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Effectiveness of an anti-inflammatory diet versus low-fat diet for knee osteoarthritis: the FEAST randomised controlled trial protocol

Por: Law · L. · Heerey · J. L. · Devlin · B. L. · Brukner · P. · Kemp · J. L. · Attanayake · A. · Hulett · M. D. · De Livera · A. · Mosler · A. B. · Morris · H. G. · White · N. P. · Culvenor · A. G.
Introduction

Chronic inflammation plays a key role in knee osteoarthritis pathophysiology and increases risk of comorbidities, yet most interventions do not typically target inflammation. Our study will investigate if an anti-inflammatory dietary programme is superior to a standard care low-fat dietary programme for improving knee pain, function and quality-of-life in people with knee osteoarthritis.

Methods and analysis

The eFEct of an Anti-inflammatory diet for knee oSTeoarthritis study is a parallel-group, assessor-blinded, superiority randomised controlled trial. Following baseline assessment, 144 participants aged 45–85 years with symptomatic knee osteoarthritis will be randomly allocated to one of two treatment groups (1:1 ratio). Participants randomised to the anti-inflammatory dietary programme will receive six dietary consultations over 12 weeks (two in-person and four phone/videoconference) and additional educational and behaviour change resources. The consultations and resources emphasise nutrient-dense minimally processed anti-inflammatory foods and discourage proinflammatory processed foods. Participants randomised to the standard care low-fat dietary programme will receive three dietary consultations over 12 weeks (two in-person and one phone/videoconference) consisting of healthy eating advice and education based on the Australian Dietary Guidelines, reflecting usual care in Australia. Adherence will be assessed with 3-day food diaries. Outcomes are assessed at 12 weeks and 6 months. The primary outcome will be change from baseline to 12 weeks in the mean score on four Knee injury and Osteoarthritis Outcome Score (KOOS4) subscales: knee pain, symptoms, function in daily activities and knee-related quality of life. Secondary outcomes include change in individual KOOS subscale scores, patient-perceived improvement, health-related quality of life, body mass and composition using dual-energy X-ray absorptiometry, inflammatory (high-sensitivity C reactive protein, interleukins, tumour necrosis factor-α) and metabolic blood biomarkers (glucose, glycated haemoglobin (HbA1c), insulin, liver function, lipids), lower-limb function and physical activity.

Ethics and dissemination

The study has received ethics approval from La Trobe University Human Ethics Committee. Results will be presented in peer-reviewed journals and at international conferences.

Trial registration number

ACTRN12622000440729.

Head impact differences in blind football between Rio 2016 and Tokyo 2020 Paralympic Games: video-based observational study

Por: Tsutsumi · S. · Sasadai · J. · Maeda · N. · Tamura · Y. · Nagao · T. · Watanabe · T. · Arima · S. · Kaneda · K. · Yoshimi · M. · Mizuta · R. · Ishihara · H. · Shimizu · R. · Fukui · K. · Tashiro · T. · Komiya · M. · Suzuki · A. · Urabe · Y.
Objective

In Tokyo 2020 Paralympic Games, there were the rule and goal size changes at the blind football competition. This study aimed to compare the scoring and head impact characteristics during blind football competition between the Rio 2016 and Tokyo 2020 Paralympic Games using the official videos.

Design

Video-based observational study.

Participants

In total, 36 blind football (men’s football 5-a-side) game videos were obtained from the official International Paralympic Committee.

Primary and secondary outcome measures

Head impact was defined as the sudden contact of any object with the head. Videos were analysed to assess the number of scores and head impacts along with their corresponding details (ie, round, playing phase, scoring situation, impact situation, occurrence area, impact object, head impact site, fall and foul).

Results

The total number of goals scored at the Tokyo 2020 Paralympic Games was nearly double that at the Rio 2016 Paralympic Games. Regarding head impacts, a total of 2036 cases (Rio 2016, n=1105; Tokyo 2020, n=931) were evaluated. Significant differences were observed in head impact characteristics between the Rio 2016 and Tokyo 2020 Paralympic Games among seven outcomes (round, scoring situation, impact situation, occurrence area, impact object, site of head impact and fall).

