What constitutes evidence in hospital new drug decision making?

In National Health Service hospitals in the UK the introduction of new drugs is controlled by a local Drug and Therapeutics Committee (DTC), which is expected to apply the principles of evidence-based medicine (EBM). In the light of growing expenditure on drugs, there is interest in how the decisions are made that lead to the local acceptance or rejection of a new drug. In this study the DTCs of two general hospitals were observed, tape-recorded and analysed to determine what was considered as evidence and how it was used in decision making. Evidence, as constituted by DTC members, was issues that affected the decision-making process and included: clinical trial data, cost, pre-existing prescribing of the drug, pharmaceutical company activities, decisions of other DTCs, patient demand, clinician excitement, and personality of the applicant. Debate usually started with a discussion of the scientific evidence, then the cost would be considered. Often this evidence was either inadequate or insufficient enough for a locally implementable decision and further types of evidence would be brought in to try and estimate the likely impact of adopting the new drug. EBM, while used in decision making, was supplemented by local knowledge, although decisions were accounted for in the language of scientific rationality. Both abstract scientific rationality and the local rationality of practical healthcare provision were present in the decisions of the DTCs on the adoption, or otherwise, of new drugs into local formularies and healthcare. We suggest the coming together of local and abstract in local decision-making needs to be taken into account when formulating policy and providing decision support.     

Clinical decision making--what every non-clinician manager should know but was never taught.

The management of a health care system requires making decisions and establishing policies that can affect the process of patient care. Clinicians often complain that these decisions and policies are made by people without clinical training. Clinical knowledge is not a prerequisite for a career in health policy or management. Even graduates of accredited health administration programs are not required to understand the process of clinical decision making or the nature of medical practice. Much of the health services literature advocates a shared decision-making model for clinicians and managers. However, most of the literature focuses on how to involve physicians in management decision making; almost none discusses management involvement in clinical decisions. This paper briefly examines how non-clinician managers can support the clinical decision-making process and then specifies the knowledge and skills required for them to play this role.     

Family physicians' use of medical abstracts to guide decision making: style or substance?

BACKGROUND: Many physicians rely on the abstracts of research articles to guide their clinical decision making. This need for expediency is one basis for many journals to reformat their abstracts. METHODS: To determine whether the format of medical abstracts affects physician decision making, we surveyed family physicians in Michigan, Pennsylvania, and Virginia. All participants were members of the American Academy of Family Physicians. The survey included three case scenarios (corneal abrasion, fibromyalgia, and hyperlipidemia) followed by structured and open-ended assessments of usual management. After assessing their usual management in each scenario, the respondents were provided with an abstract of a valid research paper. The format of abstracts (unstructured, IMRAD [introduction, methods, results, and discussion], structured, and POEM [patient-oriented evidence that matters]) were randomly assigned. After reading the abstract, we assessed changes in management of the case scenario. RESULTS: Two hundred eighty-nine family physicians responded to the survey. At baseline, 187 (65%) of physicians patched corneal abrasions. After reading the abstract, 142 (76%) would no longer use eye patches. Two hundred forty-five (83%) of physicians did not use the combination of fluoxetine and amitriptyline for managing fibromyalgia. After reading the abstract, 179 (73%) would use combination therapy. Two hundred thirty-four (84%) of physicians used "statins" when managing hyperlipidemia. After reading the abstract, 211 (90%) would continue using statins. The format of abstract had no significant effect on physicians' decision making. CONCLUSIONS: Whereas the format of abstract in this study had no effect on physician decision making, having valid information available in the context of a clinical scenario appeared to influence decisions.     

Attitudes toward genetic testing: gender,role, and discipline

As a result of the Human Genome Project, genetic testing could result in the availability of detailed genetic information (presence of disease, genetic risk or predisposition to disease, and characteristics or traits) that can ultimately be used for healthcare-related decisions. This study explored whether gender, role, and professional discipline would influence attitudes toward genetic testing when making reproductive decisions, as interpreted by 2 roles--as a parent making decisions or as a professional giving advice. An original research instrument was administered to masters and doctoral genetics students, pediatric residents, and masters-level ministry students. Statistical analyses revealed that discipline strongly influenced decision making while gender rarely did. In addition, differences in attitudes were also found based on parental and professional roles.     

