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Patient consent for publication | Not applicable. | PMC10447378 | ||
Ethics approval | This study involves human participants and was approved by South Central Oxford REC B (Ref: 118784, Ethics number: 12/SC/0713). Participants gave informed consent to participate in the study before taking part. | PMC10447378 | ||
References | PMC10447378 | |||
Methods | apnea hypopnea, CRAE, hypertension/hypercholesterolemia, CRVE, SDB | REGRESSION | Patients for SDB assessment were recruited (Main Group, n = 264, age: 58.5 ± 8.9 yrs [mean ± SD]; males: 141) for in-laboratory polysomnography (standard metrics, eg apnea hypopnea index, AHI) and retinal photographs (evening and morning). A more severe SDB sub-group (n = 85) entered a 12-month cardiovascular risk factor minimisation (hypertension/hypercholesterolemia control; RFM) and continuous positive airway pressure (CPAP) intervention (RFM/CPAP Sub-Group); successfully completed by n = 66 (AHI = 32.4 [22.1–45.3] events/hour, median[IQR]). Univariate (Spearman’s correlation, t-test) and multiple linear regression models examined non-SDB and SDB associations with CRAE and CRVE measures. | PMC9831323 |
Conclusion | cerebro-vascular disease, CRAE, OSA, CRVE, SDB | No major SDB associations with CRAE or CRVE were identified, although the RFM/CPAP intervention reduced evening CRVE for severe OSA patients. Implications for cerebro-vascular disease risk remain uncertain. | PMC9831323 | |
Trial registration | The protocol was registered with the Australian New Zealand Clinical Trials Registry (Trial Id: | PMC9831323 | ||
Data Availability | All relevant data are within the article and its | PMC9831323 | ||
Introduction | cardiovascular disease, CRAE, stroke, cardio- and cerebro-vascular diseases, OSA, hypertension, CRVE, diabetes | CARDIOVASCULAR DISEASE, OBSTRUCTIVE SLEEP APNEA, STROKE, CORONARY HEART DISEASE, HYPERTENSION, DIABETES | A number of studies have suggested that obstructive sleep apnea (OSA) increases risk for cardio- and cerebro-vascular diseases, including hypertension, coronary heart disease and stroke [There is one microvascular bed that can be readily and non-invasively accessed in clinical settings by using digital photography to provide qualitative and quantitative assessment of the retinal microcirculation [Large population-based studies have reported that relative narrowing of retinal arteriolar calibre, and/or widening of retinal venular calibre, carries predictive significance for hypertension, stroke and coronary heart disease [The aim of the present study was to conduct a cross-sectional descriptive study to determine relationships between the morphology of the retinal microvascular bed and OSA severity in a sleep clinic cohort from which the potentially confounding influence of diabetes, a known cardio-vascular risk factor, was excluded. The primary analysis focused on cross-sectional associations between CRAE and CRVE with OSA severity metrics, and included examination of relationships with overnight change (if any) in retinal vessel diameters. In addition, we undertook a 12 month Risk Factor Minimisation/CPAP (RFM/CPAP) sub-group study aimed at evaluating whether stabilising known cardiovascular disease risk factors, while concurrently treating OSA with continuous positive airway pressure (CPAP), modified retinal vessel size. | PMC9831323 |
Methods | PMC9831323 | |||
Registration | This study was not initially registered as a clinical trial before enrolment of participants because it was originally conceived as an observational study. The authors confirm that all onging and related trials for this intervention are registered. The protocol was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR; ACTRN12620000694910). | PMC9831323 | ||
Study participants | Respiratory Disturbance, diabetes | DIABETES | We recruited 335 adults all over the age of 35 years, referred to a sleep clinic at Westmead Hospital between 2Participants were screened for diabetes and 40 were subsequently excluded on the basis of either a history of diabetes or a fasting blood sugar level ≥ 6.9 mmol/L, while 31 other participants either withdrew or were excluded for other reasons (e.g. failure to attend study visits, retinal photography and/or polysomnography (PSG) not performed). The remaining 264 participants formed the study “Main Group”.Participants who were found on in-laboratory, overnight, PSG to have a Respiratory Disturbance Index (RDI) ≥ 29 events/hr, were then invited to participate in a 12-month duration cardio-vascular risk factor minimisation and CPAP intervention study between 16Participants in this present report also underwent carotid and femoral artery ultrasonography for measurement of intima media thickness. These results have been reported previously [ | PMC9831323 |
Study flow diagram. | respiratory disturbance, SDB | RECRUITMENT, SLEEP DISORDERED BREATHING | Study flow diagram showing movement of participants and data through the recruitment and screening phases, the “Main Group” and “RFM/CPAP sub-group” Cross-Sectional Analyses and the Intervention Study. SDB = sleep disordered breathing; BSL = blood sugar level; PSG = polysomnography; CPAP = continuous positive airway pressure; RDI = respiratory disturbance index; CRAE_PM = central retinal artery equivalent evening value. | PMC9831323 |
Polysomnography | PSG studies were recorded using Compumedics Profusion PSG4 software (Compumedics Limited; Abbotsford, Victoria, Australia) and scored according to standard guidelines [ | PMC9831323 | ||
Retinal photography | CRVE, CRAE | DILATION | Retinal images were obtained from each eye with a non-mydriatic digital camera (Canon CR2-Plus, Canon, Japan) before (evening-pm) and after (morning-am) sleep, and after pupil dilation (one drop of 1% Tropicamide) in most subjects (n = 239 [pm] and n = 194 [am]). A retinal photograph centred on the optic disc was taken for each eye, with gating to diastole in most subjects (n = 242 pm and n = 238 am). Digital images were examined by a single experienced technician, using a semi-automated interactive vessel analysis (IVAN; University of Wisconsin, Madison) program. For each image, the largest six arterioles and six venules in a zone one half to one-disc diameter from the optic disc margin were measured. Average retinal arteriolar and venular width (diameter) were calculated using the Parr-Hubbard Formula and expressed as the central retinal arteriole equivalent (CRAE), central retinal venule equivalent (CRVE) and retinal arteriole:venule ratio (AVR) [ | PMC9831323 |
RFM/CPAP intervention (RFM/CPAP sub-group only) | hypertension, hypercholesterolaemia | MINOR, HYPERTENSION, RECRUITMENT, HYPERCHOLESTEROLAEMIA | After recruitment to the intervention study, participants with hypertension or hypercholesterolaemia were prescribed appropriate medication and undertook a 1-month run-in stabilisation period. Participants underwent a second PSG at Westmead Hospital Sleep Laboratory to determine the appropriate CPAP treatment pressure [Note: The study described in this manuscript has minor deviations from the registered clinical trial (ACTRN12620000694910). In particular, patients aged ≥43yrs were recruited, smokers were not excluded but smoking status was noted, and the RFM/CPAP sub-group included patients with an RDI ≥ 29 events/hr. | PMC9831323 |
Data analysis | ±, CRVE, CRAE, SDB | REGRESSION | All statistical analyses were performed using SPSS version 24.0 (IBM SPSS Statistics for Windows, Version 24.0. Armonk, NY: IBM Corp.).Main and RFM/CPAP Sub-Group data were expressed as mean (± standard deviation) or median (interquartile range) for continuous variables, and frequency and percentage for categorical variables. Spearman’s rank-order correlation were used to test for relationships between continuous variables. Differences between the Main Group and RFM/CPAP sub-group were tested using independent sample t-tests or Mann-Whitney U tests for continuous variables, and Chi-Square tests for categorical variables. A paired t-test was used to examine overnight change (morning minus evening) in CRAE and CRVE (ΔCRAE; ΔCRVE, respectively).Backwards, stepwise, multiple linear regression (variables removed at p>0.1) was used to establish predictive variables for retinal vessel size and overnight change using a strategy of first establishing non-SDB related predictive factors operating in the data set (Base Models) and then assessing the impact of adding individual SDB-variables to the base models (SDB Variable Models).Non-SDB variable predictor candidates were identified in two ways: 1) from published models for retinal vessel size [SDB variables were skewed (Kolmogorov-Smirnov Test for Normality) and, therefore, log transformed (e.g. ln AHI+1) before being individually added to the base models as required. Any improvement in the model RFor the RFM/CPAP intervention study, paired t-tests were used to identify differences in retinal vessel diameter size (ie evening CRAE, CRVE and overnight change in CRAE/CRVE) over 12 months. Spearman’s Rho rank correlation was used to test for correlations between the change (Δ) in retinal vessel diameter, CPAP use, Δ base model variables (age, systolic and diastolic blood pressure) and SDB variables. Multiple linear regression analysis was used to establish predictive variables for: 1) Δ evening retinal vessel diameter, and 2) Δ overnight change in retinal vessel diameter. | PMC9831323 |
