We aim to estimate the impact of various mitigation strategies on COVID-19 transmission in a US jail beyond those offered in national guidelines.
We developed a stochastic dynamic transmission model of COVID-19.
One anonymous large urban US jail.
Several thousand staff and incarcerated individuals.
There were four intervention phases during the outbreak: the start of the outbreak, depopulation of the jail, increased proportion of people in single cells and asymptomatic testing. These interventions were implemented incrementally and in concert with one another.
The basic reproduction ratio, R0, in each phase, as estimated using the next generation method. The fraction of new cases, hospitalisations and deaths averted by these interventions (along with the standard measures of sanitisation, masking and social distancing interventions).
For the first outbreak phase, the estimated R0 was 8.44 (95% credible interval (CrI): 5.00 to 13.10), and for the subsequent phases, R0,phase 2=3.64 (95% CrI: 2.43 to 5.11), R0,phase 3=1.72 (95% CrI: 1.40 to 2.12) and R0,phase 4=0.58 (95% CrI: 0.43 to 0.75). In total, the jail’s interventions prevented approximately 83% of projected cases, hospitalisations and deaths over 83 days.
Depopulation, single celling and asymptomatic testing within jails can be effective strategies to mitigate COVID-19 transmission in addition to standard public health measures. Decision makers should prioritise reductions in the jail population, single celling and testing asymptomatic populations as additional measures to manage COVID-19 within correctional settings.
Commentary on: Carlton E, Kohne J, Shankar-Hari, et al. Readmission diagnoses after paediatric severe sepsis hospitalisation. Crit Care Med 2019;47:583–90.
Children with coexisting comorbidities when discharged following severe sepsis have a higher rate of readmission as compared with matched hospitalisations for other acute medical conditions. There is a need for internationally agreed evidence-based guidelines/consensus paper to minimise post-sepsis readmissions through identification of potentially preventable factors, appropriate discharge criteria and parental education. More research is required into strategies towards prevention of readmissions following discharge after an episode of severe sepsis in children.
Children with coexisting comorbidities when discharged following severe sepsis have a higher rate of readmission as compared with matched hospitalisations for other acute medical conditions.
There is a need for internationally agreed evidence-based guidelines/consensus paper to minimise post-sepsis readmissions through identification of potentially preventable factors, appropriate discharge criteria and parental education.
More research is required into strategies towards prevention of readmissions following discharge after an episode of severe sepsis in children.
Sepsis is a leading cause of avoidable death across all age groups.
The negative impacts of COVID-19 have rippled through every facet of society. Understanding the multidimensional impacts of this pandemic is crucial to identify the most critical needs and to inform targeted interventions. This population survey study aimed to investigate the acute phase of the COVID-19 outbreak in terms of perceived threats and concerns, occupational and financial impacts, social impacts and stress between 3 April and 15 May 2020.
6040 participants are included in this report. A multivariate linear regression model was used to identify factors associated with stress changes (as measured by the Cohen’s Perceived Stress Scale (PSS)) relative to pre-outbreak retrospective estimates.
On average, PSS scores increased from low stress levels before the outbreak to moderate stress levels during the outbreak (p
Cross-sectional analyses showed a significant increase from low to moderate stress during the COVID-19 outbreak. Identified modifiable factors associated with increased stress may be informative for intervention development.
People receiving haemodialysis experience a high symptom burden and impaired quality of life. The use of patient-reported outcome measures (PROMs) is increasing in nephrology care, however their acceptability, utility and impacts are not well understood.
We describe a protocol for a qualitative study to evaluate the feasibility and acceptability of electronic-PROMs (e-PROMs) data capture and feedback in haemodialysis following the pilot
Ethics approval was obtained from the relevant hospital Human Research Ethics Committees (HREC/18/CALHN/481; HREC/MML/54599). The findings from the SWIFT pilot and qualitative evaluation will inform the implementation of the SWIFT main trial, and more broadly, the use of e-PROMs in clinical settings and registries.