Conclusions

Compared with the Rio 2016 Paralympic Games, the Tokyo 2020 Paralympic Games showed an increase in the number of points scored and different head impact characteristics.

Information needs on type 1 diabetes mellitus (T1DM) and its management in children and adolescents: a qualitative study

Por: Muhammed Elamin · S. · Muhamad Arshad · N. F. · Md Redzuan · A. · Abdul Aziz · S. A. · Hong · J. · Chua · X. Y. · Bin-Abbas · B. S. · Alsagheir · A. · Mohamed Shah · N.
Objective

The objective of this study is to explore the information needs related to insulin therapy in children and adolescents with type 1 diabetes mellitus (T1DM) from the children’s perspectives as well as their caregivers.

Design

Qualitative study; semistructured interviews. To identify emerging themes relating to information needs, open coding and thematic analysis were employed.

Setting

Participants were recruited from a tertiary care children’s hospital in Kuala Lumpur, Malaysia and a specialist hospital in Riyadh, Saudi Arabia.

Participants

Thirty one children with a mean age of 11.5 years (SD=1.9) and their caregivers were interviewed. Seventeen participants were from Malaysia and 14 were from Saudi Arabia.

Results

Four themes of information emerged from the interviews, including information related to (1) hypoglycaemia and hyperglycaemia, (2) insulin therapy, (3) injection technique and (4) other information needs pertaining to continuous glucose monitoring, access to peer groups and future advances in insulin therapy.

Conclusion

This study provided valuable insights into the information needs related to T1DM and insulin therapy among children and adolescents with T1DM that should be considered by stakeholders in the development of age-appropriate education materials. Such materials will assist children and adolescents to better manage their life-long T1DM condition from adolescence until adulthood.

Estimating the return on investment of the New York Tobacco Control Programme: a synthetic control study

Por: Nonnemaker · J. · Mann · N. · MacMonegle · A. J. · Gaber · J. · Fajobi · O.
Objective

To assess the return on investment (ROI) of the New York Tobacco Control Programme (NY TCP).

Setting

New York and other states of the USA.

Interventions

NY TCP.

Outcomes

Smoking prevalence, smoking-attributable healthcare expenditures (SAEs), smoking-attributable mortality, years of life lost (YLL), the dollar value of YLL and the ROI for healthcare expenditures and mortality.

Design and methods

We used a synthetic control method to estimate the effectiveness of NY TCP funding on smoking prevalence. The synthetic control method created a comparison group that best matched the adult smoking prevalence trend in New York state in the period prior to implementation of the NY TCP and compared smoking prevalence in the state to smoking prevalence in the synthetic control in the period after treatment (2001–2019). The synthetic control group represents what the trend in smoking prevalence in New York would have been had there been no tobacco control expenditures. The ROI was calculated as net savings for each outcome divided by net programme expenditures.

Results

Cumulative savings in SAE in New York from 2001 to 2019 amounted to US$13.2 billion. An estimated 41 771 smoking-attributable deaths (SADs) were averted in New York from 2001 to 2019, and an estimated 672 141 YLL averted as a result of NY TCP funding in the same period. From 2001 to 2019, the ROI for SAE in New York was approximately 14, the economic value ROI of the YLL due to SAD was nearly 145 and the combined ROI was almost 160.

Conclusions

In this study, we found relatively large ROIs for the NY TCP, which suggests that the programme—which lowers SAE and saves lives—is an efficient use of public funds.

Real-world treatment patterns and clinical outcomes from a retrospective chart review study of patients with recurrent or advanced endometrial cancer who progressed following prior systemic therapy in Europe

Por: Zhang · J. · Kelkar · S. S. · Prabhu · V. S. · Qiao · Y. · Grall · V. · Miles · N. · Marth · C.
Objective

To evaluate real-world treatment patterns and clinical outcomes in recurrent/advanced endometrial cancer patients who progressed following prior systemic therapy in clinical practice in Europe.

