Acute pain pathways: protocol for a prospective cohort study

Introduction
Opioid analgesics are often used to treat moderate-to-severe acute non-cancer pain; however, there is little high-quality evidence to guide clinician prescribing. An essential element to developing evidence-based guidelines is a better understanding of pain management and pain control among individuals experiencing acute pain for various common diagnoses.

Methods and analysis
This multicentre prospective observational study will recruit 1550 opioid-naïve participants with acute pain seen in diverse clinical settings including primary/urgent care, emergency departments and dental clinics. Participants will be followed for 6 months with the aid of a patient-centred health data aggregating platform that consolidates data from study questionnaires, electronic health record data on healthcare services received, prescription fill data from pharmacies, and activity and sleep data from a Fitbit activity tracker. Participants will be enrolled to represent diverse races and ethnicities and pain conditions, as well as geographical diversity. Data analysis will focus on assessing patients’ patterns of pain and opioid analgesic use, along with other pain treatments; associations between patient and condition characteristics and patient-centred outcomes including resolution of pain, satisfaction with care and long-term use of opioid analgesics; and descriptive analyses of patient management of leftover opioids.

Ethics and dissemination
This study has received approval from IRBs at each site. Results will be made available to participants, funders, the research community and the public.

Trial registration number
NCT04509115.

Leggi
Luglio 2022

Integrating hepatitis B care and treatment with existing HIV services is possible: cost of integrated HIV and hepatitis B treatment in a low-resource setting: a cross-sectional hospital-based cost-minimisation assessment

Background
Hepatitis B and HIV care share health system challenges in the implementation of primary prevention, screening, early linkage to care, monitoring of therapeutic success and long-term medication adherence.

Setting
Arua regional referral hospital (RRH) and Koboko district hospital (DH), the West Nile region of Uganda.

Design
A cross-sectional hospital-based cost minimisation study from the providers’ perspective considers financial costs to measure the amount of money spent on resources used in the stand-alone and integrated pathways.

Data sources
Clinic inputs and procurement invoices, budgetary documents, open market information and expert opinion. Data were extracted from 3121 files of HIV and hepatitis B virus (HBV) monoinfected patients from the two study sites.

Objective
To estimate provider costs associated with running an integrated HBV and HIV clinical pathway for patients on lifelong treatment in low-resource setting in Uganda.

Outcome measures
The annual cost per patient was simulated based on the total amount of resources spent for all the expected number of patient visits to the facility for HBV or HIV care per year.

Results
Findings showed that Arua hospital had a higher cost per patient in both clinics than did Koboko Hospital. The cost per HBV patient was US$163.59 in Arua and US$145.76 in Koboko while the cost per HIV patient was US$176.52 in Arua and US$173.23 in Koboko. The integration resulted in a total saving of US$36.73 per patient per year in Arua RRH and US$17.5 in Koboko DH.

Conclusion
The application of the integrated Pathway in HIV and HBV patient management could improve hospital cost efficiency compared with operating stand-alone clinics.

Leggi
Luglio 2022

Whole-body photobiomodulation therapy for chronic pain: a protocol for a feasibility trial

Introduction
Chronic pain conditions are a leading cause of disease and disability. They are associated with symptoms such as fatigue, sleep and mood disturbances. Minimal evidence is available to support effective treatments and alternatives treatment approaches are called for. Photobiomodulation therapy has been highlighted as one promising option. A whole-body therapy device (NovoTHOR) has recently been developed with a number of potential advantages for people with chronic pain. Research is needed to consider the feasibility of this device.

Methods and analysis
A single-centre single-armed (no placebo group) feasibility study with an embedded qualitative component will be conducted. The intervention will comprise 18 treatments over 6 weeks, with 6-month follow-up, in the whole-body photobiomodulation device. A non-probability sample of 20 adult participants with a clinician diagnosis of chronic axial pain, polyarthralgia, myofascial pain or widespread pain will be recruited (self-referral and clinician referral). Outcome measures will focus on acceptability of trial processes with a view to guiding a definitive randomised controlled trial. Analyses will use descriptive statistics for quantitative aspects. The qualitative element will be assessed by means of a participant-reported experience questionnaire postintervention and semistructured audio-recorded interviews at three stages; preintervention, midintervention and postintervention. The latter will be transcribed verbatim and a reflexive thematic analysis will be used to identify emerging themes. Exploratory outcomes (participant-reported and performance-based measures) will be analysed according to data distribution.