Individualizing treatment decisions. The likelihood of being helped or harmed

Clinical decision making cannot rely on evidence alone. Although significant advances have occurred in the development of high-quality evidence, similar efforts must be made to develop and evaluate tools that can be used at the bedside to individualize treatment decisions and to facilitate the incorporation of our patients' unique values and circumstances into the decision-making process. These tools should express the helpful and harmful effects of treatment, and it must be possible to modify these statements using patients' values. Finally, this process should be accomplished in real time in a busy clinical practice. In this article, the author outlines some of these decision support tools, describes an attempt to meet some of the challenges inherent in the goal of achieving effective shared decision making, and proposes a patient-centered measure of the likelihood of being helped and harmed by an intervention and discusses its derivation and an evaluation of its usefulness.     

The role of physicians' recommendations in medical treatment decisions.

BACKGROUND: A shift away from the medical paternalism of the past has occurred, and today, the law and ethics advocate that physicians share decision-making responsibility with their patients. It is unclear, however, what the appropriate role of physicians' recommendations ought to be in this new shared decision-making paradigm. One way to approach this question is to assess the influence of physicians' recommendations. OBJECTIVE: In this study, the authors examine the influence of physicians' recommendations on hypothetical treatment decisions. Do physicians' recommendations influence treatment decisions in scenarios where the decision that maximizes health is obvious and apparent to subjects? Do recommendations pull subjects away from the treatment choice that they otherwise prefer (based on their decision when unaware of the physicians' recommendation)? DESIGN: An experimental web questionnaire presented hypothetical medical treatment scenarios in which the treatment choice that maximized health was obvious. Across scenarios, the authors varied physicians' recommendations in 3 ways: (1) physicians' recommendations supporting what maximized health, (2) physicians' recommendations that went against what maximized health, and (3) no physicians' recommendation. The participants were 102 volunteers. RESULTS: Hypothetical treatment decisions were significantly influenced by physicians'recommendations (P < 0.0001), and physicians'recommendations against the decision that maximized health pulled subjects away from the treatment decision that they made when no recommendation was given (P < 0.0001). CONCLUSION: Physicians' recommendations can lead people to make decisions that go against what is best and against what they would otherwise prefer. Physicians must take care in making recommendations and should incorporate patient preferences into their recommendations.     

Colorectal cancer screening attitudes and practices preferences for decision making

BACKGROUND: The availability of several effective screening options for colorectal cancer (CRC) screening calls for involving patients in decision making about CRC screening. The current study examined (1) participant characteristics associated with their preferences for participation in CRC screening decision making, (2) correspondence between participant preferences for decision making and their usual participation in decision making, and (3) associations between participant decision-making preferences and CRC screening practices and attitudes. METHODS: Data were obtained using a random, population-based telephone survey, conducted during August 2001 and April 2002, of 2119 community-living adults aged 50 to 75 years (56% female) residing in Long Island, NY. RESULTS: Overall, 77% reported that preferences for CRC screening decision making matched how screening decisions were usually made (simple kappa coefficient=0.67 [0.64-0.69]). Fifteen percent preferred to make screening decisions themselves, while 25% preferred to make decisions after considering their physician's opinion; nearly 50% preferred to share decision making, and 16% preferred that their physician make all screening decisions. Less education was associated with preferring that the physician make all screening decisions. Preferring physician involvement in screening decision making was associated with greater odds of citing no physician recommendation as a barrier to CRC screening, when compared to those who preferred no physician involvement. Preferring no physician involvement in decision making was associated with lower odds of reporting a recent CRC screening exam, as well as lower odds of endorsing positive attitudes and greater odds of endorsing negative attitudes toward CRC screening, when compared to participants who preferred physician involvement in decision making. Their attitudes also reflected intentions not to screen for CRC if they were asymptomatic, as well as the perception that they were not at personal risk for CRC. CONCLUSIONS: Several factors were identified as significantly associated with preferences for decision making and deserve further exploration for their application to clinical practice.     

Observing decision‐making in the general practice consultation: who makes which decisions?