Design

Endometrial Cancer Health Outcomes-Europe (ECHO-EU) is a retrospective patient chart review study.

Setting

ECHO-EU is a multicentre study conducted in the UK, Germany, Italy, France and Spain.

Participants

Patients with recurrent/advanced endometrial cancer who progressed between 1 July 2016 and 30 June 2019 following prior first-line systemic therapy were eligible and data were collected until last available follow-up through November 2021.

Primary and secondary outcome measures

Data collected included patient demographics, clinical and treatment characteristics, and clinical outcomes. Kaplan-Meier analyses were performed since initiation of second-line therapy to estimate time to treatment discontinuation, real-world progression-free survival (rwPFS) and overall survival (OS).

Results

A total of 475 patients were included from EU5 countries. Median age was 69 years at advanced endometrial cancer diagnosis, 78.7% had stage IIIB–IV disease, 45.9% had Eastern Cooperative Oncology Group status ≥2 at second-line therapy initiation. In second line, a majority of patients initiated either non-platinum-based chemotherapy (55.6%) or endocrine therapy (16.2%). Physician-reported real-world overall response rate (classified as complete or partial response) to second-line therapy was 34.5%, median rwPFS was 7.4 months (95% CI 6.2 to 8.0) and median OS was 11.0 months (95% CI 9.9 to 12.3).

Conclusions

Patients had poor clinical outcomes with a median OS of

Supplements for cognitive ability in patients with mild cognitive impairment or Alzheimers disease: a protocol for systematic review and network meta-analysis of randomised controlled trials

Por: Zhang · X.-Y. · Li · Y.-Q. · Yin · Z.-H. · Bao · Q.-N. · Xia · M.-Z. · Chen · Z.-H. · Zhong · W.-Q. · Wu · K.-X. · Yao · J. · Liang · F.-R.
Introduction

Considering the increasing incidence of Alzheimer’s disease (AD) and mild cognitive impairment (MCI) worldwide, there is an urgent need to identify efficacious, safe and convenient treatments. Numerous investigations have been conducted on the use of supplements in this domain, with oral supplementation emerging as a viable therapeutic approach for AD or MCI. Nevertheless, given the multitude of available supplements, it becomes imperative to identify the optimal treatment regimen.

Methods and analysis

Eight academic databases and three clinical trial registries will be searched from their inception to 1 June 2023. To identify randomised controlled trials investigating the effects of supplements on patients with AD or MCI, two independent reviewers (X-YZ and Y-QL) will extract relevant information from eligible articles, while the risk of bias in the included studies will be assessed using the Rob 2.0 tool developed by the Cochrane Collaboration. The primary outcome of interest is the overall cognitive function. Pair-wise meta-analysis will be conducted using RevMan V.5.3, while network meta-analysis will be carried out using Stata 17.0 and ADDIS 1.16.8. Heterogeneity test, data synthesis and subgroup analysis will be performed if necessary. The GRADE system will be employed to assess the quality of evidence. This study is scheduled to commence on 1 June 2023 and conclude on 1 October 2023.

Ethics and dissemination

Ethics approval is not required for systematic review and network meta-analysis. The results will be submitted to a peer-reviewed journal or at a conference.

Trial registration number

PROSPERO (CRD42023414700).

Gender differences found in fall-related factors among community-dwelling Korean older adults

Por: Zhang · N. · Arunachalam · U.

Commentary on: Suh M, Kim DH, Cho I, Ham OK. Age and gender differences in fall-related factors affecting community-dwelling older adults. J Nurs Res. 2023 Apr 1;31(2):e270. doi: 10.1097/jnr.0000000000000545.

Implications for practice and research

  • Future research could explore and test the efficacy of gender-specific fall prevention protocols.

