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Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational clinical trial

Por: Phillips · A. E. · Afghani · E. · Akshintala · V. S. · Benos · P. Y. · Das · R. · Drewes · A. M. · Easler · J. · Faghih · M. · Gabbert · C. · Halappa · V. · Khashab · M. A. · Olesen · S. S. · Saloman · J. L. · Sholosh · B. · Slivka · A. · Wang · T. · Yadav · D. · Singh · V. K.
Introduction

Treatment for abdominal pain in patients with chronic pancreatitis (CP) remains challenging in the setting of central nervous system sensitisation, a phenomenon of remodelling and neuronal hyperexcitability resulting from persistent pain stimuli. This is suspected to render affected individuals less likely to respond to conventional therapies. Endotherapy or surgical decompression is offered to patients with pancreatic duct obstruction. However, the response to treatment is unpredictable. Pancreatic quantitative sensory testing (P-QST), an investigative technique of standardised stimulations to test the pain system in CP, has been used for phenotyping patients into three mutually exclusive groups: no central sensitisation, segmental sensitisation (pancreatic viscerotome) and widespread hyperalgesia suggestive of supraspinal central sensitisation. We will test the predictive capability of the pretreatment P-QST phenotype to predict the likelihood of pain improvement following invasive treatment for painful CP.

Methods and analysis

This observational clinical trial will enrol 150 patients from the University of Pittsburgh, Johns Hopkins and Indiana University. Participants will undergo pretreatment phenotyping with P-QST. Treatment will be pancreatic endotherapy or surgery for clearance of painful pancreatic duct obstruction. Primary outcome: average pain score over the preceding 7 days measured by Numeric Rating Scale at 6 months postintervention. Secondary outcomes will include changes in opioid use during follow-up, and patient-reported outcomes in pain and quality of life at 3, 6 and 12 months after the intervention. Exploratory outcomes will include creation of a model for individualised prediction of response to invasive treatment.

Ethics and dissemination

The trial will evaluate the ability of P-QST to predict response to invasive treatment for painful CP and develop a predictive model for individualised prediction of treatment response for widespread use. This trial was approved by the University of Pittsburgh Institutional Review Board. Data and results will be reported and disseminated in conjunction with National Institutes of Health policies.

Trial registration number

NCT04996628.

Using the Power Wheel as a transformative tool to promote equity through spaces and places of patient engagement

Por: Sayani · A. · Cordeaux · E. · Wu · K. · Awil · F. · Garcia · V. · Hinds · R. · Jeji · T. · Khan · O. · Soh · B.-L. · Mensah · D. · Monteith · L. · Musawi · M. · Rathbone · M. · Robinson · J. · Sterling · S. · Wardak · D. · Amsdr · I. · Khawari · M. · Niwe · S. · Hussain · A. · Forster · V. · May
Background

Patient engagement is the active collaboration between patient partners and health system partners towards a goal of making decisions that centre patient needs—thus improving experiences of care, and overall effectiveness of health services in alignment with the Quintuple Aim. An important but challenging aspect of patient engagement is including diverse perspectives particularly those experiencing health inequities. When such populations are excluded from decision-making in health policy, practice and research, we risk creating a healthcare ecosystem that reinforces structural marginalisation and perpetuates health inequities.

Approach

Despite the growing body of literature on knowledge coproduction, few have addressed the role of power relations in patient engagement and offered actionable steps for engaging diverse patients in an inclusive way with a goal of improving health equity. To fill this knowledge gap, we draw on theoretical concepts of power, our own experience codesigning a novel model of patient engagement that is equity promoting, Equity Mobilizing Partnerships in Community, and extensive experience as patient partners engaged across the healthcare ecosystem. We introduce readers to a new conceptual tool, the Power Wheel, that can be used to analyse the interspersion of power in the places and spaces of patient engagement.

Conclusion

As a tool for ongoing praxis (reflection +action), the Power Wheel can be used to report, reflect and resolve power asymmetries in patient-partnered projects, thereby increasing transparency and illuminating opportunities for equitable transformation and social inclusion so that health services can meet the needs and priorities of all people.

