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3.1. Baseline characteristics | As depicted in | PMC10745664 | ||
3.2. 24 h Ambulatory Blood Pressure Monitoring | Results were obtained before and after each intervention period. We analysed 24 h measurements, however, no intra- or inter group differences were found ( | PMC10745664 | ||
3.3. Blood Analyses | Overall, we observed no effects on hs-CRP or adiponectin. However, there was a trend towards improvements upon supplementation with AE, with a 17% decrease in hs-CRP and −0.59 ± 0.26 mg/L decrease in adiponectin. Regarding lipids, the intra-group analysis revealed several increases distributed across all groups after supplementation, and an overview is provided in | PMC10745664 | ||
4. Discussion | T2D | CVD, LIPIDAEMIA | In this study, we investigated the effects on cardiovascular risk factors of an eight-week supplementation with aronia extract, fermented aronia extract, and placebo, respectively, in subjects with T2D. After an 8-week supplementation with aronia, we did not observe any significant differences in blood pressure, adiponectin, or hs-CRP. Regarding blood pressure, our results are in line with findings from Simeonov et al. who did not find any significant effect on blood pressure in individuals with T2D after a 3-month non-blinded, non-controlled supplementation regimen [No changes were observed for hs-CRP. However, baseline values were generally low with values below 1 mg/L, and a value below 10 mg/L indicates a low cardiovascular risk [In accordance with the European Society of Cardiology, it is recommended that individuals with T2D and high CVD risk are more closely monitored in regard to lipid levels than healthy people with LDL-cholesterol levels below 1.8 mmol/L [In accordance with to the European Society of Cardiology, it is recommended that fasting triglyceride levels are maintained below 2.3 mmol/L [Since placebo, FAE, and AE are similar in nutritional composition, but all contain rather large amounts of sugar, it is interesting that lipid levels changed less than 0.1 mmol/L after supplementation with FAE and AE, with the exception of triglycerides, which were increased by 0.23 ± 0.08 mmol/L after AE supplementation. This could suggest that FAE and AE might have protective effects by preventing rises in lipid levels after the consumption of an unhealthy amount of sugar for eight weeks. On the other hand, it remains puzzling why triglycerides would increase after supplementation with AE. However, a higher intake of saturated fatty acids and a lower intake of polyunsaturated fatty acids and carbohydrates have been connected to lower triglyceride levels [Furthermore, it has previously been reported that raisins have a low glycaemic index, and that 50 g of raisins can be considered a healthy snack for individuals with T2D [Even though the supplements have small variations in nutritional composition, it is unlikely that this alone could account for the observed differences. It is possible that the high content of anthocyanins, in AE and FAE, prevented increases in blood lipids like those observed after supplementation with placebo. In line with this postulation, a meta-analysis has reported that a supplementation with anthocyanins had a positive effect in individuals with lipidaemia [ | PMC10745664 |
5. Conclusions | cardiometabolic diseases, T2D | In conclusion, aronia extracts, both fermented and non-fermented, could contribute to improvements in lipid profiles in subjects with T2D, but more high-quality studies are needed to confirm our findings. Preferably, these studies should be performed using aronia in its pure form to avoid the possible interference of raisins and coconut oil. If such studies could confirm aronia’s presumed lipid-lowering effects, aronia could have a wide application as a supplement not only in relation to T2D but also in relation to cardiometabolic diseases in general. Apparently, aronia does not affect blood pressure, adiponectin, or hs-CRP. | PMC10745664 | |
Author Contributions | Conceptualization, C.B.C., P.B.J., K.H. and S.G.; validation, C.B.C., P.B.J., K.H. and S.G.; formal analysis, C.B.C.; investigation, C.B.C.; data curation, C.B.C.; writing—original draft preparation, C.B.C.; writing—review and editing, P.B.J., K.H. and S.G.; supervision, P.B.J., K.H. and S.G.; project administration, C.B.C., P.B.J., K.H. and S.G.; funding acquisition, C.B.C., P.B.J., K.H. and S.G. All authors have read and agreed to the published version of the manuscript. | PMC10745664 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board (or Ethics Committee) of The Central Denmark Region Committees on Health Research Ethics (Journal no. 1-10-72-102-19, 12 August 2019). | PMC10745664 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10745664 | ||
Data Availability Statement | Data supporting reported results can be obtained by contacting the corresponding author. | PMC10745664 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10745664 | ||
References | Study design. (CONSORT diagram with overview of enrolment and discontinuation. Reprinted with permission from [Mean pre and post values for fasting levels of LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglycerides. Data are presented as mean ± standard error. * indicates a significant difference between pre and post values. Nutritional composition of FAE, AE, and placebo. Data are provided for 2 bars, which correspond to each participant’s daily intake. Energy percentages in relation to the total energy content in the bars are stated in square brackets for total fats (9 kcal per gram), total carbohydrates (4 kcal per gram), and protein (4 kcal per gram). Reprinted with permission from [Saturated [g]Unsaturated [g]Polyunsaturated [g]Free sugars [g]Abbreviations: FAE: fermented aronia extract, AE: aronia extract.Mean measurements at baseline for completers and non-completers. Reprinted with modifications from [Abbreviations: SD: standard deviation, IQR: interquartile range, W: women, M: men.Overview of participants’ medications. Reprinted with modifications from [Results for 24 h ambulatory blood pressure monitoring, inflammatory markers, and blood lipid levels. Results are provided as mean difference (Δ-mean) along with pre and post measurements. However, a ratio (confidence level) is used instead of Δ-mean in case of a non-normal distribution. The data on hs-CRP were not normally distributed; therefore, we compared ratios instead of Δ-means. To clarify, a ratio of 1.10 signifies a 10% increase from pre to post, whereas a value of 0.83 denotes a 17% decrease. All pre and post measurements are provided on the scale outlined in the left column ± standard error. Significant differences are given in bold and marked by *. If several significant values are present in one line, differences are marked by superscript letters.Abbreviations: FAE: fermented aronia extract, AE: aronia extract, BP: blood pressure, Hs-CRP: high-sensitive C-reactive protein, HDL-cholesterol: high-density lipoprotein cholesterol, LDL-cholesterol: low-density lipoprotein cholesterol. | PMC10745664 | ||
Abstract | PMC10128158 | |||
Background | Communal exercise interventions may help prevent falls and injuries. However, pragmatic trials demonstrating the effectiveness of such strategies are sparse. | PMC10128158 | ||
Methods | We determined whether a cost-free 12-month admission to the city’s recreational sports facilities including initial 6 months of supervised weekly gym and Tai Chi sessions decreases the number of falls and related injuries. The mean (SD) follow-up time was 22·6 (4.8) months in 2016–19. A total of 914 women from a population-based sample with a mean age of 76.5 (SD 3.3, range 71.1–84.8) years were randomized into exercise intervention ( | PMC10128158 | ||
Results | A 14.3% fall rate reduction was detected in the exercise group (Incidence rate ratio (IRR) = 0.86; CI 95% 0.77–0.95) compared with the control group. Approximately half of the falls caused moderate ( | PMC10128158 | ||
Conclusions | fractures | A community-based approach for a 6-month exercise period combined with a 12-month free use of sports premises can reduce falls, fractures and other fall-related injuries in aging women. | PMC10128158 | |
Key Points | injuries, pain | A two-year randomized controlled fall prevention study on community-dwelling older women.The greatest reduction was observed in falls with severe injury and pain.Community-driven fall prevention with light- or moderate-intensity exercise group programmes can reduce falls and fall injuries on a municipal scale. | PMC10128158 | |
