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.

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

According to W. Edwards Deming, American companies require nothing less than a transformation of management style and of governmental relations with industry. In Out of the Crisis, originally published in 1982, Deming offers a theory of management based on his famous 14 Points for Management. Management's failure to plan for the future, he claims, brings about loss of market, which brings about loss of jobs. Management must be judged not only by the quarterly dividend, but by innovative plans to stay in business, protect investment, ensure future dividends, and provide more jobs through improved product and service. In simple, direct language, he explains the principles of management transformation and how to apply them.

Out of the Crisis

The Standards for the Diagnosis and Treatment of Patients with COPD document 2004 updates the position papers on chronic obstructive pulmonary disease (COPD) published by the American Thoracic Society (ATS) and the European Respiratory Society (ERS) in 1995 1, 2. Both societies felt the need to update the previous documents due to the following. 1) The prevalence and overall importance of COPD as a health problem is increasing. 2) There have been enough advances in the field to require an update, especially adapted to the particular needs of the ATS/ERS constituency. 3) It allows for the creation of a “live” modular document based on the web; it should provide healthcare professionals and patients with a user friendly and reliable authoritative source of information. 4) The care of COPD should be comprehensive, is often multidisciplinary and rapidly changing. 5) Both the ATS and the ERS acknowledge the recent dissemination of the Global Initiative of Obstructive Lung Disease (GOLD) 3 as a major worldwide contribution to the battle against COPD. However, some specific requirements of the members of both societies require adaptation of the broad GOLD initiative. Those requirements include specific recommendations on oxygen therapy, pulmonary rehabilitation, noninvasive ventilation, surgery in and for COPD, sleep, air travel, and end-of-life. In addition, special emphasis has been placed on issues related to the habit of smoking and its control.

### Goals and objectives

The main goals of the updated document are to improve the quality of care provided to patients with COPD and to develop the project using a disease-oriented approach. To achieve these goals, both organisations have developed a modular electronic web-based document with two components. 1) A component for health professionals that intends to: raise awareness of COPD; inform on the latest advances in the overall pathogenesis, diagnosis, monitoring and management of COPD; and …

https://erj.ersjournals.com/content/erj/23/6/932.full.pdf

Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper

Shared decision-making in the medical encounter: What does it mean? (or it takes at least two to tango)

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.

https://www.bmj.com/content/bmj/346/bmj.e7586.full.pdf

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

During the last two decades or so, there has been a struggle over the patient's role in medical decision-making that is often characterized as a conflict between autonomy and health, between the values of the patient and the values of the physician. Seeking to curtail physician dominance, many have advocated an ideal of greater patient control.',' Others question this ideal because it fails to acknowledge the potentially imbalanced nature of this interaction when one party is sick and searching for security, and when judgments entail the interpretation of technical information.14 Still others are trying to delineate a more mutual relationship.5,6 This struggle shapes the expectations of physicians and patients as well as the ethical and legal standards for the physician's duties, informed consent, and medical malpractice. This struggle forces us to ask, What should be the ideal physician-patient relationship? We shall outline four models of the physicianpatient interaction, emphasizing the different understandings of (1) the goals of the physicianpatient interaction, (2) the physician's obligations, (3) the role of patient values, and (4) the conception of patient autonomy. To elaborate the abstract description of these four models, we shall indicate the types of response the models might suggest in a clinical situation. Third, we shall also indicate how these models inform the current debate about the ideal physician-patient relationship. Finally, we shall evaluate these models and recommend one as the preferred model. As outlined, the models are Weberian ideal types. They may not describe any particular physician-patient interactions but highlight, free from complicating details, different visions of the essential characteristics of the physician-patient interaction. 7 Consequently, they do not embody minimum ethical or legal standards, but rather constitute regulative ideals that are "higher than the law" but not "above the law."' THE PATERNALISTIC MODEL First is the paternalistic model, sometimes called the parental 9 or priestly model. In this model, the physician-patient interaction ensures that patients receive the interventions that best promote their health and well-being. To this end, physicians use their skills to determine the patient's medical condition and his or her stage in the disease process and to identify the medical tests and treatments most likely to restore the patient's health or ameliorate pain. Then the physician presents the patient with selected information that will encourage the patient to consent to the intervention the physician considers best. At the extreme, the physician authoritatively informs the patient when the intervention will be initiated. The paternalistic model assumes that there are shared objective criteria for determining what is best. Hence the physician can discern what is in the patient's best interest with limited patient participation. Ultimately, it is assumed that the patient will be thankful for decisions made by the physician even if he or she would not agree to them at the time." In the tension

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Four Models of the Physician-Patient Relationship

Background. Advance directives for medical care and the designation of proxy decision makers to guide medical care after a patient has become incompetent have been widely advocated but little studied. We investigated the attitudes of patients toward planning, perceived barriers to such planning, treatment preferences in four hypothetical scenarios, and the feasibility of using a particular document (the Medical Directive) in the outpatient setting to specify advance directives. Methods. We surveyed 405 outpatients of 30 primary care physicians at Massachusetts General Hospital and 102 members of the general public in Boston and asked them as part of the survey to complete the Medical Directive. Results. Advance directives were desired by 93 percent of the outpatients and 89 percent of the members of the general public (P>0.2). Both the young and the healthy subgroups expressed at least as much interest in planning as those older than 65 and those in fair-to-poor health. Of the perceived barriers ...

https://www.nejm.org/doi/pdf/10.1056/NEJM199103283241305

Advance Directives for Medical Care — A Case for Greater Use

A published article is the primary means whereby new work is communicated, priority is established, and academic promotion is determined. Publication depends on trust and requires that authors be held to standards of honesty, completeness, and fairness in their reporting, and to accountability for their statements. The system of authorship, while appropriate for articles with only 1 author, has become inappropriate as the average number of authors of an article has increased; as the work of coauthors has become more specialized and relationships between them have become more complex; and as both credit and, even more, responsibility have become obscured and diluted. Credit and accountability cannot be assessed unless the contributions of those named as authors are disclosed to readers, so the system is flawed. We argue for a radical conceptual and systematic change, to reflect the realities of multiple authorship and to buttress accountability. We propose dropping the outmoded notion of author in favor of the more useful and realistic one of contributor. This requires disclosure to readers of the contributions made to the research and to the manuscript by the contributors, so that they can accept both credit and responsibility. In addition, certain named contributors take on the role of guarantor for the integrity of the entire work. The requirement that all participants be named as contributors will eliminate the artificial distinction between authors and acknowledgees and will enhance the integrity of publication.

When authorship fails: A proposal to make contributors accountable

The promise of a good death

Substantial care needs are an important cause of the economic and noneconomic burdens imposed by terminal illness. Through an empathetic approach, physicians may be able to ameliorate some of these...

Linda L. Emanuel

Papers

Four Models of the Physician-Patient Relationship

Advance Directives for Medical Care — A Case for Greater Use

When authorship fails: A proposal to make contributors accountable

The promise of a good death

Understanding Economic and Other Burdens of Terminal Illness: The Experience of Patients and Their Caregivers