Post-COVID pain and quality of life in COVID-19 patients: protocol for a meta-analysis and systematic review

Introduction
During the COVID-19 pandemic, approximately 10%–35% of COVID-19 infected patients experience post-COVID sequela. Among these sequelae, pain symptoms should not be neglected. In addition, the sequelae of COVID-19 also decrease the quality of life of these populations. However, meta-analyses that systematically evaluated post-COVID pain are sparse.

Methods and analysis
A comprehensive screening will be performed by searching MEDLINE and Embase without language restriction from inception to August 2021. Cohort studies, case–control studies, cross-sectional studies and case series will be included. Case report and interventional studies will be excluded. Studies with less than 20 participants will be also excluded. We aim to investigate the prevalence of pain-related symptoms in patients after the acute phase of COVID-19. The impact of COVID-19 on the quality of life and pain symptoms among these populations in the post-acute phase will also be evaluated. ROBINS-I tool will be used to assess the risk of bias of cohort studies. The risk of bias tool developed by Hoy et al will be used to assess the risk of bias of prevalence studies. Metaprop command in Stata will be used to estimate the pooled prevalence of pain symptoms. DerSimonian and Laird random-effects models will be used to calculate the pooled relative risks. All analyses will be calculated using Stata software (V.15.0; StataCorp)

Ethics and dissemination
Ethics approval is not required. Results of our study will be submitted to a peer-review journal.

PROSPERO registration number
CRD42021272800.

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Luglio 2022

An Unusual Cause of Rectal Pain

Question: A 79-year-old man presented with a 1-week history of rectal pain. He had passed a painful, jagged stool with fresh red rectal bleeding. The patient reported that it felt like passing “broken glass.” He had previously undergone a laparoscopic anterior resection with a nonfunctioning ileostomy for adenocarcinoma of rectum (T3 M0 N1) 7 years prior. His ileostomy had been closed and there had been no evidence of disease recurrence on follow-up. In addition, he has atrial fibrillation, hypertension, type 2 diabetes mellitus, and had acute cholecystitis with calcification that was managed conservatively 4 years ago.

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Luglio 2022

Perspectives on adapting a mobile application for pain self-management in neurofibromatosis type 1: results of online focus group discussions with individuals living with neurofibromatosis type 1 and pain management experts

Objective
Neurofibromatosis type 1 (NF1) is a genetic disorder in which chronic pain commonly occurs. The study sought to understand the needs of individuals with NF1 and pain management experts when adapting a pain self-management mobile health application (app) for individuals with NF1.

Design
We conducted a series of online, audio-recorded focus groups that were then thematically analysed.

Setting
Online focus groups with adults currently residing in the USA.

Participants
Two types of participants were included: individuals with NF1 (n=32 across six focus groups) and pain management experts (n=10 across three focus groups).

Results
Six themes across two levels were identified. The individual level included lifestyle, reasons for using the mobile app and concerns regarding its use. The app level included desired content, desired features and format considerations. Findings included recommendations to grant free access to the app and include a community support feature for individuals to relate and validate one another’s experience with pain from NF1. In addition, participants noted the importance of providing clear instructions on navigating the app, the use of an upbeat, hopeful tone and appropriate visuals.

Conclusions
Both participant groups endorsed the use of iCanCope (iCC) as an NF1 pain self-management mobile app. Differences between groups were noted, however. The NF1 group appeared interested in detailed and nuanced pain tracking capabilities; the expert group prioritised tracking information such as mood, nutrition and activity to identify potential associations with pain. In tailoring the existing iCC app for individuals with NF1, attention should be paid to creating a community support group feature and to tailoring content, features and format to potential users’ specific needs.

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Luglio 2022

Its safe to move! A protocol for a randomised controlled trial investigating the effect of a video designed to increase peoples confidence becoming more active despite back pain

Introduction
Social media provide promising contemporary platforms for sharing public health information with a broad audience. Before implementation, testing social media campaigns that are intended to engage audiences and initiate behaviour change is necessary. This trial aims to investigate the effectiveness of a public health campaign to increase people’s confidence in becoming more active despite low back pain in comparison with no intervention.