  • In practice, understanding that there are gender-based risk factors for falls would assist and prompt nurses and health professionals to perform assessments or interventions to specifically mitigate those risks

  • Context

    Falls are an incredibly common issue among older adults, with potentially serious downstream consequences. Suh et al (2023) aimed to explore not only the prevalence of falls but also the factors relating to age, gender and falls. It is well established that there are gender differences in the prevalence of falls, however, the reasoning is not fully understood. This study was conducted to address the paucity in...

    Low-quality evidence for medication errors reduction strategies in hospital paediatrics

    Por: Desforges · J. · Roumeliotis · N.

    Commentary on: King C, Dudley J, Mee A, Tomlin S, Tse Y, Trivedi A, Hawcutt DB; Royal College of Paediatrics and Child Health/Neonatal and Paediatric Pharmacist Group Joint Standing Committee on Medicines. For children admitted to hospital, what interventions improve medication safety on ward rounds? A systematic review. Arch Dis Child. 2023 Jul;108(7):583–588. doi: 10.1136/archdischild-2022-324772. Epub 2023 Feb 15. PMID: 36792347.

    Implications for practice and research

  • Medication errors can occur throughout many complex steps.

  • Children are exposed to a higher risk of harm than adults when it comes to medication errors.

  • High-quality evidence for interventions that reduce medication errors in children on rounds is lacking.

  • Context

    King et al conducted a systematic review of interventions aimed at reducing medication errors during inpatient rounds in children’s hospitals.1 Medication errors in hospitals may arise at many points in a complicated cascade of steps...

    How healthy dietary patterns have an impact on overall and cause-specific mortality?

    Por: Nguyen · N. T. H. · Duong · T. V.

    Commentary on: Shan Z, Wang F, Li Y, Baden MY, Bhupathiraju SN, Wang DD, Sun Q, Rexrode KM, Rimm EB, Qi L, Tabung FK, Giovannucci EL, Willett WC, Manson JE, Qi Q, Hu FB. Healthy Eating Patterns and Risk of Total and Cause-Specific Mortality. JAMA Intern Med. 2023 Feb 1;183(2):142-153. doi: 10.1001/jamainternmed.2022.6117. Erratum in: JAMA Intern Med. 2023 Jun 1;183(6):627.

    Implications for practice and research

  • Wholesome eating diets can be customised to align with person’s culinary traditions and tastes in accordance with the Dietary Guidelines for Americans to decrease the mortality risk.

  • Provide updated scientific evidences on the benefits of maintaining a healthy diet throughout the life course to take appropriate strategies and policies.

  • Context

    Healthy eating patterns play a prominent role in preserving public health. The association between dietary patterns with the mortality risk has been investigated in numerous countries.1 2

    Impact of moral distress on early career nurses: an integrative review

    Por: Finch · N.

    This is a summary of Loyd et al.1

    Background and purpose

  • ‘Moral distress’ is described by Jameton as ‘...aris[ing] when one knows the right thing to do, but institutional constraints make it nearly impossible to pursue the right course of action’ (p. 6).2

  • Moral distress may cause nurses to question their career choice, and to feel disempowered and unhappy in their work. This may have a negative impact on the physical and mental well-being of nursing staff, leading to burnout and high staff turnover.

  • Nurses in the first 5 years of their career (early career nurses) may be particularly at risk of experiencing moral distress as they make the stressful and challenging transition from student to qualified practice.

  • The purpose of the review is to synthesise the literature regarding moral distress in the first 5 years of qualified practice.

  • ...

    Assessing the accuracy of health facility typology in representing the availability of health services: a case study in Mali

    Por: Petragallo · S. · Timoner · P. · Hierink · F. · Fuhrer · C. · Toure · O. · Iknane · A. · Coulibaly · Y. · Fall · I.-S. · Ray · N.
    Introduction

    Using health facility types as a measure of service availability is a common approach in international standards for health system policy and planning. However, this proxy may not accurately reflect the actual availability of specific health services.

    Objective

    This study aims to evaluate the reliability of health facility typology as an indicator of specific health service availability and explore whether certain facility types consistently provide particular services.

    Design

    We analysed a comprehensive dataset containing information from 1725 health facilities in Mali. To uncover and visualise patterns within the dataset, we used two analytical techniques: Multiple Correspondence Analysis and Between-Class Analysis. These analyses allowed us to quantitatively measure the influence of health facility types on the variation in health service provisioning. Additionally, we developed and calculated a Consistency Index, which assesses the consistency of a health facility type in providing specific health services. By examining various health facilities and services, we sought to determine the accuracy of facility types as indicators of service availability.

    Setting

    The study focused on the health system in Mali as a case study.

    Results

    Our findings indicate that using health facility types as a proxy for service availability in Mali is not an accurate representation. We observed that most of the variation in service provision does not stem from differences between facility types but rather within facility types. This suggests that relying solely on health facility typology may lead to an incomplete understanding of health service availability.

    Conclusions

    These results have significant implications for health policy and planning. The reliance on health facility types as indicators for health system policy and planning should be reconsidered. A more nuanced and evidence-based understanding of health service availability is crucial for effective health policy and planning, as well as for the assessment and monitoring of health systems.

    What impact has the Centre of Research Excellence in Digestive Health made in the field of gastrointestinal health in Australia and internationally? Study protocol for impact evaluation using the FAIT framework

    Por: Koloski · N. · Duncanson · K. · Ramanathan · S. A. · Rao · M. · Holtmann · G. · Talley · N. J.
    Introduction

    The need for public research funding to be more accountable and demonstrate impact beyond typical academic outputs is increasing. This is particularly challenging and the science behind this form of research is in its infancy when applied to collaborative research funding such as that provided by the Australian National Health and Medical Research Council to the Centre for Research Excellence in Digestive Health (CRE-DH).

    Methods and analysis

    In this paper, we describe the protocol for applying the Framework to Assess the Impact from Translational health research to the CRE-DH. The study design involves a five-stage sequential mixed-method approach. In phase I, we developed an impact programme logic model to map the pathway to impact and establish key domains of benefit such as knowledge advancement, capacity building, clinical implementation, policy and legislation, community and economic impacts. In phase 2, we have identified and selected appropriate, measurable and timely impact indicators for each of these domains and established a data plan to capture the necessary data. Phase 3 will develop a model for cost–consequence analysis and identification of relevant data for microcosting and valuation of consequences. In phase 4, we will determine selected case studies to include in the narrative whereas phase 5 involves collation, data analysis and completion of the reporting of impact.

    We expect this impact evaluation to comprehensively describe the contribution of the CRE-DH for intentional activity over the CRE-DH lifespan and beyond to improve outcomes for people suffering with chronic and debilitating digestive disorders.

    Ethics and dissemination

    This impact evaluation study has been registered with the Hunter New England Human Research Ethics Committee as project 2024/PID00336 and ethics application 2024/ETH00290. Results of this study will be disseminated via medical conferences, peer-reviewed publications, policy submissions, direct communication with relevant stakeholders, media and social media channels such as X (formely Twitter).

    Communication to adult patients undergoing cancer care by non-specialist nurses: a scoping review protocol

    Por: Kachimanga · C. · McGlashan · J. · Cunningham · N. · Hoyle · L.
    Introduction

    Little is known regarding how non-specialist nurses communicate with patients living with cancer when the patients are receiving care outside of their cancer units/teams. This scoping review aims to identify, examine and report on the currently available evidence about communication by non-specialist nurses when caring for adults living with cancer outside of their cancer care unit/teams.

