Real-life Impact Research Articles

Impact of performance status on overall survival in patients with relapsed and/or refractory multiple myeloma: Real-life outcomes of daratumumab treatment.

Little is reported on the real-life impact of daratumumab in relapsed and/or refractory multiple myeloma patients (RRMM). We analyzed a cohort of 156 patients who received daratumumab as a single agent concerning ECOG status, eGFR, cytogenetics, lines of prior treatment, and their impact on survival. Eighty-two (53%) patients were triple refractory, 54 (35%) patients were single or double refractory, and 20 (12%) patients were non-refractory. Following daratumumab treatment, the progression-free survival (PFS) in these groups was 7.2%, 11.4%, and 53% (P<.001), and overall survival (OS) was 34%, 73%, and 58% (P<.001) at 36months, respectively. Poor ECOG, three lines of prior treatment, and triple refractoriness were all associated with inferior PFS and OS in a multivariate analysis including ECOG, high-risk chromosomal aberrations, refractoriness, number of treatment lines, and eGFR. Daratumumab remains an attractive treatment option, especially in patients with poor performance and increased frailty. Furthermore, our observations suggest that patients with ECOG 2 and 3 status require additional supportive and/or palliative therapies to compensate for a potentially effective but encompassing late-line therapy. In conclusion, further prospective studies are needed to elucidate the impact of ECOG 2 and 3 status in patients with RRMM.

Sustained adherence to ESC guideline-recommended medications is associated with lower long-term mortality in heart failure and reduced ejection fraction: Insights from the EPICAL2 cohort.

The real-life prognostic impact on long-term survival of continuous or discontinuous adherence to ESC guideline-recommended drugs in heart failure with reduced ejection fraction (HFrEF) patients has rarely been investigated. Here, we present the long-term association of longitudinal prescription of guideline-recommended drugs with 3-year all-cause and cardiovascular (CV) mortality in HFrEF patients. We used data from the EPICAL2 cohort study of 624 hospitalized HFrEF patients. Using the sequence analysis, we classified patients into five groups of long-term adherence according to the continuity/discontinuity of their prescription adherence to guidelines over a 3-year follow-up, as follow: 316 (50.6%) patients in the sustained adherence group, 163 (26.1%) in the sustained non-adherence group, 79 (12.6%) in the adherence to non-adherence group, 43 (6.9%) in the non-adherence to adherence group and 23 (3.7%) in the multiple switches group. The associations between all-cause mortality and CV mortality and the adherence groups were determined by Cox and Fine-Gray models, respectively. To account for immortal time bias, we performed a landmark analysis at 24months. Patients who died, prior to the landmark time, were excluded from this analysis and long-term adherence groups were redefined. After adjustment for confounding factors, as compared to the sustained non-adherence group, the sustained adherence group showed lower all-cause and CV mortality (hazard ratio HR=0.37 [0.25-0.56] and sub-distribution hazard ratio SHR=0.33 [0.20-0.56]). Both clinical outcomes were also significantly improved in the adherence to non-adherence group (HR=0.25 [0.13-0.45] and SHR=0.20 [0.10-0.41]), the non-adherence to adherence (HR=0.24 [0.11-0.55] and SHR=0.11 [0.04-0.30]), and for the multiple switches group (HR=0.13 [0.07-0.51] and SHR=0.12 [0.08-0.43]). Results from landmark analysis were comparable to the main results. As in all observational studies, our results may be affected by residual confounding related to unmeasured confounders, although we attempted to adjust for many confounders. Even a discontinuous prescription of the recommended drugs over time was associated with better long-term outcomes. In other words, whatever the time of HFrEF evolution, prescribing recommended drugs at some point was always better than never prescribing.

Which patients with pre-treated locally advanced or metastatic sarcoma benefit most from trabectedin treatment: First results of a retrospective study of the German Interdisciplinary Sarcoma Group (GISG-14 - ReTraSarc).

