Study drop-out and attrition from treating clinics is common among persons with chronic health conditions. However, if attrition is associated with adverse health outcomes, it may bias or mislead inferences for health policy and resource allocation.
This retrospective cohort study uses data attained through the Swiss Spinal Cord Injury (SwiSCI) cohort study on persons with spinal cord injury (SCI). Vital status (VS) was ascertained either through clinic medical records (MRs) or through municipalities in a secondary tracing effort. Flexible parametric survival models were used to investigate risk factors for going lost to clinic (LTC) and the association of LTC with subsequent risk of mortality.
1924 individuals were included in the tracing study; for 1608 of these cases, contemporary VS was initially checked in the MRs. VS was ascertained for 704 cases of the 1608 cases initially checked in MRs; of the remaining cases (n=904), nearly 90% were identified in municipalities (n=804). LTC was associated with a nearly fourfold higher risk of mortality (HR=3.62; 95% CI 2.18 to 6.02) among persons with traumatic SCI. Extended driving time (ie, less than 30 min compared with 30 min and longer to reach the nearest specialised rehabilitation facility) was associated with an increased risk of mortality (HR=1.51, 95% CI 1.02 to 2.22) for individuals with non-traumatic SCI.
The differential risk of LTC according to sociodemographic and SCI lesion characteristics underscores the importance of accounting for attrition in cohort studies on chronic disease populations requiring long-term care. In addition, given the associated risk of mortality, LTC is an issue of concern to clinicians and policy makers aiming to optimise the long-term survival of community-dwelling individuals with traumatic SCI. Future studies are necessary to verify whether it is possible to improve survival prospects of individuals LTC through more persistent outreach and targeted care.
Despite 40 randomised controlled trials (RCTs) investigating preoperative oral antibiotics (OA) and mechanical bowel preparation (MBP) to reduce surgical site infection (SSI) rate following colon surgery, there has never been an RCT published comparing OA alone versus no preparation. Of the four possible regimens (OA alone, MBP alone, OA plus MBP and no preparation), randomised evidence is conflicting for studied groups. Furthermore, guidelines vary, with recommendations for OA alone, OA plus MBP or no preparation. The National Surgical Quality Improvement Program (NSQIP) has automated data collection for surgical patients. Similarly, the ‘REthinking Clinical Trials’ (REaCT) platform increases RCT enrolment by simplifying pragmatic trial design. In this novel RCT protocol, we combine REaCT and NSQIP to compare OA alone versus no preparation for SSI rate reduction in elective colon surgery. To our knowledge, this is the first published RCT protocol that leverages NSQIP for data collection. In our feasibility study, 67 of 74 eligible patients (90%) were enrolled and 63 of 67 (94%) were adherent to protocol. The ‘REaCT–NSQIP’ trial design has great potential to efficiently generate level I evidence for other perioperative interventions.
SSI rates following elective colorectal surgery after preoperative OA or no preparation will be compared. We predict 45% relative rate reduction of SSI, improvement in length of stay, reduced costs and increased quality of life, with similar antibiotic-related complications. Consent, using the ‘integrated consent model’, and randomisation on a mobile device are completed by the surgeon in a single clinical encounter. Data collection for the primary end point is automatic through NSQIP. Analysis of cost per weighted case, cost utility and quality-adjusted life years will be done.
This study is approved by The Ontario Cancer Research Ethics Board. Results will be disseminated in surgical conferences and peer-reviewed journals.
NCT03663504; Pre-results, recruitment phase.
Anxiety has been suggested to be associated with poor outcomes in patients with acute coronary syndrome (ACS). However, results of previous follow-up studies were inconsistent. The aim of this meta-analysis was to evaluate the association between anxiety and clinical outcomes in patients with ACS, and to investigate the potential role of depression underlying the above association.
A meta-analysis of prospective follow-up studies.
Patients with ACS.
We included related prospective follow-up studies up through 20 July 2019 that were identified by searching PubMed and Embase databases. A random-effect model was used for the meta-analysis. Anxiety was evaluated by validated instruments at baseline.