OBJECTIVE: To investigate opportunities for, and types of decision making in the general practice (primary care) consultation, and examine differences in skills of those doctors who are successful at meeting their patients' preferences and those who are less successful. DESIGN: Observation study of doctor-patient consultations in general practice. PARTICIPANTS: Patients attending for routine appointments in 12 general practice surgeries across Oxfordshire. METHODS: A total of 212 doctor-patient consultations were video-recorded. The patients involved completed a questionnaire to elicit their perceptions of how decisions were made. The video-taped recordings were coded with a new instrument, the Evidence Based Patient Choice Instrument (EBPCI), to classify the number and type of decision-making opportunities arising during each consultation. A total of 149 recordings were coded using the Oxbridge Rating Scale to assess the doctors' consultation styles. RESULTS: There was a range of decision-making opportunities in addition to those involving medical treatment. With the exception of 'fitness for work', decisions were generally 'doctor led'. There was only moderate agreement between patient perceptions of their level of involvement in decision making and the objective ratings using the EBPCI. There was wide variation in the ability of doctors to meet their patients' preferences for involvement. CONCLUSIONS: There are many decisions made in primary care consultations, in addition to those about medical treatments, in which patients could be involved to a greater extent than they currently are. Some doctors are significantly better than others at meeting different patients' preferences for their decision-making role. Patients' perceptions of shared decision making appears to be influenced by the doctors' general consultation skills.     

Should Age be a Deciding Factor in Ethical Decision-Making?

The question of age as a factor in ethical decision-making takes two forms. The first form considers age as a factor at the societal, or policy, level, and the second as a factor in determining the capacity of the individual patient to make decisions regarding their own care. This article satisfies itself with a consideration of only the latter question. The issue of whether age is contributing factor in medical decision-making is frequently posited when one considers ethically charged instances of medical decision making at the end of life. Few would argue that the person who has the capacity for decision-making should be denied the ability to exercise that facility and so, it is when a person has lost their ability for making those choices that the question of age as a contributing factor in ethical decision making is raised. The question therefore becomes one of capacity more then age, with age as a useful, but inexact, gauge of that capacity. The inexactitude of age as a surrogate of capacity is a contributing factor to the problem posed in this series of articles. Therefore, to define the relative contribution of age to the capacity for ethical decision-making this article will focus not on the loss of that ability, but rather on the factors that define the realization of that faculty. To do this it will be necessary to define how that faculty is to be to be measured and what are the characteristics of an ethical decision that define it apart from other decisions. Since at the beginning of life, if age is the only variable (adjusting for other co-morbid states) then the issue of surrogacy is a temporary one and is unlike the adult where the presumption is that the person is unlikely to regain decision-making capacity as they slip further into their morbid state.     

‘It’s really complicated’: How Canadian university women students navigate gendered risk and human papillomavirus (HPV) vaccine decision-making

In this article I examine how a group of female university students in Ontario, Canada navigated the notion of ‘gendered risk’ that underpins the current promotion of human papillomavirus (HPV) vaccine. In 2010, I interviewed 24 female university students from across the province of Ontario focussing on their experiences of making decisions about whether or not to have the HPV vaccine. I found that each student’s vaccine decision – whether it was to forgo vaccination, to wait to make a decision or to vaccinate – involved the consideration of notions of gender, negotiation of sexual health issues and management of the uncertainty of a relatively new vaccine. These considerations created a complex situation and produced a complex decision-making context, one that required the women to reflect on the ways in which they exercised their ethical agency. As a result, the women in my sample practiced identity-based vaccine decision-making that was driven by their developing sense of self as a young woman emerging into adulthood.     