11554 Background: Despite the growing amount of published data regarding the outcomes of sarcoma patients treated with trabectedin, still some questions remain unanswered. The aim of the ReTraSarc trial (NCT03284320) was to evaluate the efficacy and safety of trabectedin in a large German population. Methods: Patients treated between 2007-2018 were retrospectively analyzed. All patients had histologically confirmed soft tissue (STS; n = 478) or bone (BS; n = 31) sarcoma; either metastatic (n = 468) or locally advanced (n = 41) disease, and had received at least one cycle of trabectedin. Based on follow-up data (until October 2019), progression-free survival (PFS) and overall survival (OS) after initiation of trabectedin treatment were estimated according to the Kaplan-Meier method. Results: A total of 509 patents were analyzed. Patients had a mean age of 54 years for STS and 30 years for BS-patients, and 25.4% of them aged &gt; 65 years. Overall, 71.4% of patients had a good performance status (ECOG 0/1), and 37.7% received two prior lines, 28.3% three and 34% received &gt; 3 prior lines of systemic treatment. Patients received a median of 3 cycles (IQR: 2-6 cycles) of trabectedin. Trabectedin resulted in an objective response rate (ORR) of 10% with a 37.4% of disease control rate (DCR). The median PFS and OS were 2.5 months (IQR: 1.4-6.1 months) and 8.2 months (IQR: 3-21 months), respectively. Significantly more patients with liposarcoma (22.1%; 95% CI: 15.2-32.2) were free from progression at 12 months after treatment as compared with patients with leiomyosarcoma (8.5%; 95% CI: 4.8-14.9). More analyses of effectiveness and safety are in progress (e.g. stratified per sarcoma subtypes or therapeutic line) and will be presented. Conclusions: The results of this real-life study, with a large number of patients and long-term follow-up, allow us to better analyze PFS and OS in sarcoma patients treated with trabectedin, given in different treatment lines and after dose modifications and/or cycle delays. Additionally, the results of this study enable us to evaluate the real-life impact of rechallenge with trabectedin in a further therapy line. Clinical trial information: NCT03284320 .

Impacts of the Coronavirus 2019 Pandemic on Gastrointestinal Endoscopy Volume and Diagnosis of Gastric and Colorectal Cancers: A Population-Based Study

Impacts of the Coronavirus 2019 Pandemic on Gastrointestinal Endoscopy Volume and Diagnosis of Gastric and Colorectal Cancers: A Population-Based Study

Utilization-focused scientific policy advice: a six-point checklist

ABSTRACT Knowledge utilization depends on how well the scientific community communicates knowledge to its target audiences’ needs. We argue that policy-relevant science communication can increase the real-life impact of scientific evidence by moving beyond political agenda-setting and providing concrete advice to policy drafters. Agenda-setting seeks to raise politicians’ and the wider public’s awareness of a problem (problem advice). However, for scientific evidence to translate into effective policy interventions, the scientific community and non-governmental organizations (NGOs) must also provide policy drafters with advice on policy design and implementation (policy advice). Political attention is volatile, and – except for particularly policy-driven and solution-focused actors – politicians have little incentive to address long-term issues such as climate change if voters do not punish short-term thinking. In contrast, the public administration (government agencies) carries out long-term expert work. Government agencies are therefore the primary recipients of evidence-based knowledge transfer that aims to create concrete policy solutions. We develop hands-on recommendations for tailoring scientific advice to the needs of policy drafters through a six-point checklist. Based on utilization-focused evaluation research, we argue that scientific evidence should not only address the causes of public problems but also the effectiveness of proposed policy solutions and the consequences of policy decisions. We also highlight the need to assess the political feasibility of a given policy proposal (potential oppositions and stumbling blocks) and its practical implementability (likely reaction of the target groups). Ensuring effective policy advice requires transdisciplinary dialogue between natural, social, and policy scientists, as well as dialogue between research and government agencies. Key policy insights There is a gap between public and political awareness of climate change issues and effective policy solutions. Due to their respective roles within the policy process, politicians and government agencies have different knowledge needs. In addition to providing politicians and the general public with problem advice, a specific form of policy advice, that is, policy-prescriptive evidence-based information, should be developed and provided for policy drafters within government agencies. Natural, social and policy scientists must team up to provide policy advice that is not only evidence-based but also utilization-focused.