We determined the association between anxiety and risks of mortality and adverse cardiovascular events (MACEs) in patients with ACS.
Our analysis included 17 studies involving 39 038 patients wqith ACS. Anxiety was independently associated with increased mortality risk (adjusted risk ratio (RR) 1.21, 95% CI 1.07 to 1.37, p=0.002) and MACEs (adjusted RR 1.47, 95% CI 1.24 to 1.74, p
Anxiety is associated with increased risk of mortality and MACEs in patients with ACS. However, at least part of the association may be confounded by concurrent depressive symptoms in these patients.
As systems of health and social care in England move towards more integrated and collaborative models, leaders will need different skills than their predecessors to enable system leadership, building partnerships and working across organisations and sectors. There is little understanding of what the mechanisms for effective leadership across integrated health and social care systems might be, the contexts that influence good leadership, or the nature of the resulting outcomes. This review aims to identify, refine and test programme theories of leadership of integrated team-based services in health and social care, exploring what works, for whom and in what circumstances.
This study uses a realist synthesis approach, following RAMESES guidelines, supported by stakeholder consultation. Stage 1 will develop initial programme theories about leadership of integrated health and social care based on a review of the scientific and grey literature and a stakeholder consultation workshop. Stage 2 will involve focused searching of empirical literature, data extraction and synthesis to refine the initial programme theories and identify relationships between identified contexts, mechanisms and outcomes. A second stakeholder event will guide the focus of the review. Stage 3 will further refine and interrogate the theories testing them against substantive theory on leadership of complex systems and through the experiences and expertise of the stakeholder group.
Our study does not require ethics committee approval. This research will contribute to building an in-depth understanding of what aspects of leadership of integrated team-based services work, for whom and in what circumstances. It will identify the professional development needs of leaders and provide recommendations about optimal organisational and interorganisational structures and processes that support effective leadership in integrated health and social care systems. Findings will be disseminated through peer-reviewed journal publications, conference presentations and formal and informal reports.
Dunn K, Rydzewska E, Fleming M, et al. Prevalence of mental health conditions, sensory impairments and physical disability in people with co-occurring intellectual disabilities and autism compared with other people: a cross-sectional total population study in Scotland. BMJ Open 2020;10:e035280. doi: 10.1136/bmjopen-2019-035280.
This article was previously published with an error. The funding information in the published article was incomplete. The updated funding information is stated below:
This work was supported by the UK Medical Research Council, grant number: MC_PC_17217) and the Scottish Government via the Scottish Learning Disabilities Observatory.
Poor worldwide rate of blood pressure control is largely due to poor adherence to antihypertensive (AHT) drug treatment. The question of whether sex affects adherence has long been debated but conflicting findings have been reported on this issue. Our objective was to evaluate sex differences in the adherence to AHT therapy.
Studies were identified through a systematic search of PubMed, CINAHL, PsycINFO, Web of Science and Google Scholar (through January 2020) and manual handsearching of relevant articles. Observational studies reporting adherence to AHT drugs measured by self-report or pharmacy refill prescription-based methods among men and women were included. Summarised estimates of ORs with 95% CIs were calculated using random-effects model and meta-regression models.
From 12 849 potentially relevant publications, 82 studies (15 517 457 men and 18 537 599 women) were included. No significant between-sex differences in adherence to AHT were observed, whether all study-specific estimates were summarised (ORs 1.04, 95% CI 1.00 to 1.09, p=0.07), nor estimates were pooled according to the method for measuring adherence. Among patients aged 65 years or older, lower self-reported adherence was observed in women (ORs 0.84, 95% CI 0.72 to 0.97, p=0.02), while the main result remained unchanged according to other subgroup analyses.
Definitive evidence of sex differences in adherence to AHT therapy cannot be drawn. Our little knowledge about factors affecting adherence, in particular of sex effect among elderly, urgently requires high-quality studies investigating these issues.
