Ethics information retrieval in HTA: state of current practice.

OBJECTIVES: Though there have been longstanding discussions on the value of ethics in health technology assessment (HTA), less awareness exists on ethics information retrieval methods. This study aimed to scope available evidence and determine current practices for ethics information retrieval in HTA. METHODS: Literature searches were conducted in Ovid MEDLINE, LISTA, Scopus, and Google Scholar. Once a list of relevant articles was determined, citation tracking was conducted via Scopus. HTA agency websites were searched for published guidance on ethics searching, and for reports which included ethical analyses. Methods sections of each report were analyzed to determine the databases, subject headings, and keywords used in search strategies. The team also reached out to information specialists for insight into current search practices. RESULTS: Findings from this study indicate that there is still little published guidance from HTA agencies, few HTAs that contain substantial ethical analysis, and even less information on the methodology for ethics information retrieval. The researchers identified twenty-five relevant HTAs. Ten of these reports did not utilize subject-specific databases outside health sciences. Eight reports published ethics searches, with significant overlap in subject headings and text words. CONCLUSIONS: This scoping study of current practice in HTA ethics information retrieval highlights findings of previous studies-while ethics analysis plays a crucial role in HTA, methods for literature searching remain relatively unclear. These findings provide insight into the current state of ethics searching, and will inform continued work on filter development, database selection, and grey literature searching.

Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group.

OBJECTIVES: Uncertainty is a fundamental component of decision making regarding access to and pricing and reimbursement of drugs. The context-specific interpretation and mitigation of uncertainty remain major challenges for decision makers. Following the 2021 HTAi Global Policy Forum, a cross-sectoral, interdisciplinary HTAi-DIA Working Group (WG) was initiated to develop guidance to support stakeholder deliberation on the systematic identification and mitigation of uncertainties in the regulatory-HTA interface. METHODS: Six online discussions among WG members (Dec 2021-Sep 2022) who examined the output of a scoping review, two literature-based case studies and a survey; application of the initial guidance to a real-world case study; and two international conference panel discussions. RESULTS: The WG identified key concepts, clustered into twelve building blocks that were collectively perceived to define uncertainty: "unavailable," "inaccurate," "conflicting," "not understandable," "random variation," "information," "prediction," "impact," "risk," "relevance," "context," and "judgment." These were converted into a checklist to explain and define whether any issue constitutes a decision-relevant uncertainty. A taxonomy of domains in which uncertainty may exist within the regulatory-HTA interface was developed to facilitate categorization. The real-world case study was used to demonstrate how the guidance may facilitate deliberation between stakeholders and where additional guidance development may be needed. CONCLUSIONS: The systematic approach taken for the identification of uncertainties in this guidance has the potential to facilitate understanding of uncertainty and its management across different stakeholders involved in drug development and evaluation. This can improve consistency and transparency throughout decision processes. To further support uncertainty management, linkage to suitable mitigation strategies is necessary.

Barriers in accessing medical cannabis for children with drug-resistant epilepsy in Canada: A qualitative study.

INTRODUCTION: The use of medical cannabis to treat drug-resistant epilepsy in children is increasing; however, there has been limited study of the experiences of parents with the current system of accessing medical cannabis for their children. METHODS: In this qualitative study, we used a patient-centered access to care framework to explore the barriers faced by parents of children with drug-resistant epilepsy when trying to access medical cannabis in Canada. We conducted semistructured interviews with 19 parents to elicit their experiences with medical cannabis. We analyzed the data according to five dimensions of access, namely approachability, acceptability, availability, affordability, and appropriateness. RESULTS: Parents sought medical cannabis as a treatment because of a perceived unmet need stemming from the failure of antiepileptic drugs to control their children's seizures. Medical cannabis was viewed as an acceptable treatment, especially compared with adding additional antiepileptic drugs. After learning about medical cannabis from the media, friends and family, or other parents, participants sought authorization for medical use. However, most encountered resistance from their child's neurologist to discuss and/or authorize medical cannabis, and many parents experienced difficulty in obtaining authorization from a member of the child's existing care team, leading them to seek authorization from a cannabis clinic. Participants described spending up to $2000 per month on medical cannabis, and most were frustrated that it was not eligible for reimbursement through public or private insurance programs. CONCLUSIONS: Parents pursue medical cannabis as a treatment for their children's drug-resistant epilepsy because of a perceived unmet need. However, parents encounter barriers in accessing medical cannabis in Canada, and strategies are needed to ensure that children using medical cannabis receive proper care from healthcare professionals with training in epilepsy care, antiepileptic drugs, and medical cannabis.

