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Treatments | ADVERSE REACTIONS | Treatment was initiated at the baseline visit. After baseline data were collected, women allocated to the IV iron group received a single dose of 1000 mg FDI diluted in 100 mL 0.9% sodium chloride (or if pre-pregnancy body weight was < 50 kg, the dose was 20 mg/kg based on pre-pregnancy body weight). Infusions were administered over approximately 20 min and participants were observed for adverse reactions during, and 30 min after, the end of the infusion. Women in the oral iron group received ferrous fumarate tablets (equivalent to 100 mg elemental iron) combined with 60 mg ascorbic acid for self-administration once daily throughout the trial (i.e., 18 weeks). Compliance was encouraged at each visit and assessed by pill count at Weeks 6 and 18. Regardless of initial allocation, all participants presenting with IDA (Hb < 11.0 g/dL and ferritin < 30 µg/L) at the 6 or 12-week visits were offered an additional IV iron infusion, dosed and administered in the same way as described for the baseline visit. In women who received additional IV iron at, or after, 26 weeks gestational age, foetal heart rate was monitored with cardiotocography. Participants in the oral iron group who received additional IV iron stopped oral iron therapy when IV treatment was initiated. | PMC10435604 | |
Efficacy assessment | anaemia, Chronic Illness Therapy-fatigue, fatigue | ANAEMIA | Efficacy outcomes were assessed through blood sampling and questionnaire completion, which occurred at all trial visits. The primary efficacy endpoint assessed the avoidance of anaemia by determining the proportion of women with Hb ≥ 11.0 g/dL (≥ 6.8 mmol/L) at all follow-up visits during the 18-week trial period. Secondary efficacy outcomes included changes in haematological parameters (Hb, ferritin, and transferrin saturation [TSAT]) and changes in patient-reported outcomes (PROs). PROs included fatigue and quality of life (QoL), which were assessed at each visit by the official Danish versions of two self-administered generic questionnaires: the Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) scale [ | PMC10435604 |
Safety assessment | hypophosphatemia | HYPOPHOSPHATEMIA, ADVERSE EVENTS, ADVERSE EVENT, EVENT, ADVERSE EVENT | The investigators recorded and assessed all adverse events up until the final follow-up visit including clinical assessment of various laboratory parameters measured at each follow-up visit (complete blood count, C-reactive protein [CRP], alanine aminotransferase [ALAT], bilirubin, sodium, potassium, calcium, phosphate, urea, creatinine, and albumin). An adverse event was defined as an event that occurred or increased in severity after the first dose of medication was administered. Investigators assessed all adverse events for relatedness to trial treatment, severity, and seriousness. Adverse events were categorised using the Medical Dictionary for Regulatory Activities (version 20.0). Safety assessments also included the incidence of hypophosphatemia (phosphate < 2 mg/dL), severe hypophosphatemia (phosphate < 1 mg/dL), and discontinuations due to lack of response or intolerance.In addition, pre-defined obstetric and perinatal outcomes occurring up to seven days postpartum were retrieved from medical records. | PMC10435604 |
Statistical analysis | anaemia, fatigue | ANAEMIA, ADVERSE EVENTS, HYPOPHOSPHATEMIA | Sample size was determined based on the primary hypothesis that IV iron is superior to oral iron for avoiding anaemia. It was assumed that 95% of the IV iron group and 82.5% of the oral iron group would be non-anaemic (Hb ≥ 11.0 g/dL at all follow-up visits). Using a significance level of 5%, and setting the power to 80%, 100 participants in each treatment group were required to detect a difference between IV iron and oral iron.Statistical analyses were performed using SASEfficacy analyses were conducted on all randomised participants (i.e., the intention-to-treat analysis set). Based on Kaplan–Meier statistics using scheduled follow-up visits, the proportion of women who were non-anaemic was assessed and continuously multiplied at follow-up visits (i.e., the product-limit survival estimates). The cumulative proportion at the last study visit (i.e., 18 weeks after treatment initiation) reflected the primary endpoint (i.e., avoidance of anaemia throughout follow-up) and was compared between the treatment groups as risk difference with 95% confidence intervals (CIs). Women who were anaemic and/or who received prohibited medication during follow-up (iron formulations other than the trial drugs, erythropoiesis-stimulating agents, or RBC transfusion) were set to failures. Women censored at the final, 18-week visit included those who remained non-anaemic, were lost to follow-up, withdrew consent to participate, or lacked a Hb measurement at this visit. Because additional IV iron was only offered to participants with Hb < 11.0 g/dL, (i.e., those who failed to meet the primary endpoint) only the initial treatment allocated at baseline had an impact on the primary analysis. Least squares mean changes (referred to as mean change hereafter) in haematological parameters, fatigue, and QoL from baseline to each follow-up visit were analysed in the intention-to-treat analysis set using a restricted maximum likelihood-based mixed model for repeated measures (MMRM) approach. Observed data were included for all women and, for women without follow-up measurements, the change from baseline was set to 0 at the first follow-up visit. The model included treatment, week, treatment-by-week interaction and stratum as factors, with baseline value and baseline value-by-week interaction as covariates. Compliance data were summarised with descriptive statistics.Safety analyses were conducted on all women who received treatment (i.e., the safety analysis set). Incidences of adverse events that were related to, or possibly related to, trial treatment, hypophosphatemia, and of discontinuations due to intolerance of, or a lack of response to, trial treatment were compared between the treatment groups using Fisher’s exact test. Biochemical safety parameters were assessed using the same maximum likelihood-based MMRM used for analyses of haematological parameters.Baseline demographics and clinical characteristics, and obstetric and perinatal outcomes were summarised using descriptive statistics and compared between the treatment groups (post-hoc) using Fisher’s exact test for categorical data and two-sample | PMC10435604 |
Ethics | The trial was approved by the relevant authorities (Danish Medicines Agency and the Danish Scientific Ethics Committees) and was registered in the European Clinical Trials Database (EudraCT no.: 2017-000776-29) and on ClinicalTrials.gov (NCT03188445). The trial complied with Good Clinical Practice guidelines. Participation was voluntary and written informed consent was obtained by the trial investigators from all participants, with personal data protected in accordance with the General Data Protection Regulation. | PMC10435604 | ||