Primary care interventions are often multicomponent, with several targets (eg, patients and healthcare professionals). Improving Primary Care After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in general practice, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT). Informed by Medical Research Council guidance for complex interventions and the Behaviour Change Consortium fidelity framework, this protocol outlines the process evaluation of IPCAS within this RCT. The process evaluation aimed to explore how the intervention was delivered in context and how participants engaged with the intervention.
Mixed methods will be used: (1) design: intervention content will be compared with ‘usual care’; (2) training: intervention training sessions will be audio/video-recorded where feasible; (3) delivery: healthcare professional self-reports, audio recordings of intervention delivery and observations of My Life After Stroke course (10% of reviews and sessions) will be coded separately; semistructured interviews will be conducted with a purposive sample of healthcare professionals; (4) receipt and (5) enactment: where available, structured stroke review records will be analysed quantitatively; semistructured interviews will be conducted with a purposive sample of study participants. Self-reports, observations and audio/video recordings will be coded and scored using specifically developed checklists. Semistructured interviews will be analysed thematically. Data will be analysed iteratively, independent of primary endpoint analysis.
Favourable ethical opinion was gained from Yorkshire & The Humber-Bradford Leeds NHS Research Ethics Committee (19 December 2017, 17/YH/0441). Study results will be published in a peer-reviewed journal and presented at relevant conferences.
This study is aimed to develop and validate a prediction model for multistate transitions across different stages of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus under primary care.
We retrieved the anonymised electronic health records of a population-based retrospective cohort in Hong Kong.
A total of 26 197 patients were included in the analysis.
The new-onset, progression and regression of CKD were defined by the transitions of four stages that were classified by combining glomerular filtration rate and urine albumin-to-creatinine ratio. We applied a multiscale multistate Poisson regression model to estimate the rates of the stage transitions by integrating the baseline demographic characteristics, routine laboratory test results and clinical data from electronic health records.
During the mean follow-up time of 1.8 years, there were 2632 patients newly diagnosed with CKD, 1746 progressed to the next stage and 1971 regressed into an earlier stage. The models achieved the best performance in predicting the new-onset and progression with the predictors of sex, age, body mass index, systolic blood pressure, diastolic blood pressure, serum creatinine, haemoglobin A1c, total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides and drug prescriptions.
This study demonstrated that individual risks of new-onset and progression of CKD can be predicted from the routine physical and laboratory test results. The individualised prediction curves developed from this study could potentially be applied to routine clinical practices, to facilitate clinical decision making, risk communications with patients and early interventions.
African, Caribbean and Black (ACB) communities are disproportionately infected by HIV in Ontario, Canada. They constitute only 5% of the population of Ontario yet account for 25% of new diagnoses of HIV. The aim of this study is to understand underlying factors that augment the HIV risk in ACB communities and to inform policy and practice in Ontario.
We will conduct a cross-sectional study of first-generation and second-generation ACB adults aged 15–64 in Toronto (n=1000) and Ottawa (n=500) and collect data on sociodemographic information, sexual behaviours, substance use, blood donation, access and use of health services and HIV-related care. We will use dried blood spot testing to determine the incidence and prevalence of HIV infection among ACB people, and link participant data to administrative databases to investigate health service access and use. Factors associated with key outcomes (HIV infection, testing behaviours, knowledge about HIV transmission and acquisition, HIV vulnerability, access and use of health services) will be evaluated using generalised linear mixed models, adjusted for relevant covariates.
This study has been reviewed and approved by the following Research Ethics Boards: Toronto Public Health, Ottawa Public Health, Laurentian University; the University of Ottawa and the University of Toronto. Our findings will be disseminated as community reports, fact sheets, digital stories, oral and poster presentations, peer-reviewed manuscripts and social media.
To assess the effects of perinatal death (PND) audit on perinatal outcomes in a tertiary hospital in Kampala.
Interrupted time series (ITS) analysis.
Nsambya Hospital, Uganda.
Live births and stillbirths.
Primary outcomes: perinatal mortality rate, stillbirth rate, early neonatal mortality rate. Secondary outcomes: case fatality rates (CFR) for asphyxia, complications of prematurity and neonatal sepsis.
