Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm

Background Four randomized controlled trials have demonstrated the short-term efficacy and safety of transoral esophagogastric fundoplication (TF) performed with the EsophyX® device in eliminating troublesome gastroesophageal reflux disease (GERD) symptoms in well-selected patient populations. The aim of this study was to assess the durability of these outcomes at 3 years post-procedure. Methods The TF EsophyX versus Medical PPI Open Label trial was conducted in seven US sites. Between June and August 2012, we enrolled patients with small (\u3c2 cm) or absent hiatal hernias who suffered from troublesome GERD symptoms while on PPI therapy for at least 6 months and had abnormal esophageal acid exposure (EAE). Randomization was to TF group (n = 40) or to PPI group (n = 23). Following evaluation at 6 months, all remaining PPI patients (n = 21) elected to undergo crossover to TF. Fifty-two patients were assessed at 3 years for (1) GERD symptom resolution using three GERD-specific quality of life questionnaires, (2) healing of esophagitis using endoscopy, (3) EAE using 48-h Bravo testing, and (4) discontinuation of PPI use. Two patients who underwent revisional procedures by year 3 were included in the final analysis. Results At 3-year follow-up, elimination of troublesome regurgitation and all atypical symptoms was reported by 90 % (37/41) and 88 % (42/48) of patients, respectively. The mean Reflux Symptom Index score improved from 22.2 (9.2) on PPIs at screening to 4 (7.1) off PPIs 3 years post-TF, p \u3c 0.0001. The mean total % time pH \u3c4 improved from 10.5 (3.5) to 7.8 (5.7),p = 0.0283. Esophagitis was healed in 86 % (19/22) of patients. At the end of study, 71 % (37/52) of patients had discontinued PPI therapy. All outcome measures remained stable between 1-, 2-, and 3-year follow-ups. Conclusion This study demonstrates that TF can be used to achieve long-term control of chronic GERD symptoms, healing of esophagitis, and improvement in EAE

Using Social Marketing to Engage Extension Audiences: Lessons from an Effort Targeting Woodland Owners

Social marketing involves applying traditional commercial marketing techniques to public good outcomes. We share findings from use of this approach in reaching woodland owners to promote sustainable forestry in southwest Wisconsin. We experimentally tested three direct mail campaigns. Each included two offers—a free handbook and a free forester visit, but the campaigns varied in terms of landowner segments and marketing messages. Key results across the campaigns include consistent performance of the offers (handbook 17%–19%, forester visit 3%–5%) but varied effects of segment and message. Our results suggest that social marketing can pay dividends in reaching landowners and, potentially, other Extension clientele, but there is more to learn

How Qualitative Methods Contribute to Understanding Combination Antiretroviral Therapy Adherence

Strict adherence to medication regimens is generally required to obtain optimal response to combination antiretroviral therapy (ART). Yet, we have made limited progress in developing strategies to decrease the prevalence of nonadherence. As we work to understand adherence in developed countries, the introduction of ART in resource-poor settings raises novel challenges. Qualitative research is a scientific approach that uses methods such as observation, interviews, and verbal interactions to gather rich in-depth information about how something is experienced. It seeks to understand the beliefs, values, and processes underlying behavioral patterns. Qualitative methods provide powerful tools for understanding adherence. Culture-specific influences, medication beliefs, access, stigma, reasons for nonadherence, patterns of medication taking, and intervention fidelity and measurement development are areas ripe for qualitative inquiry. A disregard for the social and cultural context of adherence or the imposition of adherence models inconsistent with local values and practices is likely to produce irrelevant or ineffective interventions. Qualitative methods remain underused in adherence research. We review appropriate qualitative methods for and provide an overview of the qualitative research on ART nonadherence. We discuss the rationales for using qualitative methods, present 2 case examples illustrating their use, and discuss possible institutional barriers to their acceptance

Directly observed antiretroviral therapy: a systematic review and meta-analysis of randomised clinical trials.

BACKGROUND: Directly observed therapy has been recommended to improve adherence for patients with HIV infection who are on highly active antiretroviral therapy, but the benefit and cost-effectiveness of this approach has not been established conclusively. We did a systematic review and meta-analysis of randomised trials of directly observed versus self-administered antiretroviral treatment. METHODS: We did duplicate searches of databases (from inception to July 27, 2009), searchable websites of major HIV conferences (up to July, 2009), and lay publications and websites (March-July, 2009) to identify randomised trials assessing directly observed therapy to promote adherence to antiretroviral therapy in adults. Our primary outcome was virological suppression at study completion. We calculated relative risks (95% CIs), and pooled estimates using a random-effects method. FINDINGS: 12 studies met our inclusion criteria; four of these were done in groups that were judged to be at high risk of poor adherence (drug users and homeless people). Ten studies reported on the primary outcome (n=1862 participants); we calculated a pooled relative risk of 1.04 (95% CI 0.91-1.20, p=0.55), and noted moderate heterogeneity between the studies (I(2)= 53.8%, 95% CI 0-75.7, p=0.0247) for directly observed versus self-administered treatment. INTERPRETATION: Directly observed antiretroviral therapy seems to offer no benefit over self-administered treatment, which calls into question the use of such an approach to support adherence in the general patient population. FUNDING: None

Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: The TEMPO randomized clinical trial

Background. Incomplete control of troublesome regurgitation and extraesophageal manifestations of chronic gastroesophageal reflux disease (GERD) is a known limitation of proton pump inhibitor (PPI) therapy. This multicenter randomized study compared the efficacy of transoral incisionless fundoplication (TIF) against PPIs in controlling these symptoms in patients with small hiatal hernias. Methods. Between June and August 2012, 63 patients were randomized at 7 US community hospitals. Patients in the PPI group were placed on maximum standard dose (MSD). Patients in the TIF group underwent esophagogastric fundoplication using the EsophyX2 device. Primary outcome was elimination of daily troublesome regurgitation or extraesophageal symptoms. Secondary outcomes were normalization of esophageal acid exposure (EAE), PPI usage and healing of esophagitis. Results. Of 63 randomized patients (40 TIF and 23 PPI), 3 were lost to follow-up leaving 39 TIF and 21 PPI patients for analysis. At 6-month follow-up, troublesome regurgitation was eliminated in 97% of TIF patients versus 50% of PPI patients, relative risk (RR) = 1.9, 95% confidence interval (CI) = 1.2-3.11 (P = .006). Globally, 62% of TIF patients experienced elimination of regurgitation and extraesophageal symptoms versus 5% of PPI patients, RR = 12.9, 95% CI = 1.9-88.9 (P = .009). EAE was normalized in 54% of TIF patients (off PPIs) versus 52% of PPI patients (on MSD), RR = 1.0, 95% CI = 0.6-1.7 (P = .914). Ninety percent of TIF patients were off PPIs. Conclusion. At 6-month follow-up, TIF was more effective than MSD PPI therapy in eliminating troublesome regurgitation and extraesophageal symptoms of GERD

Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study.

Background The aim of this randomized, crossover study was to determine if transoral fundoplication (TF) could further improve clinical outcomes in partial responders to high-dose (HD) proton-pump inhibitor (PPI) therapy and to evaluate durability of TF. Methods In seven United States centers, patients with hiatal hernia ≤2 cm and abnormal esophageal acid exposure (EAE) were randomized to TF (n = 40) or HD PPIs (n = 23) group. At 6-month follow-up, PPI patients underwent crossover. We assessed clinical outcomes 6-month post TF in crossover patients (COP), as compared to 6-month of HD PPI therapy, and 12-month outcomes in patients initially randomized to TF. The primary outcome was symptom control evaluated by Reflux Disease Questionnaire and Reflux Symptom Index. Secondary outcomes included healing of esophagitis, normalization of EAE and PPI use after TF. We analyzed 21 COP and 39 TF patients. McNemar’s test or Fisher exact test was used to compare proportions. Results Of 63 randomized patients, 3 were lost to follow-up, leaving 39 TF and 21 COP for analyses. In the COP, TF further improved control of regurgitation and of atypical symptoms achieved after six months of HD PPIs. Of 20 patients with GERD symptoms after six months of high-dose PPI therapy, 65% (13/20) reported global elimination of troublesome regurgitation and atypical symptoms post TF off PPIs; 67% (6/9) reported no troublesome regurgitation. Esophagitis further healed in 75% (6/8) of patients. Seventy-one percent of COP patients were off PPIs six months following TF. Normalization of EAE decreased from 52% after HD PPIs (on PPIs) to 33% after TF (off PPIs), p =0.388. In the original TF group, 12-month post TF, 77% of patients achieved complete symptom control, 82% ceased PPI therapy, 100% healed esophagitis and 45% normalized EAE. Conclusions The results of this study indicate that in patients with incomplete symptom control on high-dose PPI therapy TF may provide further elimination of symptoms and esophagitis healing. In the original TF group, the clinical outcomes of TF remained stable between 6- and 12-month follow-up. Trial registration Clinicaltrials.gov: NCT01647958

The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective.

BACKGROUND: Questions remain about the therapeutic durability of transoral incisionless fundoplication (TIF). In this study, clinical outcomes were evaluated at 5 years post-TIF 2.0. METHODS: A total of 63 chronic gastroesophageal reflux disease (GERD) sufferers with troublesome symptoms refractory to proton pump inhibitor (PPI) therapy, absent or ≤2 cm hiatal hernia, and abnormal esophageal acid exposure were randomized to the TIF group or PPI group. Following the 6-month evaluation, all patients in the PPI group elected for crossover to TIF; therefore, all 63 patients underwent TIF 2.0 with EsophyX RESULTS: Of 63 patients, 60 were available at 1 year, 52 at 3 years, and 44 at 5 years for evaluation. Troublesome regurgitation was eliminated in 88% of patients at 1 year, 90% at 3 years, and 86% at 5 years. Resolution of troublesome atypical symptoms was achieved in 82% of patients at 1 year, 88% at 3 years, and 80% at 5 years. No serious adverse events occurred. There were 3 reoperations by the end of the 5-year follow-up. At the 5-year follow-up, 34% of patients were on daily PPI therapy as compared with 100% of patients at screening. The total GERD Health-related quality-of-life score improved by decreasing from 22.2 to 6.8 at 5 years ( P \u3c .001). CONCLUSION: In this patient population, the TIF 2.0 procedure provided safe and sustained long-term elimination of troublesome GERD symptoms

Sirkulær masseforvaltning. Materialstrømsanalyse av overskuddsmasser fra bygg- og anleggsnæringen