Methods and analysis
This is an online randomised controlled trial with two intervention groups and one control group in a 1:1:1 allocation. People over 18 years of age and fluent in English will be recruited via social media advertising. We developed a social media-based public health campaign to support recommendations for managing low back pain. The interventions are two videos. Participants in the control group will be asked questions about low back pain but will not view either video intervention. The primary outcome will be item 10 of the Pain Self-Efficacy Questionnaire, which asks participants to rate how confident they would feel to gradually become more active despite pain ranging from 0 (not at all confident) to 6 (completely confident). This outcome will be measured immediately in all participant groups. We will compare group mean of the three arms of the trial using univariate analyses of variance.

Ethics and dissemination
This trial has been prospectively registered with the Australian New Zealand Clinical Trials Registry. We obtained ethical approval from our institutions Human Research Ethics Committee before data collection. We will publish the results in a peer-reviewed medical journal and on institution websites.

Trial registration number
Australian New Zealand Clinical Trials Registry (ACTRN12622000466741).

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Luglio 2022

Cohort profile: the Halland osteoarthritis (HALLOA) cohort-from knee pain to osteoarthritis: a longitudinal observational study in Sweden

Purpose
The overall objective in this study is to investigate the early development of radiographic knee osteoarthritis (OA) and its association with hand or/and knee OA, metabolic diseases, biomarkers, chronic pain, physical function and daily physical activity types.

Participants
The Halland osteoarthritis (HALLOA) cohort is a longitudinal cohort study that includes individuals with knee pain in the southwest of Sweden. Enrolment took place from 2017 to 2019. The inclusion criteria were current knee pain, with no former known radiographic knee OA and no cruciate ligament rupture or rheumatological disorder. The participants were recruited: (1) when seeking care for knee pain in primary healthcare or (2) by advertisements in local newspapers. There are 306 individuals included in the study, mean age (SD) 51.7 (8.7) years and 69% are women. The baseline and follow-ups include clinical tests, radiographical examinations, blood samples, metabolic measures, pain pressure thresholds, tests of physical functions, daily physical activity types and patient-reported outcomes.

Findings to date
There were associations between metabolic factors and radiographic knee OA, even in those with normal body mass index at baseline. In addition, clinical hand OA was positively associated with fasting plasma glucose. We also found that modifiable factors as increased visceral fat and total body fat were associated with increased pain sensitivity among individuals with knee pain.

Future plans
By studying possible pathophysiological mechanisms of OA over time, we aim to provide new insights on OA progression, identify usable preventive measures helping the clinicians in the management of the disease and improve health for the patients. It is also important to study the development of chronic pain in OA, to get tools to identify individuals at risk and to be able to offer them treatment.

Trial registration number
ClinicalTrials.gov (NCT04928170).

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Luglio 2022

Predictive value of the New Zealand Early Warning Score for early mortality in low-acuity patients discharged at scene by paramedics: an observational study

Objectives
The utility of New Zealand Early Warning Score (NZEWS) for prediction of adversity in low-acuity patients discharged at scene by paramedics has not been investigated. The objective of this study was to evaluate the association between the NZEWS risk-assessment tool and adverse outcomes of early mortality or ambulance reattendance within 48 hours in low-acuity, prehospital patients not transported by ambulance.

Design
A retrospective cohort study.

Setting
Prehospital emergency medical service provided by St John New Zealand over a 2-year period (1 July 2016 through 30 June 2018).

Participants
83 171 low-acuity, adult patients who were attended by an ambulance and discharged at scene. Of these, 41 406 had sufficient recorded data to calculate an NZEWS.

Primary and secondary outcome(s) and measure(s)
Binary logistic regression modelling was used to investigate the association between the NZEWS and adverse outcomes of reattendance within 48 hours, mortality within 2 days, mortality within 7 days and mortality within 30 days.

