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This retrospective study aimed to establish a robust rating system for assessing post-operative outcomes in congenital aural atresia patients undergoing auricular reconstruction. The newly introduced EAR scale, a weighted grading system, not only considers anatomical landmarks but also factors such as ear alignment. In addition, the outer-ear cartilage scale and the visual analogue scale (VAS) were introduced. These scales were compared among themselves and against two established scales.
Methods
Nine raters assessed 17 eligible patients who underwent auricular reconstruction between 2001 and 2020.
Results
The study compared inter-rater agreement among scales, with the EAR scale proving the most reliable (Krippendorff's alpha coefficient, α = 0.45), outperforming existing measures. The outer-ear cartilage scale and the VAS exhibited lower inter-rater agreement, indicating inferiority in assessing aesthetic outcomes.
Conclusion
The EAR scale emerged as an effective tool for evaluating post-operative outcomes in congenital aural atresia auricular reconstruction.
This study examines how psychological aspects of vestibular disorders are currently addressed highlighting any national variation.
Method
An online survey was completed by 101 UK healthcare professionals treating vestibular disorders. The survey covered service configurations, attitudes towards psychological aspects and current clinical practice.
Results
Ninety-six per cent of respondents thought there was a psychological component to vestibular disorders. There was a discrepancy between perceived importance of addressing psychological aspects and low confidence to undertake this. Those with more experience felt more confident addressing psychological aspects. History taking and questionnaires containing one or two psychological items were the most common assessment approaches. Discussing symptoms and signposting were the most frequent management approaches. Qualitative responses highlighted the interdependence of psychological and vestibular disorders which require timely intervention. Barriers included limited referral pathways, resources and interdisciplinary expertise.
Conclusion
Although psychological distress is frequently identified, suitable psychological treatment is not routinely offered in the UK.
The reimbursement process for innovative health technologies in Hungary lacks any formalized assessment of clinical added benefit (CAB). The aim of this research is to present the development, retrospective testing, and implementation of a local assessment framework for determining the CAB of cancer treatments at the Department of Health Technology Assessment of the National Institute of Pharmacy and Nutrition in Hungary.
Methods
The assessment framework was drafted after screening existing methods and a retrospective comparison of local reimbursement dossiers to that of German and French methods. The Magnitude of Clinical Benefit Scale of the European Society for Medical Oncology was chosen to rate the extent of CAB in oncology, as part of a conclusion complemented by the assessment of endpoint relevance and the quality of evidence. Several rounds of retrospective assessments have been conducted involving all clinical assessors, iterated with semistructured discussions to consolidate divergence between assessors. External stakeholders were consulted to provide feedback on the framework.
Results
Retrospective assessments resulted in average more than 75 percent concordance between assessors on each element of the conclusion. Input from ten stakeholders was also incorporated; stakeholders were generally supportive, and they mostly commented on the concept, the elements of the framework, and its implementation.
Conclusions
The procedure is suitable for routine use in the decision-making process to describe the CAB of antineoplastic technologies in Hungary. Further extension of the framework is required to cover more disease areas for structured and comparable conclusions on CAB of innovative health technologies.
To review the clinical characteristics, prevalence and outcomes of chronic rhinosinusitis patients with a hypoplastic maxillary sinus who underwent functional endoscopic sinus surgery.
Methods
A retrospective review was performed for the 814 consecutive, elective functional endoscopic sinus surgery procedures performed at an academic centre from 2010 to 2020, to identify patients with a hypoplastic maxillary sinus.
Result
A total of 56 hypoplastic maxillary sinus cases were detected. Maxillary sinus hypoplasia presented unilaterally in 20 cases and bilaterally in 18 cases. Of the maxillary sinus hypoplasia cases, 38 were type I, 17 were type II and 1 was type III. The average Lund–McKay score was 8.6. No major post-operative complications were reported. Four patients had minor complications and one had persistent post-nasal drip.