Introduction | fractures | SECONDARY | The global proportion of people over 60 years is expected to double between 2000 and 2050 [Community-wide effects of fall prevention in the aging population warrant large-scale studies. Thus, pragmatic randomized controlled trial (RCT) studies with societal fall prevention strategies showing real-world effectiveness should be conducted. Population-based studies involving city populations could indicate whether physical exercise can provide a meaningful and tangible tool for fall prevention in urban environments, where the majority of municipal services are within reach.However, the use of such services may be more appealing if they involve group activities. As participation in physical activities with a group of similar age and gender has promoted better compliance, it should be considered as a part of communal strategies in fall prevention [In this study, we present the effectiveness of fall prevention for primary and secondary outcomes of falls, fall incidences, fall types, fall-related fractures and clinical measurements in community-dwelling aging women. We hypothesized that a 6-month introduction to physical activities combined with free use of all municipal sports premises could prevent falls and related injuries. | PMC10128158 |
Methods | PMC10128158 | |||
Study design | Kuopio Fall Prevention Study (KFPS) is a randomized controlled study conducted in cooperation with the municipality of Kuopio, with a population of ~120,000 inhabitants in eastern Finland. All the participants living in Kuopio urban area, born between 1932 and 1945, were invited through mass mailings using their home addresses. Institutional long-term care addresses were excluded. The trial is registered with | PMC10128158 | ||
Participants, randomization and masking | dementia | PULMONARY DISEASE, UNSTABLE ANGINA PECTORIS | Between 1 January 2016 and 31 March 2016, an information letter was sent to 4,262 home dwelling women living within a 10-km radius of the city centre, asking their willingness to participate in the 2-year randomized exercise trial, resulting in 1,600 responses. The exclusion criteria were self-reported unstable angina pectoris, severe pulmonary disease, at least moderate dementia, or being non-ambulatory. After a phone review, a total of 1,208 invitations were sent. Of these, a total of 914 women participated in the baseline clinical measurement. From 14 March 2016 to 7 April 2017, randomization to exercise intervention ( | PMC10128158 |
Primary and secondary outcomes | Fracture, fractures, syncope, pain | SECONDARY, EVENT | We studied the effect of an exercise intervention on the primary outcome, i.e. falls. In addition, falling mechanisms, injurious falls and fractures were analysed as the secondary outcome. All outcomes shared the same inclusion criteria (of tripping, slipping, syncope or similar event from less than 1-m height). The mean (SD) follow-up time for falls was 22.6 (4.8) months, with 1716.4 person-years. Recording of fall was done using cellular phone-based automated biweekly short message service (SMS) and subsequent phone interview. Thus, falls were verified within 2 weeks of the incident by a structured phone interview to provide details of fall mechanism, location, terrain, level of injury and pain (none/moderate/severe), medical treatment and induced fear of fall. In addition, the self-administered study diary was used as a backup method for the fall recording in 3-month intervals, including falls and time spent in physical activities. Fall risk estimates covered the time from the baseline up to the last contact date when any confirmed fall information, i.e. the last SMS response, returned study diary or study visit. ‘Outdoor falls’ required location with seasonal exposure to the elements. ‘Indoor falls’ definition required standard climate conditions. Self-reported fall types that are subject to individual interpretation, miscellaneous or unclear cause were categorized as unspecified. Fracture analysis was based on hospital discharge registry and patient perusals with a mean (SD) follow-time of 23.4 (3.8) months. | PMC10128158 |
Clinical measurements | RECRUITMENT | Clinical measurements were accomplished in Kuopio Musculoskeletal Research Unit at baseline for 914 (100%), and at 12- and 24-month follow-ups for 850 (93.0%) and 838 (91.7%) women, respectively (The study recruitment, screening and participation. | PMC10128158 | |
Exercise intervention and use of city premises | The women randomized to exercise intervention were allocated to 27 groups, each including 15–18 attendees. Same groups were maintained in both Tai Chi (‘Taiji’) and gym sessions. No additional support (such as motivational reminders, etc.) was given to women during the trial. The control group received education on fall prevention at the baseline visit and was free to pursue their personal activities as before. The intervention groups were provided with a personal electronic access card for free access to all the city exercise premises including swimming halls, gyms and other sports premises administered by the municipality for the first 12 months. At baseline visit, participants were verbally informed about the possibility to use any of the municipal exercise premises for free, in addition to the scheduled sessions, without any obligation to do so. The card was also obtainable from municipal offices by anyone with a pensioner status for an annual fee of 65 euros.In addition to free use of premises, supervised exercise intervention was carried out during the first 6 months, aiming to improve muscle strength focusing on lower limbs, postural balance, active range of motion and joint mobility. The protocol included a 1-hour circuit type gym session and a 1-hour Tai Chi session each week, with a warm-up and 50 minutes of training. The adherence was measured by women’s participation to supervised sessions, based on logging data of the access cards. Group exercises were discontinued after the initial 6 months. However, women who wanted to continue gym training or Tai Chi at their own expense were not restricted from doing so. No individual modifications were done to training protocol during the intervention. However, in case of health restrictions, women were free to adapt the training with the instructors in a way they felt reasonable and pain-free. | PMC10128158 | ||
Gym | All gym sessions were supervised by two physiotherapists for the initial 6 months. The aim of the first four visits (weeks) to the gym was to familiarize study subjects with the safe and appropriate use of the weight training equipment. No free weights were used. The training prioritized postural muscle groups of legs (quadriceps/hamstring), back (lower/upper) and trunk, with additional workouts for the chest and arms. Starting weights were based on the participant’s results of a 4-week tutorial and prediction of one repetition maximum (1RM) (Borg’s scale) [ | PMC10128158 | ||
Tai chi | The Tai Chi course—designed and executed in cooperation with a professional Tai Chi instructor—aimed to reduce falls by improving balance, posture and active range of motion through the variations of classic Tai Chi exercises. The protocol progressed from simple postural control, body weight shifting and static balance training to the coordinated series of Tai Chi movements which eventually allowed independent training. Particular attention was given to lower limb strength, postural muscles and coordination. A standard Tai Chi protocol was issued for all participants throughout the study. | PMC10128158 | ||
Sample size and statistical analysis | fall injury, Fracture | REGRESSION | Previous meta-analyses and RCTs reported heterogeneous dropout rates depending on factors such as geographic location, sociodemographic status, and duration and intensity of the protocol [The Fall risk analyses were conducted according to the intention-to-treat by including all women up to their last confirmed fall information, regardless of their exercise adherence. The predefined statistical analysis was conducted by an unblinded researcher who had access to the outcome data. All available cases were included in the follow-up analyses of clinical measurement data. Chi-square test was used to compare proportion of women with any fall and fall injury between groups. Incidence rate ratios (IRR) were obtained using Poisson regression analysis with a 95% confidence interval (CI) for multiple falls and contributing fall mechanisms. Fracture IRR and survival curves were analysed using the Poisson regression model and Kaplan–Meier curves with Log-rank test, respectively. | PMC10128158 |
Results | PMC10128158 | |||
Participants and adherence | deaths | The mean age of the women at baseline was 76.5 (3.3). The total number of dropouts was 76 (8.3%) including deaths (Baseline characteristics of the study population with the follow-up change of bone densitometry and functional tests
| PMC10128158 | |
