Abstract Background Osteoporosis is a skeletal disease characterized by loss of bone mass, reduced bone strength and increased bone fragility predisposing to fractures. Objectives To study the efficacy, safety and relative bioavailability of Microcore NESC® (Natural Egg Shell Calcium) in osteopenia and Osteoporotic patients. Methods This was a Randomized, Open label, parallel group interventional clinical trial which included 60 study participants with osteopenia and osteoporosis who were randomized into 3 groups (20 each). Group 1 - Microcore NESC®, Group 2- Shelcal and Group 3- CCM with 12 weeks treatment period. The participants were evaluated for relative oral bioavailability, Bone mineral density (BMD), Serum Osteocalcin, change in VAS pain scale and quality of life- Questionnaires. Results There was significant improvement in the BMD T scores- post treatment with MICROCORE NESC® and shelcal. Higher percentage of improvement in calcium absorption as depicted by an increase in serum calcium levels (10.23%) in the MICROCORE NESC® treated group when compared to Shelcal (7.7%) and CCM (7.2%). The relative bio availability of MICROCORE NESC® with respect to shelcal was 93%. Discussion MICROCORE NESC®, has shown a better oral relative bio availability of calcium (93%), better improvement of BMD T score compared to Shelcal and CCM. The general health status has improved to very good/ excellent in 83% of patients in MICROCORE NESC® treated group. Conclusion MICROCORE NESC® can be considered a better and safe calcium supplement, as there are very few side effects observed without any clinically significant abnormalities in lab parameters.

Abstract Background Major depressive disorder and exposure to antidepressants during pregnancy have been previously associated with preterm birth (PTB). However, the reported results are difficult to interpret due to the inherent confounding by indication bias. We aimed to estimate the disentangled effects of antidepressants and maternal depression on the risk of PTB using data from electronic health records (EHRs). Methods This is a population-based retrospective cohort study, utilizing data from a primary care EHR. The cohort included 216,070 deliveries of 176,866 patients from the United Kingdom between January 1996 and February 2019. We analyzed the effects of antidepressant exposure, in particular selective serotonin reuptake inhibitors (SSRI), during pregnancy on the risk of PTB and additional control outcomes in subgroups of patients with a history of depression, and with recent pre-pregnancy treatment. We also assessed the effect of depression alone, in a subgroup of untreated patients. The analysis utilized large-scale propensity score matching that included all demographic and clinical covariates (conditions, drug prescriptions, observations, and procedures), and effect estimation using a Cox model. Results The main cohort included 17,615 (8.2%) PTBs of 16,946 mothers. Among patients who were not exposed to antidepressants during pregnancy, a history of depression was associated with an increased risk of PTB (HR 1.10, CI [1.04,1.15], P < 0.01]. Patients exposed to SSRIs during the first 22 weeks of gestation were at a marginally higher risk of PTB (during weeks 23 to 37) compared to unexposed patients (HR 1.08, CI [0.98,1.18], P = 0.11). However, subgroup analysis demonstrated that among patients with pre-pregnancy use of SSRIs, treatment continuation during pregnancy did not affect the risk of PTB (HR 1.03 [0.92,1.15], P = 0.61), as well as among patients with history of depression (HR 1.00 [0.90,1.11], P = 0.98). Additionally, in these subgroups exposure to antidepressants was associated with a reduced risk of some common medical conditions during the PTB follow-up window. These conditions, which are otherwise increased by depression, included upper respiratory infection, constipation, and headache. Conclusion Depression is associated with a higher risk of PTB, while exposure to antidepressants during pregnancy does not affect the observed risk. The clinical decision regarding antidepressant treatment during pregnancy should therefore consider the patient-specific risk-benefit potential, regardless of the concern of PTB.

<b>Introduction:</b> Patients with severe COPD accounts for 40 percent of the patients being treated with home oxygen therapy in Denmark. The Department of Respiratory Medicine offers a semi-annually follow up but experiences many absences and cancellations. Patients were therefore offered virtual consultation as an alternative to physical attendance. <b>Aims and objectives:</b> To uncover patients´ experiences of virtual consultation, thereby ensuring a patient-centered clinical practice for patients with COPD being treated with home oxygen therapy. <b>Methods:</b> A qualitative study encompassing semi-structured interviews with 20 patients was conducted during the winter 2021. The patients had tried or been given the opportunity of virtual consultation. Data was analyzed inspired by Kvale et al. focusing on the patient’s perspectives on virtual consultation. <b>Results:</b> The patients expressed an experience that everyday life was characterized by limited resources in terms of energy and air, which, among other things, resulted in unwanted dependence on other people. The virtual consultation was considered air- and energy preserving due to avoiding transportation, waiting time, handling oxygen tanks, and not having to involve others for help with transportation. Most participants emphasized their fear and vulnerability in relation to Covid-19 infection, so being able to stay at home was a welcome initiative. <b>Conclusions:</b> The patients´ perspective showed that follow up of home oxygen therapy as a virtual consultation was considered a qualitative offer. The chosen method thus proving relevant in uncovering patients´ attitudes.

Introduction We designed a randomized controlled trial with a complex intervention where nurse-navigators in whole cancer trajectories address healthcare sectorial gaps and act as integration hubs for psychosocial care from healthcare- and social systems. How could we refine the intervention and measure the primary outcome?MethodsBased on literature search and discussions among clinician-scientists, ideas of effect types were specified and outcomes selected, notably self-efficacy. Bandura’s theory of self-efficacy states: your judgement of own ability to meet challenges increase, if you or a known another has overcome similar situations, if you have relevant knowledge, and/or significant others trust your abilities(1). Discussions with lay-persons allowed us to transform the theory to actions, and pilot-audit it.ResultsThe navigators must screen for self-efficacy and act upon results within the frame of navigation(2,3). If, for instance, a person is afraid to die of cancer, the navigator must take this as point of departure: examine the patient’s knowledge and experienced similar situations, and from here educate and point out potentially useful resources for the patient. Pilot audits showed, that the intervention can be refined in clarifying the role of navigators and delivered as intended. A validated questionnaire of self-efficacy for cancer was chosen(4) and should be analyzed as group differences in change, from enrolment in a “possible-cancer-trajectory” to “end-of-cancer-treatment”.Discussion If patients in the intervention arm do better regarding self-efficacy than those receiving standard care, our complex intervention contributes to Integrated Care. In this case, the above described attitude in connecting patients to relevant psychosocial support opportunities whoever offers them will be recommended. However, the same continuously available nurse navigator throughout cancer trajectories might foster her as a significant other to the patient(5), and when signalling trust in the patient’s ability to act, the nurse navigator, as such, might support patient experienced self-efficacy. Therefore, this construct will be recommended as well.Conclusion Designing a coherent theoretical basis-intervention, involving people and piloting helped to refine the complex intervention and confirmed the relevance of self-efficacy as primary outcome.Lessons learnedBreaking down theories underlying wishes for effect, makes it possible to refine a complex intervention and audit it.LimitationsSelf-efficacy is a part of a larger complex intervention on Danes.Suggestions for future researchMore focus on reporting theories underlying complex interventions is needed.