Funding | The trial was sponsored and fully funded by Pharmacosmos A/S, Holbæk, Denmark. The sponsor was involved in the study design, analysis and interpretation of the data, and approval of the final manuscript.Further detailed information about trial methods can be obtained in the published protocol article [ | PMC10435604 | ||
Discussion | PMC10435604 | |||
Main findings | anaemia | ANAEMIA, INFANT MORBIDITY | The trial results show that IV iron is superior to oral iron in preventing anaemia and improving Hb and ferritin levels in pregnant women with persistent ID. This is crucial, as ID and IDA in pregnancy can increase maternal and infant morbidity [ | PMC10435604 |
Strengths and limitations | PRETERM BIRTH | A strength of our design was the narrow gestational age range for trial visits, which increased the homogeneity of the data by ensuring that participants were at the same physiological stages of pregnancy at the respective visits. Our trial adds to the knowledge of PROs and clinical outcome measures when comparing IV and oral iron treatment in pregnant women, which has not been described in most previous similar trials. An obvious limitation of our trial was the lack of blinding. It is possible that participants had different expectations of the different treatment types, which may have biased PROs, especially. However, effective and feasible blinding would have been challenging, as IV iron is a dark fluid and oral iron frequently leads to dark-coloured stools. Second, the use of generic questionnaires is a limitation. As there are no existing questionnaires validated for pregnant women that evaluate the burden of symptoms possibly related to ID and IDA, we chose generic questionnaires that seemed most appropriate. Another limitation was the lack of power to measure clinical outcomes such as low birth weight and preterm birth. However, a proper power to investigate the effect of treatment on such rare outcomes would have required an unrealistic number of participants to be randomised. Lastly, the diversity of the study population was limited as most women were white. | PMC10435604 | |
Interpretation | HYPERSENSITIVITY REACTIONS | Many of our results are in line with previous findings. Studies evaluating various IV iron preparations for the treatment of IDA in pregnant women have shown consistent improvements in maternal haematological parameters and suggest that hypersensitivity reactions are rare [The oral iron group was highly compliant but, even so, 20 (20%) women in the group had IDA at the 6 and/or 12-week visit(s). Outside a trial setting, it is plausible that compliance would have been lower, probably leading to more severe ID and maybe even IDA in a larger number of women than observed in this trial. Although the ferritin increase in the IV iron group was, initially, rapid, ferritin levels before treatment and at Week 18 of follow-up were similar in most women. This probably indicates that some women needed additional iron treatment, which may be appropriate to administer before ferritin returns to pre-treatment levels.Few previous trials of IV iron in pregnancy have explored PROs [ | PMC10435604 | |
Conclusion | In conclusion, the results of this trial indicate that IV iron is an effective and safe alternative to oral iron for the treatment of persistent ID in pregnant women. Biochemical superiority of IV iron over oral iron treatment in pregnancy has been repeatedly demonstrated and, therefore, future studies should focus on the effects of iron treatment on clinical obstetric and perinatal outcomes, which remain sparsely described. | PMC10435604 | ||
Acknowledgements | JENSEN | We gratefully acknowledge the data collecting contributions from the investigators Simon Victor, MD, and Line Fogtmann Dohn, midwife. We acknowledge and are thankful for the statistical support from Jens-Kristian Slott Jensen. | PMC10435604 | |
Author contributions | RECRUITMENT | RH, VMS, LLT and CH were involved in the conception and design of the study, and in the establishment of the study data analysis plan. Recruitment, randomisation, drug administration, and data collection were carried out by RH and VMS. All authors contributed to the interpretation of the data. RH drafted the manuscript and all authors reviewed and approved the final version. | PMC10435604 | |
Funding | The trial was sponsored and fully funded by Pharmacosmos A/S, Holbæk, Denmark. | PMC10435604 | ||
Data availability | The study data will not be available for sharing. The published study protocol is available at | PMC10435604 | ||
Declarations | PMC10435604 | |||
Conflict of interest | Rebecka | HANSEN, THOMSEN | The trial was sponsored and fully funded by Pharmacosmos A/S, Holbæk, Denmark. The sponsor was involved in the study design, analysis and interpretation of the data, and approval of the final manuscript. Charlotte Holm was the primary investigator of the trial. Lars Lykke Thomsen is employed by Pharmacosmos A/S, as was Veronika Markova Sommer during the trial. Rebecka Hansen was employed by the institution with salary costs funded by Pharmacosmos A/S. Charlotte Holm and Rebecka Hansen have served on advisory boards for Pharmacosmos A/S. Charlotte Holm has received speaker honoraria from Pharmacosmos A/S. The remaining authors have no conflicts of interest to declare. | PMC10435604 |
Ethical approval | hypophosphatemia | HYPOPHOSPHATEMIA, MAY, IRON DEFICIENCY, IRON DEFICIENCY ANAEMIA, SECONDARY | The trial was approved by the Danish Medicines Agency and the Danish Scientific Ethics Committees (H-17005699) and registered in the European Clinical Trials Database (EudraCT no.: 2017–000776-29) and on ClinicalTrials.gov (NCT03188445). The authorities approved the study protocol in May 2017 and further amendments in November 2017 (key changes: inclusion criteria of iron deficiency anaemia changed to both non-anaemic and anaemic iron deficiency, and the upper gestational time window changed from 16 + 0 to 19 + 0 weeks). The first randomisation was performed in December 2017; hence, these first amendments were approved before the randomisation of any participants. Additional amendments were approved in July 2018 (key change: upper gestational age time window changed from 19 + 0 to 21 + 0 weeks) and September 2019 (key changes: adding hypophosphatemia as a secondary endpoint and including a detailed definition of obstetric and perinatal endpoints). | PMC10435604 |
Consent to participate | Written informed consent was obtained from all individual participants included in the study. | PMC10435604 | ||
References | PMC10435604 | |||
Keywords | PMC10589893 | |||
