Objective To investigate whether placebo controls should be used in the evaluation of surgical interventions.Design Systematic review.Data sources We searched Medline, Embase, and the Cochrane Controlled Trials Register from their inception to November 2013.Study selection Randomised clinical trials comparing any surgical intervention with placebo. Surgery was defined as any procedure that both changes the anatomy and requires a skin incision or use of endoscopic techniques.Data extraction Three reviewers (KW, BJFD, IR) independently identified the relevant trials and extracted data on study details, outcomes, and harms from included studies.Results In 39 out of 53 (74%) trials there was improvement in the placebo arm and in 27 (51%) trials the effect of placebo did not differ from that of surgery. In 26 (49%) trials, surgery was superior to placebo but the magnitude of the effect of the surgical intervention over that of the placebo was generally small. Serious adverse events were reported in the placebo arm in 18 trials (34%) and in the surgical arm in 22 trials (41.5%); in four trials authors did not specify in which arm the events occurred. However, in many studies adverse events were unrelated to the intervention or associated with the severity of the condition. The existing placebo controlled trials investigated only less invasive procedures that did not involve laparotomy, thoracotomy, craniotomy, or extensive tissue dissection.Conclusions Placebo controlled trial is a powerful, feasible way of showing the efficacy of surgical procedures. The risks of adverse effects associated with the placebo are small. In half of the studies, the results provide evidence against continued use of the investigated surgical procedures. Without well designed placebo controlled trials of surgery, ineffective treatment may continue unchallenged.

The lack of interoperability in Britain’s medical records systems precludes the realisation of benefits generated by increased spending elsewhere in healthcare. Growing concerns regarding the security of online medical data following breaches, and regarding regulations governing data ownership, mandate strict parameters in the development of efficient methods to administrate medical records. Furthermore, consideration must be placed on the rise of connected devices, which vastly increase the amount of data that can be collected in order to improve a patient’s long-term health outcomes. Increasing numbers of healthcare systems are developing Blockchain-based systems to manage medical data. A Blockchain is a decentralised, continuously growing online ledger of records, validated by members of the network. Traditionally used to manage cryptocurrency records, distributed ledger technology can be applied to various aspects of healthcare. In this manuscript, we focus on how Electronic Medical Records in particular can be managed by Blockchain, and how the introduction of this novel technology can create a more efficient and interoperable infrastructure to manage records that leads to improved healthcare outcomes, while maintaining patient data ownership and without compromising privacy or security of sensitive data.

Background The decentralized nature of sensitive health information can bring about situations where timely information is unavailable, worsening health outcomes. Furthermore, as patient involvement in health care increases, there is a growing need for patients to access and control their data. Blockchain is a secure, decentralized online ledger that could be used to manage electronic health records (EHRs) efficiently, therefore with the potential to improve health outcomes by creating a conduit for interoperability. Objective This study aimed to perform a systematic review to assess the feasibility of blockchain as a method of managing health care records efficiently. Methods Reviewers identified studies via systematic searches of databases including PubMed, MEDLINE, Scopus, EMBASE, ProQuest, and Cochrane Library. Suitability for inclusion of each was assessed independently. Results Of the 71 included studies, the majority discuss potential benefits and limitations without evaluation of their effectiveness, although some systems were tested on live data. Conclusions Blockchain could create a mechanism to manage access to EHRs stored on the cloud. Using a blockchain can increase interoperability while maintaining privacy and security of data. It contains inherent integrity and conforms to strict legal regulations. Increased interoperability would be beneficial for health outcomes. Although this technology is currently unfamiliar to most, investments into creating a sufficiently user-friendly interface and educating users on how best to take advantage of it would lead to improved health outcomes. International Registered Report Identifier (IRRID) RR2-10.2196/10994

CAR-T cells are a promising new therapy that offer significant advantages compared with conventional immunotherapies. This systematic review and clinical trial landscape identifies and critiques published CAR-T cell clinical trials and examines the critical factors required to enable CAR-T cells to become a standard therapy. A review of the literature was conducted to identify suitable studies from the MEDLINE and Ovid bibliographic databases. The literature and database searches identified 20 studies for inclusion. The average number of participants per clinical trial examined was 11 patients. All studies included in this systematic review investigated CAR-T cells and were prospective, uncontrolled clinical studies. Leukemia is the most common cancer subtype and accounts for 57.4% (n = 120) of disease indications. The majority of studies used an autologous cell source (85%, n = 17) rather than an allogeneic cell source. Translational challenges encompass technical considerations relating to CAR-T cell development, manufacturing practicability, clinical trial approaches, CAR-T cell quality and persistence, and patient management.

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Bioprocess forces such as shear stress experienced during routine cell culture are considered to be harmful to cells. However, the impact of physical forces on cell behavior is an area of growing interest within the tissue engineering community, and it is widely acknowledged that mechanical stimulation including shear stress can enhance osteogenic differentiation. This paper considers the effects of bioprocess shear stress on cell responses such as survival and proliferation in several contexts, including suspension-adapted cells used for recombinant protein and monoclonal antibody manufacture, adherent cells for therapy in suspension, and adherent cells attached to their growth substrates. The enhanced osteogenic differentiation that fluid flow shear stress is widely found to induce is discussed, along with the tissue engineering of mineralized tissue using perfusion bioreactors. Recent evidence that bioprocess forces produced during capillary transfer or pipetting of cell suspensions can enhance osteogenic responses is also discussed.

Induced pluripotent stem cells (iPSCs) have the potential to transform drug discovery and healthcare in the 21(st) century. However, successful commercialization will require standardized manufacturing platforms. Here we highlight the need to define standardized practices for iPSC generation and processing and discuss current challenges to the robust manufacture of iPSC products.