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  1. Article ; Online: Graded exercise therapy compared to activity management for paediatric chronic fatigue syndrome/myalgic encephalomyelitis: pragmatic randomized controlled trial.

    Gaunt, Daisy M / Brigden, Amberly / Harris, Shaun R S / Hollingworth, William / Jago, Russell / Solomon-Moore, Emma / Beasant, Lucy / Mills, Nicola / Sinai, Parisa / Crawley, Esther / Metcalfe, Chris

    European journal of pediatrics

    2024  Volume 183, Issue 5, Page(s) 2343–2351

    Abstract: The MAGENTA pragmatic parallel groups randomized controlled trial compared graded exercise therapy (GET) with activity management (AM) in treating paediatric myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). Children aged 8-17 years with ... ...

    Abstract The MAGENTA pragmatic parallel groups randomized controlled trial compared graded exercise therapy (GET) with activity management (AM) in treating paediatric myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). Children aged 8-17 years with mild/moderate ME/CFS and presenting to NHS specialist paediatric services were allocated at random to either individualised flexible treatment focussing on physical activity (GET, 123 participants) or on managing cognitive, school and social activity (AM, 118 participants) delivered by NHS therapists. The primary outcome was the self-reported short-form 36 physical function subscale (SF-36-PFS) after 6 months, with higher scores indicating better functioning. After 6 months, data were available for 201 (83%) participants who received a mean of 3.9 (GET) or 4.6 (AM) treatment sessions. Comparing participants with measured outcomes in their allocated groups, the mean SF-36-PFS score changed from 54.8 (standard deviation 23.7) to 55.7 (23.3) for GET and from 55.5 (23.1) to 57.7 (26.0) for AM giving an adjusted difference in means of -2.02 (95% confidence interval -7.75, 2.70). One hundred thirty-five participants completed the mean SF-36-PFS at 12 months, and whilst further improvement was observed, the difference between the study groups remained consistent with chance. The two study groups showed similar changes on most of the secondary outcome measures: Chalder Fatigue, Hospital Anxiety and Depression Scale: Depression, proportion of full-time school attended, a visual analogue pain scale, participant-rated change and accelerometer measured physical activity, whether at the 6-month or 12-month assessment. There was an isolated finding of some evidence of an improvement in anxiety in those allocated to GET, as measured by the Hospital Anxiety and Depression Scale at 6 months, with the 12-month assessment, and the Spence Children's Anxiety scale being aligned with that finding. There was weak evidence of a greater risk of deterioration with GET (27%) than with AM (17%; p = 0.069). At conventional UK cost per QALY thresholds, the probability that GET is more cost-effective than AM ranged from 18 to 21%. Whilst completion of the SF-36-PFS, Chalder Fatigue Scale and EQ-5D-Y was good at the 6-month assessment point, it was less satisfactory for other measures, and for all measures at the 12-month assessment.  Conclusion: There was no evidence that GET was more effective or cost-effective than AM in this setting, with very limited improvement in either study group evident by the 6-month or 12-month assessment points.  Trial registration: The study protocol was registered at www.isrctn.com (3rd September 2015; ISRCTN 23962803) before the start of enrolment to the initial feasibility phase.
    MeSH term(s) Humans ; Fatigue Syndrome, Chronic/therapy ; Fatigue Syndrome, Chronic/psychology ; Child ; Male ; Female ; Exercise Therapy/methods ; Adolescent ; Treatment Outcome ; Quality of Life
    Language English
    Publishing date 2024-03-02
    Publishing country Germany
    Document type Journal Article ; Randomized Controlled Trial ; Pragmatic Clinical Trial ; Comparative Study
    ZDB-ID 194196-3
    ISSN 1432-1076 ; 0340-6199 ; 0943-9676
    ISSN (online) 1432-1076
    ISSN 0340-6199 ; 0943-9676
    DOI 10.1007/s00431-024-05458-x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Dental opioid prescribing rates after the up-scheduling of codeine in Australia.

    Teoh, L / Hollingworth, S / Marino, R / McCullough, M J

    Scientific reports

    2020  Volume 10, Issue 1, Page(s) 8463

    Abstract: The misuse of pharmaceutical opioids is a major public health issue. In Australia, codeine was re-scheduled on 1 February 2018 to restrict access; it is now only available on prescription. The aim of this study was to measure the change in dental opioid ... ...