Introduction | MDD, depressed, depressive symptoms | SECONDARY | With a lifetime prevalence of up to 20 % (Up to date, there are several treatment options for MDD with relatively high response rates (On a neural level, enhanced activations in areas of the Cognitive Control Network (CCN) and the Default Mode Network (DMN) were found in depressed patients during guided rumination-induction paradigms (Understanding rumination as a result of maladaptive ER (Following these first promising results, we developed an eight-session psychotherapeutic training, combining mindfulness-based as well as cognitive behavioral ER therapy: Mindfulness-based Emotion Regulation Training (MBERT). This approach was fNIRS-adapted, allowing in situ measurements of neural processes. To the best of our knowledge, this study is the first to investigate the efficacy and the in situ neural correlates of such a mindfulness-based ER approach in the treatment of MDD. In the study at hand, we compared MBERT in a RCT with treatment as usual (TAU; no additional interventions with unrestricted continuation of existing treatments) in 42 patients suffering from MDD using a cross-over design. Our treatment consisted of a psychoeducative explanation of rumination, its link to negative emotions and impairments in ER, followed by eight psychotherapeutic training sessions practicing cognitive behavioral and mindfulness-based ER strategies under instruction and support by a clinical psychologist/psychotherapist. Each of the eight training sessions consisted of 20 training trials, in which the ER strategies were practiced, and rest trials without any specific (cognitive) task as control condition. To evaluate the efficacy of this treatment approach, we used psychometric (primary outcomes) and subjective (secondary outcomes) rating endpoints. Further, in situ fNIRS measurements were conducted to measure hemodynamic responses in the course of each session (secondary outcome). In general, we hypothesized a reduction in depressive symptoms as well as increases in self-compassion and self-efficacy due to the MBERT compared to TAU (primary outcomes). These hypotheses are derived from the knowledge about the general factors and mechanisms of psychotherapy and of “third wave CBT” in particular, namely enhanced self-compassion ( | PMC10589893 |
Materials and methods | PMC10589893 | |||
Participants | depressed | We recruited participants via emails and flyers at the University Hospital of Tuebingen, the University of Tuebingen and via outpatient psychotherapists. All procedures are in line with the Declaration of Helsinki in its latest version and were approved by the ethics committee at the University Hospital and University of Tuebingen. The study protocol is registered at In the final sample we collected data of 56 depressed patients and of 43 healthy controls. Sample sizes were determined by a previously performed power analysis that identified 42 patients and 42 healthy controls as needed. In the study at hand, only the clinical sample will be analyzed, which after dropouts was composed of the data of 42 patients (see Flow of participants. | PMC10589893 | |
Procedures | MDD | All measurements were performed in the premises of the Clinic for Psychiatry and Psychotherapy Tuebingen. For MDD patients a complete participation in the study lasted approximately ten weeks and consisted of twelve in-person appointments. All participants took part in a TSST (Study design of the project. Note. BDI-II = Beck-Depressions-Inventar II ( | PMC10589893 | |
MBERT | infection | INFECTION | The psychotherapeutic training sessions followed a predefined script (see also Procedure of the trials in the MBERT.During each training session, which took approximately 1 to 1.5 h, patients sat in front of a table on a comfortable chair with the fNIRS-cap on their head and the fNIRS-machine in their back. The psychotherapist was sitting on their left-hand side at an angle of approximately 90 degrees. As the study was conducted during the COVID-19 pandemic, for reasons of infection protection there was a plexiglass shield between the patients and the therapist and the latter wore a face mask.Between sessions the patients were encouraged to practice the taught ER strategies in their daily lives and to also do mindfulness training and meditation using a free-access application (“Meditation Time”). For this purpose, they were further given worksheets they could use to go through the strategy of the sessions by themselves (see | PMC10589893 |
fNIRS | During all therapeutic training sessions, an fNIRS measurement was performed to assess cortical oxygenated (ORegions of interest and corresponding probesets and channels, extrapolated based on the Colin 27 template (After export of the NIRS data, we computed changes in O | PMC10589893 | ||
Data analysis | equanimity, cognitive reframing / reappraisal, anxiety, depressive symptoms | To analyze the overall efficacy of the MBERT, we analyzed changes in depressive symptoms, self-efficacy, self-compassion and state rumination by using the data of corresponding questionnaires (BDI-II, SWE, SCS, SRQ). We conducted a repeated measurements multivariate analysis of variance (rmMANOVA) for the factor group (treatment vs. TAU) and measurement point (tWe analyzed the used therapeutic techniques that have been instructed during the therapeutic talk phase. This qualitative data was categorized into 11 interventions: Attention regulation and focus (e.g. on the main emotion in a burdening topic and its emotional network), chaining (e.g. linking different aspects or substeps of the used strategies), cognitive perspective change (consisting of acceptance (e.g. of negative emotions), cognitive reframing / reappraisal (e.g. seeing the functional aspects of negative emotions, such as signals of needs) and self-compassion (e.g. giving oneself the same kindness and care as if it was to a good friend)), distancing and equanimity (e.g. observing an actual burdening emotion from a distanced perspective), metaphor (e.g. seeing anxiety as a smoke detector / alarm signal), motivational interviewing, self-verbalization / self-instruction (e.g. formulation of self-verbalization “Even if I feel weak sometimes, I’m not a failure”), socratic questioning, “pretending to” (e.g. thinking about how a situation would be without a certain negative emotion), validation (e.g. seeing that every person would have certain emotions in situations the patient is burdened by) and control of body function (e.g. controlled breathing or relaxation). Using Chi-squared tests we analyzed if the frequency of intervention implementation of any as well as of specific interventions differed between sessions and session phases.We finally conducted an exploratory analysis to investigate the relationship between behavioral ratings and OAll analyses were done using R ( | PMC10589893 | |
Results | PMC10589893 | |||
Efficacy compared to waiting list: Questionnaires | depressive, TAU | Data of 41 patients could be included in the analyses of the questionnaire data (see Our analyses revealed a significant interaction effect for time and group (Changes in depressive symptom severity (4a), self-efficacy (4b), self-compassion (4c) and ruminative thoughts (4d) in the course of the study participation, differentiated by group (treatment vs. TAU). Small brackets symbolize significant group differences. | PMC10589893 | |
Subjective ratings | The results concerning the subjective ratings are based on the experimental contrast (training-control). We found a highly significant constant term, representing a main effect of the condition contrast (With respect to the main effect of session phase, all contrasts changed significantly within the three session phases with a decrease in the case of subjective burden (Huynh-Feldt Changes in subjective rating means over sessions and session phases.Concerning the main effect of session, the condition contrasts of subjective burden and effort decreased significantly (subjective burden: Huynh-Feldt Further, no significant interaction of session and session phase was observed. | PMC10589893 | ||