Shattering Populists’ Rhetoric with Satire at Elections Times: The Effect of Humorously Holding Populists Accountable for Their Lack of Solutions

The popularity of populist parties has increased worldwide, and disproportionate media attention for these parties arguably fueled their success. We empirically test our theoretical argument that political satire—with its humor, focus on internal contradictions, and lack of journalistic principles regarding objectivity and facticity—may be an effective antidote to populism’s success. Using a representative panel survey that functions as a natural experiment in the context of the Netherlands, we show that consumption of the satire show Zondag met Lubach (ZML) indeed lowered support for a right-wing populist party (PVV), its leader (Wilders), and the perceived capability of this party. Specifically, this study shows how satirically revealing the “weak spot” of populism (i.e., lacking concrete treatment recommendations) lowers populist support particularly among citizens already inclined to vote for populist parties. These findings have important democratic implications as they reveal that satire can have a real-life impact on the political decisions that voters make.

The Mobile-Based 6-Minute Walk Test: Usability Study and Algorithm Development and Validation.

BackgroundThe 6-min walk test (6MWT) is a convenient method for assessing functional capacity in patients with cardiopulmonary conditions. It is usually performed in the context of a hospital clinic and thus requires the involvement of hospital staff and facilities, with their associated costs.ObjectiveThis study aimed to develop a mobile phone–based system that allows patients to perform the 6MWT in the community.MethodsWe developed 2 algorithms to compute the distance walked during a 6MWT using sensors embedded in a mobile phone. One algorithm makes use of the global positioning system to track the location of the phone when outdoors and hence computes the distance travelled. The other algorithm is meant to be used indoors and exploits the inertial sensors built into the phone to detect U-turns when patients walk back and forth along a corridor of fixed length. We included these algorithms in a mobile phone app, integrated with wireless pulse oximeters and a back-end server. We performed Bland-Altman analysis of the difference between the distances estimated by the phone and by a reference trundle wheel on 49 indoor tests and 30 outdoor tests, with 11 different mobile phones (both Apple iOS and Google Android operating systems). We also assessed usability aspects related to the app in a discussion group with patients and clinicians using a technology acceptance model to guide discussion.ResultsThe mean difference between the mobile phone-estimated distances and the reference values was −2.013 m (SD 7.84 m) for the indoor algorithm and −0.80 m (SD 18.56 m) for the outdoor algorithm. The absolute maximum difference was, in both cases, below the clinically significant threshold. A total of 2 pulmonary hypertension patients, 1 cardiologist, 2 physiologists, and 1 nurse took part in the discussion group, where issues arising from the use of the 6MWT in hospital were identified. The app was demonstrated to be usable, and the 2 patients were keen to use it in the long term.ConclusionsThe system described in this paper allows patients to perform the 6MWT at a place of their convenience. In addition, the use of pulse oximetry allows more information to be generated about the patient’s health status and, possibly, be more relevant to the real-life impact of their condition. Preliminary assessment has shown that the developed 6MWT app is highly accurate and well accepted by its users. Further tests are needed to assess its clinical value.