Investigation of divergent thinking among surgeons and surgeon trainees in Canada (IDEAS): a mixed-methods study

Por: Thabane · A. · McKechnie · T. · Arora · V. · Calic · G. · Busse · J. W. · Sonnadara · R. · Bhandari · M.
Objective

To assess the creative potential of surgeons and surgeon trainees, as measured by divergent thinking. The secondary objectives were to identify factors associated with divergent thinking, assess confidence in creative problem-solving and the perceived effect of surgical training on creative potential, and explore the value of creativity in surgery.

Design

We used a mixed-methods design, conducting a survey of divergent thinking ability using a validated questionnaire followed by two semi-structured interviews with top-scoring participants.

Participants & setting

Surgeons and surgeon trainees in the Department of Surgery at McMaster University.

Outcomes

The primary outcome was divergent thinking, assessed with the Abbreviated Torrance Test for Adults. Participants also self-assessed their confidence in creative problem-solving and the effect of surgical training on their creative potential. We performed descriptive analyses and multivariable linear regression to identify factors associated with divergent thinking. We conducted a thematic analysis of the interview responses.

Results

82 surgeons and surgeon trainees were surveyed; 43 were junior trainees and 28 were senior trainees. General surgery, orthopaedic surgery and plastic surgery represented 71.9% of the participants. The median participant age was 28 years (range 24–73), 51.2% of whom were female. Participants demonstrated levels of divergent thinking that were higher but not meaningfully different from the adult norm (62.39 (95% CI 61.25, 63.53), p

Conclusions

The divergent thinking ability among surgeons and surgeon trainees was not meaningfully different from the adult normative score; however, their ability to generate original ideas was below average.

Work environment and hypertension in industrial settings in Benin in 2019: a cross-sectional study

Por: Adjobimey · M. · Houehanou · C. Y. · Cisse · I. M. · Mikponhoue · R. · Hountohotegbe · E. · Tchibozo · C. · Adjogou · A. · Dossougbete · V. · Gounongbe · F. · Ayelo · P. A. · Hinson · V. · Houinato · D. S.
Objective

To determine the association between occupational factors, particularly psychosocial factors, and hypertension.

Design

Descriptive and analytical cross-sectional study using logistic multivariate regression.

Setting

Fifteen cotton ginning plants in Benin.

Participants

Permanent and occasional workers in the cotton ginning industry.

Data collection

Data on sociodemographic, occupational, behavioural and clinical history characteristics were collected using a number of standardised, interviewer-administered questionnaires. These questionnaires were based on the WHO’s non-communicable disease questionnaire, Karasek questionnaire and Siegrist questionnaire. Weight, height and blood pressure were measured. Any worker with systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg according to the WHO criteria was considered hypertensive, as was any subject on antihypertensive treatment even if blood pressure was normal.

Results

A total of 1883 workers were included, with a male to female ratio of 9.08. Of these, 510 suffered from hypertension (27.1%, 95% CI 25.1 to 29.2). In the multivariate analysis, the risk factors identified were occupational stress (adjusted OR (aOR)=3.96, 95% CI 1.28 to 12.2), age ≥25 years (aOR=2.77, 95% CI 1.55 to 4.96), body mass index of 25–30 kg/m2 (aOR=1.71, 95% CI 1.32 to 2.2), body mass index >30 kg/m2 (aOR=2.74, 95% CI 1.84 to 4.09), permanent worker status (aOR=1.66, 95% CI 1.44 to 2.41) and seniority in the textile sector >5 years (aOR=2.18, 95% CI 1.7 to 2.8). Recognition at work emerged as an effect-modifying factor subject to stratification.

Conclusions

Occupational factors, particularly job strain and recognition at work, are modifiable factors associated with hypertension in the ginning plants sector and deserve to be corrected through occupational health promotion and prevention.

SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres

Por: Del Fiol · G. · Orleans · B. · Kuzmenko · T. V. · Chipman · J. · Greene · T. · Martinez · A. · Wirth · J. · Meads · R. · Kaphingst · K. K. · Gibson · B. · Kawamoto · K. · King · A. J. · Siaperas · T. · Hughes · S. · Pruhs · A. · Pariera Dinkins · C. · Lam · C. Y. · Pierce · J. H. · Benson
Introduction

SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).

Methods and analysis

The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2x2x2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2x2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.

Ethics and dissemination

The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.

Trial registration number

ClinicalTrials.gov: NCT05533918 and NCT05533359.

Temporal trends of ambulance time intervals for suspected stroke/transient ischaemic attack (TIA) before and during the COVID-19 pandemic in Ireland: a quasi-experimental study

Por: Burton · E. · Quinn · R. · Crosbie-Staunton · K. · Deasy · C. · Masterson · S. · O'Donnell · C. · Merwick · A. · Willis · D. · Kearney · P. M. · Mc Carthy · V. J. C. · Buckley · C. M.
Objectives

Time is a fundamental component of acute stroke and transient ischaemic attack (TIA) care, thus minimising prehospital delays is a crucial part of the stroke chain of survival. COVID-19 restrictions were introduced in Ireland in response to the pandemic, which resulted in major societal changes. However, current research on the effects of the COVID-19 pandemic on prehospital care for stroke/TIA is limited to early COVID-19 waves. Thus, we aimed to investigate the effect of the COVID-19 pandemic on ambulance time intervals and suspected stroke/TIA call volume for adults with suspected stroke and TIA in Ireland, from 2018 to 2021.

Design

We conducted a secondary data analysis with a quasi-experimental design.

Setting

We used data from the National Ambulance Service in Ireland. We defined the COVID-19 period as ‘1 March 2020–31 December 2021’ and the pre-COVID-19 period ‘1 January 2018–29 February 2020’.

Primary and secondary outcome measures

We compared five ambulance time intervals: ‘allocation performance’, ‘mobilisation performance’, ‘response time’, ‘on scene time’ and ‘conveyance time’ between the two periods using descriptive and regression analyses. We also compared call volume for suspected stroke/TIA between the pre-COVID-19 and COVID-19 periods using interrupted time series analysis.

Participants

We included all suspected stroke/TIA cases ≥18 years who called the National Ambulance Service from 2018 to 2021.

Results

40 004 cases were included: 19 826 in the pre-COVID-19 period and 19 731 in the COVID-19 period. All ambulance time intervals increased during the pandemic period compared with pre-COVID-19 (p

Conclusions

A ’shock' like a pandemic has a negative impact on the prehospital phase of care for time-sensitive conditions like stroke/TIA. System evaluation and public awareness campaigns are required to ensure maintenance of prehospital stroke pathways amidst future healthcare crises. Thus, this research is relevant to routine and extraordinary prehospital service planning.

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.

Implementation of an antibiotic resistance surveillance tool in Madagascar, the TSARA project: a prospective, observational, multicentre, hospital-based study protocol

Por: Elias · C. · Raad · M. · Rasoanandrasana · S. · Raherinandrasana · A. H. · Andriananja · V. · Raberahona · M. · Moore · C. E. · Randria · M. · Raskine · L. · Vanhems · P. · Babin · F.-X.
Introduction

Antimicrobial resistance (AMR) has become a significant public health threat. Without any interventions, it has been modelled that AMR will account for an estimated 10 million deaths annually by 2050, this mainly affects low/middle-income countries. AMR has a systemic negative perspective affecting the overall healthcare system down to the patient’s personal outcome. In response to this issue, the WHO urged countries to provide antimicrobial stewardship programmes (ASPs). ASPs in hospitals are a vital component of national action plans for AMR, and have been shown to significantly reduce AMR, in particular in low-income countries such as Madagascar.

As part of an ASP, AMR surveillance provides essential information needed to guide medical practice. We developed an AMR surveillance tool—Technique de Surveillance Actualisée de la Résistance aux Antimicrobiens (TSARA)—with the support of the Mérieux Foundation. TSARA combines bacteriological and clinical information to provide a better understanding of the scope and the effects of AMR in Madagascar, where no such surveillance tool exists.

Methods and analysis

A prospective, observational, hospital-based study was carried out for data collection using a standardised data collection tool, called TSARA deployed in 2023 in 10 hospitals in Madagascar participating in the national Malagasy laboratory network (Réseau des Laboratoires à Madagascar (RESAMAD)). Any hospitalised patient where the clinician decided to take a bacterial sample is included. As a prospective study, individual isolate-level data and antimicrobial susceptibility information on pathogens were collected routinely from the bacteriology laboratory and compiled with clinical information retrieved from face-to-face interviews with the patient and completed using medical records where necessary. Analysis of the local ecology, resistance rates and antibiotic prescription patterns were collected.

Ethics and dissemination

This protocol obtained ethical approval from the Malagasy Ethical Committee n°07-MSANP/SG/AGMED/CNPV/CERBM on 24 January 2023. Findings generated were shared with national health stakeholders, microbiologists, members of the RESAMAD network and the Malagasy academic society of infectious diseases.

REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia

Por: Ho · K. Y. · Gyanwali · B. · Dimayuga · C. · Eufemio · E. M. · Bernardo · E. · Raju · G. · Chong · K. W. · Waithayayothin · K. · Ona · L. · Castro · M. A. L. · Sawaddiruk · P. · Salvador · R. C. · Roohi · S. A. · Tangwiwat · S. · Wilairatana · V. · Oon · Z. H. · Gupta · A. · Nagrale · D.
Introduction

Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

Methods and analysis

REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

Ethics and dissemination

The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

Evidence-informed and consensus-based statements about SAFEty of Physical Agent Modalities Practice in physiotherapy and rehabilitation medicine (SAFE PAMP): a national Delphi of healthcare scientific societies

Por: Gianola · S. · Bargeri · S. · Pellicciari · L. · Gambazza · S. · Rossettini · G. · Fulvio · A. · Genovese · V. · Benedini · M. · Proverbio · E. · Cecchetto · S. · Castellini · G. · Turolla · A. · SAFE PAMP Collaborators · Torresetti · Masturzo · Berliri · Roselli · Vercelli · Scorcu
Objective

A shared consensus on the safety about physical agent modalities (PAMs) practice in physiotherapy and rehabilitation is lacking. We aimed to develop evidence-informed and consensus-based statements about the safety of PAMs.

Study design and setting

A RAND-modified Delphi Rounds’ survey was used to reach a consensus. We established a steering committee of the Italian Association of Physiotherapy (Associazione Italiana di Fisioterapia) to identify areas and questions for developing statements about the safety of the most commonly used PAMs in physiotherapy and rehabilitation. We invited 28 National Scientific and Technical Societies, including forensics and lay members, as a multidisciplinary and multiprofessional panel of experts to evaluate the nine proposed statements and formulate additional inputs. The level of agreement was measured using a 9-point Likert scale, with consensus in the Delphi Rounds assessed using the rating proportion with a threshold of 75%.

Results

Overall, 17 (61%) out of 28 scientific and technical societies participated, involving their most representative members. The panel of experts mainly consisted of clinicians (88%) with expertise in musculoskeletal (47%), pelvic floor (24%), neurological (18%) and lymphatic (6%) disorders with a median experience of 30 years (IQR=17–36). Two Delphi rounds were necessary to reach a consensus. The final approved criteria list comprised nine statements about the safety of nine PAMs (ie, electrical stimulation neuromodulation, extracorporeal shock wave therapy, laser therapy, electromagnetic therapy, diathermy, hot thermal agents, cryotherapy and therapeutic ultrasound) in adult patients with a general note about populations subgroups.

Conclusions

The resulting consensus-based statements inform patients, healthcare professionals and policy-makers regarding the safe application of PAMs in physiotherapy and rehabilitation practice. Future research is needed to extend this consensus on paediatric and frail populations, such as immunocompromised patients.

Exploring the pharmacists role in optimising antithrombotic therapy in primary care: a qualitative study

Por: van Paassen · J. G. · Tan · J. P. · Deneer · V. H. M. · Bouvy · M. L.
Objective

In antithrombotic therapy, the balance between efficacy and safety is delicate, which makes it challenging for healthcare professionals, including pharmacists, to optimise therapy. Pharmacists may play an important role in optimising antithrombotic therapy, but especially in primary care, this role has not been elucidated. Here, we study how community pharmacists (pharmacists in primary care) perceive their current and future role in antithrombotic therapy.

Design

We conducted a qualitative study using semi-structured interviews. The interview protocol and subsequent analysis were based on the Theoretical Domains Framework, and the findings were interpreted with the Capability Opportunity Motivation – Behaviour System.

Setting and participants

The interview participants were community pharmacists, located across the Netherlands, from the Utrecht Pharmacy Practice network for Education and Research.

Results

We interviewed 16 community pharmacists between February and August 2021 and identified several major themes which were important for the pharmacist’s role in antithrombotic therapy. Pharmacists felt responsible for the outcome of antithrombotic treatment and intended to invest in their role in antithrombotic therapy. Pharmacists did, however, experience barriers to their role in antithrombotic therapy, like a lack of access to clinical information such as the indication of antithrombotic treatment and a lack of specific knowledge on this treatment.

