Lisa Schwartz

Bio: Lisa Schwartz is an academic researcher from McMaster University. The author has contributed to research in topics: Health care & Humanitarian aid. The author has an hindex of 34, co-authored 162 publications receiving 4050 citations. Previous affiliations of Lisa Schwartz include University of Edinburgh & George Washington University.

Ethics of qualitative research: are there special issues for health services research?

Abstract: Background An increasing volume of qualitative research and articles about qualitative methods has been published recently in medical journals. However, compared with the extensive debate in social sciences literature, there has been little consideration in medical journals of the ethical issues surrounding qualitative research. A possible explanation for this lack of discussion is that it is assumed commonly that qualitative research is unlikely to cause significant harm to participants. There are no agreed guidelines for judging the ethics of qualitative research proposals and there is some evidence that medical research ethics committees have difficulty making these judgements. Objectives Our aim was to consider the ethical issues which arise when planning and carrying out qualitative research into health and health care, and to offer a framework within which health services researchers can consider these issues. Results Four potential risks to research participants are discussed: anxiety and distress; exploitation; misrepresentation; and identification of the participant in published papers, by themselves or others. Recommended strategies for reducing the risk of harm include ensuring scientific soundness, organizing follow-up care where appropriate, considering obtaining consent as a process, ensuring confidentiality and taking a reflexive stance towards analysis. Conclusions While recognizing the reservations held about strict ethical guidelines for qualitative research, we argue for further debate of these issues so that the health services research community can move towards the adoption of agreed standards of good practice. In addition, we suggest that empirical research is desirable in order to quantify the actual risks to participants in qualitative studies.

A Met-to-Val mutation in the skeletal muscle Na+ channel alpha-subunit in hyperkalaemic periodic paralysis.

Abstract: HYPERKALAEMIC periodic paralysis (HYPP)1 is an autosomal dominant disease that results in episodic electrical inexcitability and paralysis of skeletal muscle. Electrophysiological data indicate that tetrodotoxin-sensitive sodium channels from muscle cells of HYPP-affected individuals show abnormal inactivation2,3. Genetic analysis of nine HYPP families has shown tight linkage between the adult skeletal muscle sodium channel α-subunit gene on chromosome 17q and the disease (lod score, z = 24; recombination frequency 0 = 0)4–6, strongly suggesting that mutations of the a-subunit gene cause HYPP. We sequenced the a-subunit coding region isolated from muscle biopsies from affected (familial HYPP) and control individuals by cross-species polymerase chain reaction-mediated complementary DNA cloning. We have identified an A - G substitution in the patient's messenger RNA that causes a Met-Val change in a highly conserved region of the α-subunit, predicted to be in a transmembrane domain. This same change was found in a sporadic case of HYPP as a new mutation. We have therefore discovered a voltage-gated channel mutation responsible for a human genetic disease.

Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review

Abstract: Objective To study how composite outcomes, which have combined several components into a single measure, are defined, reported, and interpreted. Design Systematic review of parallel group randomised clinical trials published in 2008 reporting a binary composite outcome. Two independent observers extracted the data using a standardised data sheet, and two other observers, blinded to the results, selected the most important component. Results Of 40 included trials, 29 (73%) were about cardiovascular topics and 24 (60%) were entirely or partly industry funded. Composite outcomes had a median of three components (range 2–9). Death or cardiovascular death was the most important component in 33 trials (83%). Only one trial provided a good rationale for the choice of components. We judged that the components were not of similar importance in 28 trials (70%); in 20 of these, death was combined with hospital admission. Other major problems were change in the definition of the composite outcome between the abstract, methods, and results sections (13 trials); missing, ambiguous, or uninterpretable data (9 trials); and post hoc construction of composite outcomes (4 trials). Only 24 trials (60%) provided reliable estimates for both the composite and its components, and only six trials (15%) had components of similar, or possibly similar, clinical importance and provided reliable estimates. In 11 of 16 trials with a statistically significant composite, the abstract conclusion falsely implied that the effect applied also to the most important component. Conclusions The use of composite outcomes in trials is problematic. Components are often unreasonably combined, inconsistently defined, and inadequately reported. These problems will leave many readers confused, often with an exaggerated perception of how well interventions work.

Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial.

Abstract: The efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset ( NCT04348656 ). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm-relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94-1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02-1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57-0.95 and OR = 0.66, 95% CI 0.50-0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14-2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.

Posttrauamatic stress disorder (PTSD) in young adult survivors of childhood cancer

Abstract: Background Posttraumatic stress symptoms (PTSS) and posttraumatic stress disorder (PTSD) were assessed in young adult survivors of childhood cancer, including the role of four sets of variables in understanding PTSD in this population: demographic characteristics, disease and treatment factors, psychosocial and functional outcomes, and cancer-related beliefs. Procedure One hundred eighty-two survivors of pediatric malignancies, ages 18–37 years old completed a psychiatric interview and self-report measures. Survivors were ≥5 years from diagnosis and ≥2 years from the completion of cancer treatment for a variety of cancers. Results Nearly 16% of the sample had PTSD. Most survivors reported re-experiencing symptoms. There were no significant differences between survivors with and without PTSD on demographic or disease and treatment variables. Survivors with PTSD reported more psychological problems and negative beliefs about their illness and health status than those without PTSD. A logistic regression model predicted 50% of the variance in PTSD. Conclusions PTSD affects a subset of young adult cancer survivors. These survivors experience more psychological problems in general. Beliefs about the cancer experience are more potent predictors of PTSD than demographic or disease and treatment factors. Screening for PTSS and PTSD in cancer survivors is recommended. Pediatr Blood Cancer 2007;49:177–182. © 2006 Wiley-Liss, Inc.

Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation.

Abstract: Protocols of systematic reviews and meta-analyses allow for planning and documentation of review methods, act as a guard against arbitrary decision making during review conduct, enable readers to assess for the presence of selective reporting against completed reviews, and, when made publicly available, reduce duplication of efforts and potentially prompt collaboration. Evidence documenting the existence of selective reporting and excessive duplication of reviews on the same or similar topics is accumulating and many calls have been made in support of the documentation and public availability of review protocols. Several efforts have emerged in recent years to rectify these problems, including development of an international register for prospective reviews (PROSPERO) and launch of the first open access journal dedicated to the exclusive publication of systematic review products, including protocols (BioMed Central's Systematic Reviews). Furthering these efforts and building on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines, an international group of experts has created a guideline to improve the transparency, accuracy, completeness, and frequency of documented systematic review and meta-analysis protocols--PRISMA-P (for protocols) 2015. The PRISMA-P checklist contains 17 items considered to be essential and minimum components of a systematic review or meta-analysis protocol.This PRISMA-P 2015 Explanation and Elaboration paper provides readers with a full understanding of and evidence about the necessity of each item as well as a model example from an existing published protocol. This paper should be read together with the PRISMA-P 2015 statement. Systematic review authors and assessors are strongly encouraged to make use of PRISMA-P when drafting and appraising review protocols.

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

Abstract: High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.

International Union of Pharmacology. XLVIII. Nomenclature and Structure-Function Relationships of Voltage-Gated Calcium Channels

Abstract: The family of voltage-gated sodium channels initiates action potentials in all types of excitable cells. Nine members of the voltage-gated sodium channel family have been characterized in mammals, and a 10th member has been recognized as a related protein. These distinct sodium channels have similar structural and functional properties, but they initiate action potentials in different cell types and have distinct regulatory and pharmacological properties. This article presents the molecular relationships and physiological roles of these sodium channel proteins and provides comprehensive information on their molecular, genetic, physiological, and pharmacological properties.