Trauma-afflicted refugees’ experiences of participating in physical activity and exercise treatment: a qualitative study based on focus group discussions

ABSTRACT Background: Refugees with prolonged and repeated experiences of trauma, often in combination with post-migration living difficulties, are subjected to severe levels of stress and stress-related ill health, including post-traumatic stress disorder (PTSD). Physical activity (PA) is well-established as an effective stress reliever. However, the effect of PA and exercise has received scarce attention in the context of PTSD, and particularly in the field of refugees’ health. Objective: The objective of this study was to explore the experience of participation in PA and exercise as part of the treatment for trauma-afflicted refugees. Method: An explorative qualitative research design was used. Six focus group discussions were conducted with 33 female and male participants that had experience of group-based PA and exercise treatment. The gathered data was analysed by qualitative content analysis. Results: The analysis resulted in one over-arching theme reflecting the participants overall experience of PA and exercise as a process of building resilience. Participants experienced improvements in both physical and mental health domains. Increased self-awareness and self-confidence were seen as additional important benefits, and the interruption of daily stressors provided a sense of relief and recovery. The treatment group settings were experienced as becoming a vehicle for overcoming social fear and isolation, which also carried an empowering and strength-building impact over to participants’ family life and social relationships. Treatment characteristics were experienced as highly supportive and often referred to as the basis of other positive experiences and perceived health benefits. Conclusions: The result of this study outlines a detailed account of trauma-afflicted refugees’ experiences and preferences of PA and exercise-based treatment from a broad range of perspectives. These findings provide a starting point for future research in this field and indicate a particular need for both research and intervention development to include the real-life impact of participating in such treatments.

Developmental toxicity of arsenic: a drift from the classical dose-response relationship.

Arsenic is a well-known natural environmental contaminant distributed in food, water, air, and soil. The developmental toxicity of arsenic exposure is a significant concern in large parts of the world. Unlike acute toxic exposure, the classical dose-response relationship is not adequate for estimating the possible impact of chronic low-level arsenic exposure. The real-life risk and impact assessments require the consideration of the co-exposure to multiple toxins, individual genetic and nutritional predisposition, and the particularly vulnerable stages of the neurodevelopment. This context shifts the assessment model away from the 'one-exposure-for-one-health-effect.' We underscore the need for a comprehensive risk assessment that takes into account all relevant determinants. We aim to elaborate a model that can serve as a basis for an understanding of complex interacting factors in a long-lasting and ongoing low-level arsenic exposure, to identify, protect, and support the children at risk.

Paramedics and serious illness: communication training

ObjectivesThe need to empower Ambulance Service staff at the point of delivery of end of life care (EoLC) is crucial. We describe the delivery, outcomes and potential impact of the...

BOne HEalth ManagEment in Patients with Early Breast Cancer: A Retrospective Italian Osteoncology Center "Real-Life" Experience (BOHEME Study).

Background: We assessed the real-life clinical impact of bone health management in patients with breast cancer (BC) receiving adjuvant endocrine therapy at an Italian Osteoncology Center. Methods: Pre- and post-menopausal women undergoing adjuvant endocrine therapy for early-stage BC who came to our institute for their first bone health evaluation from January 2011 to June 2016 were considered in this retrospective observational study. Results: 1125 pre- and post-menopausal early-stage BC patients (209 and 916, respectively) were evaluated. Median age was 61 years (range 26–88). In the pre-menopausal group, spinal x-ray revealed that 10 patients (4.7%) had a morphometric vertebral fracture. Higher age (OR: 1.14; 95% CI: 1.01–1.29) and bone mineral density (BMD) ≤ −2.5 (OR: 14.45; 95% CI: 1.70–122.67) were associated with a higher risk of bone fracture. The overall frequency of bone fracture was 17.6% (n = 161) in post-menopausal patients and a lower risk for bone fractures was associated with tamoxifen or other treatments (OR: 0.25; 95% CI: 0.12–0.53), presence of back pain (OR: 1.65; 95% CI: 1.16–2.36), lower BMD (OR: 2.09 in patients with T-score ≤ 2.5; 95% CI: 1.21–3.59) and lower vitamin D levels (OR: 1.57 in patients with ≤ 10 ng/mL; 95% CI: 1.05–2.34) in univariate analysis. Conclusion: Our findings confirm that bone health management should be an integral part of long-term cancer care.