Neurologists' perspectives on medical cannabis for pediatric drug-resistant epilepsy in Canada: A qualitative interview study.

PURPOSE: To understand the experiences with and perspectives of neurologists about the use of medical cannabis in the treatment of pediatric drug-resistant epilepsy. METHODS: In this qualitative study, we interviewed neurologists who provide care to children with drug-resistant epilepsy in Canada. Through semi-structured telephone interviews, we sought participants' views about and experiences with medical cannabis for the treatment of drug-resistant epilepsy in children. Here we present a thematic summary of the interviews. RESULTS: The 12 interviewed neurologists generally perceived medical cannabis as a viable treatment option for children with drug-resistant epilepsy; however, participants identified important gaps in the evidence and implications for their practices. Six themes were generated from the content of the interviews: learning about medical cannabis; perceptions about medical cannabis; discussing medical cannabis with parents; experiences with medical cannabis authorization; barriers to authorizing medical cannabis; and the impact of medical cannabis on clinical care. Of note, while some neurologists took on all aspects of the children's care, including medical cannabis, others referred interested families to non-neurology health care professionals. CONCLUSION: Our findings highlight the diverse opinions and experiences of neurologists in Canada with medical cannabis for the treatment of drug-resistant epilepsy in children, including with the authorization process and caring for children using medical cannabis. Additional education about medical cannabis may be warranted, in order to better prepare neurologists to have informed and open conversations with parents about this treatment option and to provide care for children using medical cannabis.

Cannabis-based products for pediatric epilepsy: An updated systematic review.

PURPOSE: To provide an up-to-date summary of the benefits and harms of cannabis-based products for epilepsy in children. METHODS: We updated our earlier systematic review, by searching for studies published up to May 2019. We included randomized controlled trials (RCTs) and non-randomized studies (NRS) involving cannabis-based products administered to children with epilepsy. Outcomes were seizure freedom, seizure frequency, quality of life, sleep, status epilepticus, death, gastrointestinal adverse events, and emergency room visits. RESULTS: Thirty-five studies, including four RCTs, have assessed the benefits and harms of cannabis-based products in pediatric epilepsy (12 since April 2018). All involved cannabis-based products as adjunctive treatment, and most involved cannabidiol. In the RCTs, there was no statistically significant difference between cannabidiol and placebo for seizure freedom (relative risk 6.77, 95 % confidence interval [CI] 0.36-128.38), quality of life (mean difference [MD] 0.6, 95 %CI -2.6 to 3.9), or sleep disruption (MD -0.3, 95 %CI -0.8 to 0.2). Data from both RCTs and NRS suggest that cannabidiol reduces seizure frequency and increases treatment response; however, there is an increased risk of gastrointestinal adverse events. CONCLUSION: Newly available evidence supports earlier findings that cannabidiol probably reduces the frequency of seizures among children with drug-resistant epilepsy. PROSPERO: CRD42018084755.

Cannabis-based products for pediatric epilepsy: A systematic review.