Conclusion
Functional endoscopic sinus surgery is a safe and effective procedure for improving the clinical condition of patients with a hypoplastic maxillary sinus; however, careful pre-operative radiological evaluation, identification of intra-operative endoscopic landmarks and use of additional techniques may be essential to achieve satisfactory results and avoid possible serious complications.
As prospective outcomes of septoplasty with or without turbinoplasty beyond the first year are few and have diverging results, this study evaluated later septoplasty results three to four years post-operatively.
Methods
Patients undergoing septoplasty completed the Nasal Surgical Questionnaire pre-operatively, and at 6–12 months (early post-operative assessment) and 36–48 months (late post-operative assessment) after surgery. Primary outcome was visual analogue scale ratings for nasal obstruction (with a scale ranging from 0 to 100).
Results
In 604 patients with high response rates, the largest improvements in nasal obstruction were from pre-operative to early post-operative assessments (daytime score reduction = 33.9, night-time reduction 40.5). Nasal obstruction ratings worsened slightly between early and late post-operative assessments (daytime score increase = 5.3, night-time score increase = 9.7). Improvements were better in patients aged over 35 years and in those with pre-operative nasal obstruction scores of more than 62. There were no differences based on surgery type, septal deviation, allergy or smoking.
Conclusion
Septoplasty improves nasal obstruction in both the first and the fourth year after surgery. Post-operative improvements decline slightly over time but remain significant.
To evaluate the properties of the cognitive battery used in the MIND Diet Intervention to Prevent Alzheimer’s Disease. The MIND Diet Intervention is a randomized control trial to determine the relative effectiveness of the MIND diet in slowing cognitive decline and reducing brain atrophy in older adults at risk for Alzheimer’s dementia.
Methods:
The MIND cognitive function battery was administered at baseline to 604 participants of an average age of 70 years, who agreed to participate in the diet intervention study, and was designed to measure change over time. The battery included 12 cognitive tests, measuring the 4 cognitive domains of executive function, perceptual speed, episodic memory, and semantic memory. We conducted a principal component analysis to examine the consistency between our theoretical domains and the statistical performance of participants in each domain. To further establish the validity of each domain, we regressed the domain scores against a late-life cognitive activity score, controlling for age, race, sex, and years of education.
Results:
Four factors emerged in the principal component analyses that were similar to the theoretical domains. In regression equations, we found the expected associations with age, education, and late-life cognitive activity with each of the four cognitive domains.
Conclusions:
These results indicate that the MIND cognitive battery is a comprehensive and valid battery of four separate domains of cognitive function that can be used in diet intervention trials for older adults.
This systemic review and meta-analysis was conducted to explore the impact of dispatcher-assisted bystander cardiopulmonary resuscitation (DA-BCPR) on bystander cardiopulmonary resuscitation (BCPR) probability, survival, and neurological outcomes with out-of-hospital cardiac arrest (OHCA).
Methods:
Electronically searching of PubMed, Embase, and Cochrane Library, along with manual retrieval, were done for clinical trials about the impact of DA-BCPR which were published from the date of inception to December 2018. The literature was screened according to inclusion and exclusion criteria, the baseline information, and interested outcomes were extracted. Two reviewers assessed the methodological quality of the included studies. Pooled odds ratio (OR) and 95% confidence interval (CI) were calculated by STATA version 13.1.
Results:
In 13 studies, 235,550 patients were enrolled. Compared with no dispatcher instruction, DA-BCPR tended to be effective in improving BCPR rate (I2 = 98.2%; OR = 5.84; 95% CI, 4.58-7.46; P <.01), return of spontaneous circulation (ROSC) before admission (I2 = 36.0%; OR = 1.17; 95% CI, 1.06-1.29; P <.01), discharge or 30-day survival rate (I2 = 47.7%; OR = 1.25; 95% CI, 1.06-1.46; P <.01), and good neurological outcome (I2 = 30.9%; OR = 1.24; 95% CI, 1.04-1.48; P = .01). However, no significant difference in hospital admission was found (I2 = 29.0%; OR = 1.09; 95% CI, 0.91-1.30; P = .36).
