Patient-reported outcome measures (PROMs) are increasingly used to assess multiple facets of healthcare, including effectiveness, side effects of treatment, symptoms, health care needs, quality of care, and the evaluation of health care options. There are thousands of these measures and yet there is very little discussion of their theoretical underpinnings. In her 2008 Presidential address to the Society for Quality of Life Research (ISOQoL), Professor Donna Lamping challenged researchers to grapple with the theoretical issues that (...) arise from these measures. In this paper, I attempt to do so by arguing for an analogy between PROMs and Hans-Georg Gadamer’s logic of question and answer. While researchers readily admit that the constructs involved in PROMs are imperfectly understood and lack a gold standard, they often ignore the consequences of this fact. Gadamer’s work on questions and their importance to philosophical hermeneutics helps to show that the questions researchers ask about such constructs are also imperfectly understood. I argue that these questions should not be standardized, and I instead propose a theoretical framework that understands PROMs as posing genuine questions to respondents—questions that are open to reinterpretation. (shrink)

There has been much philosophical interest regarding the ‘hierarchy of evidence’ used to determine which study designs are of most value for reporting on questions of effectiveness, prognosis, and so on. There has been much less philosophical interest in the choice of outcome measures with which the results of, say, an RCT or a cohort study are presented. In this paper, we examine the FDA’s recently published guidelines for assessing the psychometric adequacy of patient-reported outcome (...) measures. We focus on their recommendations for demonstrating content validity and also for how researchers should weigh up the sum of psychometric evidence when choosing these measures. We argue that questions regarding judgment and understanding meaning of these measures should play a more central role in determining their adequacy. (shrink)

Engagement with the historical and theoretical underpinnings of measuring quality of life (QoL) and patient‐reported outcomes (PROs) in healthcare is important. Ideas and values that shape such practices—and in the endgame, people's lives—might otherwise remain unexamined, be taken for granted or even essentialized. Our aim is to explicate and theoretically discuss the philosophical tenets underlying the practices of QoL assessment and PRO measurement in relation to the notion of person‐centredness. First, we engage with the late‐modern history of the (...) concept of QoL and the act of assessing and measuring it. Working with the historical method of genealogy, we describe the development of both QoL assessments and PRO measures (PROMs) within healthcare by accounting for the contextual conditions for their possibility. In this way, the historical and philosophical underpinnings of these measurement practices are highlighted. We move on to analyse theoretical and philosophical underpinnings regarding the use of PROMs and QoL assessments in clinical practice, as demonstrated in review studies thereof. Finally, we offer a critical analysis regarding the state of theory in the literature and conclude that, although improved person‐centredness is an implied driver of QoL assessments and PROMs in clinical practice, enhanced theoretical underpinning of the development of QoL assessments is called for. (shrink)

In order to investigate patients’ experience of healthcare, repeated assessments of patient-reported outcomes are increasingly performed in observational studies and clinical trials. Changes in PRO can however be difficult to interpret in longitudinal settings as patients’ perception of the concept being measured may change over time, leading to response shift and possibly to erroneous interpretation of the observed changes in PRO. Several statistical methods for response shift analysis have been proposed, but they usually assume that response shift occurs (...) in the same way in all individuals within the sample regardless of their characteristics. Many studies aim at comparing the longitudinal change of PRO into two groups of patients. The group variable could have an effect on PRO change but also on response shift effect and the perception of the questionnaire at baseline. In this paper, we propose to enhance the ROSALI algorithm based on Rasch Measurement Theory for the analysis of longitudinal PRO data to simultaneously investigate the effects of group on item functioning at the first measurement occasion, on response shift and on changes in PRO over time. ROSALI is subsequently applied to a longitudinal dataset on change in emotional functioning in patients with breast cancer or melanoma during the year following diagnosis. The use of ROSALI provides new insights in the analysis of longitudinal PRO data. (shrink)

The aim of this study was to explore patients’ experiences of using the Integrated Palliative care Outcome Scale (IPOS) during specialized palliative home care. The study adopted a qualitative approach with an interpretive descriptive design. Interviews were performed with 10 patients, of whom a majority were diagnosed with incurable cancer. Our findings suggest that the use of IPOS as a basis for conversation promotes safe care by making the patients feel confident that the care provided was adapted to them (...) which gives them a sense of safety. IPOS facilitated discussions between patients and nurses about care needs. The patients believed that using IPOS enabled reflection on their well‐being and life situation. In conclusion, the study finds that using IPOS is beneficial and provide ways to enable person‐centered care and with advantage could be used in specialized palliative home care. The results may help overcome barriers and facilitate the use of patient‐reported outcome measures (PROMs). To enable the use of PROMs such as IPOS in palliative home care, nurses need education and opportunities to develop routines that enable patients’ voice to be heard and thereby compose a basis for care. (shrink)

BackgroundClinical ethics consultations can be complex interventions, involving multiple methods, stakeholders, and competing ethical values. Despite longstanding calls for rigorous evaluation in the field, progress has been limited. The Medical Research Council proposed guidelines for evaluating the effectiveness of complex interventions. The evaluation of CEC may benefit from application of the MRC framework to advance the transparency and methodological rigor of this field. A first step is to understand the outcomes measured in evaluations of CEC in healthcare settings. ObjectiveThe primary (...) objective of this review was to identify and map the outcomes reported in primary studies of CEC. The secondary objective was to provide a comprehensive overview of CEC structures, processes, and roles to enhance understanding and to inform standardization.MethodsWe searched electronic databases to identify primary studies of CEC involving patients, substitute decision-makers and/or family members, clinicians, healthcare staff and leaders. Outcomes were mapped across five conceptual domains as identified a priori based on our clinical ethics experience and preliminary literature searches and revised based on our emerging interpretation of the data. These domains included personal factors, process factors, clinical factors, quality, and resource factors. ResultsForty-eight studies were included in the review. Studies were highly heterogeneous and varied considerably regarding format and process of ethical intervention, credentials of interventionist, population of study, outcomes reported, and measures employed. In addition, few studies used validated measurement tools. The top three outcome domains that studies reported on were quality, process factors, and clinical factors. The majority of studies examined multiple outcome domains. All five outcome domains were multidimensional and included a variety of subthemes.ConclusionsThis scoping review represents the initial phase of mapping the outcomes reported in primary studies of CEC and identifying gaps in the evidence. The confirmed lack of standardization represents a hindrance to the provision of high quality intervention and CEC scientific progress. Insights gained can inform the development of a core outcome set to standardize outcome measures in CEC evaluation research and enable scientifically rigorous efficacy trials of CEC. (shrink)

The use of composite outcomes is becoming widespread in clinical trials. By combining individual outcome measures into a composite, researchers claim a composite can increase statistical precision and trial efficiency, expediting the trial by reducing sample size and cost, and consequently enabling researchers to answer questions that could not otherwise be answered. Another rationale given for using a composite is that it provides a measure of the net effect of the intervention that is more patient-relevant than any (...) single outcome measure. Critics, on the other hand, argue that the use of composites threatens the scientific objectivity of the trial by introducing new risks, and that in practice components are inconsistently defined, unreasonably combined, and inadequately reported. Philosophical scrutiny can help shed light in these disagreements and disentangle ethical and epistemological issues of composites in clinical trials. I examine common use of composites in cardiovascular trials, and show how composite results can be problematic, even misleading, if the proper range of scientific decisions and their consequences are ignored when judging the composite. Philosophies of science that are principled on normative versions of the argument from inductive risk can help explicate issues with composites. I conclude by suggesting ways of remedying composite issues in clinical trials. (shrink)