OBJECTIVE: To assess the benefits and harms of cannabis-based products for pediatric epilepsy. METHODS: We identified in this living systematic review randomized controlled trials (RCTs) and nonrandomized studies (NRSs) involving children with epilepsy treated with cannabis-based products. We searched MEDLINE, Embase, PsycINFO, Cochrane Library, and gray literature (April 25, 2018). The primary outcome was seizure freedom; secondary outcomes were seizure frequency (total, ≥50% reduction), quality of life, sleep, status epilepticus, death, gastrointestinal adverse events, and visits to the emergency room. Data were pooled by random-effects meta-analysis. Risk of bias was assessed for each study, and GRADE was used to assess the quality of evidence for each outcome. RESULTS: Four RCTs and 19 NRSs were included, primarily involving cannabidiol. All RCTs were at low risk of bias, whereas all NRSs were at high risk. Among RCTs, there was no statistically significant difference between cannabidiol and placebo in seizure freedom (relative risk [RR] = 6.77, 95% confidence interval [CI] = 0.36-128.38; 1 RCT), quality of life (mean difference = 0.6, 95% CI = -2.6 to 3.9; 3 RCTs), sleep disruption (mean difference = -0.3, 95% CI = -0.8 to 0.2; 3 RCTs), or vomiting (RR = 1.00, 95% CI = 0.51-1.96; 4 RCTs). There was a statistically significant reduction in the median frequency of monthly seizures with cannabidiol compared with placebo (-19.8%, 95% CI = -27.0% to -12.6%; 3 RCTs) and an increase in the number of participants with at least a 50% reduction in seizures (RR = 1.76, 95% CI = 1.07-2.88; 1 RCT) and diarrhea (RR = 2.25, 95% CI = 1.38-3.68; 3 RCTs). Death and status epilepticus were infrequently reported. SIGNIFICANCE: Evidence from high-quality RCTs suggests that cannabidiol probably reduces seizures among children with drug-resistant epilepsy (moderate certainty). At this time, the evidence base is primarily limited to cannabidiol, and these findings should not be extended to all cannabis-based products.

Cannabis for pediatric epilepsy: protocol for a living systematic review.

BACKGROUND: Pediatric epilepsy, including treatment-resistant forms, has a major effect on the quality of life, morbidity, and mortality of affected children. Interest has been growing in the use of medical cannabis as a treatment for pediatric epilepsy, yet there has been no comprehensive review of the benefits and harms of cannabis use in this population. In this systematic review, we will search for, synthesize, and assess the published and gray literature in order to provide usable and relevant information to parents, clinicians, and policy makers. METHODS: We will perform a living systematic review of studies involving the use of cannabis to treat pediatric epilepsy. We will search the published and gray literature for studies involving children with any type of epilepsy taking any form of cannabis. Studies will be selected for inclusion by two independent reviewers. The primary outcome is seizure freedom. Secondary outcomes are seizure frequency, quality of life (child, caregiver), quality and quantity of sleep, status epilepticus, tonic-clonic seizures, death (all-cause, sudden unexpected death in epilepsy), gastrointestinal adverse events (diarrhea, vomiting), and visits to the emergency room. The quality of each included study will be assessed. If data are sufficient in quantity and sufficiently similar, we will conduct pairwise random-effects meta-analysis. We will repeat the literature search every 6 months to identify studies published after the previous search date. Sequential meta-analysis will be performed as necessary to update the review findings. DISCUSSION: Our review aims to provide a comprehensive and up-to-date summary of the available evidence to inform decisions about the use of cannabis in children with treatment-resistant epilepsy. The results of this review will be of use to parents, clinicians, and policy makers as they navigate this rapidly evolving area. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018084755.

Diet modification challenges faced by marginalized and nonmarginalized adults with type 2 diabetes: A systematic review and qualitative meta-synthesis.

Objectives Diet modification is an important part of the prevention and treatment of type 2 diabetes, but sustained dietary change remains elusive for many individuals. This paper describes and interprets the barriers to diet modification from the perspective of people with type 2 diabetes, paying particular attention to the experiences of people who experience social marginalization. Methods A systematic review of primary, empirical qualitative research was performed, capturing 120 relevant studies published between 2002 and 2015. Qualitative meta-synthesis was used to provide an integrative analysis of this knowledge. Results Due to the central role of food in social life, dietary change affects all aspects of a person's life, and barriers related to self-discipline, emotions, family and social support, social significance of food, and knowledge were identified. These barriers are inter-linked and overlapping. Social marginalization magnifies barriers; people who face social marginalization are trying to make the same changes as other people with diabetes with fewer socio-material resources in the face of greater challenges. Discussion A social-ecological model of behavior supports our findings of challenges at all levels, and highlights the need for interventions and counseling strategies that address the social and environmental factors that shape and sustain dietary change.