Conclusion:
This review shows DA-BPCR plays a positive role for OHCA as a critical section in the life chain. It is effective in improving the probability of BCPR, survival, ROSC before admission, and neurological outcome.
This article presents the long-term results in terms of antipsychotic medication maintenance and factors influencing it in a representative sample of patients with schizophrenia recruited in the SOHO study within Spain.
Methods
The SOHO was a prospective, 3-year observational study of the outcomes of schizophrenia treatment in outpatients who initiated therapy or changed to a new antipsychotic performed in 10 European countries with a focus on olanzapine. The Kaplan–Meier method was used to analyse the time to treatment discontinuation and the Cox proportional hazards model to investigate correlates of discontinuation.
Results and conclusions
In total, 1688 patients were included in the analyses. Medication maintenance at 3 years varied with the antipsychotic prescribed, being highest with clozapine (57.6%, 95% CI 39.2–74.5), followed by olanzapine (48.3%, 95% CI 45.1–51.5); and lowest with quetiapine (19.0%, 95% CI 13.0–26.3). Treatment discontinuation was significantly less frequent with olanzapine than with risperidone (p = 0.015), depot typical (p = 0.001), oral typical antipsychotics (p < 0.001) or quetiapine (p < 0.001); but not than with clozapine (p = 0.309). Longer maintenance was also associated with higher social abilities and better cognitive status at baseline; in contrast, a shorter time to discontinuation was associated with the need for mood stabilisers during follow-up. This study emphasises the different value of antipsychotics in day-to-day clinical practice, as some of them were associated with longer medication maintenance periods than others. This study has some limitations because of possible selection and information biases derived from the non-systematic, non-randomised allocation to treatments and the existence of unobserved covariates that may influence the outcome.
To examine the 17-year clinical outcome of schizophrenia and its predictors in Bali.
Methods
Subjects were 59 consecutively admitted first-episode schizophrenia patients. Their clinical outcome was evaluated by standardized symptomatic remission criteria based on Positive and Negative Syndrome Scale (PANSS) scores and operational functional remission criteria at 17-year follow-up. The standardized mortality ratio (SMR) over 17 years was also calculated as another index of clinical outcome.
Results
Among these 59 patients, 43 (72.9%) could be followed-up, 15 (25.4%) had died, and one (1.7%) was alive but refused to participate in the study. Combined remission (i.e. symptomatic and functional remission) was achieved in 14 patients (23.7% of original sample). Duration of untreated psychosis (DUP) was a significant baseline predictor of combined remission. Mean age at death of deceased subjects was 35.7, and SMR was 4.85 (95% CI: 2.4–7.3), indicating that deaths were premature. Longer DUP was associated with excess mortality.
Conclusions
The long-term outcome of schizophrenia in Bali was heterogeneous, demonstrating that a quarter achieved combined remission, half were in nonremission, and a quarter had died at 17-year follow-up. DUP was a significant predictor both for combined remission and mortality.
With people living longer, palliative care may be required for lengthier periods of time. This puts demands on healthcare organizations to provide optimal palliative care. Maintaining dignity is central for any person's health and quality of life, but especially for a person with palliative care needs. Dignity-conserving care needs to be evaluated to increase knowledge about outcomes and how to assess these. The purpose of this integrative review was to identify outcomes studied within dignity-conserving care and how these have been operationalized.
Methods
An integrative review was conducted in 26 quantitative or mixed-method studies and study protocols. Thematic synthesis with an abductive approach was used for analysis.
Results
Seven themes of studied outcomes were identified, as well as four cluster themes: themes related to Illness-Related Concerns, themes related to the Dignity-Conserving Repertoire, themes related to the Social Dignity Inventory, and themes regarding Overarching Dignity Issues. Most outcomes studied dealt with Illness-Related Concerns within the themes of “Performance, symptoms and emotional concerns” and “End-of-life and existential aspects”. Themes linked to the Social Dignity Inventory had the lowest number of outcomes studied. Outcomes regarding overarching dignity issues such as “Dignity-related distress” and “Quality of life” were common. However, the results lacked concrete communication outcomes.