The influence of significant others in complementary and alternative medicine decisions by cancer patients

Individuals living with cancer are faced with numerous treatment decisions that encompass both conventional therapies and complementary and alternative medicine (CAM). Although a beginning body of research has explored the CAM decision-making process by cancer patients, the social context of these treatment decisions has been largely ignored. As a part of a larger grounded theory research project exploring CAM decision-making processes of cancer patients living in British Columbia, Canada, the purpose of this secondary inquiry was to explore how significant others were involved in patients' decisions related to CAM. In total, 61 patients with early and advanced-stage breast and prostate cancer and 31 significant others participated in semi-structured interviews. Using constant comparative analysis, four main types of decisional involvement by significant others were identified: creating a safe place for the patient to make a decision, "becoming a team": collaborative decision-making, moving the patient towards a decision, and making the decision for the patient. Significant others were often found to engage in more than one type of decision involvement as a consequence of several key factors. Within the types of decisional involvement, nine distinct roles in the CAM decision-making process were described by the significant others. The findings of this inquiry extend previous research by highlighting the importance of significant others in cancer patients' CAM decisions and challenge past conceptualizations of autonomy in treatment decision making.     

Decision making in thermally stressful environments

The literature on investigations into effects of thermal stress of psychological performance is reviewed in order to hypothesize ways in which functions of a decision-making process may be affected by exposure of a decision maker to hot and cold environmental conditions. A theoretical model is described relating psycho-physiological strain, associated with exposure to environmental thermal stress, to efficiency of performance of psychological tasks, categorized in terms of demands made on the human operator. From the evidence available, it appears that three aspects of decision making may be vulnerable to adverse effects of thermal stress. The initiation of the process of decision making may occur less reliably when cold or heat stress leads to signals, which may be serving as decision-making process prompts, being missed. Cognitive operations relating to information processing and evaluative procedures may be subject to decrements in efficiency when conducted in thermally stressful conditions. Thirdly, actions intending to implement decisions taken may be less effectively performed in thermally extreme environments.     

Introducing “Evidence” Into Board Decision-Making

The purpose of this article is to report on the results of a workshop that introduced evidence-based decision-making techniques to Board members of regional health authorities in Alberta.Results and conclusions: The workshop demonstrated that it is possible to design a process for the incorporation of evidence in administrative decision-making. The participants demonstrated that they were able to apply scientific evidence in administrative decision making and that the decisions taken were reasonably consistent. Also, in the absence of evidence, values took precedence in the decision-making process and the decisions taken were less consistent.     

Impact of adjusting for inter‐rater variability in conference abstract ranking and selection processes

Background/aim

Scientific conferences provide a forum for clinicians, educators, students and researchers to share research findings. To be selected to present at a scientific conference, authors must submit a short abstract which is then rated on its scientific quality and professional merit and is accepted or rejected based on these ratings. Previous research has indicated that inter‐rater variability can have a substantial impact on abstract selection decisions. For their 2015 conference, the Occupational Therapy Australia National Conference introduced a system to identify and adjust for inter‐rater variability in the abstract ranking and selection process.

Method

Ratings for 1340 abstracts submitted for the 2015 and 2017 conferences were analysed using many‐faceted Rasch analysis to identify and adjust for inter‐rater variability. Analyses of the construct validity of the abstract rating instrument and rater consistency were completed. To quantify the influence of inter‐rater variability of abstract selection decisions, comparisons were made between decisions made using Rasch‐calibrated measure scores and decisions that would have been made based purely on raw average scores derived from the abstract ratings.

Results

Construct validity and measurement properties of the abstract rating tool were good to excellent (item fit MnSq scores ranged from 0.8 to 1.2; item reliability index = 1.0). Most raters (24 of 27, 89%) were consistent in their use of the rating instrument. When comparing abstract allocations under the two conditions, 25% of abstracts (n = 341) would have been allocated differently if inter‐rater variability was not accounted for.

Conclusion

This study demonstrates that, even with a strong abstract rating instrument and a small rater pool, inter‐rater variability still exerts a substantial influence on abstract selection decisions. It is recommended that all occupational therapy conferences internationally, and scientific conferences more generally, adopt systems to identify and adjust for the impact of inter‐rater variability in abstract selection processes.     