Results | PMC9831323 | |||
Cross-sectional study–main group | CRVE, CRAE, SDB | This section describes results for the primary study analyses which focused on determining cross-sectional associations for non-SDB (Base Models) and SDB severity metrics (SDB Variable Models) with measured evening CRAE, CRVE, and overnight change in CRAE and CRVE, in Main Group participants (n = 264). | PMC9831323 | |
Main group demographics and sleep disordered breathing status. | CRAE, Respiratory Disturbance, Apnea-Hypopnea, Desaturation, SDB | Demographics and SDB status of the Main Group at baseline, presented as mean ± SD, median (IQR) frequency, or n (%), where appropriate, plus range.SD = Standard deviation; IQ range = 25–75 interquartile range; BMI = Body Mass Index; WHR = waist/hip ratio; BP = blood pressure; MAP = Mean Arterial Pressure; HDL = high-density lipoprotein; LDL = low-density lipoprotein; AHI = Apnea-Hypopnea Index; RDI = Respiratory Disturbance Index; AI = Arousal Index; ODI = Oxygen Desaturation Index; SaO2 = Oxygen Saturation; CRAE = Central | PMC9831323 | |
Main group data for evening, morning and overnight change in CRAE and CRVE and AVR grouped by AHI category. | apnoea-hypopnea | Data are mean ± SD.CRAE = Central retinal arteriolar equivalent; CRVE = central retinal venular equivalent; AVR = arterio-venule-ratio; AHI = apnoea-hypopnea index; Delta = overnight change. | PMC9831323 | |
Cross-sectional study—RFM/CPAP sub-group | CRVE, CRAE, SDB | This section describes comparison of descriptive data for the RFM/CPAP Sub-Group (n = 85) versus those Main Group partcipants who were not recruited into the intervention study (n = 179), together with cross-sectional associations for non-SDB (Base Models) and SDB severity metrics (SDB Variable Models) with measured evening CRAE, CRVE, and the overnight change in CRAE/CRVE, in the RFM/CPAP Sub-Group participants. | PMC9831323 | |
Descriptive data and univariate analysis-RFM/CPAP sub-group | hypertension, CRVE, CRAE, SDB | HYPERTENSION | RFM/CPAP Sub-group participants differed from the Main Group participants who were not recuited into the sub-group (all p < 0.04) for gender composition, most measures of body size, hypertension history, overall cardiovascular risk, and all SDB variables. Thus, the applied selection criteria enriched the RFM/CPAP-Sub Group with more males and more severe SDB. However, there were no differences for retinal vessel diameter metrics between the RFM/CPAP Sub-Group and those Main Group participants who were not recruited into the sub-group (all p>0.06), including overnight change for both CRAE and CRVE (Correlation analyses were not performed (see below). | PMC9831323 |
RFM/CPAP sub-group intervention study | OSA, cardiovascular disease, CRAE, CRVE | HYPERCHOLESTEROLEMIA, HYPERTENSION, CARDIOVASCULAR DISEASE | This section describes results for the 12 month RFM/CPAP interventional study (n = 66) which aimed to evaluate whether stabilising known cardiovascular disease risk factors (hypertension, hypercholesterolemia), while concurrently treating OSA with continuous positive airway pressure (CPAP), would result in alterations in evening CRAE, CRVE and overnight change in CRAE and CRVE. | PMC9831323 |
Discussion | morning CRVE, CRAE, retinal microvascular, CRVE, SDB | RETINAL VASCULAR, OTHER CARDIOVASCULAR DISEASE, RETINA | The primary focus of the present study was to test for relationships, in a non-diabetic sleep-clinic patient cohort, between polysomnography determined SDB severity and retinal micro-vasculature morphology. Overall no such relationships were detected, but when a subgroup enriched with more severe levels of SDB was examined, a greater AHI value was associated with a larger evening-measured CRAE value. However, the effect size for this relationship was small, with only a ~2.5 μm (~1.7%) increase in CRAE over the AHI range 5 to 30 events/hr.Our study is unique in that we tested for acute overnight effects of SDB on retinal vascular morphology. While there was no group mean overnight change in CRAE, mean CRVE values measured in the morning, immediately upon awakening, were on average slightly larger than the prior evening values. Multivariable models failed to identify predictors for this outcome, except in a sub-group characterised by more severe SDB, where older individuals had less of an overnight change in CRVE. Another feature of our experimental design was a 12 month monitored RFM/CPAP intervention phase characterised by relatively high rates of compliance. In the subgroup enrolled in this part of the study, across the RFM/CPAP period, there were no detected group mean changes in CRAE or CRVE evening values. However, individuals with more severe SDB had a decreased evening CRVE and, correspondingly, an increased overnight change in CRVE after 12 months of RFM/CPAP treatment.In addition, this is the first study to demonstrate an effect of sleep, or circadian variation, on retinal vascular morphology. There is a small difference in morning CRVE compared to the evening CRVE, and this change increases in those with more severe SDB after treatment. Circadian changes in the retina have long been recognised [In this study any identified impacts of SDB severity on retinal vascular morphology were all characterised by effect sizes that were relatively small. Therefore, in this non-diabetic cohort, where other cardiovascular disease risk factors were minimised/controlled, it seems unlikely that such associations reflect a major pathophysiological interaction between SDB and retinal microvascular morphology. | PMC9831323 |
Study cohort characteristics | diabetes, cardio-vascular disease, SDB | DIABETES | In interpreting our results it is important to understand the characteristics of the study cohort. This was not a randomised community-recruited population-based study. We targeted a specific clinic group (i.e. patients referred to a sleep clinic for assessment of SDB) and then screened for and eliminated diabetes as a cardio-vascular risk factor. Consequently, our study group was also not a generalised sleep clinic population sample. Rather, we aimed to test for associations between specific SDB metrics and specific micro-vascular characteristics (retinal vessel calibre) in an environment where the influence of known cardio-vascular disease risk factors was absent, minimised or controlled. The rationale for this approach assumed that SDB influences were likely to be small compared with well-known systemic risk factors, such as diabetes, and therefore, would be more likely detected in the absence of such major confounders. Previous published studies that have attempted to quantify associations between retinal vessel calibre and SDB have not attempted to minimise other cardiovascular risk factors [ | PMC9831323 |
Evening CRAE | SDB RFM/CPAP, hypoxia, CRAE, SDB | HYPOXIA, EYE | Group mean values for evening CRAE in our Main Group were ~12% smaller than reported for the younger Inter99 Eye study non-sleep cohort [In our multivariate Base Models, Main Group evening CRAE values were predicted by a combination of “fixed at the time of study” individual characteristics (age, ethnicity, height, smoking history) and one “physiological variable” (systolic BP; see It should be emphasised that our Base Model for evening CRAE explains only ~18% of the total variance, leaving the vast majority of the between subject variance unexplained. This is not unusual, with published multivariate models developed using larger cohorts explaining only 8.2 to 31.7% of the variance [In the Main Group, no SDB variable correlated with CRAE, adding SDB variables to the Base Model did not improve the predictive power of the model and no SDB variable emerged as a predictor. However, in the more severe SDB RFM/CPAP Group, when AHI and AHI category were added to the Base Model, the model now explained ~25% of the variance and both AHI and AHI category emerged as predictors for a slightly larger evening CRAE. This may be a consequence of hypoxia, as AHI is a surrogate for intermittent hypoxia, and chronic hypoxia has been demonstrated in animal models to result in retinal angiogenesis [A unique feature of the present study is the measurement of both evening and morning retinal vessel diameters across a night where sleep was monitored and SDB quantitatively assessed. Multivariate models identified change in diastolic BP as a negative predictor but no SDB variable was identified as a predictor for overnight change in CRAE. | PMC9831323 |