Pregnant women's perceptions of gestational weight gain: A systematic review and meta-synthesis of qualitative research.

Excess gestational weight gain has numerous negative health outcomes for women and children, including high blood pressure, diabetes, and cesarean section (maternal) and high birth weight, trauma at birth, and asphyxia (infants). Excess weight gain in pregnancy is associated with a higher risk of long-term obesity in both mothers and children. Despite a concerted public health effort, the proportion of pregnant women gaining weight in excess of national guidelines continues to increase. To understand this phenomenon and offer suggestions for improving interventions, we conducted a systematic review of qualitative research on pregnant women's perceptions and experiences of weight gain in pregnancy. We used the methodology of qualitative meta-synthesis to analyze 42 empirical qualitative research studies conducted in high-income countries and published between 2005 and 2015. With this synthesis, we provide an account of the underlying factors and circumstances (barriers, facilitators, and motivators) that pregnant women identify as important for appropriate weight gain. We also offer a description of the strategies identified by pregnant women as acceptable and appropriate ways to promote healthy weight gain. Through our integrative analysis, we identify women's common perception on the struggle to enact health behaviors and physical, social, and environmental factors outside of their control. Effective and sensitive interventions to encourage healthy weight gain in pregnancy must consider the social environment in which decisions about weight take place.

PUBLIC AND PATIENT INVOLVEMENT IN HEALTH TECHNOLOGY ASSESSMENT: A FRAMEWORK FOR ACTION.

OBJECTIVE: As health technology assessment (HTA) organizations in Canada and around the world seek to involve the public and patients in their activities, frameworks to guide decisions about whom to involve, through which mechanisms, and at what stages of the HTA process have been lacking. The aim of this study was to describe the development and outputs of a comprehensive framework for involving the public and patients in a government agency's HTA process. METHODS: The framework was informed by a synthesis of international practice and published literature, a dialogue with local, national and international stakeholders, and the deliberations of a government agency's public engagement subcommittee in Ontario, Canada. RESULTS: The practice and literature synthesis failed to identify a single, optimal approach to involving the public and patients in HTA. Choice of methods should be considered in the context of each HTA stage, goals for incorporating societal and/or patient perspectives into the process, and relevant societal and/or patient values at stake. The resulting framework is structured around four actionable elements: (i) guiding principles and goals for public and patient involvement (PPI) in HTA, (ii) the establishment of a common language to support PPI efforts, (iii) a flexible array of PPI approaches, and (iv) on-going evaluation of PPI to inform adjustments over time. CONCLUSIONS: A public and patient involvement framework has been developed for implementation in a government agency's HTA process. Core elements of this framework may apply to other organizations responsible for HTA and health system quality improvement.

Finding Qualitative Research Evidence for Health Technology Assessment.

Health technology assessment (HTA) agencies increasingly use reviews of qualitative research as evidence for evaluating social, experiential, and ethical aspects of health technologies. We systematically searched three bibliographic databases (MEDLINE, CINAHL, and Social Science Citation Index [SSCI]) using published search filters or "hedges" and our hybrid filter to identify qualitative research studies pertaining to chronic obstructive pulmonary disease and early breast cancer. The search filters were compared in terms of sensitivity, specificity, and precision. Our screening by title and abstract revealed that qualitative research constituted only slightly more than 1% of all published research on each health topic. The performance of the published search filters varied greatly across topics and databases. Compared with existing search filters, our hybrid filter demonstrated a consistently high sensitivity across databases and topics, and minimized the resource-intensive process of sifting through false positives. We identify opportunities for qualitative health researchers to improve the uptake of qualitative research into evidence-informed policy making.

Inappropriate Ambulance Use: A Qualitative Study of Paramedics' Views.