Verma,Ravi K., Pelto,Pretti J., Schensul,Stephen L., Joshi,Archana. (Eds.). (2004). Sexuality in the time of AIDS: Contemporary perspectives from communities in India

There is an ever-growing trend toward more patient involvement in making health care decisions. This trend has been accompanied by the development of “informed decision-making” interventions to help patients become more engaged and comfortable with making these decisions. We describe the effects of a prostate cancer screening decision aid on knowledge, beliefs about screening, risk perception, control preferences, decisional conflict, and decisional anxiety. Data were collected from 200 males aged 50–70 years in the general population who randomly were assigned to exposure to the decision aid or no exposure as a control condition. A Solomon four-group design was used to test for possible pretest sensitization effects and to assess the effects of exposure to the decision aid. No significant pretest sensitization effects were found. Analysis of the exposure effects found that knowledge increased significantly for those exposed to the decision aid compared with those unexposed. Exposure to the decision aid also had some influence on decreasing both decisional conflict and decisional anxiety. Decision aids can play an important role in increasing patients' knowledge and decreasing anxiety when asked to make health care decisions.     

Country planning for health interventions under development: lessons from the malaria vaccine decision-making framework and implications for other new interventions

Traditionally it has taken years or decades for new public health interventions targeting diseases found in developing countries to be accessible to those most in need. One reason for the delay has been insufficient anticipation of the eventual processes and evidence required for decision making by countries. This paper describes research into the anticipated processes and data needed to inform decision making on malaria vaccines, the most advanced of which is still in phase 3 trials. From 2006 to 2008, a series of country consultations in Africa led to the development of a guide to assist countries in preparing their malaria vaccine decision-making frameworks. The guide builds upon the World Health Organization's Vaccine Introduction Guidelines. It identifies the processes and data for decisions, when they would be needed relative to the development timelines of the intervention, and where they will come from. Policy development will be supported by data (e.g. malaria disease burden; roles of other malaria interventions; malaria vaccine impact; economic and financial issues; malaria vaccine efficacy, quality and safety) as will implementation decisions (e.g. programmatic issues and socio-cultural environment). This generic guide can now be applied to any future malaria vaccine. The paper discusses the opportunities and challenges to early planning for country decision-making-from the potential for timely, evidence-informed decisions to the risks of over-promising around an intervention still under development. Careful and well-structured planning by countries is an important way to ensure that new interventions do not remain unused for years or decades after they become available.     

Shared decision making: informing and involving patients to do the right thing in health care

At the individual level, practicing high-quality medical care means doing the right thing for a patient as safely as possible. Some medical decisions have one optimal course of action, but most have multiple reasonable options with outcomes that will be valued differently by different people. For these preference-sensitive decisions, involving patients in a shared decision-making process is critical. Patient decision aids are tools that help make shared decision making practical. Policy changes at the federal and state level can help make shared decision making with the active participation of informed patients the rule rather than the exception.     

How top managers in health organizations set directions that guide decision making

Cases describing strategic decisions made in health care organizations were analyzed to determine how top managers set directions that guide decision making. Four tactics were identified--issue, idea, objective, and reframing. Decision-adoption rates, decision merit, and duration of the decision-making process were used to determine the effectiveness of each tactic. The effects that stem from using each tactic were qualified by factors describing urgency, importance, and differences between the tactics used by CEOs and middle managers (leverage). Tactics were found to have more influence on decision effectiveness than the intervening variables of urgency, importance, and leverage. Reframing was found to be the most effective tactic under all conditions but was the least frequently used by decision makers. Issue and idea tactics were the least effective, but idea tactics were used more often than any other tactic. Issue tactics were even less effective when applied to urgent and important decisions. Objectives were surprisingly effective in a crisis and for the more important decision.     

Health care decision-making capacity: a legal perspective for long-term care providers

While federal law establishes guidelines that designated facilities must follow in providing information about a patient's rights regarding self-determination in the health care decision-making process, state law determines the decision-making process and the legal requirements pertaining thereto. A person's capacity to make health care decisions or to have the authority and capacity to delegate the right to make such decisions is a legal conclusion based on statutory and common law principles. This article discusses the legal perspective of capacity in health care decision making and the legal framework of the question of whether or not a person has the capacity to make health care decisions. Western civilization's concepts of personal autonomy and self-determination are at the core of health care decision making, but health care providers must be aware that other cultures do not always share that value system. Sensitivity to multicultural diversity in this context is imperative to maintain individual self-esteem and respect, both for the patient and the patient's family.