Patient-reported outcome measures are now common endpoints in clinical trials. In 2009 in an effort to standardize and streamline their use in medical product labeling, the FDA published FDA Guidance for Industry Patient-Reported Outcomes Measures: Use in Medical Product Development to Support Labeling Claims. This publication drew attention to the need to ensure that PROMs are methodologically sound. Nonetheless, in this paper I discuss how many of these measures continue to fall short (...) in terms of validity, interpretability, and responsiveness. As a reaction to these shortcomings, researchers increasingly call for the development of more scientific measures. I argue that although improving PROMs’ measurement properties is a worthy endeavor, we should not be uncritical of these attempts. Calling for improved measures in the name of science should not blind us to the way that even our best measures employ values in their development—values that may further the marketing needs of industry. When values are needed to further our scientific ends, it behooves us to examine them in terms of their social consequences. Thus I argue that we ought to consider not only the scientific advances that new PROMs may bring but also the values that are used to develop them. (shrink)

ObjectivesThe purpose of the current study was to examine whether a self-report measure identifies prenatal substance use and predicts resulting adverse birth outcomes in a large cohort using electronic medical records.MethodsPregnant patients who were admitted between 2014 and 2015 at Christiana Care Health System and delivered singleton birth were included in the analyses. Participant demographic information, pregnancy comorbidities, self-reported substance use, and birth outcomes were retrieved from electronic medical records. Detailed descriptive analyses of prenatal substance use were conducted, and (...) logistic models were evaluated for the associations between substance use and each birth outcome.ResultsThe average maternal age was 30 years, 37% receiving Medicaid. Over 58% were White, 26% were Black, and 13% were Hispanic. Cigarette smoking only showed the highest prevalence among substance u... (shrink)

BackgroundSarcomas are a diverse group of neoplasms that vary greatly in clinical presentation and responsiveness to treatment. Given the differences in the sites of involvement, rarity, and treatment modality, a multidisciplinary approach is required. Previous literature suggests patients with sarcoma suffer from poorer quality of life especially physical and functional wellbeing. Adolescent and young adult patients are an underrepresented population in cancer research and have differing factors influencing QoL.MethodsRetrospective analysis of Young Adult patients enrolled in the Sarcoma Tissue Repository at (...) University of Iowa. QoL was assessed using the self-report FACT-G questionnaire at enrollment and 12 months post-diagnosis; overall scores and the 4 wellbeing subscales were calculated. Linear mixed effects models were used to measure the association between the rate of change in FACT-G subscale scores and baseline clinical, comorbidity, and treatment characteristics.Results49 patients were identified. 57.1% of patients had a malignancy involving an extremity. Mean FACT-G scores of overall wellbeing improved from baseline to 12 months. Social and emotional wellbeing did not differ significantly between baseline and 12 months. Physical wellbeing and functional wellbeing scores improved from baseline to 12 months. No difference was seen for FACT-G overall scores for age, sex, laterality, marital status, performance status, having children, clinical stage, limb surgery, chemotherapy, or tumor size. A difference was demonstrated in physical wellbeing scores for patients with baseline limitation compared to those with no baseline limitation. A difference was demonstrated in social wellbeing based on anatomical site.ConclusionYoung adults with sarcoma treated at a tertiary center had improvements in overall reported QoL at 12 months from diagnosis. Overall baseline QoL scores on FACT-G were lower than the general adult population for YA patients with sarcoma but at 12 months became in line with general population norms. The improvements seen merit further investigation to evaluate how these change over the continuum of care. Quality of life changes may be useful outcomes of interest in sarcoma trials. (shrink)

Policy makers and health professionals are grappling with the high costs of and demand for health care, questions of sustainability and value, and changing population demographics—in particular, ageing populations. Digital solutions, including the adoption of patient‐reported measures, are considered critical in achieving person‐centred and value‐based health care. However, the utility of patient‐reported measures and the data they produce may be subject to ageist beliefs, prejudices and attitudes, rendering these data ineffective at promoting improved (...) class='Hi'>patient experiences and outcomes for older adults. This article explores the ethical considerations raised in relation to patient‐reported measures and the digital agency of older patients. (shrink)

Since the 1970’s epidemiological measures focusing on “health-related quality of life” or simply “quality of life” have figured increasingly as endpoints in clinical trials. Before the 1970’s these measures were known, generically, as performance measures or health status measures. Relabeled as “quality of life measures” they were first used in cancer trials. In the early 2000’s they were relabeled again as “patient-reported outcome measures” or PROMs, in their service to the FDA (...) to support drug labeling claims. To the limited degree that the philosophical literature addresses these measures, it tends to associate them with two major theories of well-being: subjective well-being and the capabilities approach. In this paper, I argue that philosophers ought to treat quality of life measures/proms as a distinct from these theories. I argue that quality of life/proms serve healthcare as vehicles for patient-centered care and this has important consequences for how we theorize these measures. To this end, two requirements set them apart from measures of subjective well-being and the capabilities approach: quality of life/proms need to be patient-directed and inclusive. (shrink)

Measurement outcomes are frequently used as evidence in favor of or against medical and surgical interventions, health policies, and system designs. Indeed, in the medical and health services research literature, outcomes are the currency of policy debate and decision making. Yet in the philosophy of science and philosophy of medicine, the measures used in evidence-based medicine (EBM) are rarely discussed. Rather, the focus here is almost exclusively on study design and hierarchies of evidence. This concentration on the methodology of (...) study design has meant that for practical purposes the measures used in randomized controlled trials, observational studies, audits, and so forth, appear as a “black box.” Yet as I argue in the first part of this article, an engagement with measurement can improve our understanding of EBM and the quality of our evidence. In the second part of the article, I develop such an engagement with one aspect of measurement, namely, the validity of patient-reported outcome measures. Here, I illustrate some of the complexity that is required to improve the validity of these measures and hence the validity of our study outcomes, that is, evidence. The concentration in philosophy of science on study design over measurement methodology perhaps reveals the interest that many philosophers of medicine have in causation, but there is more to the production of high-quality scientific evidence than securing the causal inference. (shrink)