    Abstract The misuse of pharmaceutical opioids is a major public health issue. In Australia, codeine was re-scheduled on 1 February 2018 to restrict access; it is now only available on prescription. The aim of this study was to measure the change in dental opioid prescriptions, one year before and after the codeine re-scheduling in Australia and to assess dental prescribing rates of opioids for 2018 by population and by clinician. Data was extracted for dental opioids for the year immediately prior and after the codeine up-schedule (1 February 2017-31 January 2019) from the publicly-available national prescription database (Pharmaceutical Benefits Scheme). Descriptive statistics, T-tests and odds ratios were used to identify significant prescribing differences. Codeine, codeine/paracetamol, oxycodone and tramadol use increased significantly the year after the codeine restriction than the previous year (13.8-101.1%). Australian dentists prescribed 8.6 prescriptions/1,000 population in 2018, with codeine/paracetamol accounting for most prescriptions (96%). The significant increase in opioid prescribing highlights that Australian dentists may be contributing to the misuse of pharmaceutical opioids. Educational efforts should be targeted at the appropriate use of opioids and patient selection. Dentists should be added to the prescription monitoring system SafeScript so they can make informed decisions for patients who are potentially misusing opioids.
    MeSH term(s) Analgesics, Opioid/administration & dosage ; Analgesics, Opioid/supply & distribution ; Codeine/administration & dosage ; Codeine/supply & distribution ; Drug Prescriptions/statistics & numerical data ; Humans ; Practice Patterns, Dentists'/statistics & numerical data ; Prescription Drug Misuse/statistics & numerical data ; Prescription Drug Monitoring Programs/standards ; Tooth Diseases/drug therapy
    Chemical Substances Analgesics, Opioid ; Codeine (UX6OWY2V7J)
    Language English
    Publishing date 2020-05-21
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2615211-3
    ISSN 2045-2322 ; 2045-2322
    ISSN (online) 2045-2322
    ISSN 2045-2322
    DOI 10.1038/s41598-020-65390-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Getting to grips with sarcopenia: recent advances and practical management for the gastroenterologist.

    Hollingworth, Thomas William / Oke, Siddhartha M / Patel, Harnish / Smith, Trevor R

    Frontline gastroenterology

    2020  Volume 12, Issue 1, Page(s) 53–61

    Abstract: Sarcopenia is a progressive and generalised disorder of skeletal muscle strength, function and mass, that is most commonly associated with the normal ageing process. It is increasingly recognised that sarcopenia can also develop as a consequence of ... ...

    Abstract Sarcopenia is a progressive and generalised disorder of skeletal muscle strength, function and mass, that is most commonly associated with the normal ageing process. It is increasingly recognised that sarcopenia can also develop as a consequence of malabsorptive and inflammatory conditions, such as those seen by gastroenterologists and hepatologists. It affects 1%-30% of the general population, but is seen in approximately 40% of patients with gastrointestinal conditions including inflammatory bowel disease and cirrhosis. Within this group of patients, it is associated with increased complications and mortality. The pathogenesis of sarcopenia is multifactorial with several risk factors implicated in its development including undernutrition, physical inactivity and coexistent multimorbidity. The SARC-F questionnaire has been developed to screen for patients at risk of sarcopenia, however, this focuses on the functional consequences and will therefore not identify those patients who are early in the progression of sarcopenia. There are several different non-invasive techniques available to assess muscle quantity and quality including; grip strength, dual energy X-ray absorptiometry, CT which can be used together to diagnose sarcopenia. Assessment and correction of malnutrition, particularly protein intake, in those at risk of sarcopenia is important in preventing the development and progression of sarcopenia. There are no specific drugs that are available for the treatment of sarcopenia, however, resistance exercise programmes combined with nutritional interventions show promise. It is important that this common condition is screened for and recognised, with any contributing factors addressed to reduce the risk of its progression.
    Language English
    Publishing date 2020-01-20
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2521857-8
    ISSN 2041-4137
    ISSN 2041-4137
    DOI 10.1136/flgastro-2019-101348
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Methods for think-aloud interviews in health-related resource-use research: the PECUNIA RUM instrument.

    Janssen, L M M / Pokhilenko, I / Drost, R M W A / Paulus, A T G / Thorn, J / Hollingworth, W / Noble, S / Berger, M / Simon, J / Evers, S M A A

    Expert review of pharmacoeconomics & outcomes research

    2023  Volume 23, Issue 4, Page(s) 383–389

    Abstract: Background: The think-aloud (TA) approach is a qualitative research method that allows for gaining insight into thoughts and cognitive processes. It can be used to incorporate a respondent's perspective when developing resource-use measurement (RUM) ... ...

    Abstract Background: The think-aloud (TA) approach is a qualitative research method that allows for gaining insight into thoughts and cognitive processes. It can be used to incorporate a respondent's perspective when developing resource-use measurement (RUM) instruments. Currently, the application of TA methods in RUM research is limited, and so is the guidance on how to use them. Transparent publication of TA methods for RUM in health economics studies, which is the aim of this paper, can contribute to reducing the aforementioned gap.
    Methods: Methods for conducting TA interviews were iteratively developed by a multi-national working group of health economists and additional qualitative research expertise was sought. TA interviews were conducted in four countries to support this process. A ten-step process was outlined in three parts: Part A 'before the interview' (including translation, recruitment, training), Part B 'during the interview' (including setting, opening, completing the instrument, open-ended questions, closing), and part C 'after the interview' (including transcription and data analysis, trustworthiness).
    Conclusions: This manuscript describes the step-by-step approach for conducting multi-national TA interviews with potential respondents of the PECUNIA RUM instrument. It increases the methodological transparency in RUM development and reduces the knowledge gap of using qualitative research methods in health economics.
    MeSH term(s) Humans ; Surveys and Questionnaires ; Research Design
    Language English
    Publishing date 2023-03-08
    Publishing country England
    Document type Journal Article
    ZDB-ID 2208481-2
    ISSN 1744-8379 ; 1473-7167
    ISSN (online) 1744-8379
    ISSN 1473-7167
    DOI 10.1080/14737167.2023.2187379
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: 'Does it matter how old I feel?' The role of subjective age in a psychosocial intervention for improving depressive symptomatology among older adults in Brazil (PROACTIVE).

    de Paula Couto, M Clara / Rothermund, Klaus / Nakamura, Carina A / Seward, Nadine / van de Ven, Pepijn / Hollingworth, William / Peters, Tim J / Araya, Ricardo / Scazufca, Marcia

    Aging & mental health

    2024  , Page(s) 1–10

    Abstract: Objectives: Depression is a prevalent mental health condition that also often affects older adults. The PROACTIVE psychosocial intervention was developed to reduce depressive symptomatology among older adults within primary care settings in Brazil. An ... ...

    Abstract Objectives: Depression is a prevalent mental health condition that also often affects older adults. The PROACTIVE psychosocial intervention was developed to reduce depressive symptomatology among older adults within primary care settings in Brazil. An important psychological marker that affects individuals' aging experience relates to how old people feel. Known as subjective age, this marker has been shown to be a risk factor for experiencing greater depressive symptoms if individuals report feeling older than their (chronological) age. In this study, we perform secondary analyses of the PROACTIVE cluster-randomized controlled trial to examine the role of subjective age.
    Method: The sample included 715 Brazilian older adults (74% female,
    Results: Relevant main effects and interactions in regression models for PHQ-9 presented here found that those reporting older subjective age had worse depressive symptoms at follow-up but that they benefitted more from the intervention when initial levels of depression were high. For participants who reported younger subjective ages the intervention showed positive effects that were independent of initial levels of depression.
    Conclusion: Our findings emphasize the importance of investigating possible underlying mechanisms that can help clarify the impact of mental health interventions.
    Language English
    Publishing date 2024-04-25
    Publishing country England
    Document type Journal Article
    ZDB-ID 1474804-6
    ISSN 1364-6915 ; 1360-7863
    ISSN (online) 1364-6915
    ISSN 1360-7863
    DOI 10.1080/13607863.2024.2342959
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: What do neurosurgical trainees think about neuro-interventional training and service provision in the United Kingdom?

    Kotecha, Jay / Hollingworth, Milo / Patel, Hiren C / Lenthall, Robert

    Surgical neurology international

    2020  Volume 11, Page(s) 369

    Abstract: Background: There is a disparity between the number of interventional neuroradiologists (INRs) in the UK and the number needed to provide a comprehensive 24/7 interventional neurovascular service. It is recognized that trainees from other specialties ... ...

    Abstract Background: There is a disparity between the number of interventional neuroradiologists (INRs) in the UK and the number needed to provide a comprehensive 24/7 interventional neurovascular service. It is recognized that trainees from other specialties such as neurosurgery may be able to provide INR services after appropriate training. At present gaining skills in INR is not a mandatory requirement of the neurosurgical training curriculum in the UK. The views on this issue of current neurosurgical trainees are unknown. We aimed to address this knowledge gap.
    Methods: We performed an anonymized online survey to gauge the opinion of neurosurgical trainees about their attitudes to INR training and service provision.
    Results: 90/265 (34%) UK neurosurgical trainees responded to the survey. About 56% of respondents reported they were likely or very likely to pursue interventional training if a curriculum was approved by the general medical council. About 80% thought training should take up to 2 years. About 90% of those very likely or likely to pursue INR wanted a hybrid neurosurgical practice and 92% were willing to provide endovascular services out of hours.
    Conclusion: The responses described suggest that a significant proportion of neurosurgical trainees would pursue INR training and have realistic expectation regarding out of hours commitment and length of training.
    Language English
    Publishing date 2020-11-06
    Publishing country United States
    Document type Journal Article
    ISSN 2229-5097
    ISSN 2229-5097
    DOI 10.25259/SNI_414_2020
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Cost-effectiveness of rapid laboratory-based mass-spectrometry diagnosis of bloodstream infection: evidence from the RAPIDO randomised controlled trial.

    Dixon, Padraig / Hollingworth, William / Pike, Katie / Reynolds, Rosy / Stoddart, Margaret / MacGowan, Alasdair

    BMJ open

    2021  Volume 11, Issue 10, Page(s) e044623

    Abstract: Objectives and intervention: Bloodstream infection, the presence of viable micro-organisms in the blood, is a prevalent clinical event associated with substantial mortality. Patient outcomes may be improved when the causative micro-organism is ... ...

    Abstract Objectives and intervention: Bloodstream infection, the presence of viable micro-organisms in the blood, is a prevalent clinical event associated with substantial mortality. Patient outcomes may be improved when the causative micro-organism is identified quickly. We assessed the cost-effectiveness of rapid microbial identification by matrix-assisted laser desorption/ionisation time-of-flight (MALDI-TOF) mass spectrometry.
    Design: Economic evaluation alongside a randomised multicentre trial (RAPIDO: RAPId Diagnosis on Outcome) assessing the impact of rapid identification by MALDI-TOF spectrometry.
    Setting: Adult inpatients with bloodstream infections at seven National Health Service hospital trusts in England and Wales.
    Primary outcome: Net monetary benefit, estimated as incremental costs compared with incremental 28-day survival, of rapid identification by MALDI-TOF spectrometry compared with conventional identification.
    Methods: Patients were randomised (1:1) to receive diagnosis by conventional methods of microbial identification (conventional arm) only or by MALDI-TOF spectrometry in addition to conventional identification (RAPIDO arm).
    Results: Data from 5550 patients were included in primary analysis. Mean imputed costs in 2018/2019 prices per patient were lower by £126 in the RAPIDO arm (95% CI -£784 to £532) but the proportion of patients alive at day 28 was lower (81.4% vs 82.3%). The probability of cost-effectiveness of MALDI-TOF was <0.5 at cost-effectiveness thresholds between £20 000 and £50 000.
    Conclusions: Adjunctive MALDI-TOF diagnosis was unlikely to be cost-effective when measured as cost per death avoided at 28 days. However, the differences between arms in cost and effect were modest, associated with uncertainty and may not accurately reflect 'real-world' routine use of MALDI-TOF technology in this patient group.
    Trial registration numbers: ISRCTN97107018/UKCRN 11978.
    MeSH term(s) Adult ; Cost-Benefit Analysis ; Humans ; Laboratories ; Sepsis/diagnosis ; Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization ; State Medicine ; Time Factors
    Language English
    Publishing date 2021-10-18
    Publishing country England
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2020-044623
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Verbal fluency as a quick and simple tool to help in deciding when to refer patients with a possible brain tumour.

    Zienius, Karolis / Ozawa, Mio / Hamilton, Willie / Hollingworth, Will / Weller, David / Porteous, Lorna / Ben-Shlomo, Yoav / Grant, Robin / Brennan, Paul M

    BMC neurology

    2022  Volume 22, Issue 1, Page(s) 127

    Abstract: Background: Patients with brain tumours often present with non-specific symptoms. Correctly identifying who to prioritise for urgent brain imaging is challenging. Brain tumours are amongst the commonest cancers diagnosed as an emergency presentation. A ... ...