fNIRS data | COLD | All fNIRS results are based on the experimental contrast describing the difference of the therapeutic training trials and the control trials. Due to bad data quality, the data of five training sessions was imputed via multiple imputation with five iterations before running the analyses. Please note that inclusion and exclusion of the related patients did not lead to changes in the results.We found a highly significant constant term, representing a main effect of the condition contrast in general (Activation maps for the experimental contrast (training vs. rest) for the different sessions (S1 to S8; top to bottom). Differences are plotted as effect sizes in Cohen's d. Warm colors indicate higher activation during training trials, while cold colors indicate higher activation in rest trials. | PMC10589893 | |
Exploratory analysis | Finally, we analyzed the association of the subjective ratings with the time variables session and session phase as well as with cortical oxygenation by fitting mixed models, separately for each ROI and each subjective rating. Note that we included only training trials in this analysis to reduce the complexity of the models. The results are to be found in Results of the mixed models exploring the association between the subjective ratings, cortical oxygenation in the different ROIs, sessions and session phases in the training trials(Session:Phase:WP_OBeta-estimates and standard errors in brackets. AIC = Akaike Information Criterion; BIC = Bayesian-Information-Criterion; RPlease note that we also performed the analysis with no auto-regressor, as well as with non-centered predictors which yielded the same results (see | PMC10589893 | ||
Discussion | depressive rumination, depressive, equanimity, MDD, depression | The purpose of this study was to investigate the efficacy and neural correlates of a MBERT in the treatment of depressive rumination. More specifically, we aimed to shed light on the neural mechanisms related to typical trained emotion regulation skills in CBT. To this end, 42 subjects suffering from MDD completed an eight-session treatment in which ER strategies were taught and practiced, while cortical blood oxygenation was assessed with fNIRS. We examined the efficacy of the training on a behavioral level using psychometric measures. Impacts of the training on a psychological and neural level were investigated using subjective ratings on session variables and hemodynamic responses during the training in the CCN. We found significant and treatment-specific changes in depressive symptom severity, self-compassion, self-efficacy and ruminative thoughts after completion of the MBERT in comparison to TAU. During and between training sessions, subjective ratings on burden, self-compassion, equanimity and effort changed significantly in expected change patterns, i.e. increases in self-compassion and equanimity and decreases in subjective burden and effort. The amount of implemented therapeutic techniques provided by the therapist between the trials of the training decreased during as well as between sessions, indicating that less therapeutic guidance was needed with ongoing treatment. Concerning the neural correlates, we found higher cortical activation during training compared to rest trials in the prefrontal areas of the CCN, namely in the bilateral DLPFC and the bilateral IFG. As hypothesized, this difference between conditions decreased significantly across sessions in the bilateral DLPFC with a linear decrease. However, no significant reduction of the condition contrast was found within each session. Finally, an exploratory analysis indicated associations of the individual cortical oxygenation in the CCN and process-related subjective ratings during the training. Individual fluctuations of CCN oxygenation above the individual mean at the beginning of the training was associated with reduced subjective effort and burden, as well as increased self-compassion and equanimity. However, with procession within each training session and between training sessions, remaining higher intra- und inter-subject levels of OAs the designed MBERT training is composed of typical CBT components, it is not surprising that the observed efficacy is well in line with previous studies, showing that CBT is an effective treatment of MDD (It is known from previous studies that there are differences in the epidemiology and the course of depression between sexes, both on a behavioral as well as a neural level (Some limitations have to be addressed. First of all, even though the training was found to be highly effective, we did not collect follow-up data to examine the long-term stability of the effects. At least the effects obtained seemed to remain stable over five weeks, as we could observe by the cross-over design in those subjects that first received the training. To verify long-term effectiveness, comprehensive follow-up surveys on a larger sample and after several months would be needed. However, it was not the aim of this study to create a new treatment method as a standalone treatment, but to primarily shed light on the mechanisms and neural correlates of CBT-specific treatment components. Second, it cannot be ruled out that patients may have been influenced in their subjective ratings and the answering of the psychometric questionnaires by the presumed expectations of the investigators ( | PMC10589893 | |
Conclusion | Taken together, the study at hand showed that ER strategies that are typical components of CBT activate prefrontal areas of the CCN at the beginning of treatment. In line with theoretical accounts of model-based and model-free emotion regulation, the training of those skills results in decreases of activity in the CCN over time which is accompanied by reductions in subjective effort, burden and increases in self-compassion and equanimity. | PMC10589893 | ||
Funding | This work was supported by the fortune funding program at the University of Tuebingen [grant number F1331582]. We further acknowledge support from the Open Access Publication Fund of the University of Tuebingen. | PMC10589893 | ||
Declaration of Competing Interest | The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. | PMC10589893 | ||
References | PMC10589893 | |||
Supplementary data | The following are the Supplementary data to this article: | PMC10589893 | ||
Supplementary data 1 | PMC10589893 | |||
Data availability | Data will be made available on request. | PMC10589893 | ||
Acknowledgements | The authors would like to thank Ramona Täglich, Betti Schopp, Katja Stumper, Ferdinand Berzdorf, Lukas Viestädt, Jamie Nagel, Felix Schlüter and Florian Torka for their excellent work and their valuable support with the measurements. We further thank Thomas Dresler for his help in checking the paper linguistically and grammatically. Finally, we thank all patients for their participation in the study.Supplementary data to this article can be found online at | PMC10589893 | ||