Exergames training, as an additional therapy to standard care, has been widely used for motor recovery after patients who had a stroke, and it is a valuable and positive tool in the rehabilitation of this population. This study describes a single-blind randomised clinical trial that will aim to investigate the effects of exergames training on postural balance in patients with chronic stroke.
Forty-two individuals with chronic stroke (>6 months), aged 20–75 years, will be randomised into two groups: the experimental group, which will be subjected to an exergames protocol, and control group, which will undergo a kinesiotherapy protocol. Both protocols are based on postural balance. The intervention will consist of 40-minute sessions two times per week for 10 consecutive weeks. The volunteers will be evaluated before the treatment, at the end of the interventions and 8 weeks thereafter. The primary outcome will be postural balance (Berg Balance Scale, Functional Reach Test, Timed Up and Go test and Centre of Pressure variables) and secondary outcomes will include gait (6 m timed walk and Kinovea Software), cortical activation patterns (electroencephalography Emotiv EPOC), functional independence (Functional Independence Measure), quality of life (Stroke-Specific Quality of Life Scale) and motivation (Intrinsic Motivation Inventory).
This protocol was approved by the Ethics Committee of the Federal University of Rio Grande do Norte (number 3.434.350). The results of the study will be disseminated to participants through social networks and will be submitted to a peer-reviewed journal and scientific meetings.
Brazilian Registry of Clinical Trials (RBR-78v9hx).
Although demand for price transparency in healthcare is growing, variation in private payors’ payments to surgeons for oncologic resection has not been well characterised. Our aim was to assess variation of private payors’ payments to surgeons for cancer resection using data based on fee-for-service allowed amounts, billed by a large mix of commercial payors and third-party administrators.
Fair Health (FH), an independent, not-for-profit organisation that collects and compiles claims data from payors nationwide. FH maintains the nation’s largest repository of privately billed medical and dental claims representing over 125 million covered lives in the USA.
We performed a cross-sectional study assessing private payer data for five common types of cancer surgery: simple mastectomy (SM), modified radical mastectomy (MRM), open lobectomy, video-assisted thoracoscopic surgery (VATS) lobectomy and radical prostatectomy during 2012 and 2013.
To assess variation across regions, we compared regional median allowed payments. To assess intraregion variability, we evaluated the distribution of regional IQRs of allowed payments.
Median allowed payments varied substantially across regions. For SM, median allowed payments ranged from $550 in the least expensive to $1380 in the costliest region. For MRM, the range was $842–$1760, for lobectomy $326–$3066, for VATS $317–$3307 and for prostatectomy $1716–$4867. There was also substantial variation within geographic areas. For example, the mean IQRs in surgeon payment within regions were: SM $577 (25th percentile) to $1132 (75th percentile); MRM $850–$1620; lobectomy $861–$2767; VATS $1024–$3122; and prostatectomy $2286–$3563.
There is a wide range of variation both across and within geographic regions in allowed amounts of surgeon payments for common oncologic resections. Transparency about these allowed amounts may have a profound impact on patient and employer choice and facilitate future assessments of value in cancer care.
Cerebral palsy (CP) describes a heterogeneous group of motor disorders resulting from disturbance in the developing brain. CP occurs in approximately 2.1 per 1000 live births in high-income countries, but in low- and middle-income countries (LMICs) the prevalence and severity of CP may be greater and aetiological risk factors different. In Sri Lanka, a LMIC, there have been no epidemiological studies of CP to date. Systematically collected data are required to identify opportunities for primary and secondary prevention, to plan and establish services to support children and adults with CP and their families and to act as a sampling frame for new research. Here we describe a pilot study protocol for a CP register in Sri Lanka.