Significance of results
The results will underpin future research in which dignity-conserving care is implemented and evaluated, and contribute to the provision of evidence-based palliative care. A greater focus on outcomes within cluster themes related to the Dignity-Conserving Repertoire and the Social Dignity Inventory is needed, as is more focus on communication outcomes.
This study aimed to examine the impact of trainee involvement in performing tympanoplasty or tympano-ossiculoplasty on outcomes.
Methods
A retrospective analysis was performed of a prospective database of all patients undergoing tympanoplasty and tympano-ossiculoplasty in a single centre during a three-year period. Patients were divided into three primary surgeon groups: consultants, fellows and residents. The outcomes of operative time, surgical complications, length of hospital stay, and air–bone gap improvement were compared among the groups.
Results
The study included 398 tympanoplasty and tympano-ossiculoplasty surgical procedures, 71 per cent of which were performed by junior trainees (residents). The junior trainee group was associated with a significantly longer surgical time, without adverse impact on outcomes.
Conclusion
Trainee participation in tympanoplasty and tympano-ossiculoplasty surgery was associated with longer surgical time, but did not negatively affect the peri-operative course or hearing outcome. Therefore, resident involvement in these types of surgery is safe.
Objectives: Various minimal clinically important difference (MCID) threshold estimation techniques have been applied to seasonal allergic rhinitis (SAR). The objectives of this study are to (i) assess the difference in magnitude of alternative SAR MCID threshold estimates and (ii) evaluate the impact of alternative MCID estimates on health technology assessment (HTA).
Methods: Data describing change from baseline of the reflective Total Nasal Symptom Score (rTNSS) for four intranasal SAR treatments were obtained from United States Food and Drug Administration-approved prescribing information. Treatment effects were then compared with anchor-based MCID thresholds derived by Barnes et al. and thresholds obtained from an Agency for Healthcare Research and Quality (AHRQ) panel.
Results: The change in rTNSS score from baseline, represented as the average of the twice-daily recorded scores of the rTNSS, was -2.1 (p < .001) for azelastine hydrochloride 0.10%, 1.35 (p = .014) for ciclesonide, and -1.47 (p < .001) for fluticasone furoate. The change in the rTNSS score from baseline, represented by sum of the AM and PM score, was -2.7 for MP-AzeFlu (p < .001). The rTNSS change from baseline for each product was compared with anchor-based MCID threshold and the AHRQ panel estimates. Comparison of the observed treatment effect to the anchor-based and AHRQ panel MCID thresholds results in different conclusions, with clinically important differences being inferred when anchor-based estimates serve as the reference point.
Conclusion: The AHRQ panel MCID threshold for the rTNSS was twelve times larger than the anchor-based estimates resulting in conflicting recommendations on whether different SAR treatments provide clinically meaningful benefit.
This study reports the clinical outcomes of head and neck adenoid cystic carcinoma treatment over a 20-year period.
Methods:
The treatment outcome of 51 head and neck adenoid cystic carcinoma patients treated between 1992 and 2013 were analysed. Patients were stratified into radical treatment and disease control groups.
Results:
A total of 40 patients underwent surgery and post-operative radiotherapy. The 10-year disease-specific survival rate was 93 per cent. Eleven patients had tumour recurrence: of these, nine were pulmonary metastases. The 11 patients in the disease control group had a median follow up of 21 months (range, 2–172 months); 5 underwent radical radiotherapy with palliative intent.
Conclusion:
There was late tumour recurrence in over 25 per cent of patients. Adenoid cystic carcinoma has a high tendency to relapse even after radical excision and adjuvant therapy. However, definitive radiotherapy should still be considered on an individual basis because it may provide local control and prolong patient survival.