526 PNDs were audited: 142 (27.0%) fresh stillbirths, 125 (23.8%) macerated stillbirths and 259 (49.2%) early neonatal deaths. The ITS analysis showed a decrease in perinatal death (PND) rates without the introduction of PND audits (incidence risk ratio (IRR) (95% CI) for time=0.94, p
The introduction of PND audit showed no statistically significant effect on perinatal mortality or stillbirth rate, but a significant decrease in early neonatal mortality rate. No effect was detected on CFRs for prematurity, intrapartum-related hypoxia or infections. These findings should encourage more research to assess the effectiveness of PND reviews on perinatal deaths in general, but also on stillbirths and neonatal deaths in particular, in low-resource settings.
The Royal College of Obstetricians and Gynaecologists has advised that consolidation of birth centres, where reasonable, into birth centres of at least 6000 admissions per year should allow constant consultant presence. Currently, only 17% of mothers attend such birth centres. The objective of this work was to examine the feasibility of consolidation of birth centres, from the perspectives of birth centre size and travel times for mothers.
1.91 million admissions in 2014–2016.
A multiple-objective genetic algorithm.
Travel time for mothers and size of birth centres.
Currently, with 161 birth centres, 17% of women attend a birth centre with at least 6000 admissions per year. We estimate that 95% of women have a travel time of 30 min or less. An example scenario, with 100 birth centres, could provide 75% of care in birth centres with at least 6000 admissions per year, with 95% of women travelling 35 min or less to their closest birth centre. Planning at local level leads to reduced ability to meet admission and travel time targets.
While it seems unrealistic to have all births in birth centres with at least 6000 admissions per year, it appears realistic to increase the percentage of mothers attending this type of birth centre from 17% to about 75% while maintaining reasonable travel times. Planning at a local level leads to suboptimal solutions.
The purpose of this study is to map the characteristics of the existing medical literature describing the medications, settings, participants and outcomes of medical assistance in dying (MAID) in order to identify knowledge gaps and areas for future research.
We searched electronic databases (MEDLINE, EMBASE, PsychINFO, CINAHL and CENTRAL), clinical trial registries, conference abstracts and professional guidelines from jurisdictions where MAID is legal, up to February 2020. Eligible report types included technical summaries, institutional policies, practice surveys, practice guidelines and clinical studies that describe MAID provision in adults who have provided informed consent for MAID.
163 articles published between 1989 and 2020 met eligibility criteria. 75 studies described details for MAID administered by intravenous medications and 50 studies provided data on oral medications. In intravenous protocols, MAID was most commonly administered using a barbiturate (34/163) or propofol (22/163) followed by a neuromuscular blocker. Oral protocols most often used barbiturates alone (37/163) or in conjunction with an opioid medication (7/163) and often recommended using a prokinetic agent prior to lethal drug ingestion. Complications included prolonged duration of the dying process, difficulty in obtaining intravenous access and difficulty in swallowing oral agents. Most commonly, the role of physicians was prescribing (83/163) and administering medications (75/163). Nurses’ roles included administering medications (17/163) and supporting the patient (16/163) or family (13/163). The role of families involved providing support to the patient (17/163) and bringing medications from the pharmacy for self-administration (4/163).
We identified several trends in MAID provision including common medications and doses for oral and parenteral administration, roles of healthcare professionals and families, and complications that may cause patient, family and provider distress. Future research should aim to identify the medications, dosages, and administration techniques and procedures that produce the most predictable outcomes and mitigate distress for those involved.
The Shanghai Suburban Adult Cohort and Biobank (SSACB) was established to identify environmental, lifestyle and genetic risk factors for non-communicable chronic diseases (NCDs) in adults (20–74 years old) living in a suburban area of Shanghai with rapid urbanisation.
Two of eight suburban district were purposely selected according to participant willingness, health service facilities, population, geographic region and electronic medical record system. From these suburban districts, four communities were selected based on economic level and population size. At stage three, one-third of the committees/villages were randomly selected from each community. All residents aged 20–74 years old were invited as study participants.