INTRODUCTION: Existing studies of inappropriate ambulance use focus on its extent, employing clinical criteria. Little is known about how front-line paramedics assess appropriateness. This study investigates how paramedics view and judge appropriate versus inappropriate ambulance use. METHODS: We conducted interviews with 19 paramedics working in two regions in southwestern Ontario that were analyzed using grounded theory methods. FINDINGS: While blatantly "inappropriate" use is extraordinary, "misuse" is more common, and paramedics determine misuse largely by interpreting patients' abilities to cope with their situations. Paramedics assess this using multiple patient attributes: patient's age, knowledge of the system, system failures, social support available, presence of transportation alternatives, patient's ability to walk and trial of treatment with home remedies. CONCLUSION: In the future, paramedic-informed, contextual and non-clinical criteria might supplement clinically based criteria for emergency service-use evaluation and may inform more patient-centred policy interventions to reduce ambulance misuse and inappropriate use.

Cross-border reproductive care in North America: a pilot study testing a prospective data collection program for in vitro fertilization clinics in Canada and the United States.

OBJECTIVE: To develop and test a nonidentifying prospective data collection system for cross-border reproductive care (CBRC) in Canada and the United States (U.S.). DESIGN: Survey and cross-sectional study. SETTING: Fertility clinics. PATIENT(S): Women traveling to and from Canada and the U.S. for reproductive care. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Patients' home country, reason for crossing borders, and type of care received. RESULT(S): Of 32 Canadian and 440 U.S. clinics contacted, seven and 46, respectively, responded to the initial questionnaire. Three out of seven Canadian and 44 out of 46 U.S. clinics reported providing CBRC. Seventy five percent agreed that nonidentifying data on country of origin and reason for travel should be collected. However, only one of seven Canadian and none of 46 U.S. clinics that expressed initial interest actually collected data, despite multiple communications. CONCLUSION(S): Although CBRC is a major component of assisted reproductive technology in North America (3%-10% of IVF cycles are provided to out-of-country patients in Canada and the U.S.), clinicians are not motivated to collect the simplest of data regarding CBRC patients. Despite this, reliable data are needed to help better understand the reasons for and impact of CBRC.

Patient Perspectives on Quality of Life With Uncontrolled Type 1 Diabetes Mellitus: A Systematic Review and Qualitative Meta-synthesis.

BACKGROUND: Patients with uncontrolled type 1 diabetes mellitus may be candidates for pancreatic islet cell transplantation. This report synthesizes qualitative research on how patients with uncontrolled type 1 diabetes perceive their quality of life. OBJECTIVE: The objective of this analysis was to examine the perceptions of patients with uncontrolled type 1 diabetes on how it affects their lived experience and quality of life. DATA SOURCES: This report synthesizes 31 primary qualitative studies to examine quality of life from the perspectives of adult patients with type 1 diabetes mellitus and their families or partners. REVIEW METHODS: We performed a qualitative meta-synthesis to integrate findings across primary research studies. RESULTS: Long- and short-term negative consequences of uncontrolled type 1 diabetes affect all aspects of patients' lives: physical, emotional, practical, and social. The effect on each domain is far-reaching, and effects interact across domains. Uncontrolled blood sugar levels lead to substantial psychological distress, negative moods, cognitive difficulties, irritable or aggressive behaviour, and closely associated problems with relationships, self-image, and confidence. Emotional distress is pervasive and under-addressed by health care providers. Patients live in fear of complications from diabetes over the long term. In the shorter term, they are anxious about the personal, social, and professional consequences of hypoglycemic episodes (e.g., injury, humiliation), and may curtail normal activities such as driving or socializing because they are worried about having an episode. The quality of life for patients' family members is also negatively impacted by uncontrolled type 1 diabetes. CONCLUSIONS: Uncontrolled type 1 diabetes has significant negative impacts on the quality of life of both people with the disease and their families.

Type 2 diabetes patients' and providers' differing perspectives on medication nonadherence: a qualitative meta-synthesis.