Objective | Older people in care homes frequently experience polypharmacy, increasing the likelihood of medicine-related burden. Pharmacists working within multidisciplinary primary care teams are ideally placed to lead on medication reviews. A randomised controlled trial placed pharmacists, with independent prescribing rights (PIPs), into older people care homes. In the intervention service, PIPs worked with general practitioners (GPs) and care home staff for 6 months, to optimise medicine management at individual resident and care home level. PIP activity included stopping medicines that were no longer needed or where potential harms outweighed benefits. This analysis of qualitative data examines health and social care stakeholders’ perceptions of how the service impacted on care home medicine procedures and resident well-being. | PMC10619113 | ||
Design | SECONDARY | Pragmatic research design with secondary analysis of interviews. | PMC10619113 | |
Setting | Primary care pharmacist intervention in older people care homes in England, Scotland and Northern Ireland. | PMC10619113 | ||
Participants | Recruited from intervention arm of the trial: PIPs (n=14), GPs (n=8), care home managers (n=9) and care home staff (n=6). | PMC10619113 | ||
Results | There were resonances between different participant groups about potential benefits to care home residents of a medicine service provided by PIPs. There were small differences in perceptions about changes related to communication between professionals. Results are reported through three themes (1) ‘It’s a natural fit’—pharmacists undertaking medication review in care homes fitted within multidisciplinary care; (2) ‘The resident is cared for’—there were subjective improvements in residents’ well-being; (3) ‘Moving from “firefighting” to effective systems’—there was evidence of changes to care home medicine procedures. | PMC10619113 | ||
Conclusion | This study suggests that pharmacist independent prescribers in primary care working within the multidisciplinary team can manage care home residents’ medicines leading to subjective improvements in residents’ well-being and medicine management procedures. Care home staff appreciated contact with a dedicated person in the GP practice. | PMC10619113 | ||
Trial registration | ISRCTN 17847169 | PMC10619113 | ||
Strengths and limitations of this study | RECRUITMENT | The study draws on data from a relevant sample of 38 health and social care professionals involved in medicine management in care homes.The analytical approach foregrounded the effect of pharmacist-led medication review on the older resident in care homes, therefore having relevance to practices supporting safer medicines in this group of people.A limitation is the absence of residents’ voices, due to recruitment challenges with this group.The study provides insights into activity provided by specialist pharmacists with independent prescribing qualifications so it cannot be assumed that more generalist pharmacists would have the experience to make specialised medicine management decisions. | PMC10619113 | |
Introduction | SECONDARY | Older people in care homes (CHs) are often subject to complex medicine regimes which may include the concurrent administration of more than five different medicines daily.This paper reports on a secondary analysis of interview data collected from pharmacists with independent prescribing rights (PIPs), general practitioners (GPs) and CH staff as part of the process evaluation | PMC10619113 | |
Methods | PMC10619113 | |||
The CHIPPS study | SECONDARY | The pharmacist-led service offered in CHs is briefly described below to set the findings of the secondary analysis in the practice context; full details of the trial design are available at referencesThe pharmacist-led service was delivered through a triad of a GP, a PIP based at the GP practice, and up to 24 CH residents, from up to three CHs, registered with the GP. Service specifications were developed following focus groups with stakeholders to guide the PIPs’ work (see
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Design | Pragmatism is a research methodology suited to characterising knowledge about how behaviours and actions impact on healthcare systems and outcomes. This approach can help appreciate the value of knowledge within its context of activity, uses and how these relate to the experience of addressing practical problems. | PMC10619113 | ||
Recruitment and sample | RECRUITMENT | During the process evaluation, health and social care stakeholders in each triad where the intervention was delivered, were invited to take part in a semistructured interview at the end of each 6 month phase: PIPs n=23 (2 withdrew and contact details not available), GPs n=25 and CH managers n=38. A reminder invitation email was sent after 2 weeks. CH managers provided recruitment information to staff, residents and relatives. Those interested in participating returned expressions of interest to study researchers. A purposive sampling framework was designed to ensure representation across stakeholder roles, location and phases of the intervention. However, response rates were low and therefore all those replying were invited to interview. | PMC10619113 | |
Data collection | The process evaluation semistructured interview guide drew on outcomes from the earlier feasibility study
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Data management and analysis | An inductive thematic analysis was used to characterise participants’ experiences of delivering or receiving the pharmacist-led service. Thematic analysis provides a structured, methodical way for the researcher to familiarise with the data and to organise, analyse and report findings; importantly it is not strongly aligned to any epistemological stance,
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Patient and public involvement | Public involvement was supported by the Patient and Public Involvement in Research group (further details at | PMC10619113 | ||
Results | Interviews, lasting between 30 and 90 min, were undertaken with 38 HCPs: 14 PIPs, nine GPs, nine CH managers and six CH staff. Participants were recruited from 18 of the 25 triads: six in Scotland, four in Northern Ireland and eight in England. There was no expression of interest from any stakeholder in seven triads. In three of these triads, the PIPs did not deliver the intervention; in the remaining four triads, the demographics and trial outcomes were similar to the sample interviewed. Data were collected from a heterogeneous sample of professionals and locations as shown in
Three themes were developed. Theme (1) ‘ | PMC10619113 | ||
Theme 1: ‘It’s a natural fit’—multidisciplinary working in care homes | This theme reports GP, CH staff and PIPs’ experiences of pharmacist-led medicine management. The GP and CH staff valued the PIPs’ activity for differing reasons, suggesting that a PIP role can meet both sets of needs. | PMC10619113 | ||