This study explored calibrating a large item bank for use in multidimensional health measurement with computerized adaptive testing, using both item responses and response time (RT) information. The Activity Measure for Post-Acute Care is a patient-reported outcomes measure comprised of three correlated scales (Applied Cognition, Daily Activities, and Mobility). All items from each scale are Likert type, so that a respondent chooses a response from an ordered set of four response options. The most appropriate item response theory model (...) for analyzing and scoring these items is the multidimensional graded response model (MGRM). During the field testing of the items, an interviewer read each item to a patient and recorded, on a tablet computer, the patient’s responses and the software recorded RTs. Due to the large item bank with over 300 items, data collection was conducted in four batches with a common set of anchor items to link the scale. Van der Linden’s (2007) hierarchical modeling framework was adopted. Several models, with or without interviewer as a covariate and with or without interaction between interviewer and items, were compared for each batch of data. It was found that the model with the interaction between interviewer and item, when the interaction effect was constrained to be proportional, fit the data best. Therefore, the final hierarchical model with lognormal model for RT and the MGRM for response data was fitted to all batches of data via a concurrent calibration. Evaluation of parameter estimates revealed that (1) adding response time information did not affect the item parameter estimates and their standard errors significantly; (2) adding response time information helped reduce the standard error of patients’ multidimensional latent trait estimates, but adding interviewer as a covariate did not result in further improvement. Implications of the findings for follow up adaptive test delivery design are discussed. (shrink)

Objective: To investigate the differences between patients returning to work and those who did not after brain tumor surgery.Methods: Patients were evaluated before surgery and after 3 months. The Montreal Cognitive Assessment test, Trail-Making Test, 15-word Rey–Osterrieth Word List, F-A-S tests, and Karnosfky Performance Status were used to assess cognitive status, attention, executive functions, memory, word fluency, and functional status. Patient-reported outcome measures used to evaluate emotional distress and disability were the Hospital Anxiety and Depression Scale (...) and World Health Organization Disability Assessment Schedule. Clinical and work-related variables, PROMs, and cognitive tests were compared using chi-squared, t-test or Mann–Whitney U test.Results: Sixty patients were included. Patients returning to work were 61.3 and 31.0% among people with meningioma and glioma, respectively. They reported lower postoperative disability and lesser home-to-work travel time. Patients with meningioma also showed better preoperative and postoperative attention and executive functions, better postoperative functional and cognitive status, and lower frequency of treatments.Conclusions: These variables should be considered in a clinical context to plan interventions for people who need support during return to work and in future research to investigate preoperative and postoperative predictive factors of going back to work. (shrink)

Increased use of scales in data-driven consumer digital platforms and the management of organisations has led to greater interest in understanding social and psychological measurement expertise and techniques as historically constituted ‘technologies of power’ in the making of what Stark has labelled the ‘scalable subject’. Taking a genealogical approach, and drawing on published and archival data, this article focuses on self-rated health, a scale widely used in population censuses, national health surveys, patient-reported outcome measurement tools, and a (...) variety of digital apps. The article suggests that the first methodological articulation of self-rated health by the investigators of the Cornell Study of Occupational Retirement (1951–58) provides a window into the key epistemic, institutional, and cultural uncertainties about psychological and social measurement, processes of adjustment to ‘old age’, and the capacity of individuals to value their own health. I propose that these uncertainties have become incorporated into extant and operational measurements of health. (shrink)

PurposeContinuous patient-reported outcomes to identify and address patients’ needs represent an important addition to current routine care. The aim of this study was to identify and determine important dimensions of health-related quality of life in routine oncological care.MethodsIn a cross-sectional qualitative study, interviews and focus groups were carried out and recorded. The interviewees were asked for their evaluation on HrQoL in general and specifically regarding cancer treatment. The material was transcribed and analyzed using qualitative content analysis based on (...) Mayring. The results were reviewed in an expert discussion.ResultsInterviews with patients and clinicians, as well as five focus groups with clinicians were conducted. Initially, nine deductive and two inductive categories on HrQoL were built. Four categories were excluded following the qualitative content analysis because they were hardly or not at all mentioned by participants. Following on from the analysis of the expert discussion, one dimension was added, and two further categories were excluded. The resulting system consisted of six dimensions: emotional health, physical ailments, autonomy, social functionality, dignity, and resources.ConclusionThe identified dimensions of HrQoL in routine oncological care were found to differ from those used in existing HrQoL measurements for patients. Further research is needed to test and evaluate the presented structure in a larger sample of cancer patients to further assess its psychometric properties. (shrink)

Total knee arthroplasty (TKA) is a commonly implemented elective surgical treatment for end-stage osteoarthritis of the knee, demonstrating high success rates when assessed by objective medical outcomes. However, a considerable proportion of TKA patients report significant dissatisfaction postoperatively, related to enduring pain, functional limitations, and diminished quality of life. In this conceptual analysis, we highlight the importance of assessing patient-centred outcomes routinely in clinical practice, as these measures provide important information regarding whether surgery and postoperative rehabilitation interventions have (...) effectively remediated patients’ real-world “quality of life” experiences. We propose a novel precision medicine approach to improving patient-centred TKA outcomes through the development of a multivariate machine-learning model. The primary aim of this model is to predict individual postoperative recovery trajectories. Uniquely, this model will be developed using an interdisciplinary methodology involving non-linear analysis of the unique contributions of a range of preoperative risk and resilience factors to patient-centred TKA outcomes. Of particular importance to the model’s predictive power is the inclusion of a comprehensive assessment of modifiable psychological risk and resilience factors that have demonstrated relationships with TKA and other conditions in some studies. Despite the potential for patient psychological factors to limit recovery, they are typically not routinely assessed preoperatively in this patient group, and thus can be overlooked in rehabilitative referral and intervention decision-making. This represents a research-to-practice gap that may contribute to adverse patient-centred outcomes. Incorporating psychological risk and resilience factors into a multivariate prediction model could improve the detection of patients at risk of sub-optimal outcomes following TKA. This could provide surgeons and rehabilitation providers with a simplified tool to inform postoperative referral and intervention decision-making related to a range of interdisciplinary domains outside their usual purview. The proposed approach could facilitate the development and provision of more targeted rehabilitative interventions on the basis of identified individual needs. The roles of several modifiable psychological risk and resilience factors in recovery are summarised, and intervention options are briefly presented. While focusing on rehabilitation following TKA, we advocate for the broader utilisation of multivariate prediction models to inform individually-tailored interventions targeting a range of health conditions. (shrink)

Background: Poor mental health affects adolescent development and is associated with health and social outcomes in later life. The current study uses cross-sectional data to explore the understudied aspects of peer relationships as a predictor of depressive symptom severity of adolescents in Germany.Method: Data from the German BELLA study were analyzed. We focused on the most recent measurement point of the BELLA study and analyzed data of 446 adolescents. Peer relationship was measured using four items from the internationally established (...) class='Hi'>Patient-Reported Outcome Measurement Information System. Depressive symptoms were assessed via seven items of the German version of the Centre for Epidemiological Studies Short Depression Scale. Hierarchical linear regression models were computed to explore the association between depressive symptoms and peer relationships. Hierarchical linear regression models served to determine the added predictive effects of each aspect of peer relationships.Result: The regression model showed that 22% of the variance of the severity of depressive symptoms could be explained by the quality of adolescents’ peer relationships = 125.65, p < 0.001). Peer acceptance has the most substantial unique contribution to peer relationship as a predictor of depressive symptom severity. The gender-specific analysis shows different trends for boys and girls.Conclusion: The quality of peer relationships is a significant predictor of adolescents’ depressive symptoms severity. Improved peer acceptance, dependability, and ease of making new friends are significantly associated with reduced depression symptoms for Germany’s adolescent population. (shrink)

Measuring the effectiveness of medical interventions faces three epistemological challenges: the choice of good measuring instruments, the use of appropriate analytic measures, and the use of a reliable method of extrapolating measures from an experimental context to a more general context. In practice each of these challenges contributes to overestimating the effectiveness of medical interventions. These challenges suggest the need for corrective normative principles. The instruments employed in clinical research should measure patient-relevant and disease-specific parameters, and should (...) not be sensitive to parameters that are only indirectly relevant. Effectiveness always should be measured and reported in absolute terms (using measures such as 'absolute risk reduction'), and only sometimes should effectiveness also be measured and reported in relative terms (using measures such as 'relative risk reduction')-employment of relative measures promotes an informal fallacy akin to the base-rate fallacy, which can be exploited to exaggerate claims of effectiveness. Finally, extrapolating from research settings to clinical settings should more rigorously take into account possible ways in which the intervention in question can fail to be effective in a target population. (shrink)

Patient report of functioning is one component of the neurocognitive exam following traumatic brain injury, and standardized patient-reported outcomes measures are useful to track outcomes during rehabilitation. The Traumatic Brain Injury Quality of Life measurement system is a TBI-specific extension of the PROMIS and Neuro-QoL measurement systems that includes 20 item banks across physical, emotional, social, and cognitive domains. Previous research has evaluated the responsiveness of the TBI-QOL measures in community-dwelling individuals and found clinically important (...) change over a 6-month assessment interval in a sample of individuals who were on average 5 years post-injury. In the present study, we report on the responsiveness of the TBI-QOL Cognition–General Concerns and Executive Function item bank scores and the Cognitive Health Composite scores in a recently injured sample over a 1-year study period. Data from 128 participants with complicated mild, moderate, or severe TBI within the previous 6 months were evaluated. The majority of the sample was male, white, and non-Hispanic. The participants were 18–92 years of age and were first evaluated from 0 to 5 months post-injury. Eighty participants completed the 1-year follow-up assessment. Results show acceptable standard response mean values for all measures and minimal detectable change values ranging from 8.2 to 8.8 T-score points for Cognition–General Concerns and Executive Functioning measures. Anchor rating analysis revealed that changes in scores on the Executive Function item bank and the Cognitive Health Composite were meaningfully associated with participant-reported changes in the areas of attention, multitasking, and memory. Evaluation of change score differences by a variety of clinical indicators demonstrated a small but significant difference in the three TBI-QOL change scores by TBI injury severity grouping. These results support the responsiveness of the TBI-QOL cognition measures in newly injured individuals and provides information on the minimal important differences for the TBI-QOL cognition measures, which can be used for score interpretation by clinicians and researchers seeking patient-reported outcome measures of self-reported cognitive QOL after TBI. (shrink)

Objective: Ethical guidelines are designed to ensure benefits, protection and respect of participants in clinical research. Clinical trials must now be registered on open-access databases and provide details on ethical considerations. This systematic survey aimed to determine the extent to which recently registered clinical trials report the use of standard of care and post-trial obligations in trial registries, and whether trial characteristics vary according to setting. Methods: We selected global randomized trials registered on http://www.clinicaltrials.gov and http://www.controlled-trials.com. We searched for intervention (...) trials of HIV/AIDS, malaria, and tuberculosis from 9 October 2004, the date of the most recent version of the Helsinki Declaration, to 10 April 2007. Results: We collected data from 312 trials. Fifty-eight percent (58%, 95% CI = 53 to 64) of trial protocols report informed consent. Fifty-eight percent (58%, 95% CI = 53 to 64) of trials report active controls. Almost no trials (1%, 95% CI = 0.5 to 3) mention post-trial provisions. Most trials measure surrogate outcomes. Twenty percent (20%, 95% CI = 16 to 25) of trials measure patient-important outcomes, such as death; and the odds that these outcomes are in a low income country are five times greater than for a developed country (odds ratio (OR) 5.03, 95% CI = 2.70 to 9.35, p = < 0.001). Pharmaceutical companies are involved in 28% (CI = 23 to 33) of trials and measure surrogate outcomes more often than nonpharmaceutical companies (OR 2.45, 95% CI = 1.18 to 5.09, p = 0.31). Conclusion: We found a large discrepancy in the quality of reporting and approaches used in trials in developing settings compared to wealthier settings. (shrink)

Patient-reported outcomes are increasingly used as dependent variables in studies regarding the effectiveness of clinical interventions. But patient-reported outcome measures (PROMs) do not provide intuitively meaningful data. For instance, it is not clear what a five point increase or decrease on a particular scale signifies. Establishing ‘interpretability’ involves making changes in outcomes meaningful. Attempts to interpret PROMs have led to the development of methods for identifying a minimum important difference (MID). In this paper, however, (...) I draw on Charles Taylor’s distinction between weak and strong evaluations to suggest that identifying a MID, specifically, a MID that uses a patient-reported reference group, may not provide an adequate interpretation of these measures. Moreover, I argue that the difficulty with interpreting these measures is tied to a larger problem concerning their validity. If researchers wish to interpret PROMs, they may first need to know more about the constructs they attempt to measure, namely, quality of life. (shrink)