The aim of this study is to establish a CP register in Sri Lanka. We will use different surveillance methodologies in two provinces of Sri Lanka: hospital and community surveillance in the Western Province and community surveillance in the Eastern Province. A common record form will collect demographic, clinical and service data for children with CP
This study has ethical clearance from The University of Kelaniya, National Health Research Council, the Institutional Ethics Review Committee of the Lady Ridgeway Hospital, Colombo South Teaching Hospital and the Director of the North Colombo Teaching Hospital. Results from this research will be disseminated through local and international conferences and through publications in peer-reviewed journals.
When providing care for patients with work-related mental health conditions (MHCs), the general practitioner’s (GP) role includes clinical care, patient advocacy and assessment of a patient’s ability to work. GPs can experience difficulty representing these competing roles. As clinical guidelines were being developed to assist GPs in providing this care, our aim was to identify the clinical challenges GPs experience when diagnosing and managing patients with work-related MHCs.
This study was conducted in general practice and workers’ compensation settings across Australia.
Twenty-five GPs, seven psychiatrists and nine compensation scheme workers. GPs were eligible to participate if they were actively treating (or treated within the previous three years) patient(s) who had submitted a workers’ compensation claim for a MHC. Psychiatrists and compensation scheme workers were eligible to participate if they were active in these roles, as they are best placed to identify additional clinical challenges GPs themselves did not raise.
Participants were invited by letter to participate in qualitative semi-structured telephone interviews. Prior to each interview, participants were asked to reflect on two case vignettes, each depicting a patient’s illness trajectory over 12 months. Data were thematically analysed using inductive and deductive techniques and then categorised by stages of clinical reasoning.
Participants reported clinical challenges across four key areas: (1) Diagnosis (identifying appropriate diagnostic tools, determining the severity and work-relatedness of a MHC, and managing the implications of labelling the patient with MHC). (2) Management (determining optimal treatment, recommending work participation). (3) Referral (ambiguity of communication pathways within compensation schemes). (4) Procedure (difficulties navigating compensation systems).
We found that GPs experienced clinical challenges at all stages of care for people with work-related MHCs. We were also able to identify systemic and procedural issues that influence a GP’s ability to provide care for patients with work-related MHCs.
To assess the dose-dependent relationship between smoking history and cancer screening rates or staging of cancer diagnoses.
Prospective, population-based cohort study.
Questionnaire responses from the Women’s Health Initiative (WHI) Observational Study.
89 058 postmenopausal women.
Logistic regression models were used to assess the odds of obtaining breast, cervical, and colorectal cancer screening as stratified by smoking status. The odds of late-stage cancer diagnoses among patients with adequate vs inadequate screening as stratified by smoking status were also calculated.
Of the 89 058 women who participated, 52.8% were never smokers, 40.8% were former smokers, and 6.37% were current smokers. Over an average of 8.8 years of follow-up, current smokers had lower odds of obtaining breast (OR 0.55; 95% CI 0.51 to 0.59), cervical (OR 0.53; 95% CI 0.47 to 0.59), and colorectal cancer (OR 0.71; 95% CI 0.66 to 0.76) screening compared with never smokers. Former smokers were more likely than never smokers to receive regular screening services. Failure to adhere to screening guidelines resulted in diagnoses at higher cancer stages among current smokers for breast cancer (OR 2.78; 95% CI 1.64 to 4.70) and colorectal cancer (OR 2.26; 95% CI 1.01 to 5.05).
Active smoking is strongly associated with decreased use of cancer screening services and more advanced cancer stage at the time of diagnosis. Clinicians should emphasise the promotion of both smoking cessation and cancer screening for this high-risk group.