The baseline data on demographics, lifestyle and physical health-related factors were collected using a face-to-face questionnaire interview. All participants completed physical examinations and had blood and urine tests. Blood and urine samples from these tests were stored in a biobank. From 6 April 2016 through 31 October 2017, we conducted face-to-face interviews and clinical examinations in 44 887 participants: 35 727 from Songjiang District and 9160 from Jiading District. The average age of participants was 56.4±11.2 years in Songjiang and 56.6±10.5 years in Jiading. The prevalence of hypertension, diabetes and dyslipidaemia was 34.0%, 8.2% and 11.1%, respectively.
In-person surveys will be conducted every 5 years. For annual tracking, baseline data was linked to the local health information system, which was composed of an electronic medical record system, a chronic disease management system, a cancer registry system, an infectious disease report system and a death registry system. The data of the SSACB cohort is located in the School of Public Health, Fudan University. International and domestic collaborative research projects are encouraged and inherent in the project.
Using a standardised diagnostic and generic treatment path for breast cancer, and the molecular subtype perspective, we aim to measure the impact of several patient and disease characteristics on the overall treatment cost for patients. Additionally, we aim to generate insights into the drivers of cost variability within one medical domain.
We conducted a retrospective study at a breast clinic in Belgium. We used 14 anonymous patient files for conducting our analysis.
Significant cost variations within each molecular subtype and across molecular subtypes were found. For the luminal A classification, the cost differential amounts to roughly 166%, with the greatest treatment cost amounting to US$29 780 relative to US$11 208 for a patient requiring fewer medical activities. The major driver for these cost variations relates to disease characteristics. For the luminal B classification, a cost difference of roughly 242% exists due to both disease-related and patient-related factors. The average treatment cost for triple negative patients amounted to US$26 923, this is considered to be a more aggressive type of cancer. The overall cost for HER2-enriched is driven by the inclusion of Herceptin, thus this subtype is impacted by disease characteristics. Cost variability across molecular classifications is impacted by the severity of the disease, thus disease-related factors are the major drivers of cost.
Given the cost challenge in healthcare, the need for greater cost transparency has become imperative. Through our analysis, we generate initial insights into the drivers of cost variability for breast cancer. We found evidence that disease characteristics such as severity and more aggressive cancer forms such as HER2-enriched and triple negative have a significant impact on treatment cost across the different subtypes. Similarly, patient factors such as age and presence of gene mutation contribute to differences in treatment cost variability within molecular subtypes.
Despite the consistent evidence of the benefits of physical activity on preventing atherosclerotic cardiovascular diseases (ASCVD) and some cardiovascular risk factors, such as hypertension and dyslipidaemia, the prescription of drugs remains the most widely used approach to prevent ASCVD in clinical settings. The purpose of this study protocol is to provide a meta-synthesis methodology for comparing the effect of fixed-dose combination therapy and physical exercise on controlling cardiovascular risk factors and preventing ASCVD.
This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols and the recommendations of the Cochrane Collaboration Handbook. We plan to conduct a computerised search in Medline, Web of Science, Embase, Cochrane Database of Systematic Reviews and SPORTDiscus from inception to May 2020 for studies testing the effectiveness of physical exercise or fixed-dose combination drug therapy in preventing ASCVD, all-cause and cardiovascular mortality and controlling some cardiovascular risk factors (hypertension and dyslipidaemia). Since performing network meta-analyses (NMA) is a statistical approach that allows direct and indirect comparisons of interventions, where sufficient studies are included, we plan to perform the following NMA comparing the effect of fixed-dose combination therapy and physical exercise interventions on (1) improving lipid profile, (2) reducing blood pressure, (3) preventing cardiovascular events and all-cause and cardiovascular mortality and (4) improving compliance with the therapeutic strategy and reducing adverse events.
Ethical approval will not be needed because data included in the NMA will be extracted from published trials that meet accepted ethical standards. The results will be published in academic peer-reviewed journals, and the evidence gathered by this project could be included in the preventive cardiovascular disease guidelines.