    Methods and analysis

    A scoping review following the JBI methodology for scoping reviews will be conducted. We will search for empirical studies that meet the inclusion criteria in six databases (MEDLINE, PubMed, CINAHL, Embase, Scopus and PsycINFO). Handsearching in references of included articles will be performed to find additional articles. The population of interest will be non-specialist nurses. Three concepts will be explored, namely (1) all adult patients living with cancer, (2) a focus on three stages of the cancer continuum of care (cancer diagnosis, treatment and survivorship) and (3) a focus on communication between non-specialist nurses and patients living with cancer. We will include studies describing all healthcare settings outside patients’ specialised cancer units or oncology teams. After article selection, two reviewers will independently screen titles and abstracts and perform a full-text article review, risk of bias assessments and data extraction. A third reviewer will resolve all disagreements. A narrative summary will provide an overview of how the results relate to the research aims and questions. The included articles will be limited to English and published between 2012 and 2023.

    Ethics and dissemination

    No ethical approval is required since we will use publicly available empirical research sources. This review will provide current research on communication by non-specialist nurses with patients with a cancer diagnosis outside of an oncology setting, evidence that will support effective communication. As such, we aim to disseminate the findings in academic conferences and peer-reviewed journals.

    Preconception care: what do reproductive-aged women know and think in a community? A community-based, cross-sectional study at Mizan Aman town, Ethiopia

    Por: Guta · N. M. · Dachew · A. M.
    Objectives

    To assess factors associated with knowledge and attitudes towards preconception care among reproductive-aged women in Mizan Aman town, southwest, Ethiopia.

    Design and methods

    A community-based cross-sectional study was conducted from 1 November to 25 November 2021. The data were entered into Epidata V.3.1 and exported to SPSS V.26. Binary logistic regression analyses were performed to identify factors associated with outcome variables.

    Setting and participants

    The study was conducted in Mizan Aman town, Southwest, Ethiopia. A total of 422 reproductive-aged women were enrolled in the study.

    Outcome

    Knowledge and attitude towards preconception care, associated factors of preconception care.

    Results

    168 (39.8%) study subjects had good knowledge about preconception care, and 52.4% of the study subjects had a favourable attitude. Knowledge of preconception care was significantly associated with educational status (adjusted OR, AOR=6, p=0.01), marital status (AOR=1.47, p=0.001) and a positive attitude (AOR=1.8, p=0.08). Preconception care attitude was strongly associated with the maternal age group of 25–35 years (AOR=5.4, p=0.001), maternal age group of 36–42 years (AOR=3.5, p=0.02), source of income (AOR=5.3, p=0.01) and occupation (AOR=13.9, p=001).

    Conclusion

    The study revealed that knowledge about preconception care was significantly lower. Disseminating preconception education and incorporating preconception care into the maternal continuum of care was the most important to boost the knowledge and attitude level of women towards preconception care.

    Development of a tool for assessing the clinical competency of Chinese masters nursing students based on the mini-CEX: a Delphi method study

    Por: Peng · Q. · Gao · Y. · Liu · N. · Gan · X.
    Objective

    To construct a scientific and systematic competency evaluation tool for master of nursing specialists (MNS) and to provide a reference for the training, assessment and competency evaluation of MNS.

    Methods

    A first draft of the indicators for assessing MNS core competencies was developed on the basis of published research and group discussions. Between June and December 2020, the indicators were revised using two rounds of the Delphi expert consultation method, with questionnaires completed by 16 experts from five provinces in China.

    Results

    The valid retrieval rate of the two questionnaires was 100.00%, and the coefficient of expert authority was 0.931. The Kendall’s concordance coefficients of the two rounds of questionnaires were 0.136 (p

    Conclusions

    The MNS competency assessment tool constructed in this study is focused and highly credible. The findings can be used as a guide for the training, assessment and competence evaluation of MNS in the future.

    Self-help friendliness and cooperation with self-help groups among rehabilitation clinics in Germany (KoReS): a mixed-methods study protocol

    Por: Ziegler · E. · Bartzsch · T. · Trojan · A. · Usko · N. · Krahn · I. · Bütow · S. · Kofahl · C.
    Introduction

    Self-help is an important complement to medical rehabilitation for people with chronic diseases and disabilities. It contributes to stabilising rehabilitation success and further coping with disease and disability. Rehabilitation facilities are central in informing and referring patients to self-help groups. However, sustainable cooperation between rehabilitation and self-help, as can be achieved using the concept of self-help friendliness in healthcare, is rare, as is data on the cooperation situation.

    Methods and analysis

    The KoReS study will examine self-help friendliness and cooperation between rehabilitation clinics and self-help associations in Germany, applying a sequential exploratory mixed-methods design. In the first qualitative phase, problem-centred interviews and focus groups are conducted with representatives of self-help-friendly rehabilitation clinics, members of their cooperating self-help groups and staff of self-help clearinghouses involved based on a purposeful sampling. Qualitative data collected will be analysed through content analysis using MAXQDA. The findings will serve to develop a questionnaire for a quantitative second phase. Cross-sectional online studies will survey staff responsible for self-help in rehabilitation clinics nationwide, representatives of self-help groups and staff of self-help clearinghouses. Quantitative data analysis with SPSS will include descriptive statistics, correlation, subgroup and multiple regression analyses. Additionally, a content analysis of rehabilitation clinics’ websites will evaluate the visibility of self-help in their public relations.

    Ethics and dissemination

    The University Medical Center Hamburg-Eppendorf Local Psychological Ethics Committee at the Center for Psychosocial Medicine granted ethical approval (reference number LPEK-0648; 10.07.2023). Informed consent will be obtained from all participants. Results dissemination will comprise various formats such as workshops, presentations, homepages and publications for the international scientific community, rehabilitation centres, self-help organisations and the general public in Germany. For relevant stakeholders, practical guides and recommendations to implement self-help friendliness will derive from the results to strengthen patient orientation and cooperation between rehabilitation and self-help to promote the sustainability of rehabilitation processes.

    REST: a preoperative tailored sleep intervention for patients undergoing total knee replacement - feasibility study for a randomised controlled trial

    Por: Bertram · W. · Penfold · C. · Glynn · J. · Johnson · E. · Burston · A. · Rayment · D. · Howells · N. · White · S. · Wylde · V. · Gooberman-Hill · R. · Blom · A. · Whale · K.
    Objectives

    To test the feasibility of a randomised controlled trial (RCT) of a novel preoperative tailored sleep intervention for patients undergoing total knee replacement.

    Design

    Feasibility two-arm two-centre RCT using 1:1 randomisation with an embedded qualitative study.

    Setting

    Two National Health Service (NHS) secondary care hospitals in England and Wales.

    Participants

    Preoperative adult patients identified from total knee replacement waiting lists with disturbed sleep, defined as a score of 0–28 on the Sleep Condition Indicator questionnaire.

    Intervention

    The REST intervention is a preoperative tailored sleep assessment and behavioural intervention package delivered by an Extended Scope Practitioner (ESP), with a follow-up phone call 4 weeks postintervention. All participants received usual care as provided by the participating NHS hospitals.

    Outcome measures

    The primary aim was to assess the feasibility of conducting a full trial. Patient-reported outcomes were assessed at baseline, 1-week presurgery, and 3 months postsurgery. Data collected to determine feasibility included the number of eligible patients, recruitment rates and intervention adherence. Qualitative work explored the acceptability of the study processes and intervention delivery through interviews with ESPs and patients.

    Results

    Screening packs were posted to 378 patients and 57 patients were randomised. Of those randomised, 20 had surgery within the study timelines. An appointment was attended by 25/28 (89%) of participants randomised to the intervention. Follow-up outcomes measures were completed by 40/57 (70%) of participants presurgery and 15/57 (26%) postsurgery. Where outcome measures were completed, data completion rates were 80% or higher for outcomes at all time points, apart from the painDETECT: 86% complete at baseline, 72% at presurgery and 67% postsurgery. Interviews indicated that most participants found the study processes and intervention acceptable.