Evening CRVE | hypertension, CRVE, CRAE, SDB | HYPERTENSION, EYE | Group mean values for evening CRVE in our Main Group were ~15% smaller than reported for the younger Inter99 Eye study community cohort [In multivariate Base Models, Main Group evening CRVE values were predicted by a combination of “fixed at the time of study” individual characteristics (ethnicity, smoking history, hypertension history; with age and height borderline) and one “physiological variable” (diastolic BP, with systolic BP borderline; see As for CRAE, it should be emphasised, that our Base Model explains only ~25% of the total variance in Main Group evening CRVE, leaving the vast majority of the between subject variance unexplained. Again, this is not unusual, with published models developed using larger cohorts explaining only 4.2 to 21% of the variance [In the Main Group, no SDB variable correlated with CRVE values and when SDB variables were added to the base model there were no improvements in the amount of variance explained and no SDB variable emerged as a predictor. This outcome differs from that of Shankar et al [For CRVE in the Main Group, group mean values were slightly larger in the morning versus evening (see | PMC9831323 |
RFM/CPAP intervention study | CRAE, stroke, OSA, CRVE, SDB | STROKE | When a sub-group with a wide range of SDB severity were individually stabilised on medical therapy, monitored and given CPAP therapy over a 12 month period, there was no change in group mean evening CRAE or CRVE values or the overnight change in CRAE or CRVE. However, evening CRVE values tended to decrease over the CPAP period, especially for those with more severe SDB (AHI>30 events/hr; see In summary, treatment of OSA with CPAP (combined with medical treatment to control lipid levels and blood pressure) had some effect over 12 months in reducing evening CRVE, and thus perhaps reducing stroke risk. However, this change was not dependent on the amount of CPAP used, and therefore may reflect the impact of all the medical interventions aimed at reducing/stabilising vascular risk factors, rather than the elimination of SDB. | PMC9831323 |
Study limitations | retinal microvascular anatomy, failure, diabetes, cardio-vascular disease, hypertension, SDB | HYPERTENSION, HYPERCHOLESTEROLAEMIA, DIABETES | The study has a number of strengths and limitations. Firstly, it is essentially descriptive and exploratory in nature, consequently, its results should be interpreted accordingly. In addition, given the number of relationships explored, p-values provided should be regarded as only a guide to any potential relationships.Inclusion/exclusion criteria eliminated a major cardiovascular risk factor, diabetes, and controlled for others, eg treatment of hypertension and hypercholesterolaemia, but allowed for major anthropometric influences, e.g. age and body size. This approach aimed to avoid effects of known cardio-vascular disease confounders that typically occur in large community recruited cohorts, while simultaneously avoiding the limitations of very small groups, often produced by protocols that attempt to eliminate all known risk factors. In addition, the majority of the subjects had retinal microvasculature diameters that were within ranges seen in healthy subjects. The failure to identify any major change following treatment may be a consequence of a floor effect, where vessels are unable to change any further. Despite our efforts, classic risk factors were still present in the group and in the process, we have also restricted our ability to examine interactions between SDB and retinal microvascular anatomy when uncontrolled classic risk factors such as diabetes are fully present. The lack of a demonstrated association between SDB metrics and retinal vessel diameters needs to be interpreted with this latter point in mind. It is possible that SDB may have had an additive or even multiplicative effect on uncontrolled classic cardiovascular risk factors. However, such an interaction would have been missed by our current study design. | PMC9831323 |
Conclusion | cardiovascular disease, CRVE, CRAE, SDB | MINOR, CARDIOVASCULAR DISEASE | In this study of non-diabetic patients presenting to a sleep clinic for investigation of SDB, total variance in retinal vessel size was partially explained by a combination of anthropometric characteristics and known predictors, with measures of SDB providing very little to no contribution. In a more severely affected sub-group, increased SDB severity was a minor predictor for increased evening CRAE values, while 12 months of RFM/CPAP treatment was associated with a small decrease in evening CRVE values, which may reflect modifiable cardiovascular disease risk, particularly for patients with more severe levels of SDB. However, overall findings in this non-diabetic sleep clinic cohort do not support a major impact of SDB on the morphology of the retinal microvasculature, suggesting that SDB may also have fairly minimal impact on the cerebral microvasculature, particularly when classic cardiovascular risk factors are absent or well controlled. | PMC9831323 |
Supporting information | (PDF)Click here for additional data file. | PMC9831323 | ||
Univariate correlations- main group (n = 264). | Spearman’s Rank Correlation Coefficients for associations between anthropometric/demographic characteristics, Framingham Risk, blood test results, and SDB variables versus retinal vessel diameters and their overnight change—Main Group.(DOCX)Click here for additional data file. | PMC9831323 | ||
RFM/CPAP sub-group versus main group (minus RFM/CPAP sub-group) participant characteristics. | Continuous A) and categorical B) data comparisons for RFM/CPAP Sub-Group participants (n = 85) versus Main Group minus CPAP Sub-Group participants (n = 179).(DOCX)Click here for additional data file. | PMC9831323 | ||
Multiple linear regression models for evening retinal vessel diameters using non -SDB variables (base models)—main group (n = 264). | CRVE, CRAE, SDB | Base Models showing non- SDB variable predictors for evening CRAE (A) and evening CRVE (B) for the Main Group.(DOCX)Click here for additional data file. | PMC9831323 | |
Multiple linear regression models for evening retinal vessel diameters using SDB variables (SDB models)—main group (n = 264). | CRVE, CRAE, SDB | Results of adding each SDB variable individually to the Base Model for evening CRAE (A) and evening CRVE (B) in the Main Group.(DOCX)Click here for additional data file. | PMC9831323 | |
Multiple linear regression models for evening CRAE using SDB variables (SDB models)- RFM/CPAP sub-group (n = 85). | CRAE | Results of adding LnAHI+1 and AHI Category into the Base Model for CRAE in the RFM/CPAP Sub-Group.(DOCX)Click here for additional data file. | PMC9831323 | |
Compressed file archive–SPSS data/anonymysed data. | (ZIP)Click here for additional data file. | PMC9831323 | ||
Compressed file archive–SPSS syntax. | (ZIP)Click here for additional data file. | PMC9831323 | ||
Compressed file archive: Anonymised raw data/other. | Tracey Burns | MITCHELL | (ZIP)Click here for additional data file.(ZIP)Click here for additional data file.(PDF)Click here for additional data file.The authors thank ResMed (Australia) for providing CPAP machines; Jie-Jin Wang for advice and discussion; Karen Byth and Jannah Baker for assistance with statistical analysis; Tracey Burns, Manisha Verma, Warde Elias, Meredith Wickens, Allison Mitchell, Ayey Susan Madut, Victoria Sissanes, Aaron Lam and Heather Wood for assistance with retinal photography and data gathering; and Ava Tan and Victoria Cosatto for retinal vessel grading. | PMC9831323 |
References | PMC9831323 | |||
Background | occlusion of the aorta | HAEMORRHAGIC SHOCK | Resuscitative endovascular balloon occlusion of the aorta (REBOA) is increasingly used. The recently published UK-REBOA trial aimed to investigate patients suffering haemorrhagic shock and randomized to standard care alone or REBOA as adjunct to standard care and concludes that REBOA may increase the mortality. | PMC10619299 |
Main body | In this commentary we try to balance the discussion on use of REBOA and address limitations in the UK-REBOA trial that may have influenced the outcome of the study. | PMC10619299 | ||
