting needles are thought to be effective as biopsy needles. A few types of cutting needles are available for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), and the Menghini-type needle is an end-type cutting needle. AIMS: A prospective randomized controlled trial was conducted to compare the results of EUS-FNA using a Menghini-type needle (needle M) versus a conventional needle (needle S). METHODS: The main eligibility criteria were as follows: patients with a pancreatic mass referred for EUS-FNA, ≥ 20 years old, and a performance status < 4. The primary outcome was the sample quality. The secondary outcomes were factors associated with the sample quality, diagnostic accuracy, and adverse events. RESULTS: A total of 97 patients were enrolled in this study. The sample quality for total puncture with needle M (92.8%) was significantly higher than that with needle S (81.4%) (p = 0.0305). The tumor size (p = 0.033) and type of needle (p = 0.031) were significant factors associated with adequate tissue collection in univariate and multivariate analyses (odds ratio [OR] 2.71; 95% confidence interval [CI] 1.12-6.54; p = 0.027 for tumor size, and OR 2.93; 95% CI 1.23-8.21; p = 0.0153 for type of needle). The diagnostic accuracy of each needle was 88.7% (86/97) with needle M and 73.2% (71/97) with needle S. Adverse events occurred in 2 of the 97 patients (0.02%). CONCLUSION: A Menghini-type needle was able to obtain core tissue for histology more effectively than a conventional aspiration needle. TRIAL REGISTRATION NUMBERS: UMIN registration number of 000020668.

Plantar Pressures Following Surgical Release in Children With Clubfoot: Comparison of Posterior Release, Posteromedial Release, and Nonoperative Correction.

BACKGROUND: Functional deficits observed at long-term follow-up in surgically released clubfeet have led to the adoption of a nonoperative approach. Gait results reported at age 5 years found ankle motion was limited in clubfeet treated by posteromedial release (PMR), compared with those that required posterior release (PR) or remained nonoperative. The purpose of this study was to assess plantar pressures in clubfeet that required surgical correction by 5 years of age. METHODS: Pedobarograph data were collected at age 5 years on patients with clubfeet that underwent surgical correction due to residual deformity or recurrence. Plantar pressures were assessed by subdividing the foot into the medial/lateral hindfoot, midfoot, and forefoot regions. Variables included maximum force, contact area%, contact time% (CT%), the hindfoot-forefoot angle, and displacement of the center of pressure line. Surgical feet were divided into those that underwent an isolated PR versus PMR. A group of 72 clubfeet that remained nonoperative were matched by initial severity and used for comparison. RESULTS: Pedobarograph data from 53 patients (72 clubfeet; 25 PR and 47 PMR) showed minimal differences between the PR and PMR feet. Compared with the nonoperative group, both surgical groups had increased CT% in the medial hindfoot and medial midfoot regions. An increase in lateral hindfoot CT% was observed in the PMR group. In addition, CT% in the first metatarsal region in the PMR group was reduced compared with the nonoperative group. Lateralization is present across both surgical groups in the center of pressure line and hindfoot-forefoot angle. CONCLUSION: While there were minimal differences between surgical groups, patients who underwent PR exhibited pressure variables that were more comparable to the nonoperative group while the PMR group had greater deviations. LEVEL OF EVIDENCE: Level II-therapeutic.

Combination of variations in inflammation- and endoplasmic reticulum-associated genes as putative biomarker for bevacizumab response in KRAS wild-type colorectal cancer.

Chemotherapy combined with the angiogenesis inhibitor bevacizumab (BVZ) is approved as a first-line treatment in metastatic colorectal cancer (mCRC). Limited clinical benefit underpins the need for improved understanding of resistance mechanisms and the elucidation of novel predictive biomarkers. We assessed germline single-nucleotide polymorphisms (SNPs) in 180 mCRC patients (Angiopredict [APD] cohort) treated with combined BVZ + chemotherapy and investigated previously reported predictive SNPs. We further employed a machine learning approach to identify novel associations. In the APD cohort IL8 rs4073 any A carriers, compared to TT carriers, were associated with worse progression-free survival (PFS) (HR = 1.51, 95% CI:1.03-2.22, p-value = 0.037) and TBK1 rs7486100 TT carriers, compared to any A carriers, were associated with worse PFS in KRAS wild-type (wt) patients (HR = 1.94, 95% CI:1.04-3.61, p-value = 0.037), replicating previous findings. Machine learning identified novel associations in genes encoding the inflammasome protein NLRP1 and the ER protein Sarcalumenin (SRL). A negative association between PFS and carriers of any A at NLRP1 rs12150220 and AA for SRL rs13334970 in APD KRAS wild-type patients (HR = 4.44, 95% CI:1.23-16.13, p-value = 0.005), which validated in two independent clinical cohorts involving BVZ, MAVERICC and TRIBE. Our findings highlight a key role for inflammation and ER signalling underpinning BVZ + chemotherapy responsiveness.