Falls and injuries | fracture, fractures | A total of 1,380 falls were registered during the 24 months. Of these, 1,281 (92.8%) were reported through SMS, the rest being recorded from study diaries. The mean follow-up (SD) for the falls was 23.8 months. In total, 15 women did not respond to any fall inquiry and were excluded from the primary analyses. The proportion of phone interviewed falls was somewhat lower in the control group (89.6%) vs. the intervention group (96.6%). Total follow-up time was 1,716.4 person-years, during which 546 women had at least one fall (range 0–28) with a crude incidence of 804.0 falls per 1,000 person-years and a prevalence of 59.7% (Characteristics and distribution of all falls (
Overall, the proportion of fallers (at least one fall) was similar in control (60.8%) and intervention groups (58.6%) during the follow-up. However, a 14.2% fall rate reduction (The characteristics of fall injuries (
Nearly half (47.5%) of the interviewed falls occurred on the street, floor or similar even surfaces, with 17.7% (Altogether 77 fractures caused by falls were observed in 66 women. The fractures caused by a vehicle (Cumulative probability of any fracture during the follow-up in the control (Yellow) and intervention (Blue) groups (Kaplan–Meier curves, log-rank). | PMC10128158 | |
Clinical measurements | A complete 24-month follow-up data were available for 831 (90.9%) women. BMD or body composition results did not change during the follow-up. However, in functional tests, the leg extension strength decreased slightly less (−1.7 versus −3.8%, | PMC10128158 | ||
Discussion | fall injuries, fall injury, fractures, fall reduction, KFPS, injury and pain | EVENTS, EVENT | The KFPS is a large population-based fall prevention RCT targeted at older community-dwelling women with minimal exclusion criteria. Weekly Tai Chi and gym exercises were combined with free access to recreational facilities, aiming to reduce the number of falls in a 24-months follow-up. The proportion of women who had at least one fall or fall injury was similar in both groups. However, the fall and fall injury rates were lower in the intervention group. Thus, the intervention’s effect was seen on repeat falls, severe fall injuries and fractures. Overall, the intervention group had a reduction of 14.3% in their overall fall rate compared with the control group. Their indoor falls—comprising a quarter of the falls—were especially decreased (−25.6%). Altogether, falls with self-reported severe injury and pain (~41%) were reduced the most. Almost half of the falls occurred on even surfaces—either indoors or outdoors—and a majority of these (68.9%) were due to tripping and slipping, as expected. In general, women’s functional capacity was not affected during the follow-up, but leg extension strength decreased less, and one-leg stance time improved slightly in the intervention group, which may relate to the number of falls. In all, perhaps the approach of working through the community rather than just through healthcare alone to prevent falls may be a better strategy.The main target was the reduction of falls by improving balance, muscle strength and functional capability by promoting physical activity. The findings suggest that the risk factors for indoor and outdoor falls may be different. Although higher fall reduction was observed indoors, the majority (69%) of the falls occurred outdoors. Nevertheless, indoor falls are a common cause of serious fractures such as of the hip, notably since frail older people stay more inside and are at higher risk for indoor falls [The strength of this study is the meticulous fall monitoring and interview within 2 weeks of the reported event. This probably ensured better recollection of the events and circumstances contributing to the falls—and resulted in capturing substantially more falls than anticipated. Previous studies have showed limitations to report falls that occurred during over the preceding 3–12 months [As the exclusion criteria were kept to a minimum, the training was designed with low to moderate intensity to suit most older women with average functional capability. Thus, we did not expect to see a change in terms of body composition or BMD. Nevertheless, slightly less reduced leg extension strength and improved one leg stance time—probably due to better muscle control in the exercise group—have been shown to be beneficial in fall prevention previously [Several factors might potentially affect the study results. For practical reasons, we could only include blinding up to the baseline visit. Some of the study effects may also be influenced by RCT participation bias since only 21.4% of the invited women were recruited. Lastly, verifying SMS fall reports through phone interviews was appropriate to eliminate false positives but did not address false negatives. The number of phone interviewed falls was somewhat lower in the control group (89.6%) versus intervention group (96.6%). This is likely to cause some underreporting of falls in the control group, which may have led to a more conservative estimate in terms of fall prevention. However, this was not the case with fractures which were recorded from registries, regardless of self-reporting.The fall prevention efficacy was as expected to differ from high-risk groups, such as hospitalized or institutionalized adults [In conclusion, fall prevention with light- or moderate-intensity exercise group programmes can reduce falls and fall injuries among older women on a municipal scale. Broader implementation of such strategies and societal health promotion should be developed through municipal services and communities to achieve these aims in the future. | PMC10128158 |
Supplementary Material | Click here for additional data file. | PMC10128158 | ||
Acknowledgements | The authors appreciate the invaluable help of Tarmo Hakkarainen in the design and implementation of the Taiji protocol. We also thank the physiotherapists Sirpa Mattsson-Taskinen and Marjatta Mäkinen for their professional management of the gym exercise protocol, research nurses Pirkko Kanerva and Saara Lappalainen for their untiring efforts to efficiently carry out the clinical measurements, secretary Seija Oinonen for managing all the patient data in various phases of the study and Janne Hentunen from the City of Kuopio well-being services for collaboration. | PMC10128158 | ||
Declaration of Conflicts of Interest | None. | PMC10128158 | ||
Data Availability Statement | The data underlying this article will be shared on reasonable request to the corresponding author. | PMC10128158 | ||
Declaration of Sources of Funding | The work was supported by the Juho Vainio Foundation, the Ministry of Education and Culture, the Academy of Finland (Grant No. 310831/2017) and the KUH Research Fund (to V.T.R.). | PMC10128158 | ||
Ethics Approval | The OSTPRE and KFPS studies have been reviewed and approved by the Ethics Committee of the Hospital District of North Savo and Kuopio University Hospital on 31 January 2014, 29 April 2016 and 16 December 2016. All regulations and measures of confidentiality were handled in accordance with the Declaration of Helsinki. | PMC10128158 | ||
References | PMC10128158 | |||
Background | Germ Defence ( | PMC10694966 | ||
Methods | With NHS England approval, we conducted an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via general practitioner (GP) practices across England, UK, compared with usual care to disseminate Germ Defence to patients. GP practices randomised to the intervention arm ( | PMC10694966 | ||
Results | Germ Defence was used 310,731 times. The average website satisfaction score was 7.52 (0–10 not at all to very satisfied, | PMC10694966 | ||
Conclusions | While the RCT did not demonstrate a difference in health outcomes, we demonstrated that rapid large-scale implementation of a digital behavioural intervention is possible and can be evaluated with a novel efficient prospective RCT methodology analysing routinely collected patient data entirely within a trusted research environment. | PMC10694966 | ||
Trial registration | This trial was registered in the ISRCTN registry (14602359) on 12 August 2020. | PMC10694966 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13012-023-01321-z. | PMC10694966 | ||
Keywords | RECRUITMENT |
Due to the need to rapidly implement the Germ Defence intervention during the COVID-19 pandemic, a novel efficient trial design was adopted, evaluating an active intervention across all GP practices in England.The paper outlines the efficient trial design, where no GP practice or patient recruitment was required, and GP practices were not required to send the research team any data, with all outcomes assessed using anonymous patient record data in situ via the OpenSAFELY trusted research environment and website analytics. | PMC10694966 | |