Conclusion | The situation is complex, and the patients are in extremis. In summary, we do not think this is the end of balloons. | PMC10619299 | ||
Keywords | PMC10619299 | |||
Background | occlusion of the aorta | HAEMORRHAGIC SHOCK | Resuscitative endovascular balloon occlusion of the aorta (REBOA) is increasingly used, with haemorrhagic shock as the most common indication [Regardless, the recent publication of the UK-REBOA trial [ | PMC10619299 |
Main text | aortic occlusion, bleeding, head injury, Traumatic brain injury, cardiac arrest, haemorrhage, trauma | AORTIC OCCLUSION, BLEEDING, STILL, CARDIAC ARREST, HAEMORRHAGE, HAEMORRHAGIC SHOCK | The UK-REBOA trial aimed to investigate patients suffering haemorrhagic shock and randomized to standard care alone (SC) or REBOA as adjunct to standard care. The study (and subsequently commentators on social media platforms such as Twitter/X) concludes that REBOA may increase the mortality [The study leaves numerous points to discuss and to cut it short, we do not necessarily agree with the study’s conclusion.Just 90 out of the intended 120 patients were included, with 44 patients in the SC group and 46 in the REBOA group. Randomization is a means to obtain matching study groups, but given that the trial was stopped early, the groups may not actually be comparable. A sensitivity analysis was performed to adjust for differences, without significant effects. Still, there are some striking differences between the groups that may not have been included into the analysis.All patients were critically injured, with a median injury severity score of 41. Twenty-three percent of the patients were in cardiac arrest at some point, demonstrating the severity of the situation and realistically poor prognosis, as cardiac arrest following trauma has devastatingly low survival [The abbreviated injury scales in the groups were similar, except for head injury where the REBOA group scored higher. Traumatic brain injury itself is associated with mortality [Only 19 (41%) patients received aortic occlusion in the REBOA group and arterial access failed in 8 (17%) patients. Two (5%) patients in the SC group received REBOA, without explanation for the cross-over. Hence, this is a very low number for a strong worded conclusion.However, this is not the most concerning finding. It’s the matter of minutes. We recognise that this is not the authors fault, but more a systematic health care limitation. Prehospital times were long, with a median of 90 min from injury to hospital arrival. As prehospital physicians, we understand that prehospital time may be prolonged due to weather, difficulties to extract trauma patients etc., but 90 min from injury to admission, without haemorrhage control, will surely influence outcome. The time from randomization in the emergency room to ‘definitive haemorrhagic controlling procedure’ was 64 min in the SC and 83 min in the REBOA group. The interquartile range in the REBOA group was 56 to concerning 156 min. This leaves the patient with hours of bleeding prior to being subject to a haemorrhage controlling procedure. Such time expenditure is neither the study nor the REBOA procedure’s fault, but a characteristic of the health care system investigated.Further, 32 min to perform REBOA is a surprisingly high procedure time, considered this is performed in the emergency room with adequate ambient lighting and temperature, multiple available personnel and equipment. In the setting of out-of-hospital cardiac arrest, REBOARREST trial participants use approximately 12 min on the REBOA procedure (one physician and one paramedic) [ | PMC10619299 |
Conclusions | non-traumatic haemorrhage | Obviously, these patients are in extremis and the situation is complex. With all the abovementioned limitations, we believe that it is wrong to solely credit (or discredit) REBOA for the results. To successfully salvage the critically injured patient, we need to improve the sum of marginal gains. Short prehospital time and procedural competence are two obvious factors of importance. In the UK-REBOA trial most patients did not receive a definitive haemorrhagic controlling procedure and exsanguinated. Hence, we think that the UK-REBOA trial does not describe the true effect of REBOA. We still consider REBOA as a potential bridge to therapy, but emphasize that it is important to avoid delay in time to definitive surgery [Additionally, this harmonizes with our comment published earlier [In summary, we do not think this is the end of balloons. We salute the investigators for their efforts and challenge others to assess REBOA in non-traumatic haemorrhage. | PMC10619299 | |
Acknowledgements | Not applicable. | PMC10619299 | ||
Author contributions | MR | JRB drafted the manuscript. MR reviewed the manuscript. Both authors read and approved the final manuscript. | PMC10619299 | |
Funding | Not applicable. | PMC10619299 | ||
Availability of data and materials | Not applicable. | PMC10619299 | ||
Declarations | PMC10619299 | |||
Ethics approval and consent to participate | Not applicable. | PMC10619299 | ||
Consent for publication | Not applicable. | PMC10619299 | ||
Competing interests | CARDIAC ARREST | The authors declare that they have no financial competing interest. JRB and MR are both involved in REBOA research in cardiac arrest. Both authors are partially employed in the Norwegian Air Ambulance Foundation for research purposes. | PMC10619299 | |
References | PMC10619299 | |||
Background | Advancing the health of adolescents, particularly their sexual and reproductive health, including HIV prevention and care, is a development imperative. A critical part for improving their wellbeing and economic development is the social status accorded to adolescent girls and young women (AGYW). However, AGYW in many countries including Zambia, encounter health challenges that stem from gender inequalities, lack of empowerment, inaccurate knowledge on sexuality, and poor access to sexual and reproductive health (SRH) services and information. Addressing the knowledge gaps through comprehensive sexuality education (CSE) and improving access to SRH services and appropriate information, should reduce school attrition from early and unintended pregnancies (EUP) and enhance realization of their full potential. | PMC9933327 | ||
Methods | The aim was to reduce EUP and improve SRH outcomes among AGYW in Zambia through provision of CSE linked to receptive SRH services. A 3-Arm randomized control study collected cross-sectional data at baseline, midline and Endline. Schools where CSE was being routinely provided were randomized into a non-intervention arm (arm1), an intervention arm in which information on available SRH services was provided in schools by health workers to complement CSE, (arm 2), and arm 3 in which pupils receiving CSE were also encouraged or supported to access pre-sensitized, receptive SRH services. | PMC9933327 | ||
Results | Following 3 years of intervention exposure (CSE-Health Facility linkages), findings showed a significant decline of in-school pregnancies amongst AGYW in both intervention arms, with arm two exhibiting a more significant decline, having recorded only 0.74% pregnancies at endline ( | PMC9933327 | ||
Conclusion | Linking provision of CSE with accessible SRH services that are receptive to needs of adolescents and young people reduces EUP, which provides the opportunity for higher retention in school for adolescent girls. | PMC9933327 | ||
Plain English summary | Among Zambia’s key health and development challenges, are high rates of EUP, and disproportionately higher HIV rates among AGYW. Pregnancy among girls in school poses a challenge. CSE programmes are part of available armamentarium to improve knowledge on the risks. Poor SRH places a heavy strain on health systems and undermines sustainable development efforts. In response to these challenges, we initiated implementation research to develop and test a model linking CSE programs in schools with access to SRH services and information. Research was conducted in 23 schools and their local catchment health care facilities in two North Western province districts of Zambia. Following baseline data collection, schools were selected to ensure comparability of indicators such as reported pregnancy rates, CSE, and subsequently randomized into three study arms, with the first arm continuing standard instruction of CSE (control). The second arm was designed to bring information on available SRH services to schools, including raising awareness through health fares and clubs. In the third arm, health providers were trained to be more receptive to ASRH health needs, in addition to encouraging teachers to introduce students to health services. Pregnancies declined in all intervention arms at endline, with marked reductions in intervention Arm 2 which recorded 0.74% of in school pregnancies ( | PMC9933327 | ||