The Chicago Multiscale Depression Inventory (CMDI) was developed to improve accuracy in measuring depression symptoms in individuals with non-psychiatric medical illness. Earlier psychometric evaluation of the CMDI has emphasized properties of items that measure negative affect and experience. In this study, we provide an initial evaluation of an outcome scale of positive items that are also included within the CMDI but have previously been excluded from calculation of the total score. Psychometric data for the CMDI negative and positive item subscales were determined in healthy adults and patients with multiple sclerosis. Analysis included measurements of factor structure, reliability, and validity in comparison with other established measures of depression and affect. Study findings indicate that in healthy and patient samples, the CMDI Positive scale has very good reliability and validity. The Positive scale score also appears to predict depression symptoms beyond the negative item scale scores. The CMDI Positive scale could be a valuable clinical and research tool. Inclusion of the Positive scale in the CMDI total score appears to improve the measure by further capturing symptoms of affect and experience that are important to diagnosis of depression and are not covered by the negative scales alone. (JINS, 2016, 22, 76–82)
The first cohorts to survive childhood lymphoid malignancies treated with cranial irradiation are now aging into adulthood, and concerns are growing about the development of radiotherapy-induced cognitive deficits in the aging brain. These deficits are hypothesized to increase over time. Their impact on daily functioning of older survivors, and the accompanying need for interventions, should be anticipated. By describing a detailed profile of executive function deficits and their associations with age, specific targets for neuropsychological intervention can be identified. Fifty survivors of childhood lymphoid malignancies and 58 related controls were assessed with the Amsterdam Neuropsychological Tasks program. The survivors were on average 31.1 (4.9) years old, treated with 22.5 (6.8) Gy cranial irradiation, and examined on average 25.5 (3.1) years after diagnosis. The survivors showed significantly decreased response speed, irrespective of the task at hand. Furthermore, we found deficits in working memory capacity, inhibition, cognitive flexibility, executive visuomotor control, attentional fluctuations, and sustained attention. Older age was associated with poorer performance on executive visuomotor control and inhibition. On executive visuomotor control, 50% of female survivors performed more than 1.5 SD below average, versus 15.4% of male survivors. The combination of visuospatial working memory problems and decreasing executive visuomotor control could result in difficulty with learning new motor skills at older ages, like walking with a cane. Deterioration of executive control and inhibition may result in decreased behavioral and emotional regulation in aging survivors. Especially the deficiency in executive visuomotor control in female survivors should be considered for (prophylactic) intervention. (JINS, 2015, 21, 657–669)
The Beck Depression Inventory, 2nd edition (BDI-II) is widely used in research on depression. However, the minimal clinically important difference (MCID) is unknown. MCID can be estimated in several ways. Here we take a patient-centred approach, anchoring the change on the BDI-II to the patient's global report of improvement.
Method
We used data collected (n = 1039) from three randomized controlled trials for the management of depression. Improvement on a ‘global rating of change’ question was compared with changes in BDI-II scores using general linear modelling to explore baseline dependency, assessing whether MCID is best measured in absolute terms (i.e. difference) or as percent reduction in scores from baseline (i.e. ratio), and receiver operator characteristics (ROC) to estimate MCID according to the optimal threshold above which individuals report feeling ‘better’.
Results
Improvement in BDI-II scores associated with reporting feeling ‘better’ depended on initial depression severity, and statistical modelling indicated that MCID is best measured on a ratio scale as a percentage reduction of score. We estimated a MCID of a 17.5% reduction in scores from baseline from ROC analyses. The corresponding estimate for individuals with longer duration depression who had not responded to antidepressants was higher at 32%.
Conclusions
MCID on the BDI-II is dependent on baseline severity, is best measured on a ratio scale, and the MCID for treatment-resistant depression is larger than that for more typical depression. This has important implications for clinical trials and practice.
