Alliance between selective serotonin reuptake inhibitors and fracture risk: an updated systematic review and meta-analysis

Purpose In the past few years, several fracture-related events have been reported with chronic use of selective serotonin reuptake inhibitors (SSRIs) throughout the globe. Hence, an updated systematic review and meta-analysis was necessary to ascertain the risk involved. The present work evaluated the association of SSRIs with the risk of fracture in adults. Methods We systematically searched PubMed, Cochrane library, and Google Scholar for observational studies on the same from inception to April 2019. Screening, data extraction, and risk of bias assessment were conducted independently by 2 authors. Results We assessed 69 studies out of which 37 (14 case-control, 23 cohorts) were included. Our results showed that SSRIs were significantly associated with an increased fracture risk (relative risk of 1.62, 95% CI 1.52–1.73; P < 0.000; I2 = 90.8%). The relative risk values for case-control and cohort studies were found to be 1.80 (95% CI 1.58–2.03; P < 0.000; I2 = 93.2%) and 1.51 (95% CI 1.39–1.64; P < 0.000; I2 = 88.0%) respectively. Subgroup analysis showed that association of risk of fracture persisted regardless of geographical location, study design, risk factors, defined daily dose, SSRI use duration, site of the fracture, period of study and after adjusting for depression, physical activity, gender, and age group. The sensitivity analysis data shows that the studies adjusted for bone mineral density and osteoporosis show lesser fracture risk. Conclusion Our findings suggests that SSRIs may be associated with an increased fracture risk; hence, bone health should be taken into consideration while prescribing this class of drugs

Early-stage Fundraising of University Spin-offs: A Study through Demand-site Perspectives

University spin-offs have increasingly received attention from academia, governments and policy-makers. However, there are only a limited number of studies which fully understand the contribution made by the founding team to fundraising, specifically how they use their social networks and capabilities, especially within the university spin-off context. Employing a resource-based view theory and social networks approach, this paper examines whether a founding team exploits its social networks and capabilities to signal the value of a university spin-off. Capabilities are analysed through a set of constructs - technology, strategy, human capital, organizational viability and commercial resource - that have been derived from previous literature. The contribution made by social networks is evaluated using three dimensions - structure, governance and content - which form the construct of relationships within a network. Based on data from 181 university spin-offs in Spain, this paper empirically demonstrates that by exploiting social networks a founding team can improve its capabilities which, in turn, enhance its fundraising ability

Transcutaneous electrical nerve stimulation for the management of tennis elbow: a pragmatic randomized controlled trial: the TATE trial (ISRCTN 87141084)

<p>Abstract</p> <p>Background</p> <p>Tennis elbow is a common and often extremely painful musculoskeletal condition, which has considerable impact on individuals as well as economic implications for healthcare utilization and absence from work. Many management strategies have been studied in clinical trials. Whilst corticosteroid injections offer short term pain relief, this treatment is unpleasant and is used with caution due to an associated high risk of pain recurrence in the long term. Systematic reviews conclude that there is no clear and effective treatment for symptoms of pain in the first 6 weeks of the condition. There is a clear need for an intervention that is acceptable to patients and provides them with effective short-term pain relief without increasing the risk of recurrence. Transcutaneous electrical nerve stimulation (TENS) is an inexpensive, non-invasive, non-pharmacological form of analgesia that is commonly used in the treatment of pain. TENS has very few contraindications and is simple to apply. It also benefits from being patient controlled, thereby promoting self-management. This study aims to assess the effectiveness, in terms of pain relief, and cost-effectiveness of a self-management package of treatment that includes TENS.</p> <p>Methods/Design</p> <p>The design of the study will be a two-group pragmatic randomized clinical trial. 240 participants aged 18 years and over with tennis elbow will be recruited from 20-30 GP practices in Staffordshire, UK. Participants are to be randomized on a 1:1 basis to receive either primary care management (standard GP consultation, medication, advice and education) or primary care management with the addition of TENS, over 6 weeks. Our primary outcome measure is average intensity of elbow pain in the past 24 hours (0-10 point numerical rating scale) at 6 weeks. Secondary outcomes include pain and limitation of function, global assessment of change, days of sick leave, illness perceptions, and overall health status. A cost-effectiveness analysis will also be performed. Patient adherence and satisfaction data will be collected at 6 weeks, 6 months and 12 months by postal questionnaire. A diary will also be completed for the first 2 weeks of treatment. Clinical effectiveness and cost-effectiveness analyses will be carried out using an intention-to-treat approach as the primary analysis.</p> <p>Discussion</p> <p>This paper presents detail on the rationale, design, methods and operational aspects of the trial.</p> <p>Trial registration</p> <p>Current Controlled Trials. ISRCTN87141084</p

Technology transfer offices as boundary spanners in the pre-spin-off process: the case of a hybrid model

Over the past decades, universities have increasingly become ambidextrous organizations reconciling scientific and commercial missions. In order to manage this ambidexterity, technology transfer offices (TTOs) were established in most universities. This paper studies a specific, often implemented, but rather understudied type of TTO, namely a hybrid TTO model uniting centralized and decentralized levels. Employing a qualitative research design, we examine how and why the two TTO levels engage in diverse boundary spanning activities to help nascent spin-off companies move through the pre-spin-off process. Our research identifies differences in the types of boundary spanning activities that centralized and decentralized TTOs perform and in the parties they engage with. We find geographical, technological and organizational proximity to be important antecedents of the TTOs’ engagement in external and internal boundary spanning activities. These results have important implications for both academics and practitioners interested in university technology transfer through spin-off creation

Relevance of the Weber effect in contemporary pharmacovigilance of oncology drugs

Ankur Arora,1,2 Rajinder K Jalali,1,2 Divya Vohora1 1School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India; 2Medical Affairs and Clinical Research, Sun Pharmaceutical Industries Limited, Gurgaon, Haryana, India Background: Numerous reporting biases have been known to affect spontaneous reporting databases. The Weber effect, which constitutes a peak in adverse event (AE) reporting of a drug at the end of second year after regulatory approval followed by a continuous decline thereafter, has been considered an important bias for a long time. The existence of this bias in AE reporting of oncology drugs remains an underevaluated area, prompting a targeted examination.Methods: The US Food and Drug Administration (USFDA) Adverse Event Reporting System (FAERS) was studied for AE reporting patterns of 5 years of 15 new molecular entities (NMEs) and biologics used in oncology. This 5-year period started from the USFDA date of approval for the NMEs and biologics. The number of AEs reported for each of the drugs was plotted against time (years). The AE reporting patterns were specifically examined for the existence of the Weber effect. In addition, AE reporting rate patterns of 5 years of seven NMEs and biologics used in oncology were examined.Results: A total of 50,630 AE reports were logged in to the FAERS for all 15 drugs examined for AE reporting patterns. We observed five distinct AE reporting patterns for 15 drugs; however, none of the AE patterns were identical to the Weber effect. We did not observe a consistent AE reporting rate pattern for the seven drugs examined for AE reporting rates. With the exception of one drug (cetuximab), none of the drugs exhibited a second-year peak in AE reporting rates. This peak was not followed by continuous decline in AE reporting rate thereafter.Conclusion: This study does not support the existence of the Weber effect in AE reporting of oncology drugs. The contemporary AE reporting of oncology drugs does not exhibit a consistent pattern. Keywords: Weber effect, adverse event reporting patterns, oncology drugs, USFDA, FAERS&nbsp