2832 Real Life Impact of Physician Awareness of a Positive Stool DNA Test on Subsequent Colonoscopy Outcome in Colorectal Cancer Screening

INTRODUCTION: A recent study that included 244 subjects has looked into clinical outcome of colonoscopy based on the physician’s awareness of the positive result. That study showed significant differences in colonoscopy findings. We present a larger real-life study on the impact of physician awareness of a positive stool DNA test on colonoscopy results. METHODS: Chart review of 1413 patients who had a positive stool DNA followed by documented subsequent colonoscopy was done. Attention was made to the indication of the procedure in the colonoscopy report. A total of 5 patients were excluded, 3 of them had unknown indication and 2 of them had a finding of “other carcinoma” aside from adenocarcinoma. Index lesions were recorded and patients were divided in 2 groups. Group 1 included patient who had indication of “stool DNA testing” or its equivalent, while group 2 included all the other indications assuming that the provider was not aware of the positive stool DNA testing. Advanced adenoma was defined as an adenoma that is larger than 10 mm or had high risk features such as villous transformation or high grade dysplasia. Nonadvanced adenoma was defined as an adenoma that is smaller than 10 mm and had no high risk features. Statistical analysis with Chi-square was done to compare the proportions. A P-value &lt; 0.05 was considered to be statistically significant. RESULTS: Out of the 1408 patients included in the analysis, 979 (70%) patients had an indication of “stool DNA testing” or its equivalent while 429 (30%) had another indication. Results of group 1 and group 2 were as follows. “Adenocarcinoma” was found in 1.84% vs. 1.4% respectively (P = 0.56). “Advanced adenoma” was found in 24.82% vs. 21.21% respectively (P = 0.14). “10 mm adenoma” was found in 7.25% vs. 6.99% respectively (P = 0.86). Non advanced adenoma was found in 28.7% vs. 31.24% respectively (P = 0.57). Finally, no adenomas were found in 37.39% vs. 39.16% respectively (P = 0.33). CONCLUSION: Following a positive stool DNA test, 1 out of 3 colonoscopies are done without the physician’s awareness of the positive result. Fortunately, there was no difference in the outcome of colonoscopy whether the physician was aware of the positive result or not.

Preliminary development of proxy-rated quality-of-life scales for children and adults with Niemann-Pick type C

ObjectivesNiemann-Pick disease type C (NPC) is a rare life-limiting disease for which there is no cure. No scales currently exist to measure the impact of medication, physical therapy or clinical trials. The aim of this study was to develop age-appropriate Quality-of-Life (QoL) scales to measure the impact of NPC on children and adults.DesignScale development study using a phenomenological approach to data generation and analysis.MethodsFourteen interviews were conducted with people living with NPC and/or their parents/carers. Themes were generated and examined against an existential-phenomenological theory of wellbeing. A matrix was constructed to represent the phenomenological insight gained on participants’ subjective experiences and a bank of items that were related to their QoL was developed.ResultsNPC quality-of-life questionnaires for children (NPCQLQ-C) and adults (NPCQLQ-A) proxy prototype scales were produced and completed by 23 parents/carers of children (child age mean = 8.61 years) and 20 parents/carers of adults (adult age = 33.4 years). Reliability analysis resulted in a 15-item NPCQLQ-C and a 30-item NPCQLQ-A, which showed excellent internal consistency, Cronbach’s α = 0.925 and 0.947, respectively.ConclusionThe NPCQLQ-C and NPCQLQ-A are the first disease-specific QoL scales to be developed for people living with NPC. This novel approach to scale development values the experiential, real life impact of living with NPC and focused on the lived-experiences and impact on QoL. The scales will enable healthcare professionals and researchers to have a better understanding and quantifiable measurement of the impact of living with NPC on a patient’s daily life.

Giving Voice to Medicaid: Waivers, Public Comments and Kentucky's "Secret Sauce".

