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A new review, launched by the Department for Health and Social Care and Led by NIHR ARC OxTV supported Dr Ben Goldacre, will focus on the more efficient and safe use of health data for research and analysis for the benefit of patients and the healthcare sector.
Predicting the risk of pancreatic cancer in adults with new-onset diabetes: development and internal-external validation of a clinical risk prediction model.
BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommends that people aged 60+ years with newly diagnosed diabetes and weight loss undergo abdominal imaging to assess for pancreatic cancer. More nuanced stratification could lead to enrichment of these referral pathways. METHODS: Population-based cohort study of adults aged 30-85 years at type 2 diabetes diagnosis (2010-2021) using the QResearch primary care database in England linked to secondary care data, the national cancer registry and mortality registers. Clinical prediction models were developed to estimate risks of pancreatic cancer diagnosis within 2 years and evaluated using internal-external cross-validation. RESULTS: Seven hundred and sixty-seven of 253,766 individuals were diagnosed with pancreatic cancer within 2 years. Models included age, sex, BMI, prior venous thromboembolism, digoxin prescription, HbA1c, ALT, creatinine, haemoglobin, platelet count; and the presence of abdominal pain, weight loss, jaundice, heartburn, indigestion or nausea (previous 6 months). The Cox model had the highest discrimination (Harrell's C-index 0.802 (95% CI: 0.797-0.817)), the highest clinical utility, and was well calibrated. The model's highest 1% of predicted risks captured 12.51% of pancreatic cancer cases. NICE guidance had 3.95% sensitivity. DISCUSSION: A new prediction model could have clinical utility in identifying individuals with recent onset diabetes suitable for fast-track abdominal imaging.
Combining endpoint and change data did not affect the summary standardised mean difference in pairwise and network meta-analyses: An empirical study in depression.
When studies use different scales to measure continuous outcomes, standardised mean differences (SMD) are required to meta-analyse the data. However, outcomes are often reported as endpoint or change from baseline scores. Combining corresponding SMDs can be problematic and available guidance advises against this practice. We aimed to examine the impact of combining the two types of SMD in meta-analyses of depression severity. We used individual participant data on pharmacological interventions (89 studies, 27,409 participants) and internet-delivered cognitive behavioural therapy (iCBT; 61 studies, 13,687 participants) for depression to compare endpoint and change from baseline SMDs at the study level. Next, we performed pairwise (PWMA) and network meta-analyses (NMA) using endpoint SMDs, change from baseline SMDs, or a mixture of the two. Study-specific SMDs calculated from endpoint and change from baseline data were largely similar, although for iCBT interventions 25% of the studies at 3 months were associated with important differences between study-specific SMDs (median 0.01, IQR -0.10, 0.13) especially in smaller trials with baseline imbalances. However, when pooled, the differences between endpoint and change SMDs were negligible. Pooling only the more favourable of the two SMDs did not materially affect meta-analyses, resulting in differences of pooled SMDs up to 0.05 and 0.13 in the pharmacological and iCBT datasets, respectively. Our findings have implications for meta-analyses in depression, where we showed that the choice between endpoint and change scores for estimating SMDs had immaterial impact on summary meta-analytic estimates. Future studies should replicate and extend our analyses to fields other than depression.
Digital Mental Health for Schizophrenia and Other Severe Mental Illnesses: An International Consensus on Current Challenges and Potential Solutions.
BACKGROUND: Digital approaches may be helpful in augmenting care to address unmet mental health needs, particularly for schizophrenia and severe mental illness (SMI). OBJECTIVE: An international multidisciplinary group was convened to reach a consensus on the challenges and potential solutions regarding collecting data, delivering treatment, and the ethical challenges in digital mental health approaches for schizophrenia and SMI. METHODS: The consensus development panel method was used, with an in-person meeting of 2 groups: the expert group and the panel. Membership was multidisciplinary including those with lived experience, with equal participation at all stages and coproduction of the consensus outputs and summary. Relevant literature was shared in advance of the meeting, and a systematic search of the recent literature on digital mental health interventions for schizophrenia and psychosis was completed to ensure that the panel was informed before the meeting with the expert group. RESULTS: Four broad areas of challenge and proposed solutions were identified: (1) user involvement for real coproduction; (2) new approaches to methodology in digital mental health, including agreed standards, data sharing, measuring harms, prevention strategies, and mechanistic research; (3) regulation and funding issues; and (4) implementation in real-world settings (including multidisciplinary collaboration, training, augmenting existing service provision, and social and population-focused approaches). Examples are provided with more detail on human-centered research design, lived experience perspectives, and biomedical ethics in digital mental health approaches for SMI. CONCLUSIONS: The group agreed by consensus on a number of recommendations: (1) a new and improved approach to digital mental health research (with agreed reporting standards, data sharing, and shared protocols), (2) equal emphasis on social and population research as well as biological and psychological approaches, (3) meaningful collaborations across varied disciplines that have previously not worked closely together, (4) increased focus on the business model and product with planning and new funding structures across the whole development pathway, (5) increased focus and reporting on ethical issues and potential harms, and (6) organizational changes to allow for true communication and coproduction with those with lived experience of SMI. This study approach, combining an international expert meeting with patient and public involvement and engagement throughout the process, consensus methodology, discussion, and publication, is a helpful way to identify directions for future research and clinical implementation in rapidly evolving areas and can be combined with measurements of real-world clinical impact over time. Similar initiatives will be helpful in other areas of digital mental health and similarly fast-evolving fields to focus research and organizational change and effect improved real-world clinical implementation.