Results
An NZEWS greater than 0 was significantly associated with all adverse outcomes studied (p10 was 70 times that of those scoring 0 (adjusted OR 70.64, 95% CI: 30.73 to 162.36). The best predictability for adverse outcome was observed for 2-day and 7-day mortality, with moderate area under the receiver operating characteristic curve scores of 0.78 (95% CI: 0.73 to 0.82) and 0.74 (95% CI: 0.71 to 0.77), respectively.

Conclusions
Adverse outcomes in low-acuity non-transported patients show a significant association with risk prediction by the NZEWS. There was a very high association between large early warning scores and 2-day mortality in this patient group. These findings suggest that NZEWS has significant utility for decision support and improving safety when determining the appropriateness of discharging low-acuity patients at the scene.

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Luglio 2022

An Unusual Cause of Intractable Hiccup and Intermittent Low Fever

Question: A 59-year-old man with autosomal dominant polycystic kidney disease (ADPKD) was hospitalized due to a history of intermittent low fever (up to 38°C) with intractable hiccup, and worsening of chronic abdominal pain for more than half a month. The patient underwent right nephrectomy and kidney transplantation 1 year ago. The patient had mild tenderness in the right upper quadrant.

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Luglio 2022

Swiss chiropractic practice-based research network and musculoskeletal pain cohort pilot study: protocol of a nationwide resource to advance musculoskeletal health services research

Introduction
Musculoskeletal (MSK) pain conditions, a leading cause of global disability, are usually first managed in primary care settings such as medical, physiotherapy, and chiropractic community-based practices. While chiropractors often treat MSK conditions, there is limited real-world evidence on the topic of health service outcomes among patients receiving this type of care. A nationwide Swiss chiropractic practice-based research network (PBRN) and MSK pain patient cohort study will have potential to monitor the epidemiological trends of MSK pain conditions and contribute to healthcare quality improvement. The primary aims of this protocol are to (1) describe the development of an MSK-focused PBRN within the Swiss chiropractic setting, and (2) describe the methodology of the first nested study to be conducted within the PBRN—an observational prospective patient cohort pilot study.

Methods and analysis
This initiative is conceptualised with two distinct phases. Phase I focuses on the development of the Swiss chiropractic PBRN, and will use a cross-sectional design to collect information from chiropractic clinicians nationwide. Phase II will recruit consecutive patients aged 18 years or older with MSK pain from community-based chiropractic practices participating in the PBRN into a prospective chiropractic cohort pilot study. All data collection will occur through electronic surveys offered in the three Swiss official languages (German, French, Italian) and English. Surveys will be provided to patients prior to their initial consultation in clinics, 1 hour after initial consultation, and at 2, 6 and 12 weeks after initial consultation.

Ethics and dissemination
Ethics approval has been obtained from the independent research ethics committee of Canton Zurich (BASEC-Nr: 2021-01479). Informed consent will be obtained electronically from all participants. Findings will be reported to stakeholders after each study phase, presented at local and international conferences, and disseminated through peer-reviewed publications.

Study pre-registration
Phase I—Swiss chiropractic PBRN (ClinicalTrials.gov identifier: NCT05046249); Phase 2—Swiss chiropractic cohort (Swiss ChiCo) pilot study (ClinicalTrials.gov identifier: NCT05116020).

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Luglio 2022

Predictors of long-term symptom burden and quality of life in patients hospitalised with chest pain: a prospective observational study

Objective
To describe the magnitude and predictors of symptom burden (SB) and quality of life (QoL) 3 months after hospital admission for acute chest pain.

Design
Prospective observational study.

Setting
Single centre, outpatient follow-up.

Participants
1506 patients.

Outcomes
Scores reported for general health (RAND-12), angina-related health (Seattle Angina Questionnaire 7 (SAQ-7)) and dyspnoea (Rose Dyspnea Scale) 3 months after hospital admission for chest pain.