In the 21st century the opportunity for the public to comment to an administrative agency typically means an invitation to go to a website, type words into a box, and hit send. Many advocacy groups provide templates for people to submit a statement in support or opposition to specific proposals. However, standardized comments do not capture the voice of Medicaid. They do not share people's personal experiences and insights. This article describes how consumer advocates in Kentucky devised a strategy, their Secret Sauce, to help consumers participate in the public comment process that is now required for Section 1115 Medicaid demonstration waiver applications. It shows how advocates can help real people's voices be heard in the public comment process, not through templates but through a process that assists people to tell their own stories in their own words. This is Medicaid's voice, the stories of real people who rely on Medicaid. Medicaid's voice can help policy makers understand the real-life impact of policy choices they make. It can also provide relevant evidence for courts reviewing the Secretary's grant of a Section 1115 waiver. Medicaid's voice can also help build political momentum, bringing those who rely on Medicaid to the polls and into the political conversation about the future of Medicaid.

PS-137-A multicentric study on real-life impact of nivolumab in patients with hepatocellular carcinoma

PS-137-A multicentric study on real-life impact of nivolumab in patients with hepatocellular carcinoma

Real life impact of educating nurses in tobacco cessation intervention

Real life impact of educating nurses in tobacco cessation intervention

Impact des comorbidités sur la stabilité de l’hémoglobine chez des patients insuffisants rénaux chroniques en hémodialyse, traités par CERA en pratique courante : l’étude MIRIADE

This national, prospective and multicenter study aimed to describe the real-life impact of comorbidities on hemoglobin stability in patients with chronic kidney disease on hemodialysis, treated with CERA in relay of an erythropoietin stimulating agent. Comorbidities were defined by the Charlson Index (adjusted on age) and hemoglobin stability as a variation of ±1g/dL after the 6-month treatment period. The 585 analyzed patients were distributed as follows according to the adjusted Charlson index: score≤3 (12% of patients), 4≤score≤5 (17%), 6≤score≤7 (31%) and score≥8 (40%). At CERA start, its median monthly dose was of 100μg for the overall population, with no changes during the treatment period and with little variation according to the comorbidity score. Patients with stable hemoglobin (56%, 67% if score≤3) were more numerous to reach the therapeutic target range between 10 and 12g/dL after 6 months (85% versus 43% if not stable hemoglobin). Patients with low C-reactive protein value (≤5mg/L ; P=0.04), no red blood cell transfusion (P=0.03), or no/low dose of intravenous iron (≤200mg ; P=0.03) were more likely to reach stable hemoglobin under CERA after 6 months. Among the 644 CERA-treated patients, 4 patients (<1%) had one serious adverse event related to treatment. A stable hemoglobin within the therapeutic target was reached in the majority of the patients after 6 months in current practice with a lower CERA dose, regardless of the comorbidities scores of patients on hemodialysis.

Results of PONDx, a prospective multicenter study of the Oncotype DX® breast cancer assay: Real-life utilization and decision impact in French clinical practice

Adjuvant chemotherapy shows clear benefits in HER2-positive and triple-negative breast cancer (BC). Its benefits are less universal in BCs expressing hormone receptors. The 21-gene Oncotype DX® Breast Recurrence Score test was designed for HR+, HER2– early-stage BC before decision on adjuvant chemotherapy. Its validity and utility was demonstrated prospectively across multiple studies.The observational study PONDx characterized the use of Oncotype DX® Breast in routine practice in France and evaluated its decision impact. Of 882 ER-positive BC patients (67% postmenopausal), most (79%) had N0/Nmic node involvement, grade 2 tumors (68%), tumor size 1–5 cm (88%), and ductal histology (78%). BCs with histopathologically elevated recurrence risk included grade 3: 18%; N1: 21%; Ki67 > 20%: 31%.Recurrence Score results by prognostic category were: <18: 54%, 18–30: 36%; >30: 10%. Compared to recommendations before individual availability of the score, results prompted net absolute reductions in chemotherapy recommendations of 36% (total population), and 29% (grade 3 and/or Ki67 > 20% histologies). Decisions reflected prognostic implications: in the Recurrence Score <18 category, 95% of patients received recommendations of hormonal therapy only, in the >30 category, 97.5% were recommended additional chemotherapy; 95% followed the final recommendations of their physicians.The Recurrence Score provides independent predictive and prognostic information in ER + N0/N1 early BC, including high-risk subgroups. PONDx further characterizes the population where the test is beneficial in real-life use and fits current clinical needs.Oncotype DX® Breast enables relevant net reductions in chemotherapy use, sparing patients from serious toxicities. Its therapeutic implications are highly accepted by physicians and patients.