BACKGROUND: Poor adherence to medication regimens increases adverse outcomes for patients with Type 2 diabetes. Improving medication adherence is a growing priority for clinicians and health care systems. We examine the differences between patient and provider understandings of barriers to medication adherence for Type 2 diabetes patients. METHODS: We searched systematically for empirical qualitative studies on the topic of barriers to medication adherence among Type 2 diabetes patients published between 2002-2013; 86 empirical qualitative studies qualified for inclusion. Following qualitative meta-synthesis methods, we coded and analyzed thematically the findings from studies, integrating and comparing findings across studies to yield a synthetic interpretation and new insights from this body of research. RESULTS: We identify 7 categories of barriers: (1) emotional experiences as positive and negative motivators to adherence, (2) intentional non-compliance, (3) patient-provider relationship and communication, (4) information and knowledge, (5) medication administration, (6) social and cultural beliefs, and (7) financial issues. Patients and providers express different understandings of what patients require to improve adherence. Health beliefs, life context and lay understandings all inform patients' accounts. They describe barriers in terms of difficulties adapting medication regimens to their lifestyles and daily routines. In contrast, providers' understandings of patients poor medication adherence behaviors focus on patients' presumed needs for more information about the physiological and biomedical aspect of diabetes. CONCLUSIONS: This study highlights key discrepancies between patients' and providers' understandings of barriers to medication adherence. These misunderstandings span the many cultural and care contexts represented by 86 qualitative studies. Counseling and interventions aimed at improving medication adherence among Type 2 diabetes might become more effective through better integration of the patient's perspective and values concerning adherence difficulties and solutions.

Fair reckoning: a qualitative investigation of responses to an economic health resource allocation survey.

OBJECTIVE: To investigate how participants in an economic resource allocation survey construct notions of fairness. DESIGN: Qualitative interview study guided by interpretive grounded theory methods. SETTING AND PARTICIPANTS: Qualitative interviews were conducted with volunteer university- (n=39) and community-based (n =7) economic survey participants. INTERVENTION OR MAIN VARIABLES STUDIED: We explored how participants constructed meanings to guide or explain fair survey choices, focusing on rationales, imagery and additional desired information not provided in the survey scenarios. MAIN OUTCOME MEASURES: Data were transcribed and coded into qualitative categories. Analysis iterated with data collection iterated through three waves of interviews. RESULTS: Participants compared the survey dilemmas to domains outside the health system. Most compared them with other micro-level, inter-personal sharing tasks. Participants raised several fairness-relevant factors beyond need or capacity to benefit. These included age, weight, poverty, access to other options and personal responsibility for illness; illness duration, curability or seriousness; life expectancy; possibilities for sharing; awareness of other's needs; and ability to explain allocations to those affected. They also articulated a fairness principle little considered by equity theories: that everybody must get something and nobody should get nothing. DISCUSSION AND CONCLUSIONS: Lay criteria for judging fairness are myriad. Simple scenarios may be used to investigate lay commitments to abstract principles. Although principles are the focus of analysis and inference, participants may solve simplified dilemmas by imputing extraneous features to the problem or applying unanticipated principles. These possibilities should be taken into account in the design of resource allocation surveys eliciting the views of the public.

Cross-border fertility services in North America: a survey of Canadian and American providers.

OBJECTIVE: To identify the scope and volume of cross-border fertility services in Canada and the U.S. and to evaluate the three-way communication between patients and their service providers in 2008. DESIGN: Mail and on-line surveys of cross-border fertility care activity were sent to 34 Canadian and 392 American fertility clinics and clinicians. MAIN OUTCOME MEASURE(S): Clinician and patient experience with assisted reproductive technologies. RESULT(S): The most commonly reported cross-border treatment sought by Canadians was anonymous donor-oocyte in vitro fertilization (IVF; 363 out of 452, 80%). For patients entering Canada to receive fertility treatment, the largest demand was for IVF (106 out of 146, 73%). The majority of out-of-country patients received by U.S. clinics sought standard IVF (927 out of 1,809, 51%), most of these coming from Europe (25%) and Latin America (39%). The largest proportion of patients leaving the U.S. to receive IVF (41%) or donor-egg IVF (52%) traveled to India/Asia. Concurrence was seen between Canadian and U.S. clinics' ratings of key data that should be provided along with returning patients. Experience of earlier patients with individual centers and perceived safety and effectiveness of care are the key factors in choice of destination. CONCLUSION(S): Anonymous donor-oocyte IVF is the main assisted reproductive technology sought by Canadians traveling to the U.S. India and Asia are the main destinations for U.S. women leaving the country for their fertility care. Three-way communication between patients and sending and receiving clinics is an important element of safe and effective care.