Benchmark performance of laparoscopic left lateral sectionectomy and right hepatectomy in expert centers.

BACKGROUND & AIMS: Herein, we aimed to establish benchmark values - based on a composite indicator of healthcare quality - for the performance of laparoscopic left lateral sectionectomy (LLLS) and laparoscopic right hepatectomy (LRH) using data from expert centers. METHODS: Data from a nationwide multicenter survey including all patients undergoing LLLS and LRH between 2000 and 2017 were analyzed. Textbook outcome (TO) completion was considered in patients fulfilling all 6 of the following characteristics: negative margins, no transfusion, no complication, no prolonged hospital stay, no readmission and no mortality. For each procedure, a cut-off laparoscopic liver resection (LLR) volume by center was associated with TO on multivariable analysis. These cut-offs defined the expert centers. The benchmark values were set at the 75th percentile of median outcomes among these expert centers. RESULTS: Among 4,400 LLRs performed in 29 centers, 855 patients who underwent LLLS and 488 who underwent LRH were identified. The overall incidences of TO after LLLS and LRH were 43.7% and 23.8%, respectively. LLR volume cut-offs of 25 LLR/year (odds ratio [OR] 2.45; bootstrap 95% CI 1.65-3.69; p = 0.001) and 35 LLR/year (OR 2.55; bootstrap 95% CI 1.34-5.63; p = 0.003) were independently associated with completion of TO after LLLS and LRH, respectively. Eight centers for LLLS and 6 centers for LRH, including 516 and 346 patients undergoing LLLS/LRH respectively, reached these cut-offs and were identified as expert centers. After LLLS, benchmark values of severe complication, mortality and TO completion were defined as ≤5.3%, ≤1.2% and ≥46.6%, respectively. After LRH, benchmark values of severe complication, mortality and TO completion were ≤20.4%, ≤2.8% and ≥24.2%, respectively. CONCLUSIONS: This study provides an up-to-date reference on the benchmark performance of LLLS and LRH in expert centers. LAY SUMMARY: In a nationwide French survey of laparoscopic liver resection, expert centers were defined according to the completion of a textbook outcome, which is a composite indicator of healthcare quality. Benchmark values regarding intra-operative details and outcomes were established using data from 516 patients with laparoscopic left lateral sectionectiomy and 346 patients with laparoscopic right hepatectomy from expert centers. These values should be used as a reference point to improve the quality of laparoscopic resections.

A five-year longitudinal study of the relation between end-stage kidney disease as the outcomes.

BACKGROUND: Patients with end-stage kidney disease (ESKD) are required to undergo consecutive time-based blood and biochemical tests to determine the progression of the disease according to changes in their blood and biochemical data. This study employed a random intercept model to investigate whether time-based blood and biochemical data present any notable clinical meaning that can be used to track disease progression. METHODS: This study conducted a retrospective analysis on the dialytic data of 148 patients with ESKD, who received hemodialysis between January 2005 and December 2015. The patients were all at least 20 years old, and the data used included patient demographic information and results for at least 60 blood and biochemical tests. A random intercept model was used to analyze the relationships among blood and biochemical test results, explanatory variables of patient comorbidities, and time. RESULTS: The age range of patients was between 33 and 98 years, with an average of 66.1 years and those over 65 years old comprising 51.3% (n = 76) of the total. Furthermore, hypertension was found to be the most common comorbidity among patients (87.2%, n = 129), followed by anemia (48.6%, n = 72), diabetes (47.3%, n = 70), dyslipidemia (19.6%, n = 29), and peptic ulcer (19.6%, n = 29). Coronary atherosclerotic heart disease is a comorbidity that can serve as a strong and independent marker for prognosis in patients with ESKD. Serum creatinine level can serve as an alternative indicator because patients with ESKD and comorbid diabetes may exhibit increased creatinine levels. CONCLUSIONS: The results of a parameter estimation for longitudinal data analysis suggested that comorbidity and time were critical variables influencing blood and biochemical test results. Furthermore, WBC and HBC, HCT, albumin, protein, and creatinine levels were recognized as variables of critical significance. The results obtained in this study indicate that multimorbidity increases the treatment burden on patients, leading to polypharmacy. For this reason, comprehensive care and treatment of ESKD cannot rely solely on data from one single time point; instead, longitudinal analysis and other data that can affect patient prognosis must also be considered.