Keywords | PMC9933327 | |||
Background | CSE | SECONDARY, SEXUALLY TRANSMITTED INFECTIONS | School attrition attributed to early and unintended pregnancy (EUP) exposes adolescent girls and young women (AGYW) to various social and financial hardships, negatively impacting access to resources and, thus, perpetuating gender-based inequities. School dropout is associated with poorer sexual and reproductive health (SRH) knowledge and, when coupled with suboptimal access to SRH services and persistent gender inequities, can elevate risks of EUP, HIV and other sexually transmitted infections, as well as sexual and gender-based violence (SGBV) [Zambia has a youthful population, with adolescents under 18 years constituting over half (52.2%) of the population [The Ministry of General Education (MoGE) in Zambia noted a gradual increase in the number of teenage pregnancies among in-school girls. Between 2011 and 2019, a total of 120,878 pregnancies among in-school girls (109,850 in primary school and 26,752 in secondary school) were recorded [To address the overlapping challenges of school attrition and EUP, innovative strategies for enhancing self-efficacy, agency, gender empowerment, and school retention are imperative. Comprehensive sexuality education (CSE), introduced throughout sub-Saharan Africa, including Zambia [CSE implementation in Zambia, nevertheless, has confronted various operational and structural challenges. A small qualitative study in rural Nyimba District (Eastern Province) found that teachers implement the CSE curriculum with substantial discretion, which has resulted in censorship of specific elements of the curriculum deemed incompatible with local norms [Without access to quality health services, young people have limited ways to adopt or implement some of the practices or behaviours promoted by CSE curricula (e.g., condom use, strategies for pregnancy and HIV prevention). Efforts to make services more amiable and responsive to adolescents have largely failed to improve outcomes unless they are coupled with demand-generation activities [The overall primary objective was to reduce EUP and improve SRH outcomes among AGYW in Zambia through increased access and utilization of SRH information and services. | PMC9933327 |
Methods | PMC9933327 | |||
Setting and study sample | SECONDARY | The study was implemented in selected schools and health facilities in Solwezi and Mufumbwe Districts (North-Western Province) of Zambia from 2017 to 2020. These two districts were selected because of high background adolescent pregnancy rates [A cross-sectional baseline assessment was conducted from August to November 2017 and followed by three subsequent rounds (R) of post-intervention (PI) data collection in November and December of each year: a first round (R1-PI) in 2018; a second round (R2-PI) in 2019; and a third and final round (R3-PI) in December 2020. At baseline, reported data on pregnancies at study sites were abstracted for 2016 and 2017.The study sample was drawn from schools selected at baseline. Schools were purposively identified and matched for consistency, according to presence of teachers trained in CSE (through orientation seminars or workshops); student access to a government health facility offering SRH services, regardless of distance; comparable student populations by age: sex composition; and annual numbers of withdrawals due to pregnancy. Using these criteria, 12 schools were selected in Solwezi (six primary and six secondary) and 11 in Mufumbwe (five secondary and six primary). Each of the schools’ Parent Teacher Association gave permission for the study, prior to IRB approvals.After baseline assessment, the 23 schools (see Fig. Distribution of schools in study districtsPrior to interventions, we engaged parents from all the study schools by convening meetings with the respective Parent Teacher Associations (PTA), and following our explanation of the study rationale, design and methods, all PTAs were unanimous in providing their approvals, in writing. Our study dissemination efforts have also included sharing of the data with the respective PTAs, community and political leaderships. | PMC9933327 | |
Measures | SECONDARY | The present paper is concerned with in-school EUP as the outcome of interest. In addition, background characteristics of the study population were collected annually at each questionnaire round. Data was collected using preloaded study instruments on tablets using SurveyCTO software. A conceptual framework (see Fig. Protocol conceptual framework developed to guide the overall study conceptualization and implementationData on annual pregnancies (number of pregnancies in enrolled primary or secondary school-going girls) from each school was collected at three time points in the post-intervention period, in the last quarter of each calendar year (2018, 2019 to 2020) and aggregated at the study arm level. Data on pre-intervention periods of 2016 and 2017 were also recorded. The study team, in collaboration with MoH and MoGE, abstracted data on pregnancies from each school’s guidance/counselling files and annual census reports during the monitoring visits. | PMC9933327 | |
Sample size | sexual behaviors | The overall sample size was calculated based on the number of adolescents required to derive differences, if any, in knowledge and behavioural variables that meet the criteria in each school and each selected grade, and thus more applicable in later analysis, while noting adequacy for lower-level variables, such as pregnancies. Thus, according to the Ministry of Education Statistical Bulletin of 2014, the estimated average number of students per classroom in North-Western Province is 55 for grades 1–7 and 45 for grades 8–12, with an average of two classroom streams per grade. Accounting for a 10% refusal rate, the minimum sample at each cross-sectional assessment was, therefore, 1704 adolescents, with upward adjustments to avoid in-classroom student discrimination, and maintaining enough power to test levels of significant differences in reported knowledge and sexual behaviors, irrespective of attrition due to in-school pregnancies.Z = Z value (e.g., 1.96 for 95% confidence level)p = percentage picking a choice, expressed as decimal (.5 used for sample size needed)c = confidence interval, expressed as decimal. | PMC9933327 | |
Data management analysis | REGRESSION | Collected data (entered using SurveyCTO) was transferred to Excel for preliminary cleaning, then transferred to Stata/IC 15.1 for further management and analysis. Bivariate logistic regression was implemented to examine whether socio-demographic characteristics in the study population differed significantly by study arm at endline (R3-PI). Within each study arm, paired t-tests were implemented to determine whether standardized pregnancy rates (number of pregnancies per 1000 AGYW enrolled at each school) changed significantly over the observation period. Guided by a difference-in-differences approach, we then implemented mixed-effects Poisson regression to determine whether observed changes in standardized pregnancy rates from baseline to endline differed significantly by arm, with the CSE-only arm serving as the referent group in analysis. Statistical significance was determined using a pre-specified alpha threshold of 0.95 ( | PMC9933327 | |
Results | PMC9933327 | |||
Background of sample socio-demographic characteristics | SECONDARY | Descriptive sample characteristics at endline (R3-PI) of 986 participating AGYW are presented in Table Descriptive sample characteristics at endline (R3-PI)Of those in secondary school, a greater proportion (21.1%) were in Grade 8 and Grade 9 (18.8%). There were no significant differences between the arms at endline, rendering them comparable. | PMC9933327 | |