The Norwegian Cardiac Arrest Registry (NorCAR) was established in 2013 when cardiac arrest became a mandatory reportable condition. The aim of this cohort study is to describe how the world’s first mandatory, population-based cardiac arrest registry evolved during its first 6 years.
Norway has a total population of 5.3 million inhabitants with a population density that varies considerably. All residents are assigned a unique identifier number, giving nationally approved registries access to information about all births and deaths in the country. Data in the registry are entered by data processors; public employees with close links to the emergency medical services. All data processors undergo a standardised training and meet for yearly retraining and updates.
All events of cardiac arrest where bystanders or healthcare professionals have started cardiopulmonary resuscitation or performed defibrillation are included into the NorCAR.
Since the establishment of the registry, the number of reporting health trusts, the number of reported events and the corresponding population at risk were followed year by year. Outcome is measured as changes in inclusion rate, incidence per 100 000 inhabitants and survival to 30 days after cardiac arrest.
In total, 14 849 cases were registered over 6 years, between 2013 and 2018. The number of health trusts reporting rose steadily from 2013. Within 3 years, all trusts reported to the registry with an increasing number of events reported; going from 1101 to 3400 per year. The prevalence of bystander cardiopulmonary resuscitation increased slightly, but the population incidence of survival did not change.
Declaring cardiac arrest as a reportable condition and close follow-up of all reporting areas is essential when building a national registry.
Continuous improvement in the delivery of health services is increasingly being demanded in the UK at a time when budgets are being cut. Simulation is one approach used for understanding and assessing the likely impact of changes to the delivery of health services. However, little is known about the usefulness of simulation for analysing the delivery of sexual health services (SHSs). We propose a simulation method to model and evaluate patient flows and resource use within an SHS to inform service redesign.
We developed a discrete event simulation (DES) model to identify the bottlenecks within the Unity SHS (Bristol, UK) and find possible routes for service improvement. Using the example of the introduction of an online service for sexually transmitted infection (STI) and HIV self-sampling for asymptomatic patients, the impact on patient waiting times was examined as the main outcome measure. The model included data such as patient arrival time, staff availability and duration of consultation, examination and treatment. We performed several sensitivity analyses to assess uncertainty in the model parameters.
We identified some bottlenecks under the current system, particularly in the consultation and treatment queues for male and female walk-in patients. Introducing the provision of STI and HIV self-sampling alongside existing services decreased the average waiting time (88 vs 128 min) for all patients and reduced the cost of staff time for managing each patient (£72.64 vs £88.74) compared with the current system without online-based self-sampling.
The provision of online-based STI and HIV self-sampling for asymptomatic patients could be beneficial in reducing patient waiting times and the model highlights the complexities of using this to cut costs. Attributing recognition for any improvement requires care, but DES modelling can provide valuable insights into the design of SHSs ensuing in quantifiable improvements. Extension of this method with the collection of additional data and the construction of more informed models seems worthwhile.
To estimate the prevalence and trends in underweight, overweight/obesity and identify their sociodemographic correlates among adults in Botswana from 2007 to 2017.
The study analysed cross-sectional and nationally representative data from 2007 to 2014 Botswana STEPS Surveys and the 2017 Botswana Demographic Survey.
Botswana adults aged 25–64 years (n=4003 in 2007, n=2983 in 2014 and n=11 550 in 2017).
Underweight and overweight/obesity.