Experiences and impact of psychiatric inpatient admissions far away from home: a qualitative study with young people, parents/carers and healthcare professionals.
BACKGROUND: There are significant clinical, policy and societal concerns about the impact on young people (YP), from admission to psychiatric wards far from home. However, research evidence is scarce. AIMS: To investigate the impact of at-distance admissions to general adolescent units, from the perspectives of YP, parents/carers and healthcare professionals (HCPs) including service commissioners, to inform clinical practice, service development and policy. METHOD: Semistructured interviews with purposive samples of YP aged 13-17 years (n=28) and parents/carers (n=19) across five large regions in England, and a national sample of HCPs (n=51), were analysed using a framework approach. RESULTS: There was considerable agreement between YP, parents/carers and HCPs on the challenges of at-distance admissions. YP and parents/carers had limited or no involvement in decision-making processes around admission and highlighted a lack of available information about individual units. Being far from home posed challenges with maintaining home contact and practical/financial challenges for families visiting. HCPs struggled with ensuring continuity of care, particularly around maintaining access to local clinical teams and educational support. However, some YP perceived separation from their local environment as beneficial because it removed them from unhelpful environments. At-distance admissions provided respite for some families struggling to support their child. CONCLUSIONS: At-distance admissions lead to additional distress, uncertainty, compromised continuity of care and educational, financial and other practical difficulties, some of which could be better mitigated. For a minority, there are some benefits from such admissions. CLINICAL IMPLICATIONS: Standardised online information, accessible prior to admission, is needed for all Child and Adolescent Mental Health Services units. Additional practical and financial burden placed on families needs greater recognition and consideration of potential sources of support. Policy changes should incorporate findings that at-distance or adult ward admissions may be preferable in certain circumstances.
In a randomized study of envelope and ink color, colored ink was found to increase the response rate to a postal questionnaire.
OBJECTIVE: To assess the effect of the colors of the envelope and ink on the response rate to a postal questionnaire in a study screening for undiagnosed parkinsonism in people aged 65 years and over in the community. STUDY DESIGN AND SETTING: A total of 2,524 people aged 65 years and over from five general practices in Aberdeen were randomized to receive a questionnaire about the symptoms of parkinsonism printed in either colored (green) or black ink, and sent out in either a brown or white envelope. RESULTS: The overall response rate was 63.5%. There was no significant interaction between envelope and ink color. The use of green ink compared to black significantly increased the response rate from 61.4% to 65.7% (OR 1.20, 95% confidence interval 1.02, 1.41). There was no overall effect of envelope color on response rate (62.3% brown and 64.8% white, OR 0.90, 95% confidence interval 0.76, 1.06) but there was significant heterogeneity between the general practices. When this general practice-envelope interaction was accounted for, brown envelopes had a significantly lower response rate than white ones (OR 0.49). CONCLUSION: This study, along with existing evidence, has shown that the use of certain ink colors in postal questionnaires is likely to increase response rates relative to black ink. The effect of envelope color was inconsistent both within this study and between previous studies.
Mortality in Parkinson's disease: a systematic review and meta-analysis.
This study was undertaken to perform a systematic review and meta-analysis of studies of mortality in Parkinson's disease (PD) and to investigate which factors were associated with mortality. We conducted comprehensive searches of studies reporting a ratio of mortality in PD versus controls, descriptive survival measures, or factors predicting survival; assessed study quality; and extracted relevant data. Descriptive analysis, meta-analysis, and meta-regression were performed as appropriate. Eighty-eight studies were included in the review with variable study methods and quality. Almost all studies reported increased mortality in PD (vs. controls), with mortality ratios ranging from 0.9 to 3.8, with major between-study heterogeneity. Inception cohorts were more consistent with a pooled mortality ratio of approximately 1.5. Inception cohorts, measurements at longer follow-up duration, and older study recruitment year were associated with lower mortality ratios, but these findings were not robust in sensitivity analyses. Within studies, mortality ratios increased over time. No robust evidence was found that mortality has decreased after the introduction of levodopa (L-dopa). On average, PD survival reduced by approximately 5% every year of follow-up, although there was significant heterogeneity. In post-mortem studies, mean duration until death ranged from 6.9 to 14.3 years. Increasing age and presence of dementia were most commonly associated with increased mortality. Parkinson's disease is associated with increased mortality, but major heterogeneity is seen in estimates of mortality, which is probably explained by variable methodology and patient selection. Individual-patient-data meta-analysis of high-quality inception studies with long-term follow-up would be the optimal way to investigate the factors influencing mortality.
Recruitment bias resulted in poorer overall health status in a community-based control group.
OBJECTIVE: During a prospective community-based incidence study of parkinsonism, a control group was recruited for comparison with the incident patients. This study compared the demographic and health status of recruited vs. nonrecruited controls. STUDY DESIGN AND SETTING: For each incident patient, attempts were made to recruit an age-gender matched control from the same general practice or, failing that, from a previously identified community cohort of people aged over 64 years who had expressed an interest in taking part in future research. Recruited controls were compared with those who were approached but not recruited in terms of age, socioeconomic status, gender, several measures of health status, and survival. RESULTS: A total of 74 controls (40%) were recruited out of 186 potential controls who were approached. Recruited controls scored slightly worse than nonrecruited controls on every measure of health status, which reached statistical significance for numbers of acute prescriptions and major surgical procedures. There were no significant differences in age, gender, socioeconomic status, or survival. CONCLUSION: The control cohort was affected by recruitment bias, which suggested that recruited controls had slightly poorer health compared to nonrecruited controls. This bias may reduce differences in health when comparisons are made between the controls and the parkinsonian patients.
Age-, and gender-specific incidence of vascular parkinsonism, progressive supranuclear palsy, and parkinsonian-type multiple system atrophy in North East Scotland: the PINE study.
INTRODUCTION: There have been few incidence studies of vascular parkinsonism (VP), progressive supranuclear palsy (PSP), and parkinsonian-type multiple system atrophy (MSA-P). We measured the age-, gender- and socioeconomic-specific incidence rates for these conditions in north-east Scotland. METHODS: Incident non drug-induced parkinsonian patients were identified prospectively over three years by several overlapping methods from a baseline primary care population of 311,357. Parkinsonism was diagnosed if patients had two or more cardinal motor signs. Patients had yearly follow-up to improve diagnostic accuracy. Incidence rates using the diagnosis by established research criteria at latest follow-up were calculated for each condition by age, gender, and socioeconomic status. RESULTS: Of 377 patients identified at baseline with possible or probable parkinsonism, 363 were confirmed as incident patients after median follow-up of 26 months (mean age 74.8 years, SD 9.8; 61% men). The crude annual incidence was 3.2 per 100,000 (95% confidence interval (CI) 2.2-4.3) for VP, 1.7 per 100,000 (95% CI 1.0-2.4) for PSP, and 1.4 per 100,000 (95% CI 0.8-2.1) for MSA-P. VP and MSA-P were more common in men (age-adjusted male to female ratios 2.58 (95% CI 1.65-3.83) and 8.65 (95% CI 4.73-14.5) respectively). Incidence did not vary with socioeconomic status. DISCUSSION: This is the first community-based, prospective study to report the incidence of vascular parkinsonism and the third to report the incidence of PSP and MSA-P. Further follow-up and comparison with similar studies in different populations will yield valuable prognostic and aetiological information on these conditions.
Validation of a UPDRS-/MDS-UPDRS-based definition of functional dependency for Parkinson's disease.
INTRODUCTION: Functional dependency in basic activities of daily living (ADLs) is a key outcome in Parkinson's disease (PD). We aimed to define dependency in PD, using the original and MDS versions of the Unified Parkinson's Disease Rating Scale (UPDRS). METHODS: We developed two algorithms to define dependency from items of UPDRS Part 2 and MDS-UPDRS Part 2 relating to basic ADLs (feeding, dressing, hygiene and walking, and getting out of a chair). We validated both algorithms using data from 1110 patients from six community-based PD incidence cohorts, testing concurrent validity, convergent validity, and predictive validity. RESULTS: Our optimal algorithm showed high specificity and moderate to high sensitivity versus Schwab & England <80% (specificity 95% [95% confidence interval (CI) 93-97] and sensitivity 65% [95% CI 55-73] at baseline; 88% [95% CI 85-91] and 85% [95% CI 79-97] respectively at five-years follow-up). Convergent validity was demonstrated by strong associations between dependency defined by the algorithm and cognition (MMSE), quality of life (PDQ39), and impairment (UPDRS part 3) (all p
Pilot study of the incidence and prognosis of degenerative Parkinsonian disorders in Aberdeen, United Kingdom: methods and preliminary results.
The objective of this study was to test the methods for a large study of the incidence and prognosis of Parkinson's disease and other degenerative parkinsonian disorders and provide provisional incidence figures. This was a community-based prospective study to identify patients with newly diagnosed non-drug-induced Parkinsonism (>or=2 of tremor, rigidity, bradykinesia, postural instability) from a population of 148,600 people in Aberdeen, Scotland, over 18 months. Multiple search strategies were used to identify patients, including some population screening. Incident patients and age/sex-matched controls had assessments of impairment, disability, quality of life, mood, and cognition and are being followed up yearly. Two hundred and two people with possible parkinsonian symptoms were assessed, and 82 incident patients were identified, 50 with probable Parkinson's disease. The crude incidences of probable Parkinsonism and probable Parkinson's disease were 31.4/100,000/year (95% CI: 24.5-39.7) and 22.4/100,000/year (95% CI: 16.6-29.6), respectively. The mean age of diagnosis of Parkinson's disease was 76.1 +/- 10.0 years and the incidence was greater in men. The methods were generally successful. Provisionally, we found a higher incidence of Parkinson's disease than other comparable studies, and our patients were considerably older. This may reflect better case ascertainment in the elderly. A larger study is planned.
Changes in quality of life in people with Parkinson's disease left untreated at diagnosis.
BACKGROUND: The issue of whether to adopt a "wait and watch" strategy or to initiate drug therapy soon after diagnosis in Parkinson's disease (PD) has been the subject of some debate. A recent observational study supported early treatment by demonstrating deterioration in self-reported health status in those left untreated, but not those who received therapy. We aimed to replicate this observation. METHODS: People with PD from a prospective incidence study underwent follow-up with yearly clinical assessment of parkinsonian impairment (Unified Parkinson's Disease Rating Scale (UPDRS)) and self-reported health status (Parkinson's Disease Questionnaire (PDQ-39)). Two year outcomes were compared with those who started treatment within 1 year of diagnosis and those left untreated. RESULTS: 42 patients with PD were followed-up for 2 years, of whom 26 started treatment during the first year and 16 remained untreated. Those receiving treatment had significantly higher UPDRS and PDQ-39 scores at baseline. There was no significant deterioration in PDQ-39 score in either group (median change untreated 0.8 vs treated 4.0; p = 0.47), despite a significant difference in the change in motor UPDRS scores (untreated 6.0 vs treated -6.0; p = 0.03). CONCLUSION: Given the lack of significant deterioration in the PDQ-39 in untreated patients, we believe a "wait and watch" strategy for the treatment of newly diagnosed PD remains a credible approach unless randomised trials prove otherwise.
Age-, gender-, and socioeconomic status-specific incidence of Parkinson's disease and parkinsonism in northeast Scotland: the PINE study.
There have been few high quality incidence studies of Parkinson's disease (PD). We measured age-, gender- and socioeconomic-specific incidence rates for parkinsonism and PD in north-east Scotland, and compared our results with those of previous high quality studies. Incident patients were identified prospectively over three years by several overlapping methods from primary care practices (total population 311,357). Parkinsonism was diagnosed if patients had two or more cardinal motor signs. Drug-induced parkinsonism was excluded. Patients had yearly follow-up to improve diagnostic accuracy. Incidence rates using clinical diagnosis at latest follow-up were calculated for all parkinsonism and for PD by age, gender and socioeconomic status. Meta-analysis with similar studies was performed. Of 377 patients identified at baseline with possible or probable parkinsonism, 363 were confirmed as incident patients after median follow-up of 26 months (mean age 74.8 years, SD 9.8; 61% men). The crude annual incidence of parkinsonism was 28.7 per 100,000 (95% confidence interval (CI) 25.7-31.8) and PD 17.9 per 100,000 (95% CI 15.5-20.4). PD was more common in men (age-adjusted male to female ratio 1.87:1, 95% CI 1.55-2.23) but there was no difference by socioeconomic status. Meta-analysis of 12 studies showed an incidence of PD (adjusted to the 1990 Scottish population) of 14.6 per 100,000 (95% CI 12.2-17.3) with considerable heterogeneity (I(2) 95%), partially explained by population size and recruitment duration. The incidence of PD was similar to other high quality studies. The incidence of PD was not affected by socioeconomic status.