by Rebecca B. Lawn, Hannah M. Sallis, Robyn E. Wootton, Amy E. Taylor, Perline Demange, Abigail Fraser, Ian S. Penton-Voak, Marcus R. MunafòThere is substantial variation in the timing of significant reproductive life events such as menarche and first sexual intercourse. Life history theory explains this variation as an adaptive response to an individual’s environment and it is important to examine how traits within life history strategies affect each other. Here we applied Mendelian randomization (MR) methods to investigate whether there is a causal effect of variation in age at menarche and age at first sexual intercourse (markers or results of exposure to early life adversity) on outcomes related to reproduction, education and risky behaviour in UK Biobank (N = 114 883–181 255). Our results suggest that earlier age at menarche affects some traits that characterize life history strategies including earlier age at first and last birth, decreased educational attainment, and decreased age at leaving education (for example, we found evidence for a 0.26 year decrease in age at first birth per year decrease in age at menarche, 95% confidence interval: -0.34 to -0.17; p
To evaluate the association between socioeconomic status (SES) and referral to cardiac rehabilitation (CR) after incident acute coronary syndrome (ACS) by dividing the referral process into three phases: (1) informed about CR, (2) willingness to participate in CR, (3) and assigned CR setting.
Department of Cardiology at a Danish University Hospital from 1 January 2011 to 31 December 2014.
A total of 1229 patients assessed for CR during hospitalisation with ACS were prospectively registered in the Rehab-North Register from 2011 to 2014. SES was assessed using data from national registers, concerning: personal income, occupational status, educational level and civil status. Patients were excluded if one of the following criteria was fulfilled: (1) missing data on SES, or (2) acceptable reason for not informing patients about CR (treatment with coronary artery bypass grafting, transfer to another hospital, still under treatment or death).
Outcomes were defined by dividing the referral process into three phases: (1) informed about CR, (2) willingness to participate, and (3) assigned CR setting (in-hospital/community centre) after ACS.
A total of 854 (69.5 %) patients were referred to CR. After adjustment for age, gender, ACS diagnosis (ST-elevated myocardial infarction, non-ST-elevated myocardial infarction, unstable angina pectoris) and comorbidity, high income had the strongest association of referral to CR in all three phases (informed about CR: OR 2.17, 95% CI 1.01 to 4.64; willingness to participate in CR: OR 1.55, 95% CI 1.02 to 2.35; assigned in-hospital CR: OR 1.47, 95% CI 0.91 to 2.36). Educational level showed similar tendencies, however not statistically significant. The results did not vary according to gender.
This is the first study to investigate the referral process to CR using a three-phase structure. It suggests income and education to influence all phases in the referral process to CR after ACS.
To describe changes in unplanned acute activity and to identify and characterise unplanned contacts in hospitals in Denmark from 2005 to 2016, including following healthcare reform.
Data from Danish nationwide registers.
Adults (≥18 years).
All adults with an unplanned acute hospital contacts (acute inpatient admissions and emergency care visits) in Denmark from 2005 to 2016.
Outcomes were annual number of contacts, length of stay, number of contacts per 1000 citizen per year, age-adjusted contacts per 1000 citizens per year, sex, age groups, country of origin, Charlson Comorbidity Index score, discharge diagnosis and time of arrival.
We included a total of 13 524 680 contacts. The annual number of acute hospital contacts increased from 1 067 390 in 2005 to 1 221 601 in 2016. The number also increased with adjustment for age per 1000 citizens. In addition, regional differences were observed.
Unplanned acute activity changed from 2005 to 2016. The national number of contacts increased, primarily because of changes in one of the five regions.
Folic acid (0.4 mg) taken prior to and during early pregnancy reduces the risk of neural tube defects (NTDs). Because these birth defects occur early in pregnancy, before women may know they are pregnant, many countries have mandated the addition of folic acid to food staples. In countries where fortification is not possible, and weekly iron folic acid programmes exist to reduce anaemia, the WHO recommends that 2.8 mg (7x0.4 mg) folic acid be given instead of the current weekly practice of 0.4 mg. Currently, there is a lack of evidence to support if the 2.8 mg folic acid per week dose is sufficient to raise erythrocyte folate concentrations to a level associated with a reduced risk of a NTD-affected pregnancy. We aim to conduct a three-arm randomised controlled trial to determine the effect of weekly folic acid with iron on erythrocyte folate, a biomarker of NTD risk.