Ethics and dissemination
The study has received ethical approval from the Leicester Central Research and Ethics Committee. Findings will be disseminated via local chronic pain groups, public register update, submission for presentation at scientific meetings and open-access peer-reviewed journals, and via academic social networks.

Trial registration number
NCT05069363.

Leggi
Giugno 2022

Self-Examination Low-Cost Full-Field Optical Coherence Tomography (SELFF-OCT) for neovascular age-related macular degeneration: a cross-sectional diagnostic accuracy study

Objectives
Self-Examination Low-Cost Full-Field Optical Coherence Tomography (SELFF-OCT) is a novel OCT technology that was specifically designed for home monitoring of neovascular age-related macular degeneration (AMD). First clinical findings have been reported before. This trial investigates an improved prototype for patients with AMD and focusses on device operability and diagnostic accuracy compared with established spectral-domain OCT (SD-OCT).

Design
Prospective single-arm diagnostic accuracy study.

Setting
Tertiary care centre (University Eye Clinic).

Participants
46 patients with age-related macular degeneration.

Interventions
Patients received short training in device handling and then performed multiple self-scans with the SELFF-OCT according to a predefined protocol. Additionally, all eyes were examined with standard SD-OCT, performed by medical personnel. All images were graded by at least 2 masked investigators in a reading centre.

Primary outcome measure
Rate of successful self-measurements.

Secondary outcome measures
Sensitivity and specificity of SELFF-OCT versus SD-OCT for different biomarkers and necessity for antivascular endothelial growth factor (anti-VEGF) treatment.

Results
In 86% of all examined eyes, OCT self-acquisition resulted in interpretable retinal OCT volume scans. In these patients, the sensitivity for detection of anti-VEGF treatment necessity was 0.94 (95% CI 0.79 to 0.99) and specificity 0.95 (95% CI 0.82 to 0.99).

Conclusions
SELFF-OCT was used successfully for retinal self-examination in most patients, and it could become a valuable tool for retinal home monitoring in the future. Improvements are in progress to reduce device size and to improve handling, image quality and success rates.

Trial registration number
DRKS00013755, CIV-17-12-022384.

Leggi
Giugno 2022

An Atypical Cause of Musculoskeletal Pain in a Patient With Chronic Inflammatory Bowel Disease

Question: A 21-year-old man presented with abdominal pain, diarrhea, and myalgia. He had been hospitalized in our unit and diagnosed with Crohn’s disease 2 months earlier, based on the results of ileo-coloscopy and biopsies. Treatment with adalimumab was started, allowing recovery from digestive symptoms after 3 injections. The next injection could not be performed because of a biological inflammatory syndrome (CRP, 80 mg/L; N

Leggi
Giugno 2022

Correction: Mediation role of low birth weight on the factors associated with newborn mortality and the moderation role of institutional delivery in the association of low birth weight with newborn mortality in a resource-poor setting

Kananura RM. Mediation role of low birth weight on the factors associated with newborn mortality and the moderation role of institutional delivery in the association of low birth weight with newborn mortality in a resource-poor setting. BMJ Open 2021;11:e046322. doi: 10.1136/bmjopen-2020-046322 This article was previously published with an error. There was a mistake in calculating the indirect effect of the Perinatal Mortality (PM) factors that are mediated through Low Birth Weight (LBW). Based on tables 1 and 2 results, the indirect effects are calculated as: Total effects are calculated as: where, represents LBW coefficient in PM model, represents variable coefficient in the LBW model and represents variable coefficient in the PM model that matches . Table 1 presents results on direct factors of PM and table 2 presents results on indirect factors of PM that are mediated through LBW. Based on the…

Leggi
Giugno 2022

Cost and cost effectiveness of reactive case detection (RACD), reactive focal mass drug administration (rfMDA) and reactive focal vector control (RAVC) to reduce malaria in the low endemic setting of Namibia: an analysis alongside a 2×2 factorial design cluster randomised controlled trial

Objectives
To estimate the cost and cost effectiveness of reactive case detection (RACD), reactive focal mass drug administration (rfMDA) and reactive focal vector control (RAVC) to reduce malaria in a low endemic setting.