GP perceptions | ’ | GPs highlighted the safety advantage of having PIPs within the multidisciplinary team, explaining that it was helpful to have ‘another pair of eyes’ to increase patient safety:Having a pharmacist who had good knowledge of all kinds of medications, going through polypharmacy, with a fine-tooth comb and picking up any errors or things we could do better. GP_21.GPs also drew on PIPs’ expertise of medicine administration for the wider benefit of CH residents, GPs explained that as PIPs could spend several hours within the home with a small number of residents, they could understand residents’ medicine needs in greater detail, ‘While GPs found it hard to quantify the impact of the intervention on their workload, on reflection they mostly described how they were now dealing with fewer daily enquiries from CHs. Where PIPs and GPs had established communication channels, the PIPs regularly identified residents and issues that the GP should look at in their weekly ward round:It has reduced the time taken to see patients as I can be confident their meds are all up to date, tests required for routine monitoring have been flagged up and I have been able to action these GP_3.Not all GPs agreed that the PIP intervention was a ‘natural fit’, rather one GP described a situation where they believed the intervention had increased their workload as the PIP had requested biochemical monitoring which was ‘ | PMC10619113 | |
Care home team perceptions | confusion | CH managers and staff identified benefits in having a dedicated pharmacist attached to the home. Most CH teams explained they had gained improved accessibility and advice by having PIPs as a point of contact in the primary care team, ‘Where multidisciplinary working was embedded, CH teams explained the clinical skills of each professional were respected, and teamwork supported effective resident care:The [CH] nurses’ assessments are being taken as a valuable tool, because the nurses are observing, the nurses are giving the assessment, and the nurses are liaising with the PIP, to prescribe what they think is needed, so I think it’s a win, win situation, the nurses are feeling valued, and the PIP as well CH manager_21b.However, in two homes, PIPs were not able to become integrated into the CH. In one, the PIP reported that CH staff were unclear of their role. In another, there was confusion about the legal position of PIPs to prescribe and the manager insisted the GP signed off all the PIP’s prescribing activity. This highlights the importance of understanding and trust across the triad. | PMC10619113 | |
PIP perceptions | PIPs commonly reported that their prescribing authority meant decisions and resident care could be followed up in a timely way:I think the benefits of having pharmacists in Primary Care is we can go in and make the changes and own it and follow it up rather than pass it on, …leaving it for other people to follow up PIP_17.A few PIPs mentioned the role of the pharmacy technician as potentially supporting their work, as pharmacy technicians would undertake stock control and check medicine administration records for accuracy with stock. Only one PIP appeared to have worked with a technician during the intervention ‘…In summary, GPs and PIPs made clear what expertise an independent prescribing pharmacist could bring to the multidisciplinary team and saw a continuing place for pharmacists in CHs. While most CH teams valued the PIP role, a few were still uncertain on the range of their specific responsibilities. | PMC10619113 | ||
Theme 2: ‘The resident is cared for’—shared goals in medicine management | ’ | ADVERSE EFFECTS, SECONDARY | GPs and PIPs highlighted a strength of having a PIP as ‘the linchpin in medicine management’ in that they had detailed pharmaceutical knowledge allowing them to take actions which would directly and specifically benefit residents. PIPs reviewed prescriptions and could actively seek to rectify any prescribing errors and reduce the drug burden related to adverse effects from medicines. By doing this, they importantly improved safety for the resident and helped to make MAR (Medication Administration Record) sheets fit for purpose thereby potentially reducing the risk of administration error. Changes PIPs could make ranged from small actions such as changing the time of eye drop administration, so residents were not woken every night by staff, changing tablet preparations to soluble form, to complex titrating of medicines, for example, reducing doses of morphine-based painkillers and stopping antipsychotic medicines. PIPs reviewed all medicines in the context of a resident’s current biomedical markers and stage of life.Residents, alongside some members of the multidisciplinary team, were sometimes uncertain of the PIP’s credentials, and PIPs reported that a few residents were reluctant to have their medicines reviewed, preferring to remain with prescriptions given by the GP or secondary care team. There were a few triads where CH teams struggled to recall changes which had impacted on residents’ well-being. These proved to be either homes where PIPs struggled to build working relationships and therefore their medication activity was negligible, or homes that already had highly developed relationships with either the PIP allocated to the intervention or with another pharmacist. In this latter case it was reported that most residents already received regular medication reviews. | PMC10619113 |
Managing resident prescriptions | pain | ADVERSE EFFECTS | Independent prescribing activity was a key role of PIPs in the multidisciplinary team. Their involvement could directly benefit residents, often because this could progress a new prescription much more speedily:If my residents are feeling their symptoms, then refer to the PIP, and the PIP will prescribe immediately, there will immediate response, and then the residents will be happy CH manager_21b.Other CH teams identified how having direct contact with a PIP stopped conditions worsening, ‘Key to successful deprescribing, reducing or stopping a medicine, was the PIP having trustful relationships with the CH team, the GP and the resident or their family. The importance of this trustful relationship was made evident when CH teams explained how they were now confident in trying to titrate prescriptions down as they knew the PIP was easy to contact and had agreed that if there were adverse effects the process could be stopped, and the medicine reinstated:Seeing PIP on a weekly basis meant we were able to make some huge reductions but also we were both very honest with each other so when we had got rid of almost everything and then resident’s behaviour got worse again, we were able to add in a tiny little bit of something and I mean tiny bit which was appropriate CH Manager_9.Titrating antipsychotic medicine is a complex process and each stakeholder needs to be fully committed and in good communication with each other. Here, a PIP explains how the process continued after the intervention ended, illustrating the continued benefit of having PIPs working in the GP practice:We had started to titrate it down and for a few days they were okay and then they started to need a lot of diazepam so we increased it back up but now it has come back down by half; they are checking and watching even though the study has ended because I have been involved and generally keeping an eye on things too they still have my contacts. PIP_1.Discussions on deprescribing were also enabled between PIPs and the resident or their relative, thereby providing more patient-centred care. A CH manager explains:…talking through that with the PIP and the resident she has come full circle and is off her Butec patches with no pain; that was agreed with her and her family … she didn’t mind coming off and giving it a trial period CH Manager_6. | PMC10619113 |
