-
[show abstract]
[hide abstract]
ABSTRACT: Background Interest in citizens' juries for eliciting the views of the public to inform coverage decisions on new health technologies has grown. However, evaluative information, particularly regarding their short- and/or longer-term impact on participants' views is limited. As citizens' juries can be resource intensive, such information is required to make 'evidence-based' decisions about their use. Objectives To assess the impact of citizens' juries on participants' preferences for the distribution of health care across populations over time. Setting and participants Two citizens' juries, involving a different representative sample of the public, were held. Participants completed identical questionnaires before (T1), directly after (T2) and 6 weeks following the jury (T3). Questionnaires comprised rating, ranking and choice-based questions related to four characteristics of competing patient populations (age, current health, life expectancy without treatment and health gain resulting from an intervention). Semi-structured telephone interviews were also conducted to explore the impact of the jury on participants' distributive preferences. Changes in responses to the self-administered survey over the three time points were assessed quantitatively, while interview questions were analysed using qualitative techniques. Results No significant differences in responses to rating questions were observed. Pre/post-jury changes in the rankings of two factors were statistically significant in one of the juries. However, in both juries, T1-T2 changes in responses to several of the choice-based questions reached statistical significance. The number was lower between T2 and T3, suggesting that jurors retained their views. According to findings from the interviews, jurors' views changed or were clarified through participation in the jury. Conclusions There appears to be evidence suggesting that the views of individuals who participate in citizens' juries change as a result of the experience, and those 'informed' views are sustained.
Health expectations: an international journal of public participation in health care and health policy 02/2012; · 1.80 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Attempts to improve the acceptability of resource allocation decisions around new health technologies have spanned many years, fields and disciplines. Various theories of decision making have been tested and methods piloted, but, despite their availability, evidence of sustained uptake is limited. Since the challenge of determining which of many technologies to fund is one that healthcare systems have faced since their inception, an analysis of actual processes, criticisms confronted and approaches used to manage them may serve to guide the development of an 'evidence-informed' decision-making framework for improving the acceptability of decisions.
The purpose of this study was to develop a technology funding decision-making framework informed by the experiences of multiple healthcare systems and the views of senior-level decision makers in Canada.
A 1-day, facilitated workshop was held with 16 senior-level healthcare decision makers in Canada. International examples of actual technology funding decision-making processes were presented. Participants discussed key elements of these processes, debated strengths and weaknesses and highlighted unresolved challenges. The findings were used to construct a technology decision-making framework on which participant feedback was then sought. Its relevance, content, structure and feasibility were further assessed through key informant interviews with ten additional senior-level decision makers.
Six main issues surrounding current processes were raised: (i) timeliness; (ii) methodological considerations; (iii) interpretations of 'value for money'; (iv) explication of social values; (v) stakeholder engagement; and (vi) 'accountability for reasonableness'. While no attempt was made to force consensus on what should constitute each of these, there was widespread agreement on questions that must be addressed through a 'robust' process. These questions, grouped and ordered into three phases, became the final framework.
A decision-making framework informed by processes in other jurisdictions and the views of local decision makers was developed. Pilot testing underway in one Canadian jurisdiction will identify any further refinements needed to optimize its usefulness.