The prevalence of underweight decreased from 18.1% (95% CI 12.0% to 26.3%) in 2007 to 11.6% (95% CI 9.5% to 13.9%) in 2014 and further dropped to 8.1% (95% CI 7.5% to 8.8%) in 2017. The prevalence of overweight/obesity increased slightly from 37.4% (95% CI 34.3% to 40.7%) in 2007 to 38.6% (95% CI 35.9% to 41.3%) in 2014 to 47.3% (95% CI 46.1% to 48.4%) in 2017. Underweight was more prevalent among males than females while overweight and obesity were more prevalent among females than males. The key risk factor for underweight was being male (adjusted OR (AOR) 2.21: 95% CI 1.80 to 2.72 in 2007, AOR 1.54: 95% CI 1.06 to 2.22 in 2014 and AOR 1.51: 95% CI 1.45 to 1.58 in 2017). For overweight/obesity, the main risk factors were being female (male AOR 0.23: 95% CI 0.15 to 0.35 in 2007, AOR 0.32: 95% CI 0.25 to 0.42 in 2014 and AOR 0.30: 95% CI 0.29 to 0.31 in 2017), being old (AOR 2.18: 95% CI 1.58 to 3.01 in 2007, AOR 2.37: 95% CI 1.71 to 3.29 in 2014) and AOR 2.10: 95% CI 1.94 to 2.27 in 2017 among those aged 55–64 years) and not working (AOR 1.70: 95% CI 1.20 to 2.42 in 2007, AOR 2.05: 95% CI 1.55 to 2.69 in 2014 and AOR 1.34: 95% CI 1.27 to 1.40 in 2017).
The findings presented in this study indicate coexistence of the double burden of underweight and overweight/obesity among adults aged 25–64 years in Botswana. Although underweight prevalence is on the decline, overweight/obesity is increasing over time. The problem of underweight and overweight/obesity needs immediate and effective interventions.
Pectus excavatum repair is associated with substantial postoperative pain, despite the use of epidural analgesia and other analgesic regimens. Perioperative recorded music interventions have been shown to alleviate pain and anxiety in adults, but evidence for children and adolescents is still lacking. This study protocol describes a randomised controlled trial that evaluates the effects of recorded music interventions on postoperative pain relief in children and adolescents after pectus excavatum repair.
A multicentre randomised controlled trial was set up comparing the effects of perioperative recorded music interventions in addition to standard care with those of standard care only in patients undergoing a Nuss procedure for pectus excavatum repair. One hundred and seventy subjects (12–18 years of age) will be included in three centres in the Netherlands. Patient inclusion has started in November 2018, and is ongoing. The primary outcome is self-reported perceived pain measured on the visual analogue scale. Secondary outcomes are anxiety level, analgesics consumption, vital parameters such as heart rate, blood pressure and respiratory rate, length of hospital stay, postoperative complications, quality of life and cost-effectiveness.
This study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Centre Rotterdam, The Netherlands, has approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations.
Longer intervals between routine clinic visits and medication refills are part of patient-centred, differentiated service delivery (DSD). They have been shown to improve patient outcomes as well as optimise health services—vital as ‘universal test-and-treat’ targets increase numbers of HIV patients on antiretroviral treatment (ART). This qualitative study explored patient, healthcare worker and key informant experiences and perceptions of extending ART refills to 6 months in adherence clubs in Khayelitsha, South Africa.
In-depth interviews were conducted in isiXhosa with purposively selected patients and in English with healthcare workers and key informants. All transcripts were audio-recorded, transcribed and translated to English, manually coded and thematically analysed. The participants had been involved in a randomised controlled trial evaluating multi-month ART dispensing in adherence clubs, comparing 6-month and 2-month refills.
Twenty-three patients, seven healthcare workers and six key informants.
Patients found that 6-month refills increased convenience and reduced unintended disclosure. Contrary to key informant concerns about patients’ responsibility to manage larger quantities of ART, patients receiving 6-month refills were highly motivated and did not face challenges transporting, storing or adhering to treatment. All participant groups suggested that strict eligibility criteria were necessary for patients to realise the benefits of extended dispensing intervals. Six-month refills were felt to increase health system efficiency, but there were concerns about whether the existing drug supply system could adapt to 6-month refills on a larger scale.
Patients, healthcare workers and key informants found 6-month refills within adherence clubs acceptable and beneficial, but concerns were raised about the reliability of the supply chain to manage extended multi-month dispensing. Stepwise, slow expansion could avoid overstressing supply and allow time for the health system to adapt, permitting 6-month ART refills to enhance current DSD options to be more efficient and patient-centred within current health system constraints.