Shared decisions | While it was intended that PIPs would be actively engaged with residents as part of the intervention, frequently residents did not have the mental capacity for this. However, even though a PIP stated that residents would possibly have little recall of their conversation, they still found it relationally valuable to meet with residents, ‘I could really get on well with the family, she wanted to know everything what I was going to do so that was more interesting because I could discuss things, a really good example of joint working with the family PIP_16.In summary, most participants readily identified ways in which the intervention had directly benefited individual residents. The key factor enabling PIPs to work in ways which benefited residents stemmed from the trust the CH team, resident and their family could place on the PIP as a readily accessible, clinically competent person who could react appropriately if adverse consequences arose to any medicine change. | PMC10619113 | ||
Theme 3: ‘Moving from “firefighting” to effective systems’ | Within the CH, most of the PIPs actively reviewed and where appropriate improved medicine ordering and administration systems, for example streamlining dispensing systems, consolidating MAR charts and stock control. | PMC10619113 | ||
Streamlining medicine supply and stock control | FIRES | PIPs could articulate their detailed knowledge of the role of the community pharmacist and the processes which may be in place when a medicine is started or stopped, particularly the time it can take for automated systems to register the change. This ‘insider knowledge’ placed PIPs in an ideal position to educate other professionals and try to streamline medicine ordering processes:Geriatrician didn’t realise that although it was stopped in the MAR chart the next month’s is out there in the van waiting to be delivered, just anticipating those fires PIP_9.PIPs explained that such lack of understanding about the medicine supply process led to stopped medicines still being dispensed and administered and this could be a patient safety issue. The majority reported developing enhanced relationships with community pharmacists and CH staff. If the PIP worked in the GP practice, these relationships were often sustained postintervention, A few PIPs explained that taking part in the intervention had prompted them to review systems in the GP surgery:We have 5 people—pharmacy technician, pharmacy assistants, generating prescriptions, dealing with questions, and discharge letters, so one of them is now appointed for the nursing home patients. If we need to discuss anything, she’s the one that helps if we make a change, she’ll change it on their file, and then she’ll liaise as well with the nursing home PIP_22. | PMC10619113 | |
Rationalising record and stock | Working alongside CH staff PIPs allocated time to review MAR charts and consider if medicines could move to PRN (as required) or homely medicines. The staff reported they appreciated dedicated time to discuss things and simplified MAR charts:It sorted out things that we didn’t need any longer and put things a bit more into place, like the PRNs particularly where some people didn’t need it on their MAR charts any longer, … I suppose that had been overlooked which does happen I’m afraid, yes it was useful CH staff_19.Removing no-longer-needed prescriptions and identifying changes in the ordering systems helped reduce workload, ‘Many of the PIPs explained that by regularly attending the care homes, they were able to identify waste and unused stock and could take measures to reduce waste:I spoke a few times with the dispensing pharmacists about errors that came up on the MAR chart etc. we tried to address those issues. I spoke to the appliance contractors not just the Pharmacy, … I had to address it in a really decisive manner PIP_16.One GP highlighted the importance of cost-saving inherent in stock control, In summary, many PIPs were found to take an active lead in reviewing and advising on more efficient medicine systems. However, their efforts to improve systems could be thwarted if either the CH staff or GP team were unwilling, or unable, to adopt new ways of working. | PMC10619113 | ||
Discussion | stock reduced wastage | SECONDARY | This secondary analysis of interview data from the process evaluation of the CHIPPS studyGPs and PIPs made clear a pharmacist independent prescriber could bring specialised clinical knowledge to the multidisciplinary team and they saw a continuing place for pharmacists in CHs. While most CH teams valued the role of the PIP, a few were still uncertain on the range of their specific responsibilities. Pharmacists have an increasingly valued place within multidisciplinary primary care teams, and this is evident within policy statements.The review of individual resident’s medicines undertaken as part of this intervention was reported by CH staff and PIPs as having readily demonstrated benefits for residents’ subjective quality of life. This understanding is important as the evidence on objective improvements in resident outcomes, that is, admission to hospital, falls or mortality from this trial and others is inconclusive.As part of the intervention service specification, PIPs spent time actively reviewing, and where appropriate, improving CH medicine systems. For example, reviewing and improving dispensing systems, consolidating MAR charts and monitoring stock control. These were reported as having benefits for CH staff in that administration and reordering were easier, and potentially safer. Improved management of stock reduced wastage and therefore had financial benefits. These findings resonate with evidence supporting the place of pharmacists within CHs.The exceptions to the positive results reported so far occurred when relational factors inhibited the scope of pharmacist contributions. For example, when the relationship between pharmacist and GP or CH could not be successfully established, or understanding of the pharmacist’s legal clinical scope was not understood. This suggests the need for strategies which will develop shared understanding of the potential of each other’s roles. Our results resonate with a survey by Kahn | PMC10619113 |