Measures are designed to evaluate the processes and outcomes of care associated with the delivery of clinical (and non-clinical) services. They allow for intra- and interorganizational comparison to be used continuously to improve patient health outcomes. The use of performance measures always means to abstract the complex reality (medical scenarios and procedures) in order to provide an understandable and comparable output. Measures can focus on global performance. The more detailed data are available the more specific judgements (...) with respect to the appropriateness of clinical decision-making and implementation of evidence are feasible. Externally reported measures are intended both to inform and lead to action. By providing this information, deficiencies in patient care and unnecessary variations in the care process can be uncovered. Such variations have contributed to disparities in morbidity and mortality. The developments in information technology, especially world-wide interconnectivity, standards for electronic data exchange and facilities to store and manage large amounts of data, offer the opportunity to analyse health-relevant information in order to make the delivery of healthcare services more transparent for consumers and providers. Global performance measures, such as the overall life expectancy (mortality) in a country, can give a rough orientation of how well health systems perform but they do not offer general solutions nor spe-cific insights into care processes that have to be improved. In contrast to population-based measures, case-based performance measures use a defined group of patients depending on specific patient characteristics and features of disease. By means of these measures we are able to compare the number of patients that receive a necessary medical procedure against those patients who do not. The use of case-based measures is a bottom-up approach to improve the overall performance in the long run. They are not only a tool for global orientation but can offer a straightforward link to the areas of deficient care and the underlying procedures. Performance measures are relevant to providers as well as consumers, from their own individual perspective. Cased-based measures focus on the management of individual patient. This approach to performance measurement can inform physicians in a meaningful and constructive way by monitoring their individual performance and by pointing out possible areas of improvement. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Subjective Experiences of Tourette SyndromeBeyond the Premonitory UrgeThe authors report no conflicts of interest.There is an evolving recognition in healthcare that the patient's subjective experience needs to be privileged both in understanding clinical phenomena and also ensuring the salience of outcomes used to evaluate the impact of treatment interventions. This is reflected in the expansion of patient-reported outcome measures to capture a person's perception (...) of their own health, and the increasing requirement of involving people with lived experience in the co-design of research studies (National Health and Medical Research Council, 2016) and care improvement initiatives. In mental health it has been long understood that observable behavioral phenomena can only partially inform clinical understanding of the experience of the patient living with the condition. However, capturing the patient's subjective experience faithfully remains a challenge.Tourette syndrome (TS) is a complex condition in which there are clearly observable behavioral phenomena (vocal and motor tics, compulsive and socially inappropriate behaviors), but also a broad and varied range of subjective phenomena reported by different individuals. These may include sensory phenomena such as the premonitory sensory urge preceding a tic, compulsions to touch things a certain number of times or do something repeatedly until it feels "just right," or bothersome intrusive thoughts or images. To further complicate the picture most patients with TS have one or more co-occurring conditions such as attention deficit hyperactivity disorder, obsessive-compulsive disorder, and anxiety, which may actually cause a greater burden of dysfunction and distress than the Tourette symptoms.In their paper, Curtis-Wendlandt et al. (2024) challenge the dependence of current psychiatric diagnostic criteria (e.g., the Diagnostic and Statistical Manual of Mental Disorders, 5th edition) on observable tics, and propose a broader and more dimensional approach to nosology which incorporates sensory, cognitive and affective phenomena. [End Page 47] Data from interviews they conducted identified that premonitory phenomena and urge experiences in tic disorders are more complex and diverse than what is currently reflected in the literature and clinical scales. They also interviewed participants who reported "no urges" or "no premonitory sensations." They commented that the literature generally treats reports of urge absences at face value, and does not address the likelihood that such reports may be ambiguous or problematic. Overall, they concluded that their research suggests that premonitory urges in TS are a complex and diverse phenomenon that requires further study. This reflects with our clinical experience in working with TS patients. Although a large proportion of older patients describe sensory-based premonitory urges, descriptions are not homogenous, with many describing other experiences preceding their tics.When evaluating a patient's response to an intervention (either behavioral or pharmacological) clinicians incorporate a range of information. This includes the severity of their tics (number, type, frequency, intensity, and associated impairment), as well as their mood, participation and performance in study, work, and social activities, and overall quality of life. Standard clinical practice would not typically include assessment of some of the subjective experiences which precede tics. If it was accepted that these subjective phenomena are indeed salient to the patient's well-being, then a challenge would be how to consistently and reliably capture these feelings to operationalize a comprehensive patient-centered assessment.The primary evidence-based treatment for tic disorders, comprehensive behavioral intervention for tics (CBIT), involves training to increase the awareness of premonitory urges (Woods et al., 2008). Furthermore, successful 'blocking' of tics during the course of CBIT requires the patient to be aware of premonitory urges. Clinicians having a better understanding of the complexity and diversity of experiences which precede tics, as well as using open-ended questioning styles, may assist with improving CBIT outcomes. [End Page 48]Related ArticlesFeature Article: Dimensions, Not Types: On the Phenomenology of Premonitory Urges in Tourette SyndromeCommentary: Priming and Narrative Habits in the Phenomenological Interview: Reflections on a Study of Tourette SyndromeCommentary: Subjective Experiences of Tourette Syndrome: Beyond the Premonitory UrgeResponse: Phenomenological Interviews and Tourette’sDaryl EfronThe Royal Children's Hospital MelbourneIvan MathiesonThe Laneway ClinicDaryl Efron Daryl Efron is a Consultant Pediatrician, Royal Children's Hospital Senior Research Fellow, Murdoch... (shrink)

Clinical research is difficult. It confronts massive heterogeneity in its participants, who are real people bumping around the world in complex ways. Clinical research in psychology is doubly difficult, since it tries systematically to study conditions that are inherently difficult to systematize. In their thoughtful and closely argued article, Truijens et al. emphasize these difficulties, and describe a novel challenge to psychotherapy research: that the support for many evidence-based therapies is weaker than previously recognized because it relies on patient- (...) class='Hi'>reported outcome measures that often yield invalid results. Despite the initial plausibility of their position, however, their... (shrink)

Patient-reported outcomes are frequently used for medical decision making, at the levels of both individual patient care and healthcare policy. Evidence increasingly shows that PROs may be influenced by patients’ response shifts and dispositions. We identify how response shifts and dispositions may influence medical decisions on both the levels of individual patient care and health policy. We provide examples of these influences and analyse the consequences from the perspectives of ethical principles and theories of just distribution. (...) If influences of response shift and disposition on PROs and consequently medical decision making are not considered, patients may not receive optimal treatment and health insurance packages may include treatments that are not the most effective or cost-effective. We call on healthcare practitioners, researchers, policy makers, health insurers, and other stakeholders to critically reflect on why and how such patient reports are used. (shrink)

Background Treatment of chronic inflammatory bowel disease (IBD) aims to improve patients’ quality of life and the extent of treatment success is measured via patient reported outcomes (PROs). However, questionnaires used to collect PROs often include scales that are not specific to IBDs. Improving these scales requires a deeper understanding of patients’ lived experience. With this study we give first insights and develop hypotheses on how patients with IBDs experience their body and self and how they adjust their (...) life plans in the context of precision medicine (PM). The guiding question is to understand what they need to achieve a good life, while facing their disease. Methods We developed a conception of the “good life” that draws on Philippa Foot’s “naturalized” approach and distinguishes six different dimensions that are relevant for a good life. This conception guided us as we conducted 10 qualitative interviews with patients suffering from IBD who were in precision medicine clinical research settings. The interviews aimed to gain insights for answering our research question: How do body experiences affect the good life of patients with IBD? We analyzed the interviews with interpretative phenomenological analysis (IPA). Results Five group experiential themes emerged: (i) Life options and plans, (ii) other people’s responses, (iii) strategies to deal with others’ responses, (iv) perception of the body and self, and (v) perception of life as good despite suffering. We report here on three of them (i, iv and v), which are primarily relevant for evaluating the outcomes of PM care. Whereas with “life options and plans (i),” our study predominantly confirmed previous research, with “perception of the body and self (iv),” we found that some of the patients changed their relationship to their body and themselves. They perceived the body or the disease as the “other” and their self appears divorced from their own body. Although this might be an avoidance strategy patients use to assign responsibility for their condition and its “disgusting” symptoms to the “other,” it is important to include it in patient reported outcome (PRO) assessments. Conclusions We conclude with the insight that the multi-dimensional approach based on Foot’s concept of a good life is well-suited as a basis for investigating the quality of life of people with IBD. Interviews based on this concept produced results that go beyond the understanding of health-related quality of life (HRQoL). Additionally, we offer some considerations about patients’ opportunities for achieving a good life and suggestions for further developing patient reported outcome scales. (shrink)