    Conclusions

    This feasibility study has demonstrated that with some amendments to processes and design, an RCT to evaluate the clinical and cost-effectiveness of the REST intervention is feasible.

    Trial registration number

    ISRCTN14233189.

    Operational priorities for engaging with Indias private healthcare sector for the control of tuberculosis: a modelling study

    Por: Ricks · S. · Singh · A. · Sodhi · R. · Pal · A. · Arinaminpathy · N.
    Objectives

    To estimate the potential impact of expanding services offered by the Joint Effort for Elimination of Tuberculosis (JEET), the largest private sector engagement initiative for tuberculosis (TB) in India.

    Design

    We developed a mathematical model of TB transmission dynamics, coupled with a cost model.

    Setting

    Ahmedabad and New Delhi, two cities with contrasting levels of JEET coverage.

    Participants

    Estimated patients with TB in Ahmedabad and New Delhi.

    Interventions

    We investigated the epidemiological impact of expanding three different public–private support agency (PPSA) services: provider recruitment, uptake of cartridge-based nucleic acid amplification tests and uptake of adherence support mechanisms (specifically government supplied fixed-dose combination drugs), all compared with a continuation of current TB services.

    Results

    Our results suggest that in Delhi, increasing the use of adherence support mechanisms among private providers should be prioritised, having the lowest incremental cost-per-case-averted between 2020 and 2035 of US$170 000 (US$110 000–US$310 000). Likewise in Ahmedabad, increasing provider recruitment should be prioritised, having the lowest incremental cost-per-case averted of US$18 000 (US$12 000–US$29 000).

    Conclusion

    Results illustrate how intervention priorities may vary in different settings across India, depending on local conditions, and the existing degree of uptake of PPSA services. Modelling can be a useful tool for identifying these priorities for any given setting.

    Experiences of the clinical academic pathway: a qualitative study in Greater Manchester to improve the opportunities of minoritised clinical academics

    Por: Lin · C.-Y. · Greco · C. · Radhakrishnan · H. · Finn · G. M. · Cowen · R. L. · Gardiner · N. J.
    Objectives

    The aim of this study was to explore the barriers and facilitators faced by clinical academics (CAs) in the Greater Manchester region, with particular attention to the experiences of minoritised groups.

    Design

    A qualitative study using semistructured interviews and focus groups was conducted. A reflexive thematic analysis was applied to identify key themes.

    Setting

    University of Manchester and National Health Service Trusts in the Greater Manchester region.

    Participants

    The sample of this study was composed of 43 participants, including CAs, senior stakeholders, clinicians and medical and dental students.

    Results

    Six themes were identified. CAs face several barriers and facilitators, some of which—(1) funding insecurity and (2) high workload between the clinic and academia—are common to all the CAs. Other barriers, including (3) discrimination that translates into struggles with self-worth and feeling of not belonging, (4) being or being perceived as foreign and (5) unequal distribution of care duties, particularly affect people from minoritised groups. In contrast, (6) mentorship was commonly identified as one of the most important facilitators.

    Conclusions

    Cultural and structural interventions are needed, such as introducing financial support for early career CAs and intercalating healthcare students to promote wider social and cultural change and increase the feelings of belonging and representation across the entire CA pipeline.

    Talking in primary care (TIP): protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients musculoskeletal pain and enablement

    Por: Bishop · F. L. · Cross · N. · Dewar-Haggart · R. · Teasdale · E. · Herbert · A. · Robinson · M. E. · Ridd · M. J. · Mallen · C. · Clarson · L. · Bostock · J. · Becque · T. · Stuart · B. · Garfield · K. · Morrison · L. · Pollet · S. · Vennik · J. · Atherton · H. · Howick · J. · Leydon · G. M
    Introduction

    Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain.

    Methods and analysis

    A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews.

    Ethics approval and dissemination

    Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country.

    Trial registration number

    ISRCTN18010240.

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