Strengths and limitations | cognitive impairment | Missing from our study are the resident and relatives’ opinions of medication review and the place of the pharmacist in this. We attempted to recruit the residents consented to the intervention arm of the trial through CH staff. It is unclear why this was unsuccessful with only three residents expressing an interest, but in part it is likely to be due to the severe cognitive impairment many residents were living with, meaning staff may not have actively encouraged residents or their families to take part in a process evaluation interview. A further point to note is that the sample, while appearing representative of the main trial sample, consists of those who volunteered for the additional process evaluation interview so may not represent the views of those who declined. This point along with the limited number of participants represented in a small number of codes means that the transferability of the data needs to be considered with caution as the results provide insights and understandings from a very specific group of HSCPs involved in supporting older resident CHs. All pharmacists were independent prescribers, and all had received additional training in medicine for older people. It cannot be assumed that more generalist pharmacists in a GP surgery would have the experience to make the specialised medicine management decisions demonstrated by these pharmacist independent prescribers who had received additional training. There are recommendations to make CH pharmacists a designated specialty.The CHIPPS RCT found the fall rate risk ratio for the intervention group compared with the control group was not significant. However, the Drug Burden Index outcome significantly favoured the intervention.There are practice implications for other roles within the wider healthcare team. For example, during interviews, PIPs referred to their work with community pharmacists, describing the community pharmacist position as key in dispensing medicines. Future work exploring medicines management in CHs might include the community pharmacist or dispensing pharmacy so that the efficiency of medicine ordering and dispensing can be further optimised. This might reduce the potential safety risk, reported in this study, which occurs when medicines which have been deprescribed remain on the MAR chart.The CHIPPS process evaluation was completed in 2020 just as primary care networks (PCN) were being introduced in England and at the start of the COVID-19 pandemic. A key aspect of the role was the presence of the pharmacy within the CH, the move to more ‘on-line’ working since the COVID-19 pandemic may make this aspect of the intervention more difficulty to implement. Within PCNs, pharmacists work across several GP practices rather than being within a single practice. | PMC10619113 | |
Conclusion | Independent prescribing pharmacists can successfully take responsibility for medicine management and SMR for older people in CHs. When pharmacists develop professional trustful relationships with GP colleagues and CH staff, they can independently make changes to medicines which benefit resident well-being. Their expertise in medicine systems including stock control and ordering enabled them to streamline CH systems with the potential benefit of reducing waste and likelihood of administration errors. The changing landscape of global primary care provision indicates that pharmacists will continue to have a key role in leading management of medicines but that how this happens may require monitoring to enable refinement of the delivery model. | PMC10619113 | ||
Supplementary Material | PMC10619113 | |||
Reviewer comments | PMC10619113 | |||
Data availability statement | Data are available upon reasonable request. The data sets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10619113 | ||
Ethics statements | PMC10619113 | |||
Patient consent for publication | Not required. | PMC10619113 | ||
Ethics approval | This study involves human participants. English ethical approval was gained from East of England Cambridge Central Research Ethics Committee 17/EE/0360 (28 November 2017; this applied to research in Northern Ireland). Scottish ethical approval was gained from Scotland A research Ethics Committee 17/SS/0118 (7 December 2017). Participants gave informed consent to participate in the study before taking part. | PMC10619113 | ||
References | PMC10619113 | |||
Background | RECRUITMENT | Evaluating digital interventions using remote methods enables the recruitment of large numbers of participants relatively conveniently and cheaply compared with in-person methods. However, conducting research remotely based on participant self-report with little verification is open to automated “bots” and participant deception. | PMC10540014 | |
Objective | This paper uses a case study of a remotely conducted trial of an alcohol reduction app to highlight and discuss (1) the issues with participant deception affecting remote research trials with financial compensation; and (2) the importance of rigorous data management to detect and address these issues. | PMC10540014 | ||
Methods | We recruited participants on the internet from July 2020 to March 2022 for a randomized controlled trial (n=5602) evaluating the effectiveness of an alcohol reduction app, Drink Less. Follow-up occurred at 3 time points, with financial compensation offered (up to £36 [US $39.23]). Address authentication and telephone verification were used to detect 2 kinds of deception: “bots,” that is, automated responses generated in clusters; and manual participant deception, that is, participants providing false information. | PMC10540014 | ||
Results | RECRUITMENT | Of the 1142 participants who enrolled in the first 2 months of recruitment, 75.6% (n=863) of them were identified as bots during data screening. As a result, a CAPTCHA (Completely Automated Public Turing Test to Tell Computers and Humans Apart) was added, and after this, no more bots were identified. Manual participant deception occurred throughout the study. Of the 5956 participants (excluding bots) who enrolled in the study, 298 (5%) were identified as false participants. The extent of this decreased from 110 in November 2020, to a negligible level by February 2022 including a number of months with 0. The decline occurred after we added further screening questions such as attention checks, removed the prominence of financial compensation from social media advertising, and added an additional requirement to provide a mobile phone number for identity verification. | PMC10540014 | |
Conclusions | Data management protocols are necessary to detect automated bots and manual participant deception in remotely conducted trials. Bots and manual deception can be minimized by adding a CAPTCHA, attention checks, a requirement to provide a phone number for identity verification, and not prominently advertising financial compensation on social media. | PMC10540014 | ||
Trial Registration | ISRCTN Number ISRCTN64052601; https://doi.org/10.1186/ISRCTN64052601 | PMC10540014 | ||
Introduction | RECRUITMENT | Conducting studies remotely using digital technology such as web-based survey tools offers several benefits and was particularly useful during the COVID-19 pandemic, which precluded face-to-face contact for long periods. Remote participation has benefits for both participants and researchers. It is accessible [A major disadvantage is that conducting studies remotely tends to rely on participant honesty in self-report, and researchers cannot be sure that the participant is who they say they are; participants have been known to engage in deception to take part in research with financial incentives available [This study differentiates between 2 main types of participant deception that can occur in remotely conducted studies and cause significant issues for researchers: