The 24-h lung-function profile of once-daily tiotropium and olodaterol fixed-dose combination in chronic obstructive pulmonary disease

Background: This study investigated the effects on 24-h lung function and lung volume of a once-daily fixed-dose combination (FDC) of the long-acting muscarinic antagonist tiotropium and the long-acting beta(2)-agonist olodaterol in patients with chronic obstructive pulmonary disease. Methods: This was a randomised, double-blind, placebo-controlled, Phase III trial with an incomplete crossover design. Patients received four of the following six treatment options for 6 weeks each: placebo, olodaterol 5 mu g, tiotropium 2.5 mu g, tiotropium 5 mu g, tiotropium + olodaterol FDC 2.5/5 mu g and tiotropium + olodaterol FDC 5/5 mu g, all delivered via the Respimat (R) inhaler. The primary end point was forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 24 h (AUC(0-24)) response after 6 weeks of treatment; key secondary end points were FEV1 AUC from 0 to 12 h and AUC from 12 to 24 h, and further end points included lung-volume parameters measured using body plethysmography (subset of patients), measures of peak and trough FEV1, and incidence of adverse events. Results: A significant improvement in FEV1 AUC(0-24) response was observed with tiotropium + olodaterol 5/5 mu g and 2.5/5 mu g versus placebo and monotherapies after 6 weeks of treatment; mean response with tiotropium + olodaterol 5/5 mu g versus placebo was 0.280 L (p < 0.0001). Differences to monotherapies with tiotropium + olodaterol 5/5 mu g were 0.115 L versus olodaterol 5 mu g, 0.127 L versus tiotropium 2.5 mu g and 0.110 L versus tiotropium 5 mu g (p < 0.0001 for all comparisons). Secondary end points supported these data. No safety concerns were identified. Conclusions: Overall, this study demonstrated improvements in lung function over 24 h with an FDC of tiotropium + olodaterol over tiotropium or olodaterol alone, with no observed difference in tolerability. ClinicalTrials.gov number: NCT01559116

Pårørendes erfaringer av kvalitet i helse- og omsorgstjenester til personer med demens og pårørende. En longitudinell narrativ studie.

Bakgrunn: Det har de siste årene vært en stor satsing på å utvikle og styrke demensomsorgen i Norge. Ett av målene er at personer med demens og pårørende skal få dekket sine individuelle behov ved tjenester preget av høy kvalitet, fleksibilitet og individuell tilrettelegging. Hensikt: Studiens hensikt var å få økt kunnskap om pårørendes opplevelser av helse- og omsorgstjenester til personer med demens og pårørende over tid. Metode: Studien har et kvalitativt longitudinelt casestudiedesign. Data er samlet inn gjennom tre omganger over en to-års periode, med narrative dybdeintervjuer med fem pårørende; tre ektefeller og to voksne barn. Hovedfunn: Pårørende opplevde at dagaktivitetstilbudene hadde høy kvalitet og ga god avlastning, mens avlastnings- og langtidsopphold i sykehjem hadde forbedringspotensiale knyttet til kvalitet, fleksibilitet og individuell tilrettelegging. Deltakelse på pårørendeskoler opplevdes ulikt. Hjemmesykepleie ga de voksne barna i studien trygghet og opplevelse av delt ansvar, men opplevdes som utilstrekkelig og lite individuelt tilpasset for ektefeller, særlig ved alvorlig demens. Konklusjon: Pårørendes behov for og opplevelse av helse- og omsorgstjenester er varierende. Pårørende kan oppleve at dagaktivitetstilbudet i høy grad dekker deres behov, mens pårørendeskoler, hjemmesykepleie, avlastnings- og langtidsopphold i sykehjem kan være mindre fleksible og mindre tilpasset individuelle behov hos personen med demens og/eller pårørende. Nøkkelord: demens, pårørendeomsorg, helse- og omsorgstjenester.publishedVersio

Prognosis and longitudinal changes of physical activity in idiopathic pulmonary fibrosis

Background: Physical activity (PA) is associated with disease severity in idiopathic pulmonary fibrosis (IPF), but longitudinal studies evaluating its prognostic value and changes over time are lacking. Methods: We measured PA (steps per day, SPD) in a cohort of 46 IPF-patients (mean age, 67 years; mean FVC, 76.1%pred.) by accelerometry at baseline, recorded survival status during 3 years follow-up and repeated measurements in survivors. We compared the prognostic value of PA to established mortality predictors including lung function (FVC, DLCO) and 6-min walking-distance (6MWD). Results: During follow-up (median 34 months) 20 patients (43%) died. SPD and FVC best identified non-survivors (AUROC-curve 0.79, p < 0.01). After adjustment for confounders (sex, age, therapy), a standardized increase (i.e. one SD) in SPD, FVC%pred. or DLCO%pred. was associated with a more than halved risk of death (HR < 0.50; p < 0.01). Compared to baseline, SPD, FVC, and 6MWD annually declined in survivors by 973 SPD, 130 ml and 9 m, resulting in relative declines of 48.3% (p < 0.001), 13.3% (p < 0.001) and 7.8% (p = 0.055), respectively. Conclusion: While PA predicts mortality of IPF patients similar to established functional measures, longitudinal decline of PA seems to be disproportionally large. Our data suggest that the clinical impact of disease progression could be underestimated by established functional measures