Methods
A total of 1506 patients received questionnaires assessing general health (RAND-12), angina-related health (SAQ-7) and dyspnoea (Rose Dyspnea Scale) 3 months after discharge. Univariable and multivariable regression models identified predictors of SB and QoL scores. A mediator analysis identified factors mediating the effect of an unstable angina pectoris (UAP) diagnosis.

Results
774 (52%) responded. Discharge diagnoses were non-ST elevation myocardial infarction (NSTEMI) (14.2%), UAP (17.1%), non-coronary cardiac disease (6.6%), non-cardiac disease (6.3%) and non-cardiac chest pain (NCCP) (55.6%). NSTEMI had the most favourable, and UAP patients the least favourable SAQ-7 scores (median SAQ7-summary; 88 vs 75, p

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Luglio 2022

Investigating service delivery and perinatal outcomes during the low prevalence first year of COVID-19 in a multiethnic Australian population: a cohort study

Objective
Investigate the impact of the COVID-19 pandemic on perinatal outcomes in an Australian high migrant and low COVID-19 prevalent population to identify if COVID-19 driven health service changes and societal influences impact obstetric and perinatal outcomes.

Design
Retrospective cohort study with pre COVID-19 period 1 January 2018–31 January 2020, and first year of global COVID-19 period 1 February 2020–31 January 2021. Multivariate logistic regression analysis was conducted adjusting for confounders including age, area-level socioeconomic status, gestation, parity, ethnicity and body mass index.

Setting
Obstetric population attending three public hospitals including a major tertiary referral centre in Western Sydney, Australia.

Participants
Women who delivered with singleton pregnancies over 20 weeks gestation. Ethnically diverse women, 66% overseas born. There were 34 103 births in the district that met inclusion criteria: before COVID-19 n=23 722, during COVID-19 n=10 381.

Main outcome measures
Induction of labour, caesarean section delivery, iatrogenic and spontaneous preterm birth, small for gestational age (SGA), composite neonatal adverse outcome and full breastfeeding at hospital discharge.

Results
During the first year of COVID-19, there was no change for induction of labour (adjusted OR, aOR 0.97; 95% CI 0.92 to 1.02, p=0.26) and a 25% increase in caesarean section births (aOR 1.25; 95% CI 1.19 to 1.32, p

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Luglio 2022

Development of an imputation model to recalibrate birth weights measured in the early neonatal period to time at delivery and assessment of its impact on size-for-gestational age and low birthweight prevalence estimates: a secondary analysis of a pregnancy cohort in rural Nepal

Objectives
In low-income countries, birth weights for home deliveries are often measured at the nadir when babies may lose up of 10% of their birth weight, biasing estimates of small-for-gestational age (SGA) and low birth weight (LBW). We aimed to develop an imputation model that predicts the ‘true’ birth weight at time of delivery.

Design
We developed and applied a model that recalibrates weights measured in the early neonatal period to time=0 at delivery and uses those recalibrated birth weights to impute missing birth weights.

Setting
This is a secondary analysis of pregnancy cohort data from two studies in Sarlahi district, Nepal.

Participants
The participants are 457 babies with daily weights measured in the first 10 days of life from a subsample of a larger clinical trial on chlorhexidine (CHX) neonatal skin cleansing and 31 116 babies followed through the neonatal period to test the impact of neonatal massage oil type (Nepal Oil Massage Study (NOMS)).

Outcome measures
We developed an empirical Bayes model of early neonatal weight change using CHX trial longitudinal data and applied it to the NOMS dataset to recalibrate and then impute birth weight at delivery. The outcomes are size-for-gestational age and LBW.

Results
When using the imputed birth weights, the proportion of SGA is reduced from 49% (95% CI: 48% to 49%) to 44% (95% CI: 43% to 44%). Low birth weight is reduced from 30% (95% CI: 30% to 31%) to 27% (95% CI: 26% to 27%). The proportion of babies born large-for-gestational age increased from 4% (95% CI: 4% to 4%) to 5% (95% CI: 5% to 5%).

Conclusions
Using weights measured around the nadir overestimates the prevalence of SGA and LBW. Studies in low-income settings with high levels of home births should consider a similar recalibration and imputation model to generate more accurate population estimates of small and vulnerable newborns.

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Luglio 2022

Morbidity and mortality patterns of preterm low birthweight neonates admitted to referral hospitals in the Amhara region of Ethiopia: retrospective follow-up study

Objective
This study aimed to assess the morbidity and mortality patterns of preterm neonates with low birth weight admitted in the Amhara region referral hospitals in Ethiopia.

Design
Hospital-based retrospective follow-up study.

Setting
Amhara region referral hospitals, Ethiopia.

Participants
A total of 291 preterm neonates low birth weight that were admitted to referral hospitals in the Amhara region between 1 January 2017 and 30 December 2018 were reviewed. Data were entered into Epi-data V.4.4.2.1 and exported to STATA V.14 for analysis, and variables with a p value of

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Luglio 2022

Efficacy and safety of high-voltage versus standard-voltage pulsed radiofrequency ablation for patients with neuropathic pain: protocol for a systematic review and meta-analysis

Introduction
Pulsed radiofrequency (PRF) ablation is commonly used for the treatment of neuropathic pain (NP). However, it is unclear whether increasing the output voltage of PRF can safely improve its efficacy. This study aims to compare the efficacy and safety of high-voltage PRF ablation and standard-voltage PRF ablation for the treatment of patients with NP.

Methods and analysis
We will search PubMed/MEDLINE, EMBASE, Web of Science, the Cochrane Library, conference proceedings for relevant abstracts, clinical trials registers (ClinicalTrials.gov) and the WHO’s International Clinical Trial Registry Platform (from the date of inception until 15 March 2022). Only randomised controlled trials will be included. Two reviewers (YJ and GF) will independently perform study screening and selection, data extraction, risk-of-bias assessment and quality-of-evidence assessment. The primary outcome of this meta-analysis will be the efficiency rate in patients with NP. The secondary outcomes will include numeric rating scale score, visual analogue scale score, time to take effect, rescue drug dosage, quality of life using the health questionnaire (SF-36) and the incidence of adverse events. Meta-analyses will be conducted using standard meta-analysis software (RevMan V.5.3, The Nordic Cochrane Center, The Cochrane Collaboration, Copenhagen, Denmark).

Ethics and dissemination
The requirement for ethical approval was waived as our systematic review will be based on the published literature. The results of this study will be submitted to a peer-reviewed journal.

PROSPERO registration number
CRD42022297804.

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Luglio 2022

Randomised trials in maternal and perinatal health in low and middle-income countries from 2010 to 2019: a systematic scoping review

Objectives
To identify and map all trials in maternal health conducted in low and middle-income countries (LMIC) over the 10-year period from 2010 to 2019, to identify geographical and thematic trends, as well as comparing to global causes of maternal death and preidentified priority areas.

Design
Systematic scoping review.

Primary and secondary outcome measures
Extracted data included location, study characteristics and whether trials corresponded to causes of mortality and identified research priority topics.

Results
We searched the Cochrane Central Register of Controlled Trials database, a combined registry of trials from multiple sources. Our search identified 7269 articles, 874 of which were included for analysis. Between 2010 and 2019, maternal health trials conducted in LMICs more than doubled (50–114). Trials were conducted in 61 countries—231 trials (26.4%) were conducted in Iran. Only 225 trials (25.7%) were aligned with a cause of maternal mortality. Within these trials, pre-existing medical conditions, embolism, obstructed labour and sepsis were all under-represented when compared with number of maternal deaths globally. Large numbers of studies were conducted on priority topics such as labour and delivery, obstetric haemorrhage and antenatal care. Hypertensive disorders of pregnancy, diabetes and health systems and policy—despite being high-priority topics—had relatively few trials.

