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Consideration of ethical, legal, and social issues plus patient values (ELSI+) in health technology assessment (HTA) is challenging because of a lack of conceptual clarity and the multi-disciplinary nature of ELSI+. We used concept mapping to identify key concepts and inter-relationships in the ELSI+ domain and provide a conceptual framework for consideration of ELSI+ in HTA.
We conducted a scoping review (Medline and EMBASE, 2000–2016) to identify ELSI+ issues in the HTA literature. Items from the scoping review and an expert brainstorming session were consolidated into eighty ELSI+-related statements, which were entered into Concept Systems® Global MAX™ software. Participants (N = 38; 36 percent worked as researchers, 21 percent as academics; 42 percent self-identified as HTA experts) sorted the statements into thematic groups, and rated them on importance in making decisions about adopting technologies in Canada, from 1 (not at all important) to 5 (extremely important). We used Concept Systems® Global MAX™ software to create and analyze concept maps with four to sixteen clusters.
Our final ELSI+ map consisted of five clusters, with each cluster representing a different concept and the statements within each cluster representing the same concept. Based on the concepts, we named these clusters: patient preferences/experiences, patient quality of life/function, patient burden/harm, fairness, and organizational. The highest mean importance ratings were for the statements in the patient burden/harm (3.82) and organizational (3.92) clusters.
This study suggests an alternative approach to ELSI+, based on conceptual coherence rather than academic disciplines. This will provide a foundation for incorporating ELSI+ into HTA.
Mental health patients can experience involuntary treatment as disempowering and stigmatising, and contact with recovered peers is cited as important for countering stigma and fostering agency and autonomy integral to recovery.
To advance understanding of the interaction between involuntary treatment and contact with recovered peers, and explore hypothesised relationships to mechanisms of self-evaluation relevant to recovery.
Eighty-nine adults diagnosed with serious mental illness completed items to assess involuntary treatment experience and the extent of prior contact with recovered peers, the Internalised Stigma of Mental Illness Scale, the Self-efficacy for Personal Recovery Scale, the Questionnaire about the Process of Recovery and relevant demographic and clinical scales.
Contact with recovered peers was found to moderate the effects of involuntary treatment on internalised stigma. Sequential conditional process models (i.e. moderated mediation) then demonstrated that conditional internalised stigma (i.e. moderated by contact with recovered peers) mediated the indirect effect of involuntary treatment on recovery-specific self-efficacy, which in turn influenced recovery. Compared with those with low contact with recovered peers, recovery scores were 3.54 points higher for those with high contact.
Although study methods limit causative conclusions, findings are consistent with proposals that contact with recovered peers may be helpful for this patient group, and suggest this may be particularly relevant for those with involuntary treatment experience. Directions for future research, to further clarify measurement and conceptual tensions relating to the study of (dis)empowering experiences in mental health services, are discussed in detail.
The first episode of psychosis is a critical period in the emergence of cardiometabolic risk.
We set out to explore the influence of individual and lifestyle factors on cardiometabolic outcomes in early psychosis.
This was a prospective cohort study of 293 UK adults presenting with first-episode psychosis investigating the influence of sociodemographics, lifestyle (physical activity, sedentary behaviour, nutrition, smoking, alcohol, substance use) and medication on cardiometabolic outcomes over the following 12 months.
Rates of obesity and glucose dysregulation rose from 17.8% and 12%, respectively, at baseline to 23.7% and 23.7% at 1 year. Little change was seen over time in the 76.8% tobacco smoking rate or the quarter who were sedentary for over 10 h daily. We found no association between lifestyle at baseline or type of antipsychotic medication prescribed with either baseline or 1-year cardiometabolic outcomes. Median haemoglobin A1c (HbA1c) rose by 3.3 mmol/mol in participants from Black and minority ethnic (BME) groups, with little change observed in their White counterparts. At 12 months, one-third of those with BME heritage exceeded the threshold for prediabetes (HbA1c >39 mmol/mol).
Unhealthy lifestyle choices are prevalent in early psychosis and cardiometabolic risk worsens over the next year, creating an important window for prevention. We found no evidence, however, that preventative strategies should be preferentially directed based on lifestyle habits. Further work is needed to determine whether clinical strategies should allow for differential patterns of emergence of cardiometabolic risk in people of different ethnicities.