Setting
The study was part of a 2×2 factorial design cluster randomised controlled trial within the catchment area of 11 primary health facilities in Zambezi, Namibia.

Participants
Cost and outcome data were collected from the trial, which included 8948 community members that received interventions due to their residence within 500 m of malaria index cases.

Outcome measures
The primary outcome was incremental cost effectiveness ratio (ICER) per in incident case averted. ICER per prevalent case and per disability-adjusted life years (DALY) averted were secondary outcomes, as were per unit interventions costs and personnel time. Outcomes were compared as: (1) rfMDA versus RACD, (2) RAVC versus no RAVC and (3) rfMDA+RAVC versus RACD only.

Results
rfMDA cost 1.1x more than RACD, and RAVC cost 1.7x more than no RAVC. Relative to RACD only, the cost of rfMDA+RAVC was double ($3082 vs $1553 per event). The ICERs for rfMDA versus RACD, RAVC versus no RAVC and rfMDA+RAVC versus RACD only were $114, $1472 and $842, per incident case averted, respectively. Using prevalent infections and DALYs as outcomes, trends were similar. The median personnel time to implement rfMDA was 20% lower than for RACD (30 vs 38 min per person). The median personnel time for RAVC was 34 min per structure sprayed.

Conclusion
Implemented alone or in combination, rfMDA and RAVC were cost effective in reducing malaria incidence and prevalence despite higher implementation costs in the intervention compared with control arms. Compared with RACD, rfMDA was time saving. Cost and time requirements for the combined intervention could be decreased by implementing rfMDA and RAVC simultaneously by a single team.

Trial registration number
NCT02610400; Post-results.

Leggi
Giugno 2022

Making the most of existing research: an evidence gap map of the effects of food systems interventions in low-income and middle-income countries

Objective
Identify and describe the available evidence on the effects food systems interventions on food security and nutrition outcomes in low-income and middle-income countries.

Methods
An adapted version of the high-level panel of experts food systems framework defined the interventions and outcomes included studies. Included study designs were experimental and quasi-experimental quantitative impact evaluations and systematic reviews. Following standards for evidence gap maps developed by 3ie, a systematic search of 17 academic databases and 31 sector-specific repositories in May 2020 identified articles for inclusion. Trained consultants screened titles/abstracts, then full texts of identified articles. Studies meeting eligibility criteria had meta-data systematically extracted and were descriptively analysed. Systematic reviews were critically appraised.

Results
The map includes 1838 impact evaluations and 178 systematic reviews. The most common interventions, with over 100 impact evaluations and 20 systematic reviews each, were: provision of supplements, fortification, nutrition classes, direct provision of foods and peer support/counselling. Few studies addressed national-level interventions or women’s empowerment. The most common final outcomes were: anthropometry, micronutrient status, and diet quality and adequacy. Intermediate outcomes were less studied.
Most evaluations were conducted in sub-Saharan Africa (33%) or South Asia (20%). Many studies occurred in lower-middle-income countries (43%); few (7%) were in fragile countries. Among studies in a specific age group, infants were most frequently included (19%); 14% of these also considered mothers.
Few evaluations considered qualitative or cost analysis; 75% used randomisation as the main identification strategy.

Discussion
The uneven distribution of research means that some interventions have established impacts while other interventions, often affecting large populations, are underevaluated. Areas for future research include the evaluation of national level policies, evaluation of efforts to support women’s empowerment within the food system, and the synthesis of dietary quality. Quasi-experimental approaches should be adopted to evaluate difficult to randomise interventions.

Leggi
Giugno 2022

Effectiveness of nurse-led volunteer support and technology-driven pain assessment in improving the outcomes of hospitalised older adults: protocol for a cluster randomised controlled trial

Introduction
Hospitalised older adults are prone to functional deterioration, which is more evident in frail older patients and can be further exacerbated by pain. Two interventions that have the potential to prevent progression of frailty and improve patient outcomes in hospitalised older adults but have yet to be subject to clinical trials are nurse-led volunteer support and technology-driven assessment of pain.

Methods and analysis
This single-centre, prospective, non-blinded, cluster randomised controlled trial will compare the efficacy of nurse-led volunteer support, technology-driven pain assessment and the combination of the two interventions to usual care for hospitalised older adults. Prior to commencing recruitment, the intervention and control conditions will be randomised across four wards. Recruitment will continue for 12 months. Data will be collected on admission, at discharge and at 30 days post discharge, with additional data collected during hospitalisation comprising records of pain assessment and volunteer support activity. The primary outcome of this study will be the change in frailty between both admission and discharge, and admission and 30 days, and secondary outcomes include length of stay, adverse events, discharge destination, quality of life, depression, cognitive function, functional independence, pain scores, pain management intervention (type and frequency) and unplanned 30-day readmissions. Stakeholder evaluation and an economic analysis of the interventions will also be conducted.

Ethics and dissemination
Ethical approval has been granted by Human Research Ethics Committees at Ramsay Health Care WA|SA (number: 2057) and Edith Cowan University (number: 2021-02210-SAUNDERS). The findings will be disseminated through conference presentations, peer-reviewed publications and social media.

Trial registration number
ACTRN12620001173987.

Leggi
Giugno 2022

Study design and protocol of a low to high intensity computer-based cognitive training at home in supplement to standard care in patients with AD

Introduction
Recent studies on cognitive training in patients with Alzheimer’s disease (AD) showed positive long-term effects on cognition and daily living, suggesting remote computer-based programmes to increase training sessions while reducing patient’s travelling. The aim of this study is to examine short-term and long-term benefits of computer-based cognitive training at home in patients with mild to moderate AD, as a complement to the training in speech and language therapists’ (SLT) offices. The secondary purpose is to study training frequency required to obtain noticeable effects.

Methods and analyses
This is a national multicentre study, conducted in SLT offices. The patients follow training in one of three conditions: once a week in SLT office only (regular condition) and once a week in SLT office plus one or three times per week at home. The trainings’ content in SLT office and at home is identical. For all three groups near and far transfer will be compared with evaluate training frequency’s effect. Our primary outcome is executive and working memory scores in experimental tasks, and the secondary is neuropsychological tests and questionnaires’ scores. Linear models’ analyses are considered for all measures with a random intercept for patients and another for per practice. The fixed effects will be: three modality groups and time, repeated measures, (T0—pretraining, T1—post-training, T2—long-term follow-up) and the interaction pairs.

Ethics and dissemination
The study got ethics approval of the national ethical committee CPP Sud Méditerranée III (No 2019-A00458-49) and of the National Commission for Information Technology and Liberties (No 919217). Informed consent is obtained from each participant. Results will be disseminated in oral communications or posters in international conferences and published in scientific journals.

Trial registration number
NCT04010175.

Leggi
Giugno 2022

Patients and physiotherapists perspectives on implementing a tailored stratified treatment approach for low back pain in Nigeria: a qualitative study

Background
Stratified care has the potential to be efficient in addressing the physical and psychosocial components of low back pain (LBP) and optimise treatment outcomes essential in low-income countries. This study aimed to investigate the perceptions of physiotherapists and patients in Nigeria towards stratified care for the treatment of LBP, exploring barriers and enablers to implementation.

Methods
A qualitative design with semistructured individual telephone interviews for physiotherapists and patients with LBP comprising research evidence and information on stratified care was adopted. Preceding the interviews, patients completed the Subgroups for Targeted Treatment tool. The interviews were recorded, transcribed and analysed following grounded theory methodology.

Results
Twelve physiotherapists and 13 patients with LBP participated in the study (11 female, mean age 42.8 (SD 11.47) years). Seven key categories emerged: recognising the need for change, acceptance of innovation, resistance to change, adapting practice, patient’s learning journey, trusting the therapist and needing conviction. Physiotherapists perceived stratified care to be a familiar approach based on their background training. The prevalent treatment tradition and the patient expectations were seen as major barriers to implementation of stratified care by the physiotherapists. Patients see themselves as more informed than therapists realise, yet they need conviction through communication and education to cooperate with their therapist using this approach. Viable facilitators were also identified as patients’ trust in the physiotherapist and adaptations in terms of training and modification of the approach to enhance its use.