PharmacoEconomics 09/2011; 29(9):771-80. · 2.66 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Over the past decade, public distrust in unavoidable value-laden decisions on the allocation of resources to new health technologies has grown. In response, healthcare organizations have made considerable efforts to improve their acceptability by increasing transparency in decision-making processes. However, the social value judgments (distributive preferences of the public) embedded in them have yet to be defined. While the need to explicate such judgments has become widely recognized, the most appropriate approach to accomplishing this remains unclear. The aims of this review were to identify factors around which distributive preferences of the public have been sought, create a list of social values proposed or used in current resource allocation decision-making processes for new health technologies, and review approaches to eliciting such values from the general public. Social values proposed or used in making resource allocation decisions for new health technologies were identified through three approaches: (i) a comprehensive review of published, peer-reviewed, empirical studies of public preferences for the distribution of healthcare; (ii) an analysis of non-technical factors or social value statements considered by technology funding decision-making processes in Canada and abroad; and (iii) a review of appeals to funding decisions on grounds in part related to social value judgments. A total of 34 empirical studies, 10 technology funding decision-making processes, and 12 appeals to decisions were identified and reviewed. The key factors/patient characteristics addressed through policy statements and around which distributive preferences of the public have been sought included severity of illness, immediate need, age (and its relationship to lifetime health), health gain (amount and final outcome/health state), personal responsibility for illness, caregiving responsibilities, and number of patients who could benefit (rarity). Empirical studies typically examined the importance of these factors in isolation. Therefore, the extent to which preferences around one factor may be modified in the presence of others is still unclear. Research that seeks to clarify interactions among factors by asking the public to weigh several of them at once is needed to ensure the relevance of elicited preferences to real-world technology funding decisions.
The patient 08/2011; 4(4):207-25. · 0.57 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Paget's disease is a rare skin disorder occurring in the breast (mammary) or in the groin, genital, peri-anal and axillary regions (extra-mammary). Typical treatment involves surgical excision, which in the case of extra-mammary Paget's disease, can lead to significant morbidity. Photodynamic therapy (PDT) which uses a topical or intravenous photosensitizing agent that is activated by a light source to ablate abnormal tissue, offers a minimally invasive alternative. The purpose of this study was to assess the effectiveness of photodynamic therapy in the treatment of Paget's disease.
Following Cochrane guidelines, a comprehensive systematic review of all clinical studies and reports examining the use of PDT for mammary and extra-mammary Paget's disease was conducted. Study quality was assessed using the Oxford Levels of Evidence Scale.
21 retrospective and 2 prospective non-comparative studies were identified and included in the review: 9 case reports with 1-2 patients and 14 case series with 1-16 patients. These reports totalled 99 patients with 133 extra-mammary Paget's lesions and 3 patients (with 3 lesions) with mammary Paget's disease. Follow-up periods were typically one year or less, with 77/133 extra-mammary lesions exhibiting complete response to PDT. One recurrent mammary skin lesion and two mammary lesions treated concomitantly with surgery also exhibited complete responses.
Evidence of the effectiveness of PDT for Paget's disease is promising, but limited. This may, in part, be explained by the rarity of the condition, making controlled comparative clinical trials challenging.
BMC Dermatology 06/2011; 11:13.
-
[show abstract]
[hide abstract]
ABSTRACT: All healthcare systems routinely make resource allocation decisions that trade off potential health gains to different patient populations. However, when such trade-offs relate to the introduction of new, promising health technologies, perceived 'winners' and 'losers' are more apparent. In recent years, public scrutiny over such decisions has intensified, raising the need to better understand how they are currently made and how they might be improved. The objective of this paper is to critically review and compare current processes for making health technology funding decisions at the regional, state/provincial and national level in 20 countries. A comprehensive search for published, peer-reviewed and grey literature describing actual national, state/provincial and regional/institutional technology decision-making processes was conducted. Information was extracted by two independent reviewers and tabulated to facilitate qualitative comparative analyses. To identify strengths and weaknesses of processes identified, websites of corresponding organizations were searched for commissioned reviews/evaluations, which were subsequently analysed using standard qualitative methods. A total of 21 national, four provincial/state and six regional/institutional-level processes were found. Although information on each one varied, they could be grouped into four sequential categories: (i) identification of the decision problem; (ii) information inputs; (iii) elements of the decision-making process; and (iv) public accountability and decision implementation. While information requirements of all processes appeared substantial and decision-making factors comprehensive, the way in which they were utilized was often unclear, as were approaches used to incorporate social values or equity arguments into decisions. A comprehensive inventory of approaches to implementing the four main components of all technology funding decision-making processes was compiled, from which areas for future work or research aimed at improving the acceptability of decisions were identified. They include the explication of decision criteria and social values underpinning processes.