Introduction | respiratory tract infection, infection, infections | RESPIRATORY TRACT INFECTIONS, RECRUITMENT, INFECTIONS, INFECTION, RESPIRATORY TRACT INFECTION | The COVID-19 pandemic has highlighted the importance of behavioural strategies for controlling infection transmission. Effective implementation of good hygiene practices as public health measures (including social distancing, self-isolation, handwashing, mask wearing and ventilation) was vital to control the spread until a vaccine was developed [Supporting behaviour change is a complex process that requires an in-depth understanding of why people do/do not engage in target behaviours [Reducing within-household transmission pathways is important in contexts where inter-household contact is reduced (i.e. during lockdowns and self-isolation [In a previous trial of Germ Defence, 20,066 adults from UK primary care practices were randomised to be given access to Germ Defence reported fewer respiratory tract infections (mean 0.84 vs 1.09 in control group), fewer family member infections and less severe infections [Could be disseminated to patients via general practitioner (GP) practicesDecreased the number of respiratory tract infection diagnoses in GP practicesDecreased other transmissible infections (COVID-19, gastrointestinal)Decreased associated healthcare utilisation (consultations, hospital admissions, antibiotic usage)Historically, NHS (National Health Service) electronic health record data has been accessed by researchers via a process of pseudonymisation (replacing explicit identifiers such as name and address with a pseudonymous identifier) followed by dissemination of a subset of patients’ records for local analysis. Recently, published UK (United Kingdom) Department of Health and Social Care policy [We used a novel efficient trial design to evaluate the effectiveness of implementing Germ Defence through all GP practices in England being asked to send the intervention to their adult patients. The efficient trial design meant that no GP practice or patient recruitment was required, and GP practices were not required to send the research team any data, with all outcomes assessed using anonymous patient record data in situ via the OpenSAFELY platform trusted research environment and website analytics. | PMC10694966 |
Method | PMC10694966 | |||
Design | As detailed in our protocol [ | PMC10694966 | ||
Setting and participants | All GP practices in England registered with NHS Digital ( | PMC10694966 | ||
Sample size considerations | To detect a relative risk reduction of 0.14 with 90% power (alpha 0.05), based on the previous Germ Defence implementation, PRIMIT trial [ | PMC10694966 | ||
Intervention | infection | INFECTION | Germ Defence content was rapidly adapted throughout the pandemic using state-of-the-art evidence, theory and the person-based approach [The original Germ Defence intervention drew on the theory of planned behaviour [The single-session intervention sought to improve users’ awareness of risks of infection and transmission, increase skills and confidence to reduce risks and use behaviour change techniques (such as making if–then plans) to support behaviours. The Germ Defence content was tailored such that a user selected one of four streams that was relevant to the user’s situation:To protect themselves generallyTo protect others if the user was showing symptomsTo protect themselves if household member(s) showed symptomsTo protect a household member who is at high riskClear and detailed advice was provided for self-isolating, social distancing, cleaning, wearing face coverings, ventilation and handwashing. | PMC10694966 |
Intervention implementation | An initial email to practices was drafted by the research team that contained a unique weblink to the Germ Defence website and asked practices to disseminate this to all their adult patients (aged 16 +) via mobile phone text, email or social media. This email was iteratively optimised in pilot interviews with nurses, GPs and administrative staff from six practices to ensure it was acceptable and engaging. Reasons that practices might not engage were discussed (e.g. not enough time, did not perceive benefits, did not typically engage in research, concerns around privacy), and email content was refined to address these barriers.To further support engagement, the email linked to a trial information website that addressed key concerns and frequently asked questions in more detail [On 10 November 2020, intervention arm practices were emailed (see Supplementary file Data suggest that 16% of the GP practice email addresses forwarded by NHS Digital to the study team did not work, with a total of 613 ‘undelivered’ emails recorded in response to Germ Defence’s initial approach to intervention practices in England. This was usually because registered email addresses were out of date. During the intervention delivery phase, all invalid email addresses were investigated further via a series of manual Internet searches and telephone calls to practices, replacing invalid emails with new information as appropriate. This follow-up effort improved the data quality by around a third.Patients at GP practices randomised to the usual care arm received standard management for the 4-month (17 weeks) trial period. On 10 March 2021, usual care arm practices were emailed a generic weblink to Germ Defence and asked to disseminate it to all their adult patients. | PMC10694966 | ||
Measures and outcomes | RESPIRATORY TRACT INFECTIONS, GASTROINTESTINAL INFECTION, SECONDARY, RTI | The primary outcome was the rate of GP presentations for respiratory tract infections (RTI) per registered patient. Secondary outcomes comprised the rates of acute RTIs, COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic prescriptions and hospital admissions. COVID-19 symptoms were defined using two different code lists: one designed for high sensitivity and the other for high specificity. Each outcome was defined using SNOMED-CT codelists (see Supplementary file All health outcomes were analysed using routinely recorded clinical and patient information in GP practice data. All data were linked, stored and analysed securely within the OpenSAFELY platform, A further secondary outcome, uptake of the intervention by GP practices, was monitored using embedded code in a unique Germ Defence website link given to each practice. When practices communicated the unique weblink to their patients, the study team were able to record usage of the weblink. Uptake was measured using website analytics such as number of users per practice, average time spent on the Germ Defence website and pages visited, monitored using Matomo to ensure privacy [ | PMC10694966 | |
Patient and public involvement | Patient and public involvement (PPI) feedback was a key part of the co-participatory approach of the development of Germ Defence, in which members of the public were invited to feed back about the website and study in order to optimise and update it. A public contributor (C. R.) was a coinvestigator on the study team and contributed to writing the research proposal, updating and optimising the content of the intervention (including optimising intervention communications sent to patients by practices) and co-authoring the papers. Study materials were also reviewed by PPI representatives from the NIHR (National Institute of Health Research) Clinical Research Network (CRN). | PMC10694966 | ||
Data analysis | PMC10694966 | |||
Summary of baseline data | infection | INFECTION | This cluster randomised controlled trial was analysed at the practice level. Randomisation was carried out at practice level, and we did not have direct feedback on whether practices distributed the Germ Defence information to all, some or potentially no patients, nor whether individual patients were offered the information and made use of it. We, therefore, conducted all analyses using aggregated data at the practice level and considered each practice as a unit for the purpose of analysis. Outcome (consultations) and covariate data (median age, proportion of females, proportion from an ethnic minority, deprivation of practice area) from patient-level records were aggregated into weekly practice-level time-series data prior to analysis, covering the period from 17 weeks prior to randomisation until 17 weeks after randomisation (14th July 2020 to 15th March 2021) to achieve a target minimum of 15% infection rate.Primary care data in the OpenSAFELY system at the time of analysis represented approximately 40% of practices in England [ | PMC10694966 |
Intention-to-treat analyses | REGRESSION | The primary analysis used a standard intention-to-treat approach. For each of the eight health outcomes, rates of consultations per registered patient were compared at practice level between intervention and control groups for the 17-week post-intervention period. This was done using negative binomial regression with the consultation count as the outcome, the number of registered patients as the offset and the binary indicator of intervention/control group as the only independent variable. | PMC10694966 | |