Conclusion

Community pharmacists perceive a role for themselves in antithrombotic therapy. To fulfil this role, several preconditions must be met.

Can glycated haemoglobin (HbA1c) be used as a predictor of left ventricular diastolic dysfunction in non-hypertensive patients with newly diagnosed type 2 diabetes mellitus: a cross-sectional study at a tertiary care centre in Eastern India

Por: Porel · R. · Shyama · S. · Ahmad · S. · Kumar · N. · Ahmad · S. · Biswas · R. · Ojha · V. S.
Objectives

This study was conducted to establish the association between glycated haemoglobin (HbA1c) and left ventricular diastolic dysfunction (LVDD) in non-hypertensive patients with newly diagnosed type 2 diabetes mellitus (DM) and determine the cut-off value of HbA1c for detecting LVDD.

Design

Cross-sectional study.

Setting

This study was conducted in General Medicine Department in collaboration with the Cardiology Department at All India Institute of Medical Sciences, Patna.

Participants

The study population comprised patients with newly diagnosed type 2 DM within the past 3 months, aged between 18 years and 80 years, who were not hypertensive and without any systemic diseases and who presented to the General Medicine Department.

Primary and secondary outcome measures

The presence of LVDD was the primary outcome measure.

Results

Among the total of 60 participants, it was observed that age (adjusted odds ratio (AOR): 1.169, 95% CI: 1.066 to 1.283) and HbA1c (AOR: 2.625, 95% CI: 1.264 to 5.450) were found to be independent predictors for the presence of LVDD. Receiver operating characteristic analysis identified a cut-off value of HbA1c at 9.5% (80 mmol/mol) for detecting LVDD, with a specificity of 96.43%, a sensitivity of 37.5% and a positive predictive value (PPV) of 91.62%.

Conclusions

This study demonstrated that age and HbA1c levels are independent predictors of LVDD in patients with newly diagnosed type 2 DM without hypertension. A cut-off value of 9.5% for HbA1c was identified with a high specificity and PPV for predicting LVDD in patients with newly diagnosed type 2 diabetes. This underscores the importance of conducting echocardiography in patients with newly diagnosed asymptomatic type 2 diabetes with HbA1c 9.5% or more to assess LVDD, allowing for prompt interventions if necessary and to decelerate the progression towards heart failure.

Evaluating the impact of movement tracking feedback on engagement with home exercise programmes of children with cerebral palsy using a new therapy app: a protocol for a mixed-methods single-case experimental design with alternating treatments

Por: Petrevska · M. · Wright · F. V. · Khan · A. · Munce · S. · Fehlings · D. · Biddiss · E.
Introduction

Children with cerebral palsy (CP) are prescribed home exercise programmes (HEPs) to increase the frequency of movement practice, yet adherence to HEPs can be low. This paper outlines the protocol for a single-case experimental design (SCED) with alternating treatments, using a new home therapy exercise application, Bootle Boot Camp (BBCamp), offered with and without movement tracking feedback. This study will explore the impact of feedback on engagement, movement quality, lower limb function and family experiences to help understand how technology-supported HEPs should be translated and the added value, if any, of movement tracking technology.

Methods and analysis

In this explanatory sequential mixed-methods study using a SCED, 16 children with CP (aged 6–12 years, Gross Motor Function Classification System levels I–II) will set lower limb goals and be prescribed an individualised HEP by their physiotherapist to complete using BBCamp on their home television equipped with a three-dimensional camera-computer system. Children will complete four weekly exercise sessions over 6 weeks. Children will be randomised to 1 of 16 alternating treatment schedules where BBCamp will provide or withhold feedback during the first 4 weeks. The version of BBCamp that results in the most therapeutic benefit will be continued for 2 final weeks. Goals will be re-evaluated and families interviewed. The primary outcome is adherence (proportion of prescribed exercise repetitions attempted) as a measure of behavioural engagement. Secondary outcomes are affective and cognitive engagement (smiley face ratings), exercise fidelity, lower limb function, goal achievement and participant experiences. SCED data will be analysed using visual and statistical methods. Quantitative and qualitative data will be integrated using joint displays.