PharmacoEconomics 06/2011; 29(6):475-95. · 2.66 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Health technology assessment (HTA) has become an integral part of decision-making on the coverage of new health technologies in most health systems in the developed world. In recent years, pressure to involve patients and members of the public in HTA has grown. In this article, we summarize findings from peer-reviewed and 'gray' literature, and discussions with key informants to determine potential roles for patients and the public in HTA and coverage decision-making. We also summarize existing roles for both groups in jurisdictions. Although there appears to be a general view that involvement of patients and the public is highly desirable, research offering insights into the effectiveness of different approaches to accomplish this is scarce. Nonetheless, many of the HTA agencies in developed countries have established some mechanism for seeking input from patients or the public in their processes.
Expert Review of Pharmacoeconomics & Outcomes Research 02/2011; 11(1):75-89.
-
[show abstract]
[hide abstract]
ABSTRACT: Traditionally, management of early cancer (stages 0-IIA) has comprised esophagectomy, either alone or in combination with chemotherapy and/or radiotherapy. Recent efforts to improve outcomes and minimize side-effects have focussed on minimally invasive, endoscopic treatments that remove lesions while sparing healthy tissue. This review assesses their safety and efficacy/effectiveness relative to traditional, non-endoscopic treatments for early esophageal cancer.
A systematic review of peer-reviewed studies was performed using Cochrane guidelines. Bibliographic databases searched to identify relevant English language studies published in the last 3 years included: PubMed (i.e., MEDLINE and additional sources), EMBASE, CINAHL, The Cochrane Library, the UK Centre for Reviews and Dissemination (NHS EED, DARE and HTA) databases, EconLit and Web of Science. Web sites of professional associations, relevant cancer organizations, clinical practice guidelines, and clinical trials were also searched. Two independent reviewers selected, critically appraised, and extracted information from studies.
The review included 75 studies spanning 3124 patients and 10 forms of treatment. Most studies were of short term duration and non-comparative. Adverse events reported across studies of endoscopic techniques were similar and less significant compared to those in the studies of non-endoscopic techniques. Complete response rates were slightly lower for photodynamic therapy (PDT) relative to the other endoscopic techniques, possibly due to differences in patient populations across studies. No studies compared overall or cause-specific survival in patients who received endoscopic treatments vs. those who received non-endoscopic treatments.
Based on findings from this review, there is no single "best practice" approach to the treatment of early esophageal cancer.
Cancer treatment reviews 02/2011; 37(1):11-62. · 5.30 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: The rapid development of new health technologies for which there is limited, but promising, evidence has resulted in a daunting challenge - to provide care that meets population health needs and optimizes patient outcomes, demonstrates an efficient use of healthcare resources, and upholds basic principles of equity, access, and choice. In this paper, we introduce 'Access with Evidence Development' as a possible mechanism for addressing this challenge and discuss its application to the "Zamboni procedure" for Multiple Sclerosis.
Healthcare management forum / Canadian College of Health Service Executives = Forum gestion des soins de santé / Collège canadien des directeurs de services de santé 01/2011; 24(2):42-56.
-
[show abstract]
[hide abstract]
ABSTRACT: The purpose of this study was to compare centralized reimbursement/coverage decision-making processes for health technologies in 23 European countries, according to: mandate, authority, structure, and policy options; mechanisms for identifying, selecting, and evaluating technologies; clinical and economic evidence expectations; committee composition, procedures, and factors considered; available conditional reimbursement options for promising new technologies; and the manufacturers' roles in the process.
A comprehensive review of publicly available information from peer-reviewed literature (using a variety of bibliographic databases) and gray literature (eg, working papers, committee reports, presentations, and government documents) was conducted. Policy experts in each of the 23 countries were also contacted. All information collected was reviewed by two independent researchers.
Most European countries have established centralized reimbursement systems for making decisions on health technologies. However, the scope of technologies considered, as well as processes for identifying, selecting, and reviewing them varies. All systems include an assessment of clinical evidence, compiled in accordance with their own guidelines or internationally recognized published ones. In addition, most systems require an economic evaluation. The quality of such information is typically assessed by content and methodological experts. Committees responsible for formulating recommendations or decisions are multidisciplinary. While criteria used by committees appear transparent, how they are operationalized during deliberations remains unclear. Increasingly, reimbursement systems are expressing interest in and/or implementing reimbursement policy options that extend beyond the traditional "yes," "no," or "yes with restrictions" options. Such options typically require greater involvement of manufacturers which, to date, has been limited.
Centralized reimbursement systems have become an important policy tool in many European countries. Nevertheless, there remains a lack of transparency around critical elements, such as how multiple factors or criteria are weighed during committee deliberations.
ClinicoEconomics and Outcomes Research 01/2011; 3:117-86.
-
[show abstract]
[hide abstract]
ABSTRACT: Health technology assessment (HTA) is a tool intended to help policy-makers decide which technologies to fund. However, given the proliferation of new technologies, it is not possible to undertake an HTA of each one before it becomes funded. Consequently, "horizon-scanning" processes have been developed to identify emerging technologies that are likely to have a substantial impact on clinical practice. Although the importance of physicians in the adoption of new technologies is well recognized, their role in horizon scanning in Canada has been limited. The purpose of this project was to pilot an approach to engage physicians, specifically surgeons, in provincial horizon-scanning activities.
We invited 18 surgeons from Alberta's 2 medical schools to a horizon-scanning workshop to solicit their views on emerging technologies expected to impact surgical practice within the next 5 years and/or the importance of different attributes or characteristics of new technologies.
Surgeons, regardless of specialty, identified developments designed to enhance existing minimally invasive surgical techniques, such as endoscopic, robotic and image-guided surgery. Several nonsurgical areas, including molecular genetics and nano technology, were also identified. Of the 13 technology attributes discussed, safety or risk, effectiveness and feasibility were rated as most important. Lastly, participating surgeons expressed an interest in becoming further involved in local HTA initiatives.
Surgeons, as adopters and users of health technologies, represent an important and accessible information source for identifying emerging technologies for HTA. A more formal, ongoing relationship between the government, HTA and surgeons may help to optimize the use of HTA resources.
Canadian journal of surgery. Journal canadien de chirurgie 04/2010; 53(2):86-92. · 1.05 Impact Factor
-
PharmacoEconomics 01/2010; 28(2):109-11. · 2.66 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: As tensions between payers, responsible for ensuring prudent and principled use of scarce resources, and both providers and patients, who legitimately want access to technologies from which they could benefit, continue to mount, interest in approaches to managing the uncertainty surrounding the introduction of new health technologies has heightened. The purpose of this project was to compile an inventory of various types of 'access with evidence development' (AED) schemes, examining characteristics of the technologies to which they have been applied, the uncertainty they sought to address, the terms of arrangements of each scheme, and the policy outcomes. It also aimed to identify issues related to such schemes, including advantages and disadvantages from the perspectives of various stakeholder groups. A comprehensive search, review and appraisal of peer-reviewed and 'grey' literature were performed, followed by a facilitated workshop of academics and decision makers with expertise in AED schemes. Information was extracted and compiled in tabular form to identify patterns or trends. To enhance the validity of interpretations made, member checking was performed. Although the concept of AED is not new, evaluative data are sparse. Despite varying opinions on the 'right' answers to some of the questions raised, there appears to be consensus on a 'way forward'--development of methodological guidelines. All stakeholders seemed to share the view that AEDs offer the potential to facilitate patient access to promising new technologies and encourage innovation while ensuring effective use of scarce healthcare resources. There is no agreement on what constitutes 'sufficient evidence', and it depends on the specific uncertainty in question. There is agreement on the need for 'best practice' guidelines around the implementation and evaluation of AED schemes. This is the first attempt at a comprehensive analysis of methods that have been used to address uncertainty concerning a new drug or other technology. The analysis reveals that, although various approaches have been experimented with, many of them have not achieved the ostensible goal of the approach. This article outlines challenges related to AED schemes and issues that remain unresolved.
PharmacoEconomics 01/2010; 28(2):113-42. · 2.66 Impact Factor
-
BMJ (Clinical research ed.). 01/2010; 341:c4777.
-
[show abstract]
[hide abstract]
ABSTRACT: There is an inevitable tension between robust reimbursement processes and providing speedy access to new and novel technologies, given uncertainties about key pieces of evidence and subsequent concerns regarding their overall efficiency. The public perception of these treatments as 'breakthrough', combined with substantial clinical pressure, has led to healthcare payers looking for schemes that allow the new technology to be made available to (some) patients, while (at least partially) protecting the principles of their reimbursement decision-making processes. Current literature on these schemes is almost completely descriptive and provides little help in planning future schemes. We propose a framework for evaluating current schemes and informing the design of future schemes. We examine the value of the framework using the UK Multiple Sclerosis Risk-Sharing Scheme as a case study.
PharmacoEconomics 01/2010; 28(2):143-52. · 2.66 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Recently, several new endoscopic treatments have been used to treat patients with Barrett's esophagus with high grade dysplasia. This systematic review aimed to determine the safety and effectiveness of these treatments compared with esophagectomy.
A comprehensive literature search was undertaken to identify studies of endoscopic treatments for Barrett's esophagus or early stage esophageal cancer. Information from the selected studies was extracted by two independent reviewers. Study quality was assessed and information was tabulated to identify trends or patterns. Results were pooled across studies for each outcome. Safety (occurrence of adverse events) and effectiveness (complete eradication of dysplasia) were compared across different treatments.
The 101 studies that met the selection criteria included 8 endoscopic techniques and esophagectomy; only 12 were comparative studies. The quality of evidence was generally low. Methods and outcomes were inconsistently reported. Protocols, outcomes measured, follow-up times and numbers of treatment sessions varied, making it difficult to calculate pooled estimates.The surgical mortality rate was 1.2%, compared to 0.04% in 2831 patients treated endoscopically (1 death). Adverse events were more severe and frequent with esophagectomy, and included anastomotic leaks (9.4%), wound infections (4.1%) and pulmonary complications (4.1%). Four patients (0.1%) treated endoscopically experienced bleeding requiring transfusions. The stricture rate with esophagectomy (5.3%) was lower than with porfimer sodium photodynamic therapy (18.5%), but higher than aminolevulinic acid (ALA) 60 mg/kg PDT (1.4%). Dysphagia and odynophagia varied in frequency across modalities, with the highest rates reported for multipolar electrocoagulation (MPEC). Photosensitivity, an adverse event that occurs only with photodynamic therapy, was experienced by 26.4% of patients who received porfimer sodium.Some radiofrequency ablation (RFA) or argon plasma coagulation (APC) studies (used in multiple sessions) reported rates of almost 100% for complete eradication of dysplasia. But the study methods and findings were not adequately described. The other studies of endoscopic treatments reported similarly high rates of complete eradication.
Endoscopic treatments offer safe and effective alternatives to esophagectomy for patients with Barrett's esophagus and high grade dysplasia. Unfortunately, shortcomings in the published studies make it impossible to determine the comparative effectiveness of each of the endoscopic treatments.
BMC Gastroenterology 01/2010; 10:111. · 2.42 Impact Factor
-
Value in Health 07/2009; 12 Suppl 2:S14-9. · 2.19 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Despite the immature state of stem cell medicine, patients are seeking and accessing putative stem cell therapies in an "early market" in which direct-to-consumer advertising via the internet likely plays an important role. We analyzed stem cell clinic websites and appraised the relevant published clinical evidence of stem cell therapies to address three questions about the direct-to-consumer portrayal of stem cell medicine in this early market: What sorts of therapies are being offered? How are they portrayed? Is there clinical evidence to support the use of these therapies? We found that the portrayal of stem cell medicine on provider websites is optimistic and unsubstantiated by peer-reviewed literature.
Cell stem cell 01/2009; 3(6):591-4. · 23.56 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: To assess the feasibility of using a citizens' jury to elicit public values on health technologies and to develop criteria for setting priorities for health technology assessment (HTA).
Sixteen individuals were selected from 1600 randomly sampled residents of the Capital Health Region in Alberta, Canada. They participated in a 2 (1/2) day jury which comprised presentations by 'expert witnesses', who represented innovators, patients, health-care policy-makers and clinicians, as well as a series of small and large group priority-setting exercises based on actual examples of technologies that had recently been considered for assessment by local and national HTA bodies. The session was audio-taped, and transcripts were independently reviewed by two researchers using content analytical techniques in order to ensure that no important concepts expressed by individual jurors were missed during group development of the final list of priority-setting criteria. Jurors evaluated the process by completing self-administered, semi-structured questionnaires at the end of the session. Responses were analysed using qualitative methods.
The jury identified 13 criteria, which they subsequently ranked in order of importance. The top two criteria included 'potential to benefit a number of people' and 'extends life with quality'. Based on feedback from questionnaires, jurors valued the opportunity to become engaged in such a process, and expressed interest in participating in future juries.
Citizens' juries offer a feasible approach to involving the public in priority-setting for HTA. Furthermore, technologies that may benefit a number of people and improve quality of life appear to be of greatest importance to the public.
Health expectations: an international journal of public participation in health care and health policy 10/2008; 11(3):282-93. · 1.80 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: In recent years, laser treatments have re-emerged as options for treating benign prostatic hyperplasia (BPH). This paper reviews the safety, efficacy, effectiveness and economics of photoselective vapourization of the prostate (PVP), compared with transurethral resection of the prostate (TURP).
We conducted a comprehensive literature search to identify 14 studies comparing 80 W PVP and TURP. We then reviewed and pooled these studies.
We identified 12 adverse events or complications; rates were similar in both groups. No PVP patient required a blood transfusion; 5%-11% of TURP patients did. PVP patients had a significantly lower likelihood of clot retention. Collectively, the 14 studies led to the conclusion that PVP is a safe procedure. PVP is favourable to TURP regarding length of hospitalization and catheterization times. There were no meaningful differences in operation times, reoperation rates, peak flow rates, postresidual volumes or quality of life scores. Sexual function and prostate specific antigen value changes were similar. Four economic evaluations of PVP and TURP (from Canada, Switzerland, Australia and the United States) concluded that PVP is less costly per case than TURP. Cost differences are attributable to disposables, capital equipment and hospitalization. Based on our analysis of limited Canadian data, the cost of PVP is estimated to be about one-half that of TURP, even after accounting for start-up costs.
The 80 W PVP laser appears to be a viable treatment for BPH. With the recent regulatory approval of the 120 W High Performance System (HPS), an additional option has become available. Therefore, it is anticipated that PVP will soon be considered part of a physician's repertoire for managing BPH.
Canadian Urological Association journal = Journal de l'Association des urologues du Canada 05/2008; 2(2):124-34. · 1.24 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: In recent years, heightened public awareness of new medical advances that offer improved therapeutic and diagnostic options coupled with increased fiscal pressure on health care systems to deliver both equitable and efficient care have magnified the need to examine carefully how and by whom health care priorities are set.
To assess processes for setting health care priorities in Alberta, Canada.
A demographically representative sample of senior management within Regional Health Authorities (RHAs) and specialized provincial boards was selected to participate in key informant interviews. The interviews, which were audio-taped and transcribed, comprised open-ended questions addressing priority-setting approaches employed and the extent to which the public was involved. Through a series of iterations, transcripts were analyzed using content analytic techniques.
In general, priority-setting was found to involve four steps: (1) identification of health care needs, (2) allocation of resources, (3) communication of decisions to stakeholders, and (4) management of feedback from them. While approaches to accomplishing each step varied across RHAs and specialized provincial bodies, public involvement did not. In all cases, mechanisms for engaging them in priority-setting focused almost exclusively on the first step. From an "accountability for reasonableness" perspective, none of the organizations surveyed had established processes that met all four principles.
Health Policy 01/2008; 84(2-3):220-33. · 1.51 Impact Factor