    Abstract Background: Patients with brain tumours often present with non-specific symptoms. Correctly identifying who to prioritise for urgent brain imaging is challenging. Brain tumours are amongst the commonest cancers diagnosed as an emergency presentation. A verbal fluency task (VFT) is a rapid triage test affected by disorders of executive function, language and processing speed. We tested whether a VFT could support identification of patients with a brain tumour.
    Methods: This proof-of-concept study examined whether a VFT can help differentiate patients with a brain tumour from those with similar symptoms (i.e. headache) without a brain tumour. Two patient populations were recruited, (a) patients with known brain tumour, and (b) patients with headache referred for Direct-Access Computed-Tomography (DACT) from primary care with a suspicion of a brain tumour. Semantic and phonemic verbal fluency data were collected prospectively.
    Results: 180 brain tumour patients and 90 DACT patients were recruited. Semantic verbal fluency score was significantly worse for patients with a brain tumour than those without (P  <  0.001), whether comparing patients with headache, or patients without headache. Phonemic fluency showed a similar but weaker difference. Raw and incidence-weighted positive and negative predictive values were calculated.
    Conclusion: We have demonstrated the potential role of adding semantic VFT score performance into clinical decision making to support triage of patients for urgent brain imaging. A relatively small improvement in the true positive rate in patients referred for DACT has the potential to increase the timeliness and efficiency of diagnosis and improve patient outcomes.
    MeSH term(s) Brain Neoplasms/diagnostic imaging ; Cognition ; Executive Function ; Humans ; Neuropsychological Tests ; Semantics
    Language English
    Publishing date 2022-04-04
    Publishing country England
    Document type Journal Article
    ZDB-ID 2041347-6
    ISSN 1471-2377 ; 1471-2377
    ISSN (online) 1471-2377
    ISSN 1471-2377
    DOI 10.1186/s12883-022-02655-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: A Validation Study of the EQ-5D-5L and ICEpop Capability Measure for Older People Among Older Individuals With Depressive Symptoms in Brazil.

    Nakamura, Carina A / Mitchell, Paul M / Peters, Tim J / Moreno-Agostino, Darío / Araya, Ricardo / Scazufca, Marcia / Hollingworth, William

    Value in health regional issues

    2022  Volume 30, Page(s) 91–99

    Abstract: Objectives: This study aimed to assess the known-groups validity of the EQ-5D-5L and the ICEpop Capability Measure for Older People (ICECAP-O), 2 outcome measures used in economic evaluation, among older adults with depressive symptoms in ... ...

    Abstract Objectives: This study aimed to assess the known-groups validity of the EQ-5D-5L and the ICEpop Capability Measure for Older People (ICECAP-O), 2 outcome measures used in economic evaluation, among older adults with depressive symptoms in socioeconomically deprived areas of Brazil. We also explored the role of education and income on responses to these measures.
    Methods: This cross-sectional study used baseline data from PROACTIVE, a cluster randomized controlled trial to evaluate a psychosocial intervention for late-life depression among older adults. Participants aged ≥60 years with a 9-item Patient Health Questionnaire score ≥10 were recruited from 20 primary healthcare clinics. Ordered logistic regression models assessed the association between depressive symptoms severity, income, and education and dimension-level responses on the EQ-5D-5L and ICECAP-O. Multivariable regression models investigated the ability of EQ-5D-5L and ICECAP-O scores to discriminate between depressive symptoms severity levels and other characteristics, including education level and household income.
    Results: A total of 715 participants were included in the study. Depressive symptoms severity was associated with all EQ-5D-5L and ICECAP-O dimensions, except the ICECAP-O enjoyment attribute. In contrast, household income was only associated with the ICECAP-O security attribute. Higher severity of depressive symptoms (9-item Patient Health Questionnaire scores) was also strongly associated with lower (ie, worse) scores on both measures in all models. Education level and household income showed no association with either EQ-5D-5L or ICECAP-O scores.
    Conclusions: To best of our knowledge, this is the first study that investigated the validity of these 2 measures among older adults in Brazil. Both EQ-5D-5L and ICECAP-O showed evidence of validity in differentiating depressive symptom severity.
    MeSH term(s) Aged ; Brazil ; Cross-Sectional Studies ; Depression/diagnosis ; Humans ; Quality of Life/psychology ; Surveys and Questionnaires
    Language English
    Publishing date 2022-03-21
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 2679127-4
    ISSN 2212-1102 ; 2212-1099
    ISSN (online) 2212-1102
    ISSN 2212-1099
    DOI 10.1016/j.vhri.2021.11.005
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: A task-shared, collaborative care psychosocial intervention for improving depressive symptomatology among older adults in a socioeconomically deprived area of Brazil (PROACTIVE): a pragmatic, two-arm, parallel-group, cluster-randomised controlled trial.

    Scazufca, Marcia / Nakamura, Carina A / Seward, Nadine / Moreno-Agostino, Darío / van de Ven, Pepijn / Hollingworth, William / Peters, Tim J / Araya, Ricardo

    The lancet. Healthy longevity

    2022  Volume 3, Issue 10, Page(s) e690–e702

    Abstract: Background: There is an urgent need to reduce the burden of depression among older adults in low-income and middle-income countries (LMICs). We aimed to evaluate the efficacy of a task-shared, collaborative care psychosocial intervention for improving ... ...

    Abstract Background: There is an urgent need to reduce the burden of depression among older adults in low-income and middle-income countries (LMICs). We aimed to evaluate the efficacy of a task-shared, collaborative care psychosocial intervention for improving recovery from depression in older adults in Brazil.
    Methods: PROACTIVE was a pragmatic, two-arm, parallel-group, cluster-randomised controlled trial conducted in Guarulhos, Brazil. Primary care clinics (clusters) were stratified by educational level and randomly allocated (1:1) to either enhanced usual care alone (control group) or to enhanced usual care plus the psychosocial intervention (intervention group), which involved a 17-week psychosocial programme based on psychoeducation and behavioural activation approaches. Individuals approached for the initial screening assessment were selected randomly from a list of individuals provided by the Health Secretariat of Guarulhos. Face-to-face baseline assessments were conducted among adults aged 60 years or older registered with one of the primary care clinics and identified with clinically significant depressive symptomatology (9-item Patient Health Questionnaire [PHQ-9] score ≥10). Community health workers delivered the programme through home sessions, supported by a dedicated tablet application. Masking of clinic staff and community health workers who delivered the intervention was not feasible; however, research assistants conducting recruitment and follow-up assessments were masked to trial allocation. The primary outcome was recovery from depression (PHQ-9 score <10) at 8-month follow-up. All primary analyses were performed by intention to treat with imputed data. Adaptations to the protocol were made due to the COVID-19 pandemic; recruitment and intervention home sessions were stopped, and follow-up assessments were conducted by telephone. This trial is registered with the ISRCTN registry, ISRCTN57805470.
    Findings: We identified 24 primary care clinics in Guarulhos that were willing to participate, of which 20 were randomly allocated to either the control group (ten [50%] clusters) or to the intervention group (ten [50%] clusters). The four remaining eligible clusters were kept as reserves. Between May 23, 2019, and Feb 21, 2020, 8146 individuals were assessed for eligibility, of whom 715 (8·8%) participants were recruited: 355 (49·7%) in the control group and 360 (50·3%) in the intervention group. 284 (80·0%) participants in the control group and 253 (70·3%) in the intervention group completed follow-up at 8 months. At 8-month follow-up, 158 (62·5%) participants in the intervention group showed recovery from depression (PHQ-9 score <10) compared with 125 (44·0%) in the control group (adjusted odds ratio 2·16 [95% CI 1·47-3·18]; p<0·0001). These findings were maintained in the complete case analysis. No adverse events related to the intervention were observed.
    Interpretation: Although the COVID-19 pandemic altered delivery of the intervention, the low-intensity psychosocial intervention delivered mainly by non-mental health professionals was highly efficacious in improving recovery from depression in older adults in Brazil. Our results support a low-resource intervention that could be useful to reduce the treatment gap for depression among older people in other LMICs.
    Funding: São Paulo Research Foundation and Joint Global Health Trials (UK Department for International Development, Medical Research Council, and the Wellcome Trust).
    MeSH term(s) Aged ; Brazil/epidemiology ; COVID-19 ; Humans ; Pandemics ; Psychosocial Intervention ; Treatment Outcome
    Language English
    Publishing date 2022-10-07
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ISSN 2666-7568
    ISSN (online) 2666-7568
    DOI 10.1016/S2666-7568(22)00194-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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