Ethics and dissemination

Ethical approval was obtained from the Research Ethics Boards at Bloorview Research Institute and the University of Toronto. Results will be distributed through peer-reviewed journals and scientific conferences.

Trial registration number

NCT05998239; pre-results.

Identifying the top 10 research priorities for the school food system in the UK: a priority setting exercise

Por: Schliemann · D. · Spence · S. · OKane · N. · Chiang · C. C. · Olgacher · D. · McKinley · M. C. · Woodside · J. V. · on behalf of the GENIUS network · Schliemann · Spence · OKane · Chiang · Olgacher · McKinley · Woodside
Introduction

The school food system varies widely between schools and across the UK. There is a need to understand evidence gaps in school food research to allow the development, implementation and evaluation of policies and interventions to support children’s healthy eating at school. This study aimed to conduct a priority setting exercise to co-produce research priorities in relation to the UK school food system.

Methods

The James Lind Alliance process informed this priority setting exercise; all key steps engaged a wide range of UK school food stakeholders (including teachers, parents, principals, school governors, policymakers, caterers). An initial online stakeholder survey identified perceived research priorities. In a second survey, stakeholders were asked to rank these priorities. Lastly, an online priority setting workshop with stakeholders elicited the most important research priorities.

Results

In 2021, school food stakeholders (n=1280) completed the first survey, from which 136 research priorities were identified. In the second survey, participants (n=107) ranked these research priorities regarding their importance. Lastly, 30 workshop participants discussed and reached consensus on the research priorities. After final refinement by the research team, 18 priorities resulted, with the top 10 being related to the provision of free school meals (effectiveness of cost-effectiveness of different levels of eligibility, including universal provision), implementation of policy (including improving uptake) and food standards, issues around procurement, leadership, inequalities, social norms, the eating environment, food culture throughout the school setting and healthy eating.

Conclusion

The top 10 research priorities were elicited through a rigorous approach, including a wide range of stakeholders across the UK. These should be considered by policymakers, researchers and others to inform research, evidence-based policy development and, ultimately, improve the UK school food system.

Country uptake of WHO recommendations on differentiated HIV testing services approaches: a global policy review

Por: Kadye · T. · Jamil · M. S. · Johnson · C. · Baggaley · R. · Barr-DiChiara · M. · Cambiano · V.
Objectives

In 2015 and 2016, WHO issued guidelines on HIV testing services (HTS) highlighting recommendations for a strategic mix of differentiated HTS approaches. The policy review examines the uptake of differentiated HTS approaches recommendations in national policies.

Methods

Data were extracted from national policies published between January 2015 and June 2019. The WHO-recommended HTS approaches included facility-based testing, community-based testing, HIV self-testing and provider-assisted referral (or assisted partner notification). Other supportive recommendations include pre-test information, post-test counselling, lay provider testing and rapid testing. Descriptive analyses were conducted to examine inclusion of recommendations in national policies.

Results

Of 194 countries worldwide, 65 published policies were identified; 24 WHO Africa region (AFR) countries (51%, 24/47), 21 WHO European region (EUR) (40%, 21/53), 6 WHO Eastern Mediterranean region (EMR) (29%, 6/21), 5 Pan-American region (AMR) (14%, 5/35), 5 Western Pacific Region (WPR) (19%, 5/27) and 4 WHO South East Asia Region (SEAR) (36%, 4/11). Only five countries included all recommendations. 63 included a minimum of one. 85% (n=55) included facility-based testing for pregnant women, 75% (n=49) facility-based testing for key populations, 74% (n=48) community-based testing for key populations, 69% (n=45) rapid testing, 57% (n=37) post-test counselling, 45% (n=29) lay provider testing, 38% (n=25) HIV self-testing, 29% (n=19) pre-test information and 25% (n=16) provider-assisted referral. The proportion in each region that included at least one recommendation were: 100% AFR (24/47), 100% EMR (6/6), 100% AMR (5/5), 100% WPR (5/5), 100% SEAR (4/4) and 95% EUR (20/21). AFR followed by EMR included the highest number of reccomendations.

Conclusion

There was substantial variability in the uptake of the WHO-differentiated HTS recommendations. Those in EMR included the most WHO-differentiated HTS recommendation followed by AFR. Countries within AMR included the least number of recommendations. Ongoing advocacy and efforts are needed to support the uptake of the WHO-differentiated HTS recommendations in country policies as well as their implementation.