Controlled interrupted time-series analyses | REGRESSION | An additional analysis was performed for the same eight health outcomes using a controlled interrupted time-series (CITS) approach to understand temporal changes related to the intervention as distinct from the time-agnostic intention-to-treat approach. This was implemented within a generalised linear-mixed modelling framework by applying negative binomial regression to weekly level data spanning pre- and post-intervention periods for both the intervention and control groups. Data was also disaggregated by practice, allowing random intercepts at practice level. Variables included in the model were as follows: consecutively numbered weeks to capture a log-linear trend, intervention-control indicator, pre-post-intervention indicator and all two- and three-way interactions between these. Additional covariates included calendar month to capture seasonal effects and practice-level indicators such as area-level deprivation, median patient age and sex distribution represented as the proportion of females. | PMC10694966 | |
Process analysis | PMC10694966 | |||
Implementation process | Germ Defence website usage recorded from the unique identifying website links sent by each practice was used to examine whether intervention engagement (i.e. a practice effectively communicating link to patients) was predicted by practice characteristics (such as indices of deprivation, NHS Quality and Outcomes Frameworks). | PMC10694966 | ||
Individual intervention usage | A range of additional behavioural mechanisms, overall patterns of practice and user engagement were described using website analytics. Analytics included number of users per practice, average time spent on the Germ Defence website and pages visited. | PMC10694966 | ||
Association with health outcomes | To understand the mechanisms of action in the intervention, we examined the association between the rate of website usage within a practice (number of users divided by number of registered patients) and the rate of each health outcome (consultations per registered patient). A negative binomial model was applied to practice level data, and the association of interest was adjusted for decile of deprivation, proportion of patients from an ethnic minority and median age. This was done for all practices and then separately for a subset of practices that had greater than 1% uptake. | PMC10694966 | ||
Information governance and ethical approval | WEST | NHS England is the data controller for OpenSAFELY-TPP, TPP is the data processor and all study authors using OpenSAFELY have the approval of NHS England. This implementation of OpenSAFELY is hosted within the TPP environment which is accredited to the ISO 27001 information security standard and is NHS IG (information governance) Toolkit compliant [Patient data has been pseudonymised for analysis and linkage using industry standard cryptographic hashing techniques; all pseudonymised datasets transmitted for linkage onto OpenSAFELY are encrypted; access to the platform is via a virtual private network (VPN) connection, restricted to a small group of researchers; the researchers hold contracts with NHS England and only access the platform to initiate database queries and statistical models; all database activity is logged; and only aggregate statistical outputs leave the platform environment following best practice for anonymisation of results such as statistical disclosure control for low cell counts [The OpenSAFELY research platform adheres to the obligations of the UK General Data Protection Regulation (GDPR) and the Data Protection Act 2018. In March 2020, the Secretary of State for Health and Social Care used powers under the UK Health Service (Control of Patient Information) Regulations 2002 (COPI) to require organisations to process confidential patient information for the purposes of protecting public health, providing healthcare services to the public and monitoring and managing the COVID-19 outbreak and incidents of exposure; this sets aside the requirement for patient consent [Taken together, these provide the legal bases to link patient datasets on the OpenSAFELY platform. GP practices, from which the primary care data are obtained, are required to share relevant health information to support the public health response to the pandemic and have been informed of the OpenSAFELY analytics platform.This study was approved by the Health Research Authority, Yorkshire & The Humber—Leeds West Research Ethics Committee (Ref.: 20/YH/0261). | PMC10694966 | |
Results | The initial 10 November 2020 email to 3292 intervention arm practices from 133 CCGs reached 2679 GP practices. The subsequent reminder emails on 25 November and 10 December 2020 reached 2870 GP practices (Fig. Germ Defence trial CONSORT flow diagramData show that the Germ Defence website was viewed by patients from 16% of the intervention arm general practices approached as part of the trial. This is based on analysis of website analytics for the usage data which suggest that 10 + clicks were registered for 459 of the 2870 general practices offered in the intervention. A full consort diagram is presented in Fig. | PMC10694966 | ||
Controlled interrupted time series analysis | For all eight health outcomes analysed using CITS models, there was no clear evidence of intervention-related change (Table Controlled interrupted time-series estimates assessing intervention-related changesEstimates for changes in trend represent relative change in rate over the 17-week post-intervention period compared to the pre-intervention period. Both estimate types adjusted for any background changes in the control group | PMC10694966 | ||
Intervention implementation | Details of Germ Defence were emailed to 2870 intervention arm GP practices. The practice unique Germ Defence weblink was accessed by 1094 intervention arm practices (38.1%) at least once. Patient engagement within intervention arm practices ranged from no engagement (when no patient in a practice visited the Germ Defence website) to engagement from 48% of patients registered with the practice. There was no association between practice list size and proportion of uptake (Practice engagementUsage levels: none 0 user, low 0.01 to 0.99% of list, medium 1.00 to 10.99% of users, high 11 to 100% of usersFurther analysis explored whether usage rates [percentage of practice patient list that used the intervention: low (0–0.99%), medium (1–10.99), high (11 +)] differed across varying practice characteristics including population levels of deprivation (IMD), income, employment, education and skills, health and disability, barriers to housing and services, living environment, age, proportion of minority ethnic group and practice quality and outcomes framework performance. Engagement did not differ across any metrics except for ethnicity proportion, in which practices with high levels of uptake (> 11%) had a lower proportion of minority ethnic groups (10.5%) compared to practices with lower levels of use (low: 15.1%, medium: 15.8%). We report analysis of all characteristics in detail in Supplementary file | PMC10694966 | ||
Individual intervention usage | infection | INFECTION | The trial intervention link was used 310,731 times, of which 163,991 ‘bounced’, i.e. did not engage beyond first the page. Access to the Germ Defence website using the generic (‘non-trial’) link also increased substantially during the trial period. This is likely due to trial users sharing the website (e.g. with their family or via social media), but these additional users were not included in our analysis. A total of 97.29% (298,752) of users on the trial website were from patients who had been sent a text message from an intervention arm GP practice, with remaining visits via practice social media or GP websites.Average satisfaction score after using the website was 7.52 (0 meaning not at all satisfied, 10 meaning very satisfied, While using the intervention, users reported their intentions to improve all infection prevention behaviours (handwashing | PMC10694966 |
Practice-level usage and health outcomes | There was no clear evidence of an association between website usage rates and health outcomes either among all intervention practices or among those with a user rate greater than 1% (Table Process evaluation. Associations between website user rates and consultation rates for intervention practicesRate ratios indicate change in consultation rate for every 10% increase in user rate. Results are shown separately for (1) all intervention practices and (2) for a subset where the user rate was greater than 1% of patients in a practice. All estimates were adjusted for median age, deprivation percentile and the proportion of patients from an ethnic minority | PMC10694966 | ||