We will recruit non-pregnant women (n=300; 18–45 years) from Selangor, Malaysia. Women will be randomised to receive either 2.8, 0.4 or 0.0 (placebo) mg folic acid with 60 mg iron weekly for 16 weeks, followed by a 4-week washout period. The primary outcome will be erythrocyte folate concentration at 16 weeks and the mean concentration will be compared between randomised treatment groups (intention-to-treat) using a linear regression model adjusting for the baseline measure.
Ethical approval was obtained from the University of British Columbia (H18-00768) and Universiti Putra Malaysia (JKEUPM-2018-255). The results of this trial will be presented at scientific conferences and published in peer-reviewed journals.
ACTRN12619000818134 and NMRR-19-119-45736.
To describe sexual and reproductive health (SRH) needs of female sex workers (FSWs) to inform the future implementation of pre-exposure prophylaxis (PrEP) for HIV prevention in this population.
The ANRS 12361 PrEP-CI cross-sectional and mixed-methods study was designed and implemented with two community-based organisations in Côte d’Ivoire.
A convenience sample of 1000 FSWs aged ≥18, not known as HIV-positive, completed a standardised questionnaire assessing sociodemographic characteristics, sexual practices, use of community health services and a priori acceptability of PrEP. Twenty-two indepth interviews and eight focus group discussions were also conducted to document FSWs’ risky practices and sexual behaviours, experiences with violence and discrimination, attitudes regarding HIV and sexually transmitted infections (STIs), and barriers to SRH services.
Although 87% described consistent condom use with clients, more than 22% declared accepting condomless sexual intercourse for a large sum of money. Furthermore, condom use with their steady partner and knowledge of their partner’s HIV status were low despite their acknowledged concurrent sexual partnerships. While inconsistent condom use exposed FSWs to STIs and undesired pregnancies, the prevalence of contraceptive strategies other than condoms was low (39%) due to fear of contraception causing sterility. FSWs faced obstacles to accessing SRH care and preferred advice from their peers or self-medication.
Despite adoption of preventive behaviour in most cases, FSWs are still highly exposed to HIV. Furthermore, FSWs seem to face several barriers to accessing SRH. Implementing PrEP among FSWs in West Africa, such as in Côte d’Ivoire, constitutes an opportunity to consider the regular follow-up of HIV-negative FSWs. PrEP initiation should not condition access to SRH services; conversely, SRH services could be a way to attract FSWs into HIV prevention. Our results highlight the importance of developing a people-focused approach that integrates all SRH needs when transitioning from PrEP efficacy trials to implementation.
Infections remain a threat for solid organ and stem cell transplant recipients. Antimicrobial prophylaxis and pre-emptive therapy have improved survival of these patients; however, the failure rates of prophylaxis are not negligible. The aim of this systematic review is to explore the reasons behind failure of antimicrobial prophylaxis and pre-emptive therapy.
This systematic review included prospective randomised controlled trials and prospective single-arm studies.
The studies included were on prophylaxis and pre-emptive therapy of opportunistic infections in transplant recipients. Studies were included from databases MEDLINE, CENTRAL and Embase published until October first 2018.
Primary outcome measures were breakthrough infections, adverse events leading to stopping of treatment, switching medication or dose reduction. Secondary outcome measures were acquired resistance to antimicrobials, antifungals or antivirals and death.
From 3317 identified records, 30 records from 24 studies with 2851 patients were included in the systematic review. Seventeen focused on prophylactic and pre-emptive treatment of cytomegalovirus and seven studies on invasive fungal infection. The main reasons for failure of prophylaxis and pre-emptive therapy were adverse events and breakthrough infections, which were described in 54% (13 studies) and 38% (9 studies) of the included studies, respectively. In 25%, six of the studies, a detailed description of patients who experienced failure of prophylaxis or pre-emptive therapy was unclear or lacking.
Our results show that although failure is reported in the studies, the level of detail prohibits a detailed analysis of failure of prophylaxis and pre-emptive therapy. Clearly reporting on patients with a negative outcome should be improved. We have provided guidance on how to detect failure early in a clinical setting in accordance to the results from this systematic review.
In recent years, medical treatment for cancer has improved, thereby increasing the life expectancy of patients with cancer. Hence, the focus in healthcare shifted towards analysing treatments that offer to decrease distress and improve the quality of life of patients with cancer. The psychological burden of patients with cancer originates from all kinds of psychosocial challenges related to diagnosis and treatment. Cancer counselling centres (CCounCs) try to address these concerns. However, the current literature lacks research on the effectiveness of CCounCs. This study aims to assess the effectiveness of CCounCs with regard to distress and other relevant psychosocial variables (quality of life, anxietyand so on).
This prospective observational study with a non-randomised control group has three measurement points: before the first counselling session (baseline, t0) and at 2 weeks and 3 months after baseline (t1, t2). Patients and their relatives who seek counselling between December 2018 and November 2020 and have sufficient German language skills will be included. The control group will be recruited at clinics and oncological outpatient centres in Hamburg. Propensity scoring will be applied to adjust for differences between the control and intervention groups at baseline. Sociodemographic data, medical data and counselling concerns are measured at baseline. Distress (distress thermometer), quality of life (Short Form-8 Health Survey, European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30), anxiety (Generalized AnxietyDisorder-7), depression (Patient HealthQuestionnaire-9) and further psychosocial variables are assessed at all time points. With a total of 787 participants, differences between the intervention and control groups of a small effect size (f=0.10) can be detected with a power of 80%.
The study was registered prior to data collection with the German Registration of Clinical Trials in September 2018. Ethical approval was received by the local psychological ethical committee of the Center for Psychosocial Medicine at the University Medical Centre Hamburg-Eppendorf in August 2018. The results will be published in peer-reviewed journals.
To (1) examine the burden of multiple chronic conditions (MCC) in an urban health system, and (2) propose a methodology to identify subpopulations of interest based on diagnosis groups and costs.
Retrospective cross-sectional study.
Mount Sinai Health System, set in all five boroughs of New York City, USA.
192 085 adult (18+) plan members of capitated Medicaid contracts between the Healthfirst managed care organisation and the Mount Sinai Health System in the years 2012 to 2014.
We classified adults as having 0, 1, 2, 3, 4 or 5+ chronic conditions from a list of 69 chronic conditions. After summarising the demographics, geography and prevalence of MCC within this population, we then described groups of patients (segments) using a novel methodology: we combinatorially defined 18 768 potential segments of patients by a pair of chronic conditions, a sex and an age group, and then ranked segments by (1) frequency, (2) cost and (3) ratios of observed to expected frequencies of co-occurring chronic conditions. We then compiled pairs of conditions that occur more frequently together than otherwise expected.
61.5% of the study population suffers from two or more chronic conditions. The most frequent dyad was hypertension and hyperlipidaemia (19%) and the most frequent triad was diabetes, hypertension and hyperlipidaemia (10%). Women aged 50 to 65 with hypertension and hyperlipidaemia were the leading cost segment in the study population. Costs and prevalence of MCC increase with number of conditions and age. The disease dyads associated with the largest observed/expected ratios were pulmonary disease and myocardial infarction. Inter-borough range MCC prevalence was 16%.
In this low-income, urban population, MCC is more prevalent (61%) than nationally (42%), motivating further research and intervention in this population. By identifying potential target populations in an interpretable manner, this segmenting methodology has utility for health services analysts.
We sought to test hypotheses regarding the principal correlates of child-health performance among African nations based on previous evidence collected at finer spatial scales.
Retrospective, cross-sectional study.
All countries in Africa, excluding small-island nations.