Conclusion
Key barriers identified are the patients’ treatment expectations and physiotherapists’ adherence to the tradition of practice. Physiotherapists might facilitate implementation of the stratified care by communication, hierarchical implementation and utilisation of patients’ trust. Possibilities to develop a consensus on key strategies to overcome barriers and on utilisation of facilitators should be tested in future research.

Leggi
Giugno 2022

Healthcare utilization and related costs among older people seeking primary care due to back pain: findings from the BACE-N cohort study

Objectives
To describe healthcare utilization and estimate associated costs during 1 year of follow-up among older people seeking primary care due to a new episode back pain and to describe healthcare utilization across patients with different risk profiles stratified using the StarT Back Screening Tool (SBST).

Design
Prospective cohort study.

Participants and setting
A total of 452 people aged ≥55 years seeking Norwegian primary care with a new episode of back pain were included.

Outcome measures
The primary outcome of this study was total cost of healthcare utilization aggregated for 1 year of follow-up. Secondary outcomes included components of healthcare utilization aggregated for 1 year of follow-up. Healthcare utilization was self-reported and included: primary care consultations, medications, examinations, hospitalisation, rehabilitation stay, and operations. Costs were estimated based on unit costs collected from national pricelists. Healthcare utilization across patients with different SBST risk profiles was compared using Kruskal-Wallis test, post hoc Mann-Whitney U tests and Bonferroni adjustment.

Results
In total, 438 patients were included in the analysis. Mean (BCa 95% CI) total cost per patient over 1 year was 825 (682-976). Median (BCa 95% CI) total cost was 364 (307-440). The largest cost category was primary care consultations, accounting for 56% of total costs. Imaging rate was 34%. The most commonly used medication was paracetamol (27%–35% of patients). Medium- and high-risk patients had a significantly higher degree of healthcare utilization compared with low-risk patients (p

Leggi
Giugno 2022

International perspective on healthcare provider gender bias in musculoskeletal pain management: a scoping review protocol

Introduction
Chronic pain affects millions of individuals worldwide. Healthcare provider gender bias in the management of these individuals has societal and individual ramifications. Yet, a thorough and comprehensive literature summary on this topic is lacking. Therefore, this study aims to systematically: (1) identify and map the available scientific and grey literature as it relates to healthcare provider gender bias in the assessment, diagnosis and management of (chronic) musculoskeletal pain and (2) identify current gaps that necessitate further research.

Methods and analysis
This scoping review will be conducted in accordance with recent guidelines, and the results will be reported via the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. The following databases will be searched: PubMed (National Library of Medicine), Embase (Elsevier), Scopus (Elsevier), CINAHL Complete (Ovid), Academic Search Complete (Ebscohost), Pre-Prints Database (National Library of Medicine) and Rehabilitation Reference Center from inception to August 2022. Additionally, relevant grey literature will be identified. All screening will be done by two independent reviewers during two stages: first title/abstract screening followed by full-text screening. Data will be extracted from the bibliometric, study characteristics, and pain science families of variables. Results will be descriptively mapped, and the frequency of concepts, population, characteristics and other details will be narratively reported. Additionally, results will be presented in tabular and graphical form.

Ethics and dissemination
As this study will neither involve human subject participation nor utilisation of protected data, ethical approval is not required. This study’s methodological approach follows current recommendations. Study findings will be disseminated through conference presentations and international peer-review journal publication. In addition, infographics available in English, Spanish and German will be disseminated.

Registration details
This project will be registered in Open Science Framework prior to data collection.

Leggi
Giugno 2022

A Rare Cause of Chronic Abdominal Pain and Weight Loss

Question: This 63-year-old woman with a history of chronic hepatitis B infection with liver cirrhosis presented with intermittent epigastric pain in the left upper quadrant of her abdomen for 3 months. Esophagogastroduodenoscopy was performed and showed only mild gastritis without Helicobacter pylori infection. Furthermore, postprandial pain deteriorated after prokinetic agents use and proton pump inhibitor could not relieve her symptoms. Her weight loss was from 51 kg to 46 kg in the past 3 months.

Leggi
Giugno 2022