Pregnancies in school | By study endline in 2020 (R3-PI), there were noteworthy reductions in the numbers of adolescent pregnancies following exposure to the CSE linkage program, with marked reductions documented in Arms 2 and 3 (see Fig. Cumulative number of school-level pregnancies, by year and study armA test of proportion was conducted to compare the pre-intervention (2016 and 2017) and post intervention (2020) trends in pregnancy (see Table Pregnancy test of proportion at pre and post interventions by armAt endline (P3-PI), Arm 1 recorded a pregnancy fraction of 2.70 per 100 AGYW (Proportion of enrolled schoolgirls who were pregnant in 2020Figure Schematic description of pregnancies over time in each arm, from which difference in difference tests were conductedA difference-in-differences analysis was applied to compare the pre-intervention (2016) and post intervention (2020) IRR in pregnancy, between the control arm (Arm1 2016 and 2020) as compared with Arms 2 and 3, respectively, to estimate the relative measure of intervention effect (see Table Differences in pregnancies between the arms before and after interventionsPregnancy metadata were also analyzed within each school to subsequently inform school-based targeted pregnancy reduction strategies, in conformity with implementation feedback SOPs. At R2-PI and R3-PI, schools in Arm 1 showed no notable reductions, with a high number of pregnancies in two schools, while in Arm 2, one school had a high pregnancy rate, and in Arm 3, there was concern at one school. Feedback was provided in each case, in line with developed implementation science research protocols. | PMC9933327 | ||
Discussion | CSE, death | COMPLICATIONS | Findings in this paper suggest a significant decline in early and unintended pregnancies within schools featuring integrated CSE linked to SRH information and services, particularly when efforts are made to bring information on SRH services, to schools and linking CSE with health facilities that are sensitized to be more receptive to the ASRH needs of AGYW who may or not be in school. Although there are disparities in achievements, evidence from this paper suggests that pregnancies declined in the two intervention arms, but with room for additional improvement. Although in-school pregnancies were documented across arms following trial implementation, there were significantly greater declines in EUP in the two intervention arms relative to the control arm, which were associated with CSE linked to SRH services and information.Adolescent pregnancy remains a major public health concern, even when there is one pregnancy, it disrupts the learning opportunity of the adolescent, with potential negative health and social consequences. CSE, integrated in the school curriculum, confers opportunities for imparting scientifically accurate information about SRH. Despite having moderate SRH knowledge and acceptability of SRH services, few sexually experienced AGYW utilize SRH services, resulting in high EUP. Multiple reviews and studies across a diverse range of settings in Europe, the United States, Africa, and Mexico confirm that CSE contributes to preventing unintended adolescent pregnancies by providing students with knowledge, life skills, and information on contraceptive options. It can reduce early sexual debut and prevent early and unintended pregnancy among AGYW [A noteworthy finding of this study was that in-school pregnancies did not decline significantly in the CSE-only control arm, which underscores the role of combining CSE implementation with information on available and responsive SRH services. Several studies in Zambia have reported barriers to CSE implementation, including parental objections, perceived incompatibility of curricular material with social norms, inadequate training and support for teachers, instructor discomfort with material or self-efficacy delivering lesson plans, and inattention to health systems-related factors impacting SRH service provision to adolescents and SRH outcomes [According to the Ministry of General Education in Zambia [Teenaged mothers are at higher risk of adverse pregnancy outcomes or complications, and children born to very young mothers are at increased risk of sickness and early death [Sometimes shortages of essential SRH commodities and supplies are a disincentive in accessing and using SRH services in the public sector. Our mitigation approach to this has been through engaging the political leadership, including parliamentary committees, to share our findings, with a view to show and highlight the cost benefits of investing in SRH commodities, whose down-stream consequences, if neglected, far outweigh the initial costs of availing them. Such consequences include high school dropouts, unsafe abortion, maternal mortality and morbidity, needless contribution to high total fertility, and poverty through curtailed economic growth targets.While there could be gaps in the provision of CSE in some schools, based on individual ideological convictions, we did not encounter individual resistances from schools, possibly attributed to the support we received from the combination of Ministry of Education, Ministry of Health and the respective PTAs. During our pre-study orientations, we implored teachers at each school to shun from personal beliefs in approaching the issues of CSE and accessing SRH services by their pupils, in times of need.The study has a number of policy implications for consideration, with a view to reduce in-school pregnancies and allow AGYW to realize their full potential. These include the following:The need for policy decision makers and programme directorates in Ministries of Education, Health and Economic Planning and Finance to work together to facilitate access to CSE that is linked to SRH services and information;The need for constant dialogues and engagement of PTAs by Ministries of Education and Health, on the issues of preventing EUP in schools and encouraging links between provision of CSE and accessing health care.The need for constant orientation of health services and sensitization of health care providers by Ministries of Health, to be more responsive and receptive to the needs of AYP, including in-school pupils.The need for relevant civil society organizations or Development partners, or Ministries of Health, to engage in interactive health education outreach programmes in schools, which place emphasis on prevention of EUP, among other health and social wellbeing issues, such as menstrual hygiene and respectful gender relations.Our study is not without limitations. First, while our primary outcome of interest was early and unintended pregnancy, we also collected data on background characteristics of respondent pupils at each school, other key process or outcome measures, like SRH and gender equity knowledge and behaviours, which could be among mediating factors in the relationship between intervention implementation and pregnancy outcomes. However, to avoid overwhelming this paper, whose explicit measure is pregnancy outcome by study arm intervention, these multiple factors and related outcomes will be the focus of subsequent analyses of these data. Second, pregnancy data were derived from school administrative records, which may not have accurately captured all pregnancies, particularly if AGYW dropped out of school and did not report pregnancy to the school, as the reason for dropping out. However, this limitation would apply to all study arms. Lastly, the unique implementation climate of CSE in North-Western Province and health systems context in Zambia may attenuate the generalizability of our findings outside Zambia. Future research should examine the impact of comparable CSE-linked interventions in other contexts, especially in other countries in the region, affected by high school attrition from EUP. | PMC9933327 |
Conclusion | LATE PREGNANCIES | Considering that the odds of exposure to both in-school CSE and accessible receptive health facility-based SRH services, significantly increased for students in intervention arms 2 and 3, and pregnancies significantly declined, it appears that at least both of those additional interventions are beneficial and should be implemented in these and additional schools. However, to compensate individual intervention study limitations and enhance outcomes, a hybrid intervention arm incorporating both intervention elements would be ideal.In addition, further research, which employs qualitative study designs, will be required to establish the circumstances surrounding the individual in-school pregnancies, as well as health and social outcomes affecting the girls, especially among those who fail to return to school. A potential study limitation was having to rely on school records on pregnancies that occur in a calendar year, as that misses early unitended pregnancies occurring at the end of the year, but the ideal of including pregnancy tests, is not feasible, and this limitation is countered by the potential for such late pregnancies to be randomly distributed across the three study arms. | PMC9933327 | |
Acknowledgements | We are grateful to all the schools that participated, Ministries of General Education and Health, at Head Quarters; Provincial and District levels staff whose support was invaluable, all the schools’ Parent Teacher Associations (PTAs) which endorsed the study, and the implementing partner we worked with, Young Women Christian Association Council of Zambia (YWCA). | PMC9933327 | ||