We defined a composite child-health indicator for each country comprising the incidence of stunting, deaths from respiratory disease, deaths from diarrhoeal disease, deaths from other infectious disease and deaths from injuries for children aged under 5 years. We also compiled national-level data for Africa to test the effects of country-level water quality, air pollution, food supply, breast feeding, environmental performance, per capita wealth, healthcare investment, population density and governance quality on the child-health indicator.
Across nations, child health was lowest when water quality, improved sanitation, air quality and environmental performance were lowest. There was also an important decline in child health as household size (a proxy for population density) increased. The remaining variables had only weak effects, but in the directions we hypothesised.
These results emphasise the importance of continued investment in clean water and sanitation services, measures to improve air quality and efforts to restrict further environmental degradation, to promote the UN’s Sustainable Development Goal 3 target to ‘... end preventable deaths of newborns and children under 5’ and Goal 6 to ‘... ensure access to water and sanitation for all’ by 2030.
The objective of this analysis was to examine trends in malaria parasite prevalence and related socioeconomic inequalities in malaria indicators from 2006 to 2013 during a period of intensification of malaria control interventions in Siaya County, western Kenya.
Data were analysed from eight independent annual cross-sectional surveys from a combined sample of 19 315 individuals selected from 7253 households. Study setting was a health and demographic surveillance area of western Kenya. Data collected included demographic factors, household assets, fever and medication use, malaria parasitaemia by microscopy, insecticide-treated bed net (ITN) use and care-seeking behaviour. Households were classified into five socioeconomic status and dichotomised into poorest households (poorest 60%) and less poor households (richest 40%). Adjusted prevalence ratios (aPR) were calculated using a multivariate generalised linear model accounting for clustering and cox proportional hazard for pooled data assuming constant follow-up time.
Overall, malaria infection prevalence was 36.5% and was significantly higher among poorest individuals compared with the less poor (39.9% vs 33.5%, aPR=1.17; 95% CI 1.11 to 1.23) but no change in prevalence over time (trend p value
Despite attainment of equity in ITN use over time, socioeconomic inequalities still existed in the distribution of malaria. This might be due to a lower likelihood of treatment with an effective antimalarial and lower use of ITNs by poorest individuals. Additional strategies are necessary to reduce socioeconomic inequities in prevention and control of malaria in endemic areas in order to achieve universal health coverage and sustainable development goals.
After a stroke, 55% of survivors do not regain the ability to completely use their arm in daily life functioning. Currently, evidence-based guidelines recommend functional training for improving the affected hand after stroke. However, promoting an optimal quantity and quality of functional training is influenced by personal and environmental contextual factors. Studies that comprehensively target multiple factors regulating arm use are limited. This study compares the effects of functional training to multifactorial context-enhancing functional training program for improving functional arm use and recovery after stroke.
This is a protocol for an observer-blinded, two parallel groups, randomised controlled trial. A total of 126 community-dwelling subacute and chronic stroke survivors will be included in the study. A tailor-made multifactorial context-enhancing intervention-incorporating education, environmental enrichment and behaviour change techniques to reinforce functional training will be provided to the experimental group. The functional training group will be provided with functional exercises. The intervention will be delivered for 2 months. The primary outcomes of functional arm use and recovery will be measured using Motor Activity Log, Goal Attainment Scale and Rating of Everyday Arm-use in the Community and Home scale. The secondary outcomes of arm motor impairment and function will be measured using Fugl-Meyer upper limb score, Action Research Arm Test, ABILHAND questionnaire and Stroke Impact Scale. These will be measured at three points in time: before, after 2 months and after 1-month follow-up. The outcome measures will be analysed using one-way analysis of variance and regression analysis will be performed to identify factors limiting optimal task practice.
The study has been approved by the Institutional Ethics Committee of Kasturba Hospital, Manipal, India. Participants will sign a written informed consent prior to participation. The results will be published on completion of the trial and communicated to community-dwelling stroke survivors.