Shape analysis of 123I-N-omega-fluoropropyl-2-beta-carbomethoxy-3beta-(4-iodophenyl) nortropane single-photon emission computed tomography images in the assessment of patients with parkinsonian syndromes.
PURPOSE: The purpose of this study was to show the viability and performance of a shape-based pattern recognition technique applied to I-N-omega-fluoropropyl-2-beta-carbomethoxy-3beta-(4-iodophenyl) nortropane single-photon emission computed tomography (FP-CIT SPECT) in patients with parkinsonism. METHODS: A fully automated pattern recognition tool, based on the shape of FP-CIT SPECT images, was written using Java. Its performance was evaluated and compared with QuantiSPECT, a region-of-interest-based quantitation tool, and observer performance using receiver operating characteristic analysis and kappa statistics. The techniques were compared using a sample of patients and controls recruited from a prospective community-based study of first presentation of parkinsonian symptoms with longitudinal follow up (median 3 years). RESULTS: The shape-based technique as well as the conventional semiquantitative approach was performed by experienced observers. The technique had a high level of automation, thereby avoiding observer/operator variability. CONCLUSION: A pattern recognition approach is a viable alternative to traditional methods of analysis in FP-CIT SPECT and has additional advantages.
Screening for undiagnosed parkinsonism in people aged 65 years and over in the community.
We screened a random sample of 2449 people aged 65 years and over for undiagnosed parkinsonism, using a postal screening questionnaire followed by clinical neurological assessment. Amongst the 1556 (63.5%) patients who responded, four patients with previously undiagnosed parkinsonism were identified, suggesting a prevalence of 257 per 100,000 (95% CI 70, 658) in this age-group. Although only small, the numbers were sufficient to significantly increase the incidence of parkinsonism in an incidence study. Two simple screening questions achieved a high sensitivity for newly diagnosed parkinsonism of 95%, but a low specificity of 28%.
Parkinson's disease misdiagnosed as stroke
Parkinson's disease (PD) is a neurodegenerative disease, the clinical features of which are usually asymmetrical at presentation. This can lead to difficulty in differentiating it from other asymmetric neurological disorders. We present two cases where idiopathic PD was initially misdiagnosed as stroke, leading to a delay in appropriate symptomatic therapy. Physicians involved in diagnosis and treatment of people with strokes should consider PD when formulating their differential diagnosis.
Association of gestational diabetes with long-term risk of premature mortality, and cardiovascular outcomes and risk factors: A retrospective cohort analysis in the UK Biobank.
AIM: To investigate the association of gestational diabetes mellitus (GDM) with premature mortality and cardiovascular (CVD) outcomes and risk factors. MATERIALS AND METHODS: Parous women recruited to the UK Biobank cohort during 2006-2010 were followed up from their first delivery until 31 October 2021. The data were linked to Hospital Episode Statistics and mortality registries. Multivariate Cox proportional hazard models investigated associations of GDM with all-cause mortality, CVD, diabetes, hypertension and dyslipidaemia. RESULTS: The maximum total analysis time at risk and under observation was 9 694 090 person-years. Among 220 726 women, 1225 self-reported or had a recorded diagnosis of GDM. After adjusting for confounders and behavioural factors, GDM was associated with increased risk for premature mortality [hazard ratio (HR): 1.44, 95% confidence interval (CI): 1.12-1.86], particularly CVD-related death (HR: 2.38, 95% CI: 1.63-3.48), as well as incident total CVD (HR: 1.50, 95% CI: 1.30-1.74), non-fatal CVD (HR: 1.41, 95% CI: 1.20-1.65), diabetes (HR: 14.37, 95% CI: 13.51-15.27), hypertension (HR: 1.49, 95% CI: 1.38-1.60), and dyslipidaemia (HR: 1.30, 95% CI: 1.22-1.39). The total CVD risk was greater in women with GDM who did not later develop diabetes than in those with GDM and diabetes. CONCLUSIONS: Women with GDM are at increased risk of premature death and have increased CV risk, emphasizing the importance of interventions to prevent GDM. If GDM develops, the diagnosis represents an opportunity for future surveillance and intervention to reduce CVD risk factors, prevent CVD and improve long-term health.