Objective – The assessment of outcome for any purpose is not undertaken routinely in European mental health services. This paper discusses the merits of using outcome data to inform the planning of mental health care for individual patients, and provides practical advice to support the implementation of this new approach to working. Method – The use of outcomes in North America and Europe is briefly reviewed. A conceptual basis is proposed for routine outcome assessment – the ongoing measurement and use of outcome data to inform decisions about whether to continue, change or curtail treatment. A cognitive psychology model is developed which indicates that the routine use of outcomes will improve mental health care. Perceived problems with routine outcome assessment are discussed, and principles for implementation are identified. Results – Outcomes are used mainly for generating local-level (rather than patient-level) data in North America, and rarely used in Europe. The use of outcome data routinely may facilitate reflective clinical practice, a model of decision-making which leads to a higher quality of clinical care than automated problem-solving. One issue relates to the use of standardised assessments designed for research purposes in clinical settings, and this is being addressed through the development of a new generation of outcome measures which are explicitly designed for clinical use. However, most clinicians remain unconvinced of the benefits of routine outcome assessment, and relevant research is currently underway across Europe which will address this concern. Scientific principles to maximise quality and pragmatic principles to maximise the chances of successful implementation are identified. Conclusions – The routine use of outcomes will become increasingly prominent in European mental health services. This provides clinicians with an opportunity to improve the quality of clinical care offered to patients.
Delirium has been associated with institutionalization, increased length of hospital stay, cognitive and functional decline and mortality. Research in the last thirty years has recognized that accurate diagnostic criteria allow for targeted interventions for those suffering from delirium. However, despite the advances made in understanding delirium, adverse outcomes persist.
This article will first review how the evolution of diagnostic criteria has fostered improvements in the recognition of delirium and facilitated the development of therapeutic strategies. Second, we discuss how this foundation in approach to delirium has influenced outcomes and the evidence for causality. Finally, the candidate factors responsible for propagating adverse events are considered and future research direction outlined.
This study aimed to test the validity of the 21-item Depression Anxiety Stress Scales (DASS-21) as a routine clinical outcome measure in the private in-patient setting. We hypothesized that it would be a suitable routine outcome instrument in this setting.
Method:
All in-patients treated at a private psychiatric hospital over a period of 24 months were included in the study. Data were collected on demographics, service utilization, diagnosis and a set of four routine measures both at admission and discharge. These measures consisted of the Clinical Global Impressions (CGI) scales, Health of the Nation Outcome Scales (HoNOS), the Mental Health Questionnaire (MHQ-14) and DASS-21. The results of these measures were compared.
Results:
Of 786 admissions in total, the number of fully completed (ie paired admission and discharge) data sets for the DASS-21 depression, anxiety and stress subscales were 337, 328 and 347, respectively. All subscales showed statistically significant reductions in mean scores from admission to discharge (P < 0.001) and were significantly correlated with all MHQ-14 subscales and significantly related to CGI scale categories. The total DASS-21 and total HoNOS scores were also significantly correlated.
Conclusions:
The findings from the present study support the validity of DASS-21 as a routine clinical outcome measure in the private in-patient setting.
This Editorial addresses the crucial issue of which research methodology is most suited for capturing the complexity of psychosocial interventions conducted in ‘real world’ mental health settings. It first examines conventional randomized controlled trial (RCT) methodology and critically appraises its strengths and weaknesses. It then considers the specificity of mental health care treatments and defines the term ‘complex’ intervention and its implications for RCT design. The salient features of pragmatic RCTs aimed at generating evidence of psychosocial intervention effectiveness are then described. Subsequently, the conceptualization of pragmatic RCTs, and of their further developments – which we propose to call ‘new generation’ pragmatic trials – in the broader routine mental health service context, is explored. Helpful tools for planning pragmatic RCTs, such as the CONSORT extension for pragmatic trials, and the PRECIS tool are also examined. We then discuss some practical challenges that are involved in the design and implementation of pragmatic trials based on our own experience in conducting the GET UP PIANO Trial. Lastly, we speculate on the ways in which current ideas on the purpose, scope and ethics of mental health care research may determine further challenges for clinical research and evidence-based practice.