Ethics in Canadian health technology assessment: a descriptive review.

BACKGROUND: Despite the mandate to examine the medical, ethical, and economic implications of the development and use of health technology, health technology assessment (HTA) reports often emphasize the epidemiologic and economic aspects, and omit ethical considerations. This study examines both whether and how ethical issues are incorporated into HTA. OBJECTIVES: We aim to (i) review a set of Canadian HTA reports for ethics content, (ii) describe the strategies used to incorporate ethically relevant information into HTA, and (iii) determine the presence of implicit ethical issues in a sample of HTA reports. METHODS: Descriptive and qualitative content analysis of 608 HTA reports produced by six Canadian HTA agencies from January 1997 to December 2006. RESULTS: We found that (i) a minority (17 percent) of Canadian HTA reports addressed ethical issues, (ii) secondary research predominates while primary analysis is rare, (iii) implicit ethical issues are present in HTA reports that do not purport to address ethics. CONCLUSIONS: Canadian HTA reports rarely explicitly, and then only superficially, address ethics, though implicit ethical issues abound.

Life support decision making in critical care: Identifying and appraising the qualitative research evidence.

OBJECTIVE: The objective of this study is to identify and appraise qualitative research evidence on the experience of making life-support decisions in critical care. DATA SOURCES: In six databases and supplementary sources, we sought original research published from January 1990 through June 2008 reporting qualitative empirical studies of the experience of life-support decision making in critical care settings. STUDY SELECTION: Fifty-three journal articles and monographs were included. Of these, 25 reported prospective studies and 28 reported retrospective studies. DATA EXTRACTION: We abstracted methodologic characteristics relevant to the basic critical appraisal of qualitative research (prospective data collection, ethics approval, purposive sampling, iterative data collection and analysis, and any method to corroborate findings). DATA SYNTHESIS: Qualitative research traditions represented include grounded theory (n = 15, 28%), ethnography or naturalistic methods (n = 15, 28%), phenomenology (n = 9, 17%), and other or unspecified approaches (n = 14, 26%). All 53 documents describe the research setting; 97% indicate purposive sampling of participants. Studies vary in their capture of multidisciplinary clinician and family perspectives. Thirty-one (58%) report research ethics board review. Only 49% report iterative data collection and analysis, and eight documents (15%) describe an analytically driven stopping point for data collection. Thirty-two documents (60%) indicated a method for corroborating findings. CONCLUSIONS: Qualitative evidence often appears outside of clinical journals, with most research from the United States. Prospective, observation-based studies follow life-support decision making directly. These involve a variety of participants and yield important insights into interactions, communication, and dynamics. Retrospective, interview-based studies lack this direct engagement, but focus on the recollections of fewer types of participants (particularly patients and physicians), and typically address specific issues (communication and stress). Both designs can provide useful reflections for improving care. Given the diversity of qualitative research in critical care, room for improvement exists regarding both the quality and transparency of reported methodology.

Ethics frameworks in Canadian health policies: Foundation, scaffolding, or window dressing?

Health policy documents increasingly feature ethics frameworks that outline key guiding principles. It is unclear whether such frameworks function as scaffolding for creating policy, foundations for responding to policy, or mere aesthetic frames to make policies appear ethical. This study investigates the nature and quality of ethics frameworks in Canadian health documents. We reviewed the ethics frameworks of 24 strategic health policy documents published from 1998 to 2005 by Canadian government agencies. We found that frameworks typically apper as a list of principles or values. These elements vary widely across the terminal, procedural, and substantive values of conventional ethics, and many are better characterized as goals than as ethics. No two ethics frameworks matched, despite common topic areas and presumably broadly shared values within the Canadian health system. Elements shared by at least half of the documents include: access, accountability, autonomy , client-centredness, collaboration, efficiency, equity, and evidence. However, common elements are interpreted quite differently. The genesis of the framework and its elements is seldom described. Only one third of the documents relate specific ethical elements to specific policies. In conclusion, we draw on the clinical guidelines literature to propose some features of a robust, coherent and meaningful ethics framework. (AU)