Authors’ contributions | MTM: study conceptualization, design, training, generation and analysis of data and paper writing; KK, N-CM, SI, ESN: training, generation, management and analysis of data and paper writing; JGR, RM, NO, CP, NC: data analysis and scientific writing; CK: training, drafting SOPs, and data generation. The author(s) read and approved the final manuscript. | PMC9933327 | ||
Funding | 2016–2021 | This work was funded by the United Nations Education, Social and Cultural Organization (UNESCO), under Contracts 4500427570 and 4500403122-A1, and United Nations Population Fund (UNFPA), under the 2016–2021 Implementing Partners Agreement. | PMC9933327 | |
Availability of data and materials | The datasets generated and /or analysed specific to the current reported study are available on reasonable request to Population Council, Zambia, Data Manager Mr. Kondwani Kasonda kkasonda@popcouncil.org. | PMC9933327 | ||
Declarations | PMC9933327 | |||
Ethics approval and consent to participate | This study received ethical review and independent ethical approvals from Population Council’s Institutional Review Board (IRB), 1 Dag Hammarskjold, New York, NY 10017, USA; as well as the Zambia National IRB ERES CONVERRGE, Joseph Mwilwa Road, Lusaka 10100. We declare that all study methods were carried out in accordance with the respective IRB guidelines and regulations. The Ministry of General Education (Lusaka, Zambia) and Parent Teacher Associations from each participating school, provided approvals for the study. All study participants provided informed consent if they were age 18 years and older; assent following prior guardian or parental consent was obtained from all study participants under age 18. Consenting participants individually responded to study questionnaires on demographic data, CSE knowledge, and utilization of health services. Data on annual numbers of pregnancies were obtained from end of year de-identified school records, which are collated annually and submitted to the Ministry of Education by all schools. | PMC9933327 | ||
Consent for publication | Not Applicable, as that is not a prerequisite. | PMC9933327 | ||
Competing interests | The authors of this manuscript have no conflict of interest to declare. | PMC9933327 | ||
References | PMC9933327 | |||
Background | CMDs, stress-related disorders | DISORDERS | The number of people with common mental disorders (CMDs), especially stress-related disorders, has increased in several countries, including Sweden, during the past decade. Patients seeking care for long-term stress report severe symptoms. Although person-centred care (PCC) has shown several benefits, studies evaluating the effects of a PCC eHealth intervention on patients with CMDs are scarce. | PMC10585814 |
Objective | The aim of this study was to compare levels of self-reported symptoms of burnout between a control group receiving treatment as usual (TAU) and an intervention group receiving TAU with the addition of a person-centred eHealth intervention, in patients on sick leave for CMDs. | PMC10585814 | ||
Methods | SECONDARY | This study reports analysis of a secondary outcome measure from a randomized controlled trial. Patients (n = 209) on sick leave for CMDs were recruited from nine primary health care centres and allocated to either a control group (n = 107) or an intervention group (n = 102). The intervention consisted of phone support and an interactive digital platform built on PCC principles. Self-reported symptoms of burnout were assessed using the Shirom-Melamed Burnout Questionnaire (SMBQ) at baseline and at 3 and 6 months. | PMC10585814 | |
Results | Our findings showed changes in SMBQ scores over time in both the control and the intervention group. There was no significant difference in SMBQ scores between the groups; however, a difference in change over time between the groups was observed. The SMBQ scores decreased significantly more in the intervention group than in the controls between 0 and 3 months and between 0 and 6 months. No differences in change between the two groups were seen between the 3- and 6-month follow-ups. | PMC10585814 | ||
Conclusion | This person-centred eHealth intervention for patients on sick leave for CMDs showed a slight initial effect in reducing symptoms of burnout. Taking into account that both groups reported comparable SMBQ scores throughout the study period, the overall effect may be considered limited. | PMC10585814 | ||
Trial registration | : The trial was registered in ClinicalTrials.gov (Identifier NCT03404583). Date of registration: 19/01/2018. | PMC10585814 | ||
Keywords | Open access funding provided by University of Gothenburg. | PMC10585814 | ||
Introduction | CMDs, muscular pain, anxiety, exhaustion disorder, memory impairment, depression, Depression | DISORDERS | Internationally, the term “common mental disorders (CMDs)” often refers to various anxiety and depression disorders [Depression and anxiety are the most common mental health diagnoses among patients in primary care and symptoms of depression and anxiety are strongly related to psychosocial stress [In Sweden, the diagnosis “exhaustion disorder (ED)”, has been introduced in the Swedish version of the ICD, 10th revision (ICD-10) with diagnostic code F43.8 A. The diagnostic criteria state that at least one identified stressor, work- or non–work-related, should have been present for at least six months and that the clinical picture is dominated by a lack of psychological energy. Four of the following symptoms should have been present almost every day for at least two weeks: concentration or memory impairment, emotional instability, reduced ability to cope with demands and/or time pressure, disturbed sleep, apparent physical weakness, and physical symptoms such as muscular pain [Among a population of working-age patients seeking primary care, regardless of the reason, 59% reported stress-related symptoms, with high symptoms of burnout and exhaustion [Person-centred care (PCC) aims to engage the patient as an active partner in their care and treatment. It is based on ethical principles emphasizing the importance of knowing the patient as a person with resources and needs, which is essential for establishing a mutually respectful partnership between the patient (often including relatives) and health care professionals (HCPs) [This study aimed to compare levels of self-reported symptoms of burnout between a control group receiving treatment as usual (TAU), and an intervention group receiving TAU with the addition of a person-centred eHealth intervention, in patients on sick leave for CMDs. Three research questions were formulated: Does the SMBQ score change over time? Does the SMBQ score differ between the groups over time? Does the change in SMBQ score differ between the groups over time? | PMC10585814 |
Methods | PMC10585814 | |||
Study design | SECONDARY, DISORDERS | This article reports a secondary outcome analysis of the PROMISE study (“Person-centred eHealth for treatment and rehabilitation of common mental disorders”), which was an open randomized controlled trial (RCT) evaluating the effects of a six-month person-centred eHealth intervention (interactive digital platform and telephone support) for patients on sick leave for CMDs. Study methods and procedures of the PROMISE study have been presented elsewhere [ | PMC10585814 | |
Setting and participants | anxiety disorder, Anxiety, F32, depression, Depression, adjustment disorders, F33 | DISEASE, DISORDERS | Eligible patients at nine public primary health care centres in western Sweden were screened by designated HCPs and enrolled between February 2018 and June 2020. Patients were considered eligible if they were 18–65 years old, and currently employed or studying (at least part-time) during the last 9 months, had a registered address, could understand written and spoken Swedish, were currently on sick leave that had lasted no longer than 30 days, and had been diagnosed by a physician for any of the following conditions in ICD-10: mild to moderate depression (F32 and F33), mild to moderate anxiety disorder (F41), reaction to severe stress, and adjustment disorders (F43, which includes the Swedish diagnosis ED (F43.8 A)). Exclusion criteria were previous sick leave exceeding 14 days for any of the diagnoses mentioned above during the last 3 months, severe impairment hindering the use of the eHealth intervention, ongoing documented alcohol or drug abuse, severe disease that had a survival expectancy of < 1 year or that could interfere with follow-up if the intervention was assessed as a burden, or participation in a conflicting study. A flowchart of the study participants is presented in Fig.