Cold-water coral reefs are biodiversity hotspots of the deep sea. The most dominant reef-building cold-water coral in the Atlantic is Lophelia pertusa, which builds vast and structurally complex habitats. Studying the behaviours of deep-sea species is challenging due to the technological difficulties in making prolonged observations in situ, so little is known about the behavioural ecology of this important species. Observations in laboratory studies can help to enhance our understanding of the range of behaviours these species exhibit. Here we present video evidence that the cold-water coral Lophelia pertusa is capable of producing mucus nets as part of their feeding strategy. This finding suggests that L. pertusa has a more diverse range of feeding strategies than previously thought.
Reducing hospitalisation and length of stay (LOS) in hospital following first episode psychosis (FEP) is important, yet reliable measures of these outcomes and their moderators are lacking. We conducted a systematic review and meta-analysis to investigate the proportion of FEP cases who were hospitalised after their first contact with services and the LOS in a hospital during follow-up.
Studies were identified from a systematic search across major electronic databases from inception to October 2017. Random effects meta-analyses and meta-regression analyses were conducted.
81 longitudinal studies encompassing data for 23 280 FEP patients with an average follow-up length of 7 years were included. 55% (95% CI 50.3–60.5%) of FEP cases were hospitalised at least once during follow-up with the pooled average LOS of 116.7 days (95% CI 95.1–138.3). Older age of illness onset and being in a stable relationship were associated with a lower proportion of people who were hospitalised. While the proportion of hospitalised patients has not decreased over time, LOS has, with the sharpest reduction in the latest time period. The proportion of patients hospitalised during follow-up was highest in Australia and New Zealand (78.4%) compared to Europe (58.1%) and North America (48.0%); and lowest in Asia (32.5%). Black ethnicity and longer duration of untreated psychosis were associated with longer LOS; while less severe psychotic symptoms at baseline were associated with shorter LOS.
One in two FEP cases required hospitalisation at least once during a 7-year follow-up with an average length of hospitalisation of 4 months during this period. LOS has declined over time, particularly in those countries in which it was previously longest.
Health technology assessment (HTA) is value-laden. Consideration of ethical, legal, and social issues (ELSI), and patient values (ELSI+), is challenged by lack of conceptual clarity and the multi-disciplinary nature of ELSI + . This study used concept mapping to identify key concepts in the ELSI+ domain and their interrelationships.
We conducted a scoping review using Medline and EMBASE (2000-2016, English language) with search terms related to ethics, legal/law, social/society/patient, “ELSI”, and HTA/technology/assessment. Items from the review and additional items from an expert brainstorming session were consolidated into 80 ELSI+-related statements which were entered into Concept Systems® Global MAX software. Participants (N = 38; 36 percent researchers, 21 percent academics; 42 percent self-identified as HTA experts) sorted the statements into thematic groups that made sense to them, and rated the statements on their importance in decision-making about adoption of technologies in Canada: 1 (not at all important), 5 (extremely important), 2, 3, and 4 (unlabeled). We used Concept Systems® Global MAX software to create and analyze concept maps with four to 16 clusters, which were reviewed by the study team.
We selected the map with five clusters because its clusters represented different concepts and the statements within each cluster represented the same concept. Based on the concepts, we named these clusters: patient preferences and experiences, patient quality of life and function, patient burden/harm, fairness, and organizational. The highest mean importance ratings were for the statements in the patient burden/harm (3.82) and organizational (3.92) clusters.
This study suggests an alternative approach to conceptualize the domains originally described as “ELSI+”. We identified clusters of relevant concepts that focus on patient perspectives (preferences, experiences, quality of life, function), burden and harm, fairness (individual and societal), and organizational issues. Basing ELSI+ on conceptual consonance, rather than academic disciplines or traditions, provides a framework for coherent consideration of ELSI+ in HTA.
Procurement's important role in healthcare decision making has encouraged criticism and calls for greater collaboration with health technology assessment (HTA), and necessitates detailed analysis of how procurement approaches the decision task.
We reviewed tender documents that solicit medical technologies for patient care in Canada, focusing on request for proposal (RFP) tenders that assess quality and cost, supplemented by a census of all tender types. We extracted data to assess (i) use of group purchasing organizations (GPOs) as buyers, (ii) evaluation criteria and rubrics, and (iii) contract terms, as indicators of supplier type and market conditions.