Low-value MRI of the knee in Norway: a register-based study to identify the proportion of potentially low-value MRIs and estimate the related costs

Por: Hofmann · B. · Havik · V. · Andersen · E. R. · Brandsaeter · I. O. · Kjelle · E.
Objectives

The objective of this study is to investigate the proportion of potentially low-value knee MRI in Norway and to provide an estimate of the related costs.

Design

Register study based on conditional data extraction and analysis of data from Control and Reimbursement of Healthcare Claims registry in Norway.

Setting

MRI in public specialist healthcare with universal health coverage (Norway).

Participants

48 212 MRIs for 41 456 unique patients and 45 946 reimbursement claims.

Outcome measures

Proportion of MRIs of the knee that (1) did not have a relevant tentative diagnosis prior to the knee MRI, (2) did not have a relevant alternative image of the knee before the MRI or (3) did not have a relevant code from the specialist care within 6 months after the MRI, and those that had combinations of 1, 2 and 3. Estimated costs for those that had combinations of 1, 2 and 3.

Results

Very few patients (6.4%) had a relevant diagnosis code or prior imaging examination when having the MRI and only 14.6% got a knee-related diagnosis code from the specialist care within 6 months after the MRI. 21.8% of the patients had knee X-ray, CT or ultrasound within 6 months before the MRI. Between 58% and 85% of patients having knee MRIs in Norway have no relevant examinations or diagnoses six months prior to or after the MRI examination. These examinations are unlikely to benefit patients and they correspond to between 24 108 and 35 416 MRIs at a cost of 6.7–9.8 million per year.

Conclusion

A substantial proportion of MRIs of the knee in Norway have no relevant examinations or diagnoses before or after the MRI and are potentially of low value. Reducing low-value MRIs could free resources for high-value imaging, reduce waiting times, improve the quality of care and increase patient safety and professional integrity.

Cohort profile: BioMD-Y (biopsychosocial factors of major depression in youth) - a biobank study on the molecular genetics and environmental factors of depression in children and adolescents in Munich

Por: Scherff · A. D. · Feldmann · L. · Piechaczek · C. · Pehl · V. · Wagenbüchler · P. · Wermuth · I. · Ghotbi · N. · Allgaier · A.-K. · Freisleder · F. J. · Beins · E. C. · Forstner · A. J. · Nöthen · M. M. · Czamara · D. · Rex-Haffner · M. · Ising · M. · Binder · E. · Greimel · E. · Sch
Purpose

BioMD-Y is a comprehensive biobank study of children and adolescents with major depression (MD) and their healthy peers in Germany, collecting a host of both biological and psychosocial information from the participants and their parents with the aim of exploring genetic and environmental risk and protective factors for MD in children and adolescents.

Participants

Children and adolescents aged 8–18 years are recruited to either the clinical case group (MD, diagnosis of MD disorder) or the typically developing control group (absence of any psychiatric condition).

Findings to date

To date, four publications on both genetic and environmental risk and resilience factors (including FKBP5, glucocorticoid receptor activation, polygenic risk scores, psychosocial and sociodemographic risk and resilience factors) have been published based on the BioMD-Y sample.

Future plans

Data collection is currently scheduled to continue into 2026. Research questions will be further addressed using available measures.

Assessing the acceptability of, adherence to and preference for a dual prevention pill (DPP) for HIV and pregnancy prevention compared to oral pre-exposure prophylaxis (PrEP) and oral contraception taken separately: protocols for two randomised, controlle

Por: Friedland · B. A. · Mgodi · N. M. · Palanee-Phillips · T. · Mathur · S. · Plagianos · M. G. · Bruce · I. V. · Lansiaux · M. · Murombedzi · C. · Musara · P. · Dandadzi · A. · Reddy · K. · Ndlovu · N. · Zulu · S. K. · Shale · L. R. · Zieman · B. · Haddad · L. B.
Introduction

Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method; however, uptake and persistence have been low among southern African women. A dual prevention pill (DPP) that combines PrEP with oral contraception (OC) may increase PrEP use and better meet women’s sexual and reproductive health needs. We will gauge the DPP’s acceptability in two cross-over clinical trials.