The effects of the number of consecutive night shifts on sleep duration and quality

OBJECTIVES: The organization of night shift work affects sleep duration and quality. The aim of this study was to investigate the effects of the number of consecutive night shifts on sleep duration and quality among police officers with night shift work as part of their normal schedule. METHODS: This quasi-experimental, within-subject crossover study included 73 police officers. All participants performed three work schedules: two, four and seven consecutive night shifts followed by the same number of recovery days, ie, day work or days off (2+2, 4+4, and 7+7). Sleep assessed through sleep diaries and actigraphy after all night shifts and recovery days (totaling 26 days) was compared by use of repeated measures analysis. RESULTS: Participants experienced shorter sleep duration (with and without naps), more premature awakening, less difficulty falling asleep, and more non-refreshing sleep after night shifts compared with recovery days. Sleep duration and quality did not change with increasing number of consecutive night shifts. Sleep was shorter and of poorer quality after the last night shift in the 2+2 and 4+4 work schedule compared with the second and fourth night shift, respectively, in the 7+7 schedule. CONCLUSION: Sleep duration was reduced after night shift work and did not increase with more consecutive night shifts, which leads to accumulated sleep debt. Sleep duration was shortest and sleep quality was poorest after the last night shift in a series of night shifts

Addressing Health Literacy in Patient Decision Aids:An Update from the International Patient Decision Aid Standards

BACKGROUND: There is increasing recognition of the importance of addressing health literacy in patient decision aid (PtDA) development. PURPOSE: An updated review as part of IPDAS 2.0 examined the extent to which PtDAs are designed to meet the needs of low health literacy/disadvantaged populations. DATA SOURCES: Reference list of Cochrane review of randomised controlled trials (RCTs) of PtDAs (2014, 2017 and upcoming 2021 versions). STUDY SELECTION: RCTs that assessed the impact of PtDAs on low health literacy or other disadvantaged groups (i.e. ≥50% participants from disadvantaged groups and/or subgroup analysis in disadvantaged group/s). DATA EXTRACTION: Two researchers independently extracted data into a standardized form including PtDA development and evaluation details. We searched online repositories and emailed authors to access PtDAs to verify reading level, understandability and actionability. DATA SYNTHESIS: Twenty-five out of 213 RCTs met inclusion criteria illustrating that only 12% of studies addressed the needs of low health literacy or other disadvantaged groups. Reading age was calculated in 8/25 studies (33%), which is recommended in previous IPDAS guidelines. We accessed and independently assessed 11 PtDAs. None were written at 6(th) grade level or below. Ten PtDAs met the recommended threshold for understandability, but only 5 met the recommended threshold for actionability. We also conducted a post-hoc subgroup meta-analysis and found that knowledge improvements after receiving a PtDA were greater in studies that reported using strategies to reduce cognitive demand in PtDA development compared to studies that did not (Chi(2)=14.11, p=0.0002, I(2)=92.9%). LIMITATIONS: We were unable to access 13 out of 24 PtDAs. CONCLUSIONS: Greater attention to health literacy and disadvantaged populations is needed in the field of PtDAs to ensure equity in decision support

How to schedule night shift work in order to reduce health and safety risks

Objectives This discussion paper aims to provide scientifically based recommendations on night shift schedules, including consecutive shifts, shift intervals and duration of shifts, which may reduce health and safety risks. Short-term physiological effects in terms of circadian disruption, inadequate sleep duration and quality, and fatigue were considered as possible links between night shift work and selected health and safety risks, namely, cancer, cardio-metabolic disease, injuries, and pregnancy-related outcomes. Method In early 2020, 15 experienced shift work researchers participated in a workshop where they identified relevant scientific literature within their main research area. Results Knowledge gaps and possible recommendations were discussed based on the current evidence. The consensus was that schedules which reduce circadian disruption may reduce cancer risk, particularly for breast cancer, and schedules that optimize sleep and reduce fatigue may reduce the occurrence of injuries. This is generally achieved with fewer consecutive night shifts, sufficient shift intervals, and shorter night shift duration. Conclusions Based on the limited, existing literature, we recommend that in order to reduce the risk of injuries and possibly breast cancer, night shift schedules have: (i) ≤3 consecutive night shifts; (ii) shift intervals of ≥11 hours; and (iii) ≤9 hours shift duration. In special cases – eg, oil rigs and other isolated workplaces with better possibilities to adapt to daytime sleep – additional or other recommendations may apply. Finally, to reduce risk of miscarriage, pregnant women should not work more than one night shift in a weekpublishedVersio