GPOs were dominant buyers for RFPs (54/97) and all tender types (120/226), and RFPs were the most common tender (92/226), with few price-only tenders (11/226). Evaluation criteria for quality were technical, including clinical or material specifications, as well as vendor experience and qualifications; “total cost” was frequently referenced (83/97), but inconsistently used. The most common (47/97) evaluative rubric was summed scores, or summed scores after excluding those below a mandatory minimum (22/97), with majority weight (64.1 percent, 62.9 percent) assigned to quality criteria. Where specified, expected contract lengths with successful suppliers were high (mean, 3.93 years; average renewal, 2.14 years), and most buyers (37/42) expected to award to a single supplier.
Procurement's evaluative approach is distinctive. While aiming to go beyond price in the acquisition of most medical technologies, it adopts a narrow approach to assessing quality and costs, but also attends to factors little considered by HTA, suggesting opportunities for mutual lesson learning.
Objectives: The Addenbrooke’s Cognitive Examination (ACE) is a common cognitive screening test for dementia. Here, we examined the relationship between the most recent version (ACE-III) and its predecessor (ACE-R), determined ACE-III cutoff scores for the detection of dementia, and explored its relationship with functional ability. Methods: Study 1 included 199 dementia patients and 52 healthy controls who completed the ACE-III and ACE-R. ACE-III total and domain scores were regressed on their corresponding ACE-R values to obtain conversion formulae. Study 2 included 331 mixed dementia patients and 87 controls to establish the optimal ACE-III cutoff scores for the detection of dementia using receiver operator curve analysis. Study 3 included 194 dementia patients and their carers to investigate the relationship between ACE-III total score and functional ability. Results: Study 1: ACE-III and ACE-R scores differed by ≤1 point overall, the magnitude varying according to dementia type. Study 2: a new lower bound cutoff ACE-III score of 84/100 to detect dementia was identified (compared with 82 for the ACE-R). The upper bound cutoff score of 88/100 was retained. Study 3: ACE-III scores were significantly related to functional ability on the Clinical Dementia Rating Scale across all dementia syndromes, except for semantic dementia. Conclusions: This study represents one of the largest and most clinically diverse investigations of the ACE-III. Our results demonstrate that the ACE-III is an acceptable alternative to the ACE-R. In addition, ACE-III performance has broader clinical implications in that it relates to carer reports of functional impairment in most common dementias. (JINS, 2018, 24, 854–863)
Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder with onset in childhood. In Ireland adult ADHD treatment is drifting in an ad hoc manner into general adult psychiatric services. We propose this process should be halted in favour of a delivering a carefully planned adult ADHD service.
In 2007, the Ontario Health Technology Advisory Committee (OHTAC) developed a decision framework to guide decision making around nondrug health technologies. In 2012, OHTAC commissioned a revision of this framework to enhance its usability and deepen its conceptual and theoretical foundations.
The committee overseeing this work used several methods: (a) a priori consensus on guiding principles, (b) a scoping review of decision attributes and processes used globally in health technology assessment (HTA), (c) presentations by methods experts and members of review committees, and (d) committee deliberations over a period of 3 years.
The committee adopted a multi-criteria decision-making approach, but rejected the formal use of multi-criteria decision analysis. Three broad categories of attributes were identified: (I) context criteria attributes included factors such as stakeholders, adoption pressures from neighboring jurisdictions, and potential conflicts of interest; (II) primary appraisal criteria attributes included (i) benefits and harms, (ii) economics, and (iii) patient-centered care; (III) feasibility criteria attributes included budget impact and organizational feasibility.
The revised Ontario Decision Framework is similar in some respects to frameworks used in HTA worldwide. Its distinctive characteristics are that: it is based on an explicit set of social values; HTA paradigms (evidence based medicine, economics, and bioethics/social science) are used to aggregate decision attributes; and that it is rooted in a theoretical framework of optimal decision making, rather than one related to broad social goals, such as health or welfare maximization.
Remission and recovery rates for people with first-episode psychosis (FEP) remain uncertain.
To assess pooled prevalence rates of remission and recovery in FEP and to investigate potential moderators.