Efficient trial design and intervention implementation | CMO, Covid infection | The trial was endorsed by Chris Whitty, the then chief medical officer (CMO) for England, as a national priority project and adopted by the CRN as an urgent public health portfolio study. These endorsements facilitated the novel design by allowing access to email addresses of all GP practices via NHS Digital. However, despite extensive piloting of the process by which practices and patients could be contacted, several practical barriers were encountered: (i) some email addresses were ‘inactive’ due to organisational name changes or practice closure, (ii) practices expected to be contacted by CRNs to take part in research projects rather than directly from study teams and (iii) the intervention practice individualised Germ Defence weblink being perceived as spam by staff and patients, particularly where patients had never previously received a text message from their practice). While these concerns were all identified before the trial began (and addressed via the ‘FAQ’ for patients and clinical staff) [Overall, the study team received 61 enquiries/concerns from primary care staff, patients/members of the public and staff within local Clinical Research Networks during and immediately after the 4-month implementation period (Table Reasons for feedback about study intervention or implementationBecause the primary aim of the Germ Defence team was to implement Germ Defence as rapidly and widely as possible (based on the previous evidence of effectiveness), extensive implementation was also undertaken outside the defined trial context. For example, the Germ Defence website and the key messages from Germ Defence were publicised on numerous occasions (via national and local radio, TV, online and print media) and were directly linked to from online government advice for Covid infection control [We encountered no material barriers to importing and linking the trial randomisation schedule into a TRE or to evaluating outcomes using patients’ data in situ through the OpenSAFELY platform rather than via data dissemination. | PMC10694966 | |
Discussion | respiratory tract infections, infection | RESPIRATORY TRACT INFECTIONS, VIRUS, INFECTION | We implemented a novel efficient trial design which was also the first RCT where follow-up was conducted entirely within a TRE. We did not find any consistent overall evidence that the intervention impacted rates of respiratory tract infections or other health outcomes. Similarly, we found no evidence that higher user rates were associated with changes in health outcome rates at a practice level, although there was evidence that more relevant symptoms within a practice were associated with more website uptake.Although by comparison to many other trial interventions the reach of the Germ Defence intervention was extremely large (it was accessed more than 300,000 times across England during the trial period), we could only confirm that it was accessed by patients from 16% of the general practices approached, below the 25% of GP practices assumed in the sample size considerations. Therefore, it is hard to draw conclusions from our trial data. While we expected that using Germ Defence would improve infection control behaviours and reduce household virus transmission [However, these findings should not downplay the importance of the efficient trial design that allowed us to conduct a large-scale prospective randomised controlled evaluation of an active behavioural intervention during a pandemic. Our design allowed us to safely recruit GP practices in England during a national pandemic, and we used several novel techniques to minimise practice burden: (i) we recruited practices en masse via email, removing the lengthy process of contacting individual practices (although to avoid overwhelming practices this method should only be used when rapid enrolment is necessary), (ii) we set up intervention access links that were individualised to practices (meaning that practices merely had to use the intervention and we could remotely track their ‘enrolment’), (iii) we used national routinely collected patient record data (accessed through a secure TRE, OpenSAFELY) to analyse electronic health records and (iv) we recorded anonymous digital intervention analytics to understand how many individual patients used the intervention and how they used it.There was no indication that the use of Germ Defence was impacted by any factors related to deprivation. Generally, this is encouraging news that digital interventions have potential to support healthcare across the socioeconomic spectrum. However, despite substantial effort to ensure accessibility (such as translation, using infographics), we did see that practices with more patients from minority ethnic groups were less likely to have high levels of use. This needs to be examined in more detail to ensure that scalable digital solutions do not lead to digital exclusion for some groups. | PMC10694966 |
Limitations | infection, word of mouth | INFECTION | This ‘low burden’ design comes with risks. Evaluating an accessible behavioural intervention that can be passed on via multiple communication pathways means we could not prevent people from using the intervention who were not from our randomised intervention group, nor could we control broad contextual factors that may have led to increased contamination (such as the frequent public health communications about Germ Defence during the study period, users sharing the website with other members of the public or interlinked healthcare services) sharing website details with, e.g. practices randomised to the control group). The nature of behavioural interventions means their core behavioural functions can be communicated through means other than the intervention (for example word of mouth) which would have been outside of our randomisation procedure—but in contexts outside of clinical research would be important communication mechanisms. In our trial, it is likely that such contamination could have reduced possible differences between our intervention and control group. Asking people to register to use Germ Defence could have been a method to control for contamination, but this could also be a barrier to using the intervention and reduced its use. Future research should aim to monitor and control contamination; however, this was not possible within our pragmatic trial of a public health intervention during a pandemic.Despite the unusually rapid set-up and implementation of this study, Germ Defence was rolled out through primary care over 6 months after the start of the COVID-19 pandemic. It is likely that by this point in time, most people who were concerned about infection control in the home may have already obtained all the advice they wanted and needed. Additionally, the lack of lengthy individual practice enrolment processes may have meant that many practices did not have inclination or time to properly engage with the study, given the need to maintain enhanced infection control measures reduced capacity that were increasing pressure on practices during the study period [However, this means our design accurately reflects ‘real-world’ uptake of such interventions outside of usually tightly constrained trial environments. Further research should use implementation frameworks to understand how to further improve rapid adoption and implementation [ | PMC10694966 |
Conclusions | SECONDARY | In this study we used a novel, efficient prospective randomised controlled trial methodology to examine the rapid implementation and effectiveness of an active digital behavioural intervention across every GP practice in England. The RCT demonstrated that rapid large-scale implementation of a digital behavioural intervention is possible. While the trial did not demonstrate a difference in primary or secondary outcomes between the arms, we showed that it is possible to link intervention usage with individual practice health outcomes and to determine the effects of behavioural intervention engagement with health outcomes. Further work should explore how to improve rapid implementation and how this design can be applied to other types of intervention. | PMC10694966 | |
Authors’ contributions | RA, MM | LY, BA, JH, MC, JDD, JM, JS and PM contributed to the design of the trial. LY, BA, JH, MC, PM, JDD, FdV, ME, PC, RD, JM, JS, SM, BS, PL, SW, RA, NF, KM, CR, LT, MW and MM were members of the project team and contributed to trial conduct interpretation of the study findings. HJC, CB, AM, SB, BG and the OpenSAFELY Collaborative supported data management, linkage and extraction within the OpenSAFELY platform. BA, SM, JDD, FdV and SW analysed the data collected during the study. All authors contributed to editing of the manuscript. The authors read and approved the final manuscript. | PMC10694966 | |