Conclusion
Despite trials conducted in LMICs increasing from 2010 to 2019, there were significant gaps in geographical distribution, alignment with causes of maternal mortality and known research priority topics. The research gaps identified provide guidance and insight for future research conduct in low-resource settings.

Trial registration number
10.17605/OSF.IO/QUJP5.

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Luglio 2022

Measuring anti-transgender stigma in low-income and middle-income countries: a scoping review protocol

Introduction
Globally, transgender and other gender diverse (trans) people face pervasive stigma, which contributes to health inequities across multiple health outcomes. Stigma is a fundamental cause of health inequities because it simultaneously limits access to resources, contributes to systemic vulnerability and generates chronic stress. Anti-trans stigma occurs across multiple socioecological levels, resulting in multiple possible definitions and measurements of trans stigma. Understanding how trans stigma has been measured in low-income and middle-income countries (LMICs) is critical to health promotion efforts for trans communities. Accordingly, this scoping review will identify and examine how anti-trans stigma has been measured in existing LMIC-specific research to inform best practices for measurement of anti-trans stigma that includes consideration of local context.

Methods and analysis
This is the protocol for a scoping review of anti-trans stigma in LMICs. We will search (from January 2001 to December 2021) PubMed, WHO Global Medicus and EBSCO. Study selection will conform to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews Checklist. Original studies in English, Spanish, Arabic or Russian will be included. Reviewers will independently screen all citations, full-text articles and abstract data. Data analysis will involve quantitative and qualitative methods. A narrative summary of findings will be conducted.

Ethics and dissemination
As a scoping review (no direct interaction with participants), this study is exempt from human subjects oversight. Understanding context-specific ways to measure anti-trans stigma is urgently needed to support trans health globally. The planned scoping review will help to address this gap. Results of the review will be disseminated in a peer-reviewed journal and likely in other media such as conferences, seminars and symposia.

Protocol registration number
osf.io/qcs2v

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Luglio 2022

Protocol for an intervention development and pilot implementation evaluation study of an e-health solution to improve newborn care quality and survival in two low-resource settings, Malawi and Zimbabwe: Neotree

Introduction
Every year 2.4 million deaths occur worldwide in babies younger than 28 days. Approximately 70% of these deaths occur in low-resource settings because of failure to implement evidence-based interventions. Digital health technologies may offer an implementation solution. Since 2014, we have worked in Bangladesh, Malawi, Zimbabwe and the UK to develop and pilot Neotree: an android app with accompanying data visualisation, linkage and export. Its low-cost hardware and state-of-the-art software are used to improve bedside postnatal care and to provide insights into population health trends, to impact wider policy and practice.

Methods and analysis
This is a mixed methods (1) intervention codevelopment and optimisation and (2) pilot implementation evaluation (including economic evaluation) study. Neotree will be implemented in two hospitals in Zimbabwe, and one in Malawi. Over the 2-year study period clinical and demographic newborn data will be collected via Neotree, in addition to behavioural science informed qualitative and quantitative implementation evaluation and measures of cost, newborn care quality and usability. Neotree clinical decision support algorithms will be optimised according to best available evidence and clinical validation studies.

Ethics and dissemination
This is a Wellcome Trust funded project (215742_Z_19_Z). Research ethics approvals have been obtained: Malawi College of Medicine Research and Ethics Committee (P.01/20/2909; P.02/19/2613); UCL (17123/001, 6681/001, 5019/004); Medical Research Council Zimbabwe (MRCZ/A/2570), BRTI and JREC institutional review boards (AP155/2020; JREC/327/19), Sally Mugabe Hospital Ethics Committee (071119/64; 250418/48). Results will be disseminated via academic publications and public and policy engagement activities. In this study, the care for an estimated 15 000 babies across three sites will be impacted.

Trial registration number
NCT0512707; Pre-results

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Luglio 2022