Hypoglycaemia is associated with increased risk of fractures in patients with type 2 diabetes mellitus: a cohort study.

Objective Type 2 diabetes is associated with an increased risk of fracture. Any factor that incrementally increases this risk should be taken into account when individualising treatment. Hypoglycaemia is a common complication of antidiabetes medications and suggested as a risk factor for fractures; yet, its real-life clinical impact is unclear. Design A population-based, retrospective open cohort study using routinely collected data between 1st of January 1995 and 1st of May 2016 in The Health Improvement Network (THIN) database. Methods Patients with type 2 diabetes mellitus with documented hypoglycaemic events were compared to randomly matched patients with type 2 diabetes mellitus without documented hypoglycaemic events matched to exposed patients on age, sex, duration of diabetes and BMI. The primary outcome was any incident fracture. Secondary outcome was incident fragility (osteoporotic) fracture. Results A total of 41 163 patients with type 2 diabetes were included: 14 147 patients in the exposed cohort and 27 016 patients in the unexposed cohort. Patients with a documented hypoglycaemic event were significantly more likely to sustain any fracture compared to patients with no record of hypoglycaemic events: adjusted IRR = 1.20 (95% CI: 1.12-1.30; P < 0.0001). Patients who had a documented hypoglycaemic event were significantly more likely to suffer a fragility fracture compared to controls: adjusted IRR = 1.24 (95% CI: 1.13-1.37; P < 0.0001). Conclusions Hypoglycaemic events are a significant risk factor for fractures in patients with diabetes mellitus. This observation is clinically relevant when individualising targets for glycaemic control and selecting antidiabetic agents.

Antiretroviral treatment indications and adherence to the German-Austrian treatment initiation guidelines in the German ClinSurv HIV Cohort between 1999 and 2016.

The aim of the study was to assess guideline adherence to combined antiretroviral therapy (ART) in the German ClinSurv HIV Cohort and the real-life impact of the Strategic Timing of Antiretroviral Therapy (START) study, to identify patients not treated as recommended by new guidelines. We used data from the multicenter ClinSurv cohort of the Robert-Koch-Institute (RKI) between 1999 and 2016. Inclusion criteria were people living with HIV/AIDS, ≥ 18years of age and cART naïve at the first visit (FV). Adherence was defined as starting cART within 6 months of crossing the CD4+ T cell threshold as suggested by the German-Austrian treatment guidelines. Logistic regression was used to identify factors associated with non-adherence. 11,817 patients met the inclusion criteria. We observed an overall adherence rate of 60%, in patients with treatment indication who started cART timely between 2002 and 2015. Adherence rate increased constantly, demonstrating a potential increase in patients, with treatment indication, starting cART within 6 months of presentation from 55% in 2008 to 94% in 2015. Patients reporting injection drug use (OR 2.18, 95% CI 1.70-2.95) and patients between 18years and 39years of age at the time of their first visit (OR 2.89, 95% CI 1.35-6.18) were identified as risk groups associated with non-adherence. The majority of patients below the CD4+ T cell count threshold of applicable guidelines initiated treatment within 6 months. We observed a slowly diminishing proportion of patients not starting cART timely. Delayed treatment was more frequent in patients reporting injection drug use.