Funding | ARC | WEST, CORONAVIRUS | This research is funded by UKRI Coronavirus Rapid Response Call (CV220-009) and National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) West at University Hospitals Bristol and Weston NHS Foundation Trust and NIHR Health Protection Research Unit (HPRU) in Behavioural Science and Evaluation at University of Bristol. UKRI did not play any part in the design of this study, collection, analysis and interpretation of data and in writing the manuscript. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Research in OpenSAFELY uses data assets made available as part of the Data and Connectivity National Core Study, led by Health Data Research UK in partnership with the Office for National Statistics and funded by UK Research and Innovation (grant ref MC_PC_20058). In addition, the OpenSAFELY platform is supported by grants from the Wellcome Trust (222097/Z/20/Z), MRC (MR/V015737/1, MC_PC-20059, MR/W016729/1), NIHR (NIHR135559, COV-LT2-0073) and Health Data Research UK (HDRUK2021.000, 2021.0157). | PMC10694966 |
Availability of data and materials | All analyses involving health outcomes were conducted in the OpenSAFELY research platform, and data cannot be made available outside that platform other than approved aggregated study results. A GitHub repository containing all analysis scripts used in OpenSAFELY for this study can be found here: | PMC10694966 | ||
Declarations | PMC10694966 | |||
Ethics approval and consent to participate | WEST | Provisional ethics approval was originally obtained from the NHS Health Research Authority, Yorkshire & The Humber—Leeds West Research Ethics Committee (20/YH/0261) on 14 August 2020, followed by full approval on 2 September 2020. Practices which supported the study by promoting the Germ Defence website did in doing so and have been deemed to have given implicit consent to participate. Individual patent consent was not required as the study required no deviation from usual care and clinical outcomes were assessed from anonymised routinely collected NHS patient record data. Consent was assumed from Germ Defence website usage and acknowledged in the website privacy policy. | PMC10694966 | |
Consent for publication | This research has been approved for publication by NHS England. | PMC10694966 | ||
Competing interests | A. | LUNG, ASTHMA | B. G., H. J. C., S. B. and A. M. have received research funding from the Laura and John Arnold Foundation, the NHS National Institute for Health Research (NIHR), the NIHR School of Primary Care Research, NHS England, the NIHR Oxford Biomedical Research Centre, the Mohn-Westlake Foundation, NIHR Applied Research Collaboration Oxford and Thames Valley, the Wellcome Trust, the Good Thinking Foundation, Health Data Research UK, the Health Foundation, the World Health Organisation, UKRI MRC, Asthma UK, the British Lung Foundation and the Longitudinal Health and Wellbeing strand of the National Core Studies programme. B. G. is a Nonexecutive Director at NHS Digital; he also receives personal income from speaking and writing for lay audiences on the misuse of science. C. B. is employed by TPP, UK. R. A. is an employee of the UK Health Security Agency. All other authors declare that they have no competing interests. | PMC10694966 |
References | PMC10694966 | |||
Background | A barrier to achieving first trimester antenatal care (ANC) attendance in many countries has been the widespread cultural practice of not discussing pregnancies in the early stages. Motivations for concealing pregnancy bear further study, as the interventions necessary to encourage early ANC attendance may be more complicated than targeting infrastructural barriers to ANC attendance such as transportation, time, and cost. | PMC10207755 | ||
Methods | GESTATIONAL DIABETES MELLITUS | Five focus groups with a total of 30 married, pregnant women were conducted to assess the feasibility of conducting a randomised controlled trial to evaluate the effectiveness of early initiation of physical activity and/or yoghurt consumption in reducing Gestational Diabetes Mellitus in pregnant women in The Gambia. Focus group transcripts were coded through a thematic analysis approach, assessing themes as they arose in relation to failure to attend early ANC. | PMC10207755 | |
Results | ’ | MISCARRIAGE | Two reasons for the concealment of pregnancies in the first trimester or ahead of a pregnancy’s obvious visibility to others were given by focus group participants. These were ‘pregnancy outside of marriage’ and ‘evil spirits and miscarriage.’ Concealment on both grounds was motivated through specific worries and fears. In the case of a pregnancy outside of marriage, this was worry over social stigma and shame. Evil spirits were widely considered to be a cause of early miscarriage, and as such, women may choose to conceal their pregnancies in the early stages as a form of protection. | PMC10207755 |
Conclusion | Women’s lived experiences of evil spirits have been under-explored in qualitative health research as they relate specifically to women’s access to early antenatal care. Better understanding of how such sprits are experienced and why some women perceive themselves as vulnerable to related spiritual attacks may help healthcare workers or community health workers to identify in a timely manner the women most likely to fear such situations and spirits and subsequently conceal their pregnancies. | PMC10207755 | ||
Keywords | PMC10207755 | |||
Background | COMPLICATIONS | Early antenatal care (ANC) attendance (within the first trimester) is associated with fewer complications during pregnancy and delivery, reduced maternal and infant mortality, and better life course outcomes for children [The Gambia is one nation in SSA which has made recent substantial progress in improving maternal and childhood survival rates, now sitting in the mid-range of maternal mortality rates for the region. Active interventions in the nation are aimed at further encouraging ANC uptake and increasing total contacts between women and healthcare workers across the duration of a pregnancy [Previous analysis of Gambian women’s feeling toward ANC showed that women generally prefer to book for early ANC and understood benefits of doing so, although there are frequent practical barriers to doing so [ | PMC10207755 | |
Methods | PMC10207755 | |||
Design | GDM | GDM, GESTATIONAL DIABETES MELLITUS | The data analysed in this study emerged from focus groups which were collected in support of a Randomised Control Trial (RCT) evaluating the effectiveness of early initiation of physical activity and/or yoghurt consumption in reducing Gestational Diabetes Mellitus (GDM) in pregnant women [Focus groups were chosen to obtain insights into mothers’ perceptions and experiences of booking for ANC and potential participation in the RCT. Focus groups were preferred over in-depth interviews or nominal group technique because a range of divergent views and experiences were sought, rather than individual views or a consensus opinion on a single issue [ | PMC10207755 |
Study setting | The focus groups were conducted at the Kanifing General Hospital in The Gambia. Kanifing General Hospital is a tertiary referral facility, located in the urban Kanifing Municipality, the most densely populated settlement in The Gambia [ | PMC10207755 | ||
Participant sampling and recruitment | The FGDs were covered under the wider RCT’s feasibility study ethical clearance. All methods were performed in accordance with the Declaration of Helsinki’s guidelines. The study was approved by The Gambia Government/MRCG joint ethics committee (SCC 1620).We used convenience sampling to recruit participants for the focus group discussions. Pregnant mothers attending an antenatal clinic at Kanifing General Hospital were approached for their participation. Study staff (social scientist and research clinician) approached women and explained the objectives and details of the study before obtaining informed consent. An informed consent form was administered by the research clinician or field worker facilitating the FGD sessions. The consent form was written in English and was verbally translated as required. The participants were allowed as much time as wished to consider the information, and the opportunity to question the personnel administrating the ICF. Written informed consent was obtained by means of participant dated signature and dated signature of the person who administered the consent form. In cases of illiterate participants, her left thumb impression was obtained. Those women who consented when approached by researchers at the antenatal clinic were then invited to a room within the antenatal facility for the focus group discussions. | PMC10207755 | ||