A systematic approach to evaluate practice-based process- and outcome data applied to the treatment of neovascular age-related macular degeneration.

BACKGROUND: Following the principles of value-based health care, outcomes and processes of daily-practice eye care need to be systematically evaluated. We illustrate an approach that can be used to support data-driven quality improvements. We used patient data regarding the treatment of neovascular age-related macular degeneration (nAMD). METHODS: In a cohort study, we reviewed medical records of patients with nAMD confirmed on fluorescein angiography (FA). Patients were treated with intravitreal injections with bevacizumab; ranibizumab; or photodynamic therapy (PDT). Visual acuity (VA), ophthalmic exam results and treatments were recorded. VA was compared between treatments by linear mixed model. Diagnosis was re-evaluated on the original FAs. Outcome analysis was performed by 1) selecting VA as the relevant outcome parameter; 2) Preventing selection by comparing treatments with historical untreated cohort and cohorts from the literature, 3) correcting for confounding due to lesion type, and 4) identifying relevant process variables that affect the outcome. These were severity of disease at presentation, and doctor- and patient dependent process variables. RESULTS: In total, 473 eyes were included. At 12 months, change in VA was 0.54, 0.48, 0.09, and 0.07 LogMAR in the no-treatment, photodynamic therapy (PDT), bevacizumab, and ranibizumab groups, respectively. Lesion type on FA differed between groups. Diagnosis of nAMD could not be confirmed in 104 patients. Patient delay, inaccurate diagnosis and treatment intervals may have impacted outcomes. CONCLUSIONS: The effect of PDT was small to absent. Anti-VEGFs were effective and appeared as effective as in RCTs. Correct selection of a comparator cohort and addressing confounding, including confounding by indication and effect modification, are needed to achieve valid results and interpretation. Patient delay, diagnosis accuracy, indication for and application of treatment can potentially be improved to improve treatment outcomes. In a value-based care perspective, systematic evaluation of diagnostic accuracy, treatment indication, protocols, and outcomes of new interventions is needed at an early stage to improve outcomes.

Causal inference in continuous time: an example on prostate cancer therapy.

In marginal structural models (MSMs), time is traditionally treated as a discrete parameter. In survival analysis on the other hand, we study processes that develop in continuous time. Therefore, Røysland (2011. A martingale approach to continuous-time marginal structural models. Bernoulli 17, 895-915) developed the continuous-time MSMs, along with continuous-time weights. The continuous-time weights are conceptually similar to the inverse probability weights that are used in discrete time MSMs. Here, we demonstrate that continuous-time MSMs may be used in practice. First, we briefly describe the causal model assumptions using counting process notation, and we suggest how causal effect estimates can be derived by calculating continuous-time weights. Then, we describe how additive hazard models can be used to find such effect estimates. Finally, we apply this strategy to compare medium to long-term differences between the two prostate cancer treatments radical prostatectomy and radiation therapy, using data from the Norwegian Cancer Registry. In contrast to the results of a naive analysis, we find that the marginal cumulative incidence of treatment failure is similar between the strategies, accounting for the competing risk of other death.

Outcome measures for oncology alternative payment models: practical considerations and recommendations.

OBJECTIVES: This paper aims to synthesize existing scholarship on quality measures in oncology, with a specific focus on outcome-based quality measures, which are often underutilized. We also present a set of "core outcome measures" that may be considered in future oncology alternative payment models (APMs). STUDY DESIGN: Our research consists of a focused literature review, content analysis, and quality measure synthesis and categorization. METHODS: We conducted a focused literature review to generate key evidence on quality measures in oncology. We studied 7 oncology quality assessment frameworks, encompassing 142 quality metrics, and synthesized recommendations using the Center for Medicare and Medicaid Innovation APM toolkit, focusing on outcome measures. RESULTS: We present 34 outcome-based oncology quality measures for consideration, which are classified into 5 domains: clinical care (eg, hospital and emergency department visits, treatment effectiveness, mortality), safety (eg, infections, hospital adverse events), care coordination (for hospital and hospice care), patient and caregiver experience, and population health and prevention. Both general and indication-specific outcome measures should be considered in oncology APMs, as appropriate. Utilizing outcome-based measures will require addressing multiple challenges, ranging from risk adjustment to data quality assurance. CONCLUSIONS: Oncology care will benefit from a more rigorous approach to quality assessment. The success of oncology APMs will require a robust set of quality measures that are relevant to patients, providers, and payers.