The typical outcome measure in infertility treatment is the (cumulative) healthy live birth rate per patient or per cycle. This means that those who end the treatment trajectory with a healthy baby in their arms are considered to be successful and those who do not are considered to have failed. In this article, we argue that by adopting the healthy live birth standard as the outcome measure that defines a successful fertility treatment, it becomes an interpretative self-fulfilling (...) prophecy: those who achieve the goal consider themselves successful and those who do not consider themselves failures. This is regardless of the fact that having children is only one out of many ways to alleviate the suffering related to infertility and that stopping fertility treatment can also be a positive decision to move on to other goals, rather than a form of “giving up,” “dropping out,” “nonadherence,” or failure. We suggest that those seeking fertility treatment would be served better by an alternative outcome measure, which can be equally self-fulfilling, according to which a successful treatment is one in which people leave the clinic released from the suffering that accompanied their status as infertile when they first entered the clinic. This new outcome measure still implies that walking out with a healthy baby is a positive outcome. What changes is that walking out without a baby can also be a positive outcome, rather than being marked exclusively as a failure. (shrink)

Objectives: To compare attitudes of medical and law students toward informing a cancer patient about diagnosis and prognosis and to examine whether differences are related to different convictions about benefit or harm of information.Setting and design: Anonymous questionnaires were distributed to convenience samples of students at the University of Geneva containing four vignettes describing a cancer patient who wishes, or alternatively, who does not wish to be told the truth.Participants: One hundred and twenty seven medical students and 168 (...) law students.Main outcome measures: Five point Likert scale of responses to the vignettes ranging from “certainly inform” to “certainly not inform” the patient.Results: All medical students and 96% of law students favoured information about the diagnosis of cancer if the patient requests it. Seventy four per cent of medical students and 82% of law students favoured informing a cancer patient about his or her prognosis . Thirty five per cent of law students and 11.7% of medical students favoured telling about the diagnosis and 25.6% of law students and 7% of medical students favoured telling about the prognosis even if the patient had clearly expressed his wish not to be informed. Law students indicated significantly more often than medical students reasons to do with the patient’s good, legal obligations, and the physician’s obligation to tell the truth, and significantly less often than medical students that their attitude had been determined predominantly by respect for the autonomous choice of the patient.Conclusion: Differences in attitudes according to the type of case and the type of studies were related to convictions about the benefit or harm to the patient caused by being given information. The self reported reasons of future physicians and future lawyers are helpful when considering means to achieve a better acceptance of patients’ right to know and not to know. (shrink)

Introduction Current treatments for pain have limited benefits and worrying side effects. Some studies suggest that pain is reduced when clinicians deliver positive messages. However, the effects of positive messages are heterogeneous and have not been subject to meta-analysis. We aimed to estimate the efficacy of positive messages for pain reduction. -/- Methods We included randomized trials of the effects of positive messages in a subset of the studies included in a recent systematic review of context factors for treating pain. (...) Several electronic databases were searched. Reference lists of relevant studies were also searched. Two authors independently undertook study selection, data extraction, risk of bias assessment, and analyses. Our primary outcome measures were differences in patient- or observer-reported pain between groups who were given positive messages and those who were not. -/- Results Of the 16 randomized trials (1703 patients) that met the inclusion criteria, 12 trials had sufficient data for meta-analysis. The pooled standardized effect size was −0.31 (95% confidence interval [CI] −0.61 to −0.01, p = 0.04, I2 = 82%). The effect size remained positive but not statistically significant after we excluded studies considered to have a high risk of bias (standard effect size −0.17, 95% CI −0.54 to 0.19, P = 0.36, I2 = 84%). -/- Conclusion Care of patients with chronic or acute pain may be enhanced when clinicians deliver positive messages about possible clinical outcomes. However, we have identified several limitations of the present study that suggest caution when interpreting the results. We recommend further high-quality studies to confirm (or falsify) our result. -/- FUNDING -/- Alexander Mebius research has been funded through the ERC grant "Philosophy of Pharmacology: Safety, Statistical Standards, and Evidence Amalgamation" (GA: 639276). (shrink)

ObjectiveStress can play a role in the onset and exacerbation of psoriasis. Psychological interventions to reduce stress have been shown to improve psychological and psoriasis-related outcomes. This pilot randomised study investigated the feasibility of a brief interaction with a Paro robot to reduce stress and improve skin parameters, after a stressor, in patients with psoriasis.MethodsAround 25 patients with psoriasis participated in a laboratory stress task, before being randomised to either interact with a Paro robot or sit quietly for 30 min. (...) Raman spectroscopy and trans-epidermal water loss were measured at baseline, after the stressor and after the intervention as indexes of acute skin changes. Psychological variables, including self-reported stress and affect, were also measured at the three time-points.ResultsNo statistically significant differences between the two conditions were found for any of the outcomes measured. However, effect sizes suggest significance could be possible with a larger sample size. Changes in the psychological and Raman spectroscopy outcomes across the experimental session were found, indicating the feasibility of the procedures.ConclusionThis pilot study showed that a brief interaction with a Paro robot was a feasible intervention for patients with psoriasis, but future trials should broaden the inclusion criteria to try to increase recruitment rates. Studying people who are highly stressed, depressed or who are stress-responders may increase the power of the intervention to show effects using a longer-term intervention. (shrink)

BackgroundMany authors choose to work with professional medical writers when reporting the results of clinical trials. We conducted a systematic review to examine the relationship between professional medical writing support (PMWS) and the quality, ethics and timeliness of publications reporting clinical trials.MethodsUsing terms related to ‘medical writer’ and ‘observational study’, we searched MEDLINE and Embase (no date limits), as well as abstracts and posters from meetings of the International Society for Medical Publication Professionals (ISMPP; 2014–2018). We also hand-searched the journals (...) Medical Writing and The Write Stuff (2014–2018) and the bibliographies of studies identified in the electronic searches. We screened the results to identify studies that compared the quality, ethics and timeliness of clinical trial publications written with and without declared PMWS.ResultsOur searches identified 97 potentially relevant studies, of which 89 were excluded during screening and full paper review. The remaining eight studies compared 849 publications with PMWS with 2073 articles developed without such support. In these eight studies, PMWS was shown to be associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines (in 3/3 studies in which this was assessed), publication in journals with an impact factor (one study), a higher quality of written English (one study), and a lower likelihood of reporting non-pre-specified outcomes (one study). PMWS was not associated with increased adherence to CONSORT for Abstracts guidelines (one study) or with the impact of published articles (mean number of citations per year, mean number of article views per year and Altmetric score; one study). In studies that assessed timeliness of publication, PMWS was associated with a reduced time from last patient visit in clinical trials to primary publication (one study), whereas time from submission to acceptance showed inconsistent results (two studies).ConclusionsThis systematic review of eight observational studies suggests that PMWS is positively associated with measures of overall quality of reporting of clinical trials and may improve the timeliness of publication.Video abstract. (MP4 161000 kb). (shrink)