CONSORT diagramEligible patients were sent an information letter about the study by regular mail and informed that an HCP would be in contact with further details and to ask if they would like to participate in the study. They were also informed that they could contact the HCPs and/or the researchers for more information about the study. Patients who agreed to participate were sent a consent form to sign and return in a prepaid envelope. Randomization was based on a computer-generated list created by a third party and stratified by age (< 50 or ≥ 50 years) and diagnostic group (1: Depression, 2: Anxiety, 3: Stress reactions and disorders). Ethical approval was obtained from the Regional Ethical Review Board in Gothenburg, Sweden (DNr 497 − 17, T023-18, and T526-18).In total, 1,317 patients were screened for study enrolment. Of the 1,118 patients who were reached by phone, 803 met the eligibility criteria, 588 of whom declined to participate. The remaining 215 patients were randomized and assigned to either the control or the intervention group. Six of these withdrew consent, leaving 107 in the control group and 102 in the intervention group. All participants were informed of their allocation by phone. | PMC10585814 |
Control group | Patients enrolled to the control group received TAU, which for patients with CMDs often takes place in primary care. Initially, they consult a physician to initiate the consultation, treatment, and follow-up on sick leave. Treatment often consists of medication or cognitive behaviour therapy, or both [ | PMC10585814 | ||
Intervention group | The intervention, consisting of PCC delivered via an interactive digital platform (“My Health”), as well as phone support, was provided in addition to TAU. The team of HCPs (n = 5) conducting the intervention represented different disciplines (e.g. nursing, physiotherapy and occupational therapy). All received a half-day education regarding CMDs and the philosophical standpoints of PCC led by specialists for each area. They also had access to a forum where they, together with specialists in PCC, could raise questions and share experiences of practising PCC. The first phone conversation was jointly scheduled between HCPs and patients in the intervention group and a web link was sent to patients for access to the digital platform. Additional follow-ups by phone were agreed and scheduled as required. The intervention aimed to apply the ethics of PCC in practice and was designed to facilitate a partnership between patients, professionals, and, if desired, the patients’ extended social network.The telephone support consisted of an HCP listening attentively to the patient’s narratives about their daily life and current situation. The HCPs encouraged narration and established a partnership using communication skills such as asking open-ended questions, sharing reflections and summarizing. Based on the patient’s narrative a health plan was co-created, which captured the patient’s experiences of their situation, capabilities, resources, needs and goals. The health plan was uploaded to the digital platform and served as a guide to be used together by the patient and HCPs in further phone conversations and communication via the platform.The platform contained functions to facilitate patients’ self-management. Thus, the patients were invited to use a diary function for free-text entries and to rate their daily symptoms, visualized as trend graphs that allowed them to follow symptoms and their recovery process over time. Patients and HCPs communicated via the platform in a chat-like forum, and patients were able to invite and give customized access to the platform to any person they wanted, such as family, friends, and workplace representatives. They also had access to links to relevant websites containing information about CMDs. A participatory design was used in which the researchers organized workshops with patient representatives, system developers and HCPs to discuss and develop the PCC eHealth intervention [ | PMC10585814 | ||
Data collection and outcome measures | Self-reported questionnaire data were gathered by regular mail at baseline and after 3 and 6 months. The level of burnout was assessed using the SMBQ [ | PMC10585814 | ||
Statistical analysis | INTERACTIONS | Descriptive statistics are given in percentages and numbers for categorical variables and means and standard deviation (SD) for continuous variables. Longitudinal associations between the two groups (the intervention and control group) and SMBQ scores were analysed using linear mixed models with random intercept in SPSS version 25 (IBM, Armonk, NY, USA). Age and gender were tested as possible confounders and the inclusion criterion was p < 0.25. Time was included as continuous variable (0, 3 and 6 months from inclusion in the study). Interactions between the groups and time were tested to evaluate whether the development over time was different in the two groups. Parameter estimates along with 95% confidence intervals (CIs) are presented as a measure of association.Post hoc analysis was done to understand the nature of the interaction effect. Independent-sample | PMC10585814 | |
Discussion | The present study in patients on sick leave for CMDs aimed to compare levels of self-reported symptoms of burnout between a control group receiving TAU and an intervention group receiving a person-centred eHealth intervention in addition to TAU. Our findings showed changes in SMBQ scores over time in both groups. There was no significant difference in SMBQ scores between the groups. However, there was a difference in change over time between the groups. The SMBQ scores for the intervention group decreased significantly more compared to the control group between 0 and 3 months and between 0 and 6 months. No differences in change between the two groups were seen between the 3- and the 6-month follow-ups. Overall, the effect of the intervention should be considered small given that both groups had comparable levels of SMBQ throughout the study period. The cut-off for clinical burnout for the SMBQ is 79 [Previous research has shown that Internet-based interventions are an equivalent alternative to face-to-face treatments [Even though our results showed that the intervention had a limited effect, we cannot rule out that it relieved the symptom burden for some of the participants during the first 3 months. One possible advantage of the eHealth support may have been that the intervention was performed early in the sick leave period. Interventions in the early stages of sick leave have been shown to prevent both deteriorating conditions and long-term sick leave with risks of relapse [The fact that the intervention was administered from a distance may have increased accessibility for patients at risk of social isolation and patients occasionally experiencing resistance to a scheduled time in primary care [Van Dam suggests providing tailored interventions and treatment as patients require different treatment approaches and mental illness prevention strategies [In summary, our results show that the PCC eHealth intervention had a limited effect, but we cannot exclude that it relieved the symptom burden for some participants during the first 3 months and may be a feasible option for some patients. In health care encounters, professionals need to listen carefully to patients’ narratives and acknowledge their unique needs and resources in order to tailor the support based on each patient’s situation [ | PMC10585814 | ||
Study limitations | SECONDARY | Because this study is a secondary outcome analysis and was not initially used to detect differences in symptoms of burnout, a power calculation was not performed. The response rate on the self-reported questionnaire was relatively high (75%). However, there remains a risk of non-response bias. Another area for improvement is that the SMBQ might not precisely reveal the clinical picture of the different diagnoses included in CMDs, which may have impacted the results. Being involved in a research study might also have affected participants’ motivation to engage in TAU. | PMC10585814 | |
Acknowledgements | We want to thank all the participants for sharing their experiences, as well as the professional health care workers Mahboubeh Goudarzi, Eva-Lena Andersson, Paula Johansson Tunås and Emma Vasell for participating. We gratefully acknowledge the contribution of the participating primary centres, their staff, managers, and especially area manager Cathrine Thanner for support and assistance in conducting the study. | PMC10585814 |
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