Methods and analysis

PC952 (Zimbabwe) and PC953 (South Africa) will compare acceptability, adherence and preference for an over-encapsulated DPP versus PrEP and OCs taken separately. HIV-negative, non-pregnant cisgender females in Johannesburg, South Africa (n=96, 16–40 years) and Harare, Zimbabwe (n=30, 16–24 years) will be randomised 1:1 to the order of regimens—DPP or two separate tablets—each used for three 28-day cycles, followed by a 6-month choice period in South Africa. Monthly clinic visits include HIV and pregnancy testing; safety assessments and risk reduction and adherence counselling. We will assess adherence (monthly) based on tenofovir diphosphate drug levels in dried blood spots and by self-report. We will evaluate acceptability (monthly) and preference (end of cross-over) via computer-assisted self-interviewing and in-depth interviews with a subset of participants. Data collection started in September 2022 and ended in January 2024.

Ethics and dissemination

PC952 was approved by the Ministry of Health and Child Care, Medical Research Council, Research Council and Medicines Control Authority of Zimbabwe; the Chitungwiza City Health Ethics Committee; and the Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals. PC953 was approved by the South African Health Products Regulatory Authority and the University of the Witwatersrand’s Human Research Ethics Committee. The Population Council IRB approved both studies. We will disseminate results in open-access journals, clinical trials registries, and at local and international meetings and conferences.

Trial registration numbers

NCT04778514, NCT04778527.

Facilitators and barriers to codesigning social robots with older adults with dementia: a scoping review protocol

Por: Hung · L. · Chen · I. · Wong · K. L. Y. · Jackson · L. · Lou · V. W. Q.
Introduction

Social robots including telepresence robots have emerged as potential support in dementia care. However, the effectiveness of these robots hinges significantly on their design and utility. These elements are often best understood by their end-users. Codesign involves collaborating directly with the end-users of a product during its development process. Engaging people with dementia in the design of social robots ensures that the products cater to their unique requirements, preferences, challenges, and needs. The objective of this scoping review is to understand the facilitators, barriers, and strategies in codesigning social robots with older adults with dementia.

Methods and analysis

The scoping review will follow the Joanna Briggs Institute scoping review methodology and will be conducted from November 2023 to April 2024. The steps of search strategy will involve identifying keywords and index terms from CINAHL and PubMed, completing search using identified keywords and index terms across selected databases (Medline, CINAHL, PubMed, AgeLine, Web of Science, PsycINFO, Scopus, IEEE, and Google Scholar), and hand-searching the reference lists from chosen literature for additional literature. The grey literature will be searched using Google. Three research assistants will screen the titles and abstracts independently by referring to the inclusion criteria. Three researchers will independently assess the full text of literature following to the inclusion criteria. The data will be presented in a table with narratives that answers the questions of the scoping review.

Ethics and dissemination

This scoping review does not require ethics approval because it collects data from publicly available resources. The findings will offer insights to inform future research and development of robots through collaboration with older people with dementia. In addition, the scoping review results will be disseminated through conference presentations and an open-access publication in a peer-reviewed journal.

Portable devices for diagnosis and monitoring of glaucoma: a scoping review protocol

Por: Garba · F. · Kyari · F. · Nolan · W. · Burton · M. J. · Gordon · I. · Evans · J. R. · Hu · V. H.
Introduction

Glaucoma is the leading cause of irreversible blindness in the world. The need to diagnose glaucoma early in its natural history before extensive sight loss occurs cannot be overemphasised. However, glaucoma is largely asymptomatic in the early stages of the disease making it complex to diagnose clinically and requires the support of technology. The objective of this scoping review is to determine the nature and extent of the evidence for use of portable devices in the diagnosis of glaucoma.

Methods

We will consider studies conducted in all healthcare settings using portable devices for the detection of all type of adult glaucoma. We will also include any systematic reviews or scoping reviews, which relate to this topic. Searches will be conducted in MEDLINE, Embase, CENTRAL on the Cochrane Library and Global Health databases, from their inception to the present. Reference lists from publications identified in the searches will also be reviewed. Two authors will independently screen titles and abstracts, followed by full-text screening to assess studies for inclusion. Any disagreements will be discussed and resolved with a third author. Tables accompanied by narrative descriptions will be employed to discuss results and show how it relates to review questions.

Ethics and dissemination

Ethical approval is not required in this review. Only published and publicly accessible data will be used. We will publish our findings in an open-access, peer-reviewed journal and develop an accessible summary of results and recommendations.

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