IntroductionThe stressful pre-operative period exerts a profound impact on psychological, physiological and immunological outcomes. Oncological surgeries, in particular, elicit significantly higher stress responses than most other surgeries. Managing these responses through psychological interventions may improve long-term outcomes. The purpose of the current research was to review studies that have explored pre-operative psychological interventions in cancer patients in order to map the types of current interventions and provide an initial assessment of whether these interventions improved psychological, physiological, and/or immunological indices as (...) well as long-term cancer outcomes.MethodsA systematic literature search for studies that included pre-operative psychological interventions in oncology patients was conducted, using the databases PubMed and Web of Science. Inclusion criteria included studies pertaining to oncological surgery in adults, study designs that included a clearly defined pre-operative psychological intervention and control group.ResultsWe found 44 studies, each using one of the following interventions: psychoeducation, cognitive interventions, relaxation techniques, integrated approaches. All the studies reported improved immediate post-operative psychological, physiological, and/or immunological outcomes. Only a few studies addressed long-term cancer outcomes, and only one reported improved survival.ConclusionsResearch on pre-operative interventions with cancer patients is missing systematic methods. Studies provide varying results, which makes it difficult to compare them and reach reliable conclusions. There is considerable heterogeneity in the literature regarding the specific intervention used, the timing of intervention, the characteristics of the patients studied and the outcome measures. In order to improve research in this field, including the measurement of long-term outcomes, we suggest some steps that should be taken in further research. (shrink)

Background: No studies have examined the underlying structure or predictive validity of the Cognitive Therapy Adherence and Competence Scale. Examining the structure of the CTACS is of great relevance because it could provide information on what constitutes competence in CBT, and whether some underlying factors are more important for predicting treatment outcomes than others. This study investigates the psychometric properties of the Norwegian version of CTACS and its associations with treatment outcomes in a sample of primary care clients who received (...) CBT for anxiety and/or depression.Method: Independent assessors rated audiotaped therapy sessions in a sample of 132 primary care clients, participating in the Prompt Mental Health Care trial. Outcomes were symptoms of anxiety and depression assessed by patient self-report questionnaires. Structural validity was examined by means of confirmatory and exploratory factor analyses, whereas longitudinal associations with treatment outcome were explored by adopting multilevel modeling.Results: No evidence was found for the divergent validity of the constructs competence and adherence as indicated by a very high correlation between these two subscales in CTACS. Regarding reliability, ICCs for the mean score of the full competence scale and its associated subscales were generally good to excellent, although the subscale measuring the quality of the therapeutic relationship was relatively low. Internal consistency was overall acceptable, but our CFA models did not provide an acceptable fit for the pre-specified one-factor and four-factor solutions. EFA results were difficult to interpret, with a sub-optimal three-factor solution providing best model fit and only two meaningful factors [CBT specific skills and session structure ]. Overall, the results indicated no evidence for the scales' predictive validity.Conclusion: Our findings point to several psychometric problems of the CTACS that may limit both its research and clinical utility. The importance of providing empirical evidence for both reliability and validity aspects of scales are discussed and suggestions for future research are provided. (shrink)

The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees should prohibit all other, lower-quality (...) research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible. The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because “quality” is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in “usual” care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated. (shrink)

Checklists have been used to improve quality in many industries, including healthcare. The use of checklists, however, has not been extensively evaluated in clinical ethics consultation. This article seeks to fill this gap by exploring the efficacy of using a checklist in ethics consultation, as tested by an empirical investigation of the use of the checklist at a large academic medical system (Cleveland Clinic). The specific aims of this project are as follows: (1) to improve the quality of ethics consultations (...) by providing reminders to ethics consultants about process steps that are important for most patient-centered ethics consultations, (2) to create consistency in the ethics consultation process across the medical system, and (3) to establish an effective educational tool for trainers and trainees in clinical ethics consultation. The checklist was developed after a thorough literature review and an iterative process of revising and testing by a group of experienced ethics consultants. To pilot test the checklist, it was distributed to 46 ethics consultants. After a six-month pilot period in which ethics professionals used the checklist during their clinical activities, a survey was distributed to all of those who used the checklist. The 10-item survey examined consultants’ perceptions regarding the three aims listed above. Of the 25 survey respondents, 11 self-reported as experts in ethics consultation, nine perceived themselves to have mid-level expertise, and five self-reported as novices. The majority (68 percent) of all respondents, regardless of expertise, believed that the checklist could be a “helpful” or “very helpful” tool in the consultation process generally. Novices were more likely than experts to believe that the checklist would be useful in conducting consultations. The limitations of this study include: reduced generalizability given that this project was conducted at one medical system, utilized a small sample size, and used self-reported quality outcome measures. Despite these limitations, to the authors’ knowledge this is the first investigatation of the use of a checklist systematically to improve quality in ethics consultation. Importantly, our findings shed light on ways this checklist can be used to improve ethics consultation, including its use as an educational tool. The authors hope to test the checklist with consultants in other healthcare systems to explore its usefulness in different healthcare environments. (shrink)

Importance Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials.Objective To examine cancer clinical trial (CCT) participants’ perceptions of informed consent processes and variations in perceptions by cancer type.Design and Setting and Participants Cross-sectional survey from mixed-methods study at National Cancer Institute–designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic (...) malignancies, lung cancer, and breast or gynecological cancer (N = 334).Main Outcome Measures Percentages satisfied with consent process and information provided; and assessing participation’s perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type.Results Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did—47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT.Conclusions and Relevance Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making. (shrink)

BackgroundHospitals face a disclosure dilemma when large-scale adverse events affect multiple patients and the chance of harm is extremely low. Understanding the perspectives of patients who have received disclosures following such events could help institutions develop communication plans that are commensurate with the perceived or real harm and scale of the event.MethodsA mailed survey was conducted in 2008 of 266 University of Washington Medical Center (UWMC) patients who received written disclosure in 2004 about a large-scale, low-harm/low-risk adverse event involving an (...) incomplete endoscope cleaning process. The survey measured patients’ satisfaction with this disclosure, their concerns about healthcare outcomes, and their recommendations for future communication, given similar circumstances.ResultsSurveys were received from 127 of 266 (48 percent) of eligible respondents; 98 percent thought that UWMC was right to inform them about this event, and mean satisfaction with the disclosure was 7.7 on a 0 to 10 scale. Of the 127 respondents, 64 percent were somewhat or very concerned that the endoscope cleaning problem might cause them health problems; 60 percent reported their impressions of UWMC’s honesty and integrity had increased; 31 percent said their perceptions of the quality of care had increased; 94 percent agreed that institutions should tell patients about any error in their care, even when the risk of harm was low, although 28 percent agreed that such notifications would make them anxious. Respondents who reported concern that the event could cause them health problems were less likely to be satisfied with the institution’s disclosure. Patients cited their right to know information material to their own health and healthcare as an important reason for disclosure.ConclusionRecipients of disclosure of a large-scale, low-harm/low-risk event overwhelmingly supported being told of the event and endorsed notification of patients for similar events in the future. Although informing patients may cause concern for some, institutions should ensure their disclosure policies and procedures reflect their patients’ preferences. (shrink)

Background Informed consent is an integral component of good medical practice. Many researchers have investigated measures to improve the quality of informed consent, but it is not clear which techniques work best and why. To address this problem, we propose developing a core outcome set to evaluate interventions designed to improve the consent process for surgery in adult patients with capacity. Part of this process involves reviewing existing research that has reported what is important to patients and (...) doctors in the informed consent process. Methods This qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies. Results Searches of bibliographic databases returned 11,073 titles. Of these, 16 studies met the inclusion criteria. Studies were published between 1996 and 2016 and included a total of 367 patients and 74 health care providers. Thirteen studies collected data using in-depth interviews and constant comparison was the most common means of qualitative analysis. A total of 94 findings were extracted from the primary papers and divided into 17 categories and ultimately 6 synthesised findings related to: patient characteristics, knowledge, communication, the model patient, trust and decision making. Conclusions This qualitative meta-aggregation is the first to examine the issue of informed consent for surgery. It has revealed several outcomes deemed important to capture by patients and clinicians when evaluating the quality of a consent process. Some of these outcomes have not been examined previously in research comparing methods for informed consent. This review is an important step in the development of a COS to evaluate interventions designed to improve the consent process for surgery. Registration The study protocol was registered on the international prospective register for systematic reviews. (shrink)

SETTING: Medical ethics education has become common, and the integrated ethics curriculum has been recommended in Western countries. It should be questioned whether there is one, universal method of teaching ethics applicable worldwide to medical schools, especially those in non-Western developing countries. OBJECTIVE: To characterise the medical ethics curricula at Asian medical schools. DESIGN: Mailed survey of 206 medical schools in China, Hong Kong, Taiwan, Korea, Mongolia, Philippines, Thailand, Malaysia, Singapore, Indonesia, Sri Lanka, Australia and New Zealand. PARTICIPANTS: A total (...) of 100 medical schools responded, a response rate of 49%, ranging from 23%-100% by country. MAIN OUTCOME MEASURES: The degree of integration of the ethics programme into the formal medical curriculum was measured by lecture time; whether compulsory or elective; whether separate courses or unit of other courses; number of courses; schedule; total length, and diversity of teachers' specialties. RESULTS: A total of 89 medical schools (89%) reported offering some courses in which ethical topics were taught. Separate medical ethics courses were mostly offered in all countries, and the structure of vertical integration was divided into four patterns. Most deans reported that physicians' obligations and patients' rights were the most important topics for their students. However, the evaluation was diverse for more concrete topics. CONCLUSION: Offering formal medical ethics education is a widespread feature of medical curricula throughout the study area. However, the kinds of programmes, especially with regard to integration into clinical teaching, were greatly diverse. (shrink)

Objectives To determine the frequencies and types of limitation of medical treatment performed by physician members of the German Society for Palliative Medicine and to analyse the findings with respect to clinical and ethical aspects of end-of-life practices. Design Cross-sectional postal survey. Setting Data collection via the secretary of the German Society for Palliative Medicine using the German language version of the EURELD survey instrument. Subjects All 1645 physician members of the German Society for Palliative Medicine. Main outcome (...) class='Hi'>measures Types and frequencies of limitation of treatment and possible determinants. Results 901 physicians participated in the study (response rate 55.8%). Participants reported limitation of treatment in 69.1% of cases. These decisions most often affected artificial nutrition (19%), chemotherapy (14%), antibiotics (11%) and medication other than antibiotics (11%). In the majority of eligible cases, physicians estimated the life-shortening effect of limitation of treatment to be <7 days. However, estimations differ depending on the medical measures in question. Bivariate statistical analysis indicated that withholding of treatment was performed significantly more frequently for patients aged ≥65 years (p=0.019). In addition, there were significant associations between the incidence of limitation of treatment and the different diseases reported by respondents as the underlying cause of death. Conclusion The findings of this study provide information on the current state of an ethically and clinically challenging aspect of clinical practice and can serve as a starting point for further interdisciplinary research on normative and empirical aspects of treatment decision-making at the end of life. (shrink)

Background: Studies from Western countries show that doctors working in neonatal intensive care units find withdrawal of treatment to be their most difficult ethical dilemma. There is less knowledge of how this is experienced in other economic, cultural, religious and educational contexts.Objectives: To explore and describe how Indian doctors experience ethical dilemmas concerning the withdrawal of treatment among critically sick and/or premature neonates.Method: Qualitative data from interviews was analysed according to Giorgi's phenomenological approach. The subjects were 14 doctors with various (...) levels of neonatal experience, recruited from two state‐owned NICUs in India. Main outcome measures: description reflecting the nature of ethical dilemmas and how they are experienced.Results: All doctors reported situations where the question of withdrawal of treatment was experienced as the worst part of their job. They felt that they lacked training in how to handle such dilemmas, and some had never talked about ethics before. They were especially concerned about non‐medical considerations that do not feature in current treatment guidelines. In describing their personal experiences, the informants mentioned their sense of responsibility in situations where they were aware that their decisions would influence a family's economy and reputation, availability of food and education for siblings, other children's access to equipment in the unit, and the use of resources in an underprivileged population. Sometimes lack of resources, usually ventilators, forced them to make decisions about which babies should get the chance to live. Other reported dilemmas included difficulties co‐operating with uneducated and poor parents.Conclusion: While Western doctors seem to focus on the rights and problems of the individual child, Indian doctors tend to refer to consequences for other children, for parents and society. There is a need for further research in this field, and for the development of guidelines on how to cope with differences in resources, and how to handle different patient groups’ cultural and religious concerns. (shrink)

Objectives—To assess perceptions of the informed consent process in patients undergoing urgent abdominal surgery.Design—A prospective observational study was carried out using structured questionnaire-based interviews. Patients who had undergone urgent abdominal surgery were interviewed in the postoperative period to ascertain their perceptions of the informed consent process. Replies were compared to responses obtained from a control group undergoing elective surgery, to identify factors common to the surgical process and those specific to urgent surgery. Patients' perceptions of received information were also compared (...) to the information perceived to have been provided by the consent obtainers. Setting—Gastrointestinal surgical service of a university teaching hospital.Patients—Seventy-four consecutive patients undergoing urgent abdominal surgery and 80 control patients undergoing elective surgery. Main measurements—Principal outcome measures were patients' perceptions of factors interfering with the ability to give informed consent, assessment of the quality of informed consent and the degree of discussion of the expected outcomes. Results—Forty-nine of the seventy-four (66%) patients undergoing urgent surgery perceived that pain did not affect their ability to give informed consent. Twenty-seven reported an adverse effect of analgesia on the ability to give informed consent. Only 22% of patients undergoing urgent surgery perceived that there had been any discussion of potential side effects and complications of surgery. Conclusion–The majority of patients in this series with acute intra-abdominal surgical conditions perceive that they retain the ability to give informed consent for surgery. There is a need for improved discussion of therapeutic options and likely outcomes. (shrink)

The restructuring of the healthcare marketplace has exerted pressure directly and indirectly on clinical ethics programs. The fiscal orientation and emphasis on efficiency, outcome measures, and cost control have made it increasingly difficult to communicate arguments in support of the existence or growth of ethics programs. In the current marketplace, arguments that rely on the claim that ethics programs protect patient rights or assist in the professional formation of practitioners often result in minimal levels of funding and (...) preclude program growth. Where ethics programs could once sustain themselves on goodwill alone and values arguments in an expanding healthcare market they are now encountering—at least by anecdotal reports—cutbacks and even elimination. To respond to these challenges, we offer an economic model that can be used to demonstrate the “value” of an institutionally based ethics program. (shrink)