Study population | Five FGDs were conducted in February 2019 with 30 married pregnant women aged 16–37 years old who reported between one and six pregnancies (including their current pregnancy) (see Table Participant characteristics | PMC10207755 | ||
Data collection | A pre-written FGD guide was used to facilitate the discussions. The guide (Table Focus group discussion guideFGDs were facilitated by two Gambian researchers: an experienced female social scientist, who has successfully collected data on many similar studies with pregnant Gambian women, assisted by a male research clinician. Four were conducted in both the Mandinka and Wolof languages (as participants commonly spoke both languages), with one FGD conducted exclusively in Fula—these are the most commonly spoken languages in The Gambia. Sessions were recorded with participants’ permission, and the audio recordings were later transcribed by the trained field worker who led the interviews, and translated into English. The transcribed texts were independently reviewed (together with the recordings) by two study staff who were fluent in the local languages of the recordings and English. The discussions lasted an average of two hours. | PMC10207755 | ||
Patient and public involvement | Patients or the public were not involved in the design, conduct, or reporting plans of this research but the preliminary outcome of the findings were considered for the final draft of protocol of the RCT. A summary of the main trial results will be disseminated to the general public and study participants after the completion of the study. | PMC10207755 | ||
Data analysis | The analysis in this paper focuses specifically on women’s answers relating to FGD theme number one, ‘willingness to book for ANC in first trimester’, and the ways in which beliefs can be barriers to intervention and protocol adherence. Transcripts were uploaded into NVivo (v12) and, using Braun and Clarke’s thematic analysis approach [ | PMC10207755 | ||
Results | ’ | MISCARRIAGE, EARLY PREGNANCY | Two reasons for the concealment of pregnancies in the first trimester or ahead of a pregnancy’s obvious visibility to others, were given by FGD participants. These were ‘pregnancy outside of marriage’ and ‘evil spirits and miscarriage’. Concealment on both grounds was motivated through specific worries and fears. In the case of a pregnancy outside of marriage, this was worry over social stigma and shame. Evil spirits are understood as a cause of miscarriage in early pregnancy, and as such, women may choose to conceal or not disclose their pregnancy as a protection mechanism. | PMC10207755 |
Pregnancy outside of marriage | FGD participants reported that women who found themselves pregnant outside of marriage were understood to be less likely to attend early ANC for fear of running into acquaintances at the clinic and the pregnancy being revealed. This theme was spoken about in generalised terms with no specific examples presented.Respondent: FGD participants did not elaborate on what the social consequences of such a pregnancy out of marriage might be; these results will be considered in the Discussion in relation to extant literature on the social consequences of pregnancy outside marriage. Further, all FGD participants were married, and none indicated that they had concealed a pregnancy for this reason.R | PMC10207755 | ||
Evil spirits and miscarriage | miscarriages, miscarriage | MISCARRIAGES, MISCARRIAGE | The more prevalent discourse related to the concealment of pregnancy was linked to local cultural beliefs around the causes of miscarriage. Many of the women interviewed held the view that making one’s pregnancy known to others at an early stage places one at greater risk of miscarriage as pregnancy makes one vulnerable to attacks by evil spirits. The term ‘Fear of early disclosure of pregnancy leading to miscarriage resulted in some women keeping their pregnancies secret and not attending ANC.R: Divergent from the general, unspecified way in which pregnancy out of marriage was spoken about, these spiritually induced miscarriages were known to have happened to specific individuals:R: Indeed, one FGD participant, in response to a general comment from another participant, reported suffering from miscarriages attributable to these spirits and early disclosure of pregnancy:R1: R2However, some women were aware of the belief that spirits were the cause of miscarriages but did not ascribe to it, although they were aware that it influenced the actions and choices of other women. In the following exchange, the second respondent notes how a miscarriage may occur because a woman has not attended early ANC, but then perceived as being caused by spirits.R1: R2 | PMC10207755 |
Discussion | miscarriages, ’ | MISCARRIAGES, MISCARRIAGE | This qualitative analysis of FGD data considered the reasons for which women in urban Gambia might choose to conceal a pregnancy. It identified ‘pregnancy outside of marriage’ and ‘evil spirits and miscarriage’ as two distinct reasons a woman may wish to conceal a pregnancy, including from healthcare workers by not attending early ANC.Women were understood to conceal those pregnancies which occurred outside of marriage for as long as possible. Previous research in The Gambia has shown that not wanting to be the subject of gossip and avoiding the stigma of unwed motherhood drive this type of concealment among women of various ethnic groups [Regarding the question of miscarriage attributable to evil spirits, participant familiarity with both the phenomenon and individuals who have suffered such miscarriages indicates that far from an isolated or fringe cultural belief, the presence of spirits continues to inform lived pregnancy experiences for many women in The Gambia as it does other aspects of daily living. Indeed, as anthropologist Susannah Chapman has described for The Gambia, ‘it is not uncommon for If public disclosure of a pregnancy is understood to be extremely dangerous to the life of the foetus on account of harm from spirits, active concealment and reluctance to speak about a pregnancy may be read not as negligence born of ignorance of biomedical treatments and interventions, but rather, a considered act of care practiced by the woman for the benefit of her motherhood. Study participants were aware that early ANC attendance would have certain beneficial health outcomes. Yet some women continued to conceal pregnancies for the threat of evil spirits, revealing that this fear of spiritually-induced miscarriage can outweigh the recognized benefits of attending ANC early. In other words, though traditional beliefs and biomedical knowledge around causality may exist together in The Gambia, that does not mean they are weighted equally in all situations.While several studies have identified concerns about evil spirits as a driver for women to conceal pregnancies in Gambia and elsewhere across SSA [Both the fear of social stigma associated with unwed motherhood and fear of miscarriage caused by evil spirits can lead to late ANC attendance on account of non-disclosure of pregnancy in the early months. The invocation of such terms and beliefs as ‘spirits’ may appear to some biomedical practitioners as irrational or without basis. However, we can consider evil spirits as a motivation for concealment to exist, like social stigma related to being an unmarried mother, as a reflection of the multiple considerations, both medically and culturally informed, mothers must entertain in the name of caring for and protecting their unborn children. Further, there have been some noted links between gossip about a pregnancy (as was discussed by participants in relation to unmarried mothers) and miscarriage: gossip can alert evil spirits to the pregnancy in the first place, thereby making the mother a target [We call attention to the ways in which Gambian women’s concealment of pregnancy shares characteristics with other pregnancy (non) disclosure strategies already substantially accounted for in academic and clinical literature in relation to the Global North, and which all share the characteristic of being a way to manage uncertainties and fears [ | PMC10207755 |
Limitations | The limitations of this analysis are chiefly related to the targeted questions of FGDs not being focussed on concealment and with this theme arising naturally. Notably absent in FGD participants’ reasons for concealing are prohibitions on postpartum sexual relations, which are well-documented in Gambia and SSA more broadly, with mothers who become pregnant during the breastfeeding period may seek to conceal their new pregnancies while they rapidly wean the breastfeeding child [ | PMC10207755 |
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