Prosjektet "Sirkulær masseforvaltning" skal utvikle nye tjenester for å effektivisere bruk, ombruk og gjenvinning samt lagring og transport av byggeråstoff mellom aktører i bygg- og anleggsbransjen. Dette omfatter både gravemasser og sprengte steinmasser. Massehåndtering er ofte en utfordring i bygg- og anleggsprosjekter. Utfordringen er knyttet til masseoverskudd og masseunderskudd, hvor et enkelt prosjekt kan ha både overskudd og underskudd, men i ulike faser av gjennomføringen eller av ulike kvaliteter. Bruk av massene internt i prosjekter begrenses ofte av flere faktorer, slik som • mangel på nødvendig areal til å mellomlagre massene fra de tas ut til de skal brukes • massenes kvalitet med tanke på ulike bruksformål • mangel på nødvendig areal eller riktige forhold (støy, støv etc.) for å kunne prosessere ønsket produkt av massene lokalt. I et slikt grensesnitt er det nødvendig å se masseuttaket fra prosjekter i et geografisk område i sammenheng. Gjennom prosjektet "Sirkulær masseforvaltning" er det et mål å finne gode løsninger slik at man både kan identifisere gjenbrukspotensialet i overskuddsmasser fra et eller flere prosjekt med masseoverskudd og sikre tiltak for håndtering, transport, produksjon, testing og dokumentasjon så de kan benyttes til de formål de er best mulig egnet til. Det vil bidra til en mer effektiv ressursutnyttelse ved redusert behov for deponiarealer og uttak av jomfruelige masser. Der forholdene ligger til rette for det kan det også bidra til redusert CO2-fotavtrykk ved redusert behov for massetransport på grunn av større andel returlass/mindre tomtransport ved mindre deponering, at de enkelte masser håndteres færre ganger, og i enkelte tilfeller muligheter for transport direkte mellom prosjekter med nærhet til hverandre. Denne rapporten er en del av arbeidspakke "H1 Materialstrømsanalyser" og har fokus på ressurstilgang og materialflyt på tre nivåer: nasjonalt, regionalt og prosjektnivå. I dette ligger både innsamling og kartlegging av data, men også en evaluering av datakilder med tanke på kvalitet og tilgjengelighet. Byggeråstoff er essensielle for all samfunnsutvikling, og hvert år trengs det store mengder sand, grus og pukk for å bygge og vedlikeholde veger, hus, og vann-, energi- og kommunika-sjonsinfrastruktur. Basert på mineralstatistikken forbruker hver nordmann i gjennomsnitt ca. 13 tonn mineralske byggeråstoff hvert år [6]. Dette tallet er sannsynligvis for lavt da mineralstatistikken ikke omfatter uttak av såkalte ikke-konsesjonspliktige masser. Med dette menes masser fra infrastrukturprosjekter eller uttak som hovedsakelig er en del av annen utnyttelse av grunnen, for eksempel grunnarbeider i forbindelse med utvikling av næringsareal og annen bygge-aktivitet. Med bakgrunn i dette har prosjektet Sirkulær masseforvaltning kommet fram til seks anbe-falinger: #1 Systemperspektivet: Økt ombruk må bli en del av framtiden, jf. Det grønne skiftet. I dette ligger blant annet større fokus på utarbeidelse av gode massehåndteringsplaner, økt tilgang på massemottak lokalt slik at transportdistanser kan reduseres samt insentiver for god ressurs-utnyttelse. #2 Nasjonal kunnskapsbase undergrunn: Det må etableres en felles nasjonal kunnskapsdata-base med obligatorisk innrapportering av geologisk informasjon, både fra offentlige og private aktører. En slik database bør forvaltes av en offentlig aktør og være åpent tilgjengelig. #3 Ressurssikring og bærekraftig ressursutnyttelse: Sørge for tilgang til riktige masser til riktig formål. Det innebærer blant annet at man gjennom statlige føringer og retningslinjer sikrer tilgang på masser og massemottak/mellomlager på alle nivåer, både nasjonalt, regionalt og lokalt. I dette ligger også økt bevisstgjøring knyttet til behovet for byggematerialer, i tillegg til hvilke krav som settes til masser innenfor ulike bruksområder. #4 Tilrettelegging av markedet for sirkulær masseforvaltning: Tilgjengeliggjøre relevante data over framtidige (planlagte) masser som vil oppstå og knytte disse opp mot materialbehovet i et område. #5 Statistikk og data over fullført uttak: Produksjonsmengder av masser fra både konsesjonert uttak og uttak gjennom bygg- og anleggsprosjekter bør inngå i årlige statistikker. Slike statistiske data må tilgjengeliggjøres på detaljnivå (stedfestet med koordinat) for å være samfunnsnyttige. #6 Informasjonsinfrastruktur for bærekraftig ressursbruk: Det bør etableres en nasjonal informasjonsinfrastruktur for bærekraftig ressursbruk som kobler forvaltning av ressurser i undergrunnen mot planlegging og forvaltning av arealer og materialer i det bygde miljø.publishedVersio

Core repulsion effects in alkali trimers

The present paper is related to a talk presented during the Symposium on Coherent Control and Ultracold Chemistry held during the Sixth Congress of the International Society for Theoretical Chemical Physics (ISTCP-VI, July 2008). The talk was entitled "Electronic structure properties of alkali dimers and trimers. Prospects for alignment of ultracold molecules". Here we report on the electrostatic repulsion forces of the ionic cores at short separation, involved when the potential energy surfaces of alkali trimers are calculated with a quantum chemistry approach based on effective large-core potentials for ionic core description. We demonstrate that such forces in the triatomic molecule can be obtained as the sum of three pairwise terms. We illustrate our results on the lowest electronic states of Cs$_3$, which are computed for the first time within a full configuration interaction based on a large Gaussian basis set. As a preliminary section, we also propose a brief introduction about the importance of alkali trimer systems in the context of cold and ultracold molecules

Sustainability of the global sand system in the Anthropocene

Sand, gravel, and crushed rock, together referred to as construction aggregates, are the most extracted solid materials. Growing demand is damaging ecosystems, triggering social conflicts, and fueling concerns over sand scarcity. Balancing protection efforts and extraction to meet society's needs requires designing sustainable pathways at a system level. Here, we present a perspective on global sand sustainability that shifts the focus from the mining site to the entire sand-supply network (SSN) of a region understood as a coupled human-natural system whose backbone is the physical system of construction aggregates. We introduce the idea of transitions in sand production from subsistence mining toward larger-scale regional supply systems that include mega-quarries for crushed rock, marine dredging, and recycled secondary materials. We discuss claims of an imminent global sand scarcity, evaluate whether new mining frontiers such as Greenland could alleviate it, and highlight three action fields to foster a sustainable global sand system