Pooled data analysis of primary ventral (PVH) and incisional hernia (IH) repair is no more acceptable: results of a systematic review and metanalysis of current literature.

PURPOSE: Primary (PVHs) and incisional (IHs) ventral hernias represent a common indication for surgery. Nevertheless, most of the papers presented in literature analyze both types of defect together, thus potentially introducing a bias in the results of interpretation. The purpose of this systematic review and meta-analysis is to highlight the differences between these two entities. METHODS: Methods MEDLINE, Scopus, and Web of Science databases were reviewed to identify studies evaluating the outcomes of both open and laparoscopic repair with mesh of PVHs vs IHs. Search was restricted to English language literature. Risk of bias was assessed with MINORS score. Primary outcome was recurrence, and secondary outcomes were baseline characteristics and intraoperative and postoperative data. Fixed effects model was used unless significant heterogeneity, assessed with the Higgins I square (I2), was encountered. RESULTS: The search resulted in 783 hits, after screening; 11 retrospective trials were selected including 38,727 patients. Mean MINORS of included trials was 15.2 (range 5-21). The estimated pooled proportion difference for recurrence was - 0.09 (- 0.11; - 0.07) between the two groups in favor of the PVH group. On metanalysis, PVHs were smaller in area and diameters, affected younger and less comorbid patients, and were more frequently singular; the operative time and length of stay was quicker. Other complications did not differ significantly. CONCLUSION: Our paper supports the hypothesis that PVH and IH are different conditions with the latter being more challenging to treat. Accordingly, EHS classifications should be adopted systematically as well as pooling data analysis should be no longer performed in clinical trials.

Modality Selection for the Revascularization of Left Main Disease.

The management of severe left main (LM) disease remains controversial and continues to evolve as new evidence emerges. Patient selection for coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) relies on both predicting mortality with CABG from clinical characteristics using the Society of Thoracic Surgeons (STS) risk score and anatomical complexity, using the Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) score. LM stenting techniques continue to evolve; for bifurcation lesions, the use of the double-kiss crush technique may reduce the incidence of late target vessel revascularization. In patients with acute coronary syndrome (ACS) complicated by cardiogenic shock, PCI is likely the first-line option in those with anatomically amenable disease, whereas all other stable non-ST-elevated ACS should be treated similar to stable ischemic heart disease. Outcomes comparing CABG and PCI have been recently examined in 2 large randomized clinical trials. In general, early outcomes of periprocedural myocardial infarction and stroke favoured PCI or were not different from outcomes with CABG. However, the conclusions of both trials are at present discordant with respect to late major adverse cardiac and cerebral events; additional follow-up of the trial patients is important for informed patient decision making. The appropriate mode of revascularization should be selected according to patient clinical characteristics and the complexity of the coronary lesions according to European and American guidelines. In those with low or intermediate SYNTAX scores, particularly with high surgical risk, PCI may be preferred to CABG in most other scenarios. A multidisciplinary heart team is recommended to help individualize revascularization decisions.

To HTA or Not to HTA: Identifying the Factors Influencing the Rapid Review Outcome in Ireland.

OBJECTIVES: Reimbursement systems are evolving and endeavor to balance access and affordability. One such evolution in Ireland is the compulsory rapid review (RR) process, the outcome from which is a recommendation for a health technology assessment (HTA) or no HTA. For drugs that avoid an HTA, evaluation times are shorter, lengthy price negotiations are avoided, and access is faster. In the absence of formal decision-making criteria around the requirement of an HTA, this study examines the factors influencing the outcome of the RR process in Ireland. METHODS: A database was developed combining data from publicly available sources for drug evaluations conducted by the National Centre for PharmacoEconomics (NCPE) (January 2010-June 2017, n = 296). Because Irish cost data were not publicly available for all drugs, cost data from the Scottish Medicines Consortium were employed as a proxy. Employing logistic regressions, the factors influencing the RR outcome are revealed. RESULTS: After an RR, an HTA was recommended for 55% of drugs. The regression results revealed therapeutic area (endocrine, musculoskeletal, and neoplasm), first-in-class and orphan disease increased the probability of an HTA. Furthermore, when proxy costs were included, results revealed that every €1000 increase in annual drug costs per patient increased the probability of an HTA being required by 1% and that an HTA was more likely than no HTA when annual drug costs exceeded €15 000. CONCLUSION: Given the current focus on access and affordability, this study identifies the factors influencing the requirement of an HTA in Ireland.