We conducted a systematic review and meta-analysis to assess pooled prevalence rates of remission and recovery in FEP in longitudinal studies with more than 1 year of follow-up data, and conducted meta-regression analyses to investigate potential moderators.
Seventy-nine studies were included representing 19072 patients with FEP. The pooled rate of remission among 12301 individuals with FEP was 58% (60 studies, mean follow-up 5.5 years). Higher remission rates were moderated by studies from more recent years. The pooled prevalence of recovery among 9642 individuals with FEP was 38% (35 studies, mean follow-up 7.2 years). Recovery rates were higher in North America than in other regions.
Remission and recovery rates in FEP may be more favourable than previously thought. We observed stability of recovery rates after the first 2 years, suggesting that a progressive deteriorating course of illness is not typical. Although remission rates have improved over time recovery rates have not, raising questions about the effectiveness of services in achieving improved recovery.
There has been much recent excitement about the possibility that some cases of psychosis may be wholly due to brain-reactive antibodies, with antibodies to N-methyl-D-aspartate receptor (NMDAR) and the voltage-gated potassium channel (VGKC)-complex reported in a few patients with first-episode psychosis (FEP).
Participants were recruited from psychiatric services in South London, UK, from 2009 to 2011 as part of the Genetics and Psychosis study. We conducted a case–control study to examine NMDAR and VGKC-complex antibody levels and rates of antibody positivity in 96 patients presenting with FEP and 98 controls matched for age and sex. Leucine-rich glioma inactiviated-1 (LGI1) and contactin-associated protein (CASPR) antibodies were also measured. Notably, patients with suspicion of organic disease were excluded.
VGKC-complex antibodies were found in both cases (n = 3) and controls (n = 2). NMDAR antibody positivity was seen in one case and one control. Either LGI1-Abs or CASPR2-Abs were found in three cases and three controls. Neuronal antibody staining, consistent with the above results or indicating potential novel antigens, was overall positive in four patients but also in six controls. Overall, antibody positivity was at low levels only and not higher in cases than in controls.
This case–control study of the prevalence of antibodies in FEP does not provide evidence to support the hypothesis that FEP is associated with an immune-mediated process in a subgroup of patients. Nevertheless, as other bio-clinical factors may influence the effect of such antibodies in a given individual, and patients with organic neurological disease may be misdiagnosed as FEP, the field requires more research to put these findings in context.
Sexual dysfunction is common in psychotic disorder but it is not clear
whether it is intrinsic to the development of the illness or secondary to
To compare sexual function in people at ultra-high risk (UHR) of a
psychotic disorder, patients with first-episode psychosis predominantly
taking antipsychotic drugs and healthy volunteers.
Sexual function was assessed in a UHR group (n = 31), a
group with first-episode psychosis (n = 37) and a
matched control group of healthy volunteers (n = 56)
using the Sexual Function Questionnaire.
There was a significant effect of group on sexual function
(P<0.001). Sexual dysfunction was evident in 50%
of the UHR group, 65% of first-episode patients and 21% of controls.
Within the UHR group, sexual dysfunction was more marked in those who
subsequently developed psychosis than in those who did not. Across all
groups the severity of sexual dysfunction was correlated with the
severity of psychotic symptoms (P<0.001). Within the
first-episode group there was no significant difference in sexual
dysfunction between patients taking prolactin-raising v.
Sexual dysfunction is present prior to onset of psychosis, suggesting it
is intrinsic to the development of illness unlikely to be related to the
prolactin-raising properties of antipsychotic medication.
Certain styles of parental controlling behaviour influence child development. Work with mothers with eating disorders suggests that they may be particularly controlling of their infants.
To examine the nature and specificity of maternal controlling behaviour in mothers with eating disorders compared with mothers who had experienced postnatal depression and a healthy comparison group.
Mothers with eating disorders (n=34), postnatal depression (n=39) and a healthy comparison group (n=61) and their 12-month-old infants were observed during play and mealtimes, and blind ratings made of verbal and non-verbal control exerted by the mother.
Mothers in the eating disorder group used more verbal control, especially strong control. There were no differences between the groups on gentle verbal control and physical contact. Maternal dietary restraint was the one feature of eating disorder psychopathology associated with the use of verbal control. Marital criticism was also associated with the extent of verbal controlling behaviour.
Aspects of maternal control of infants were found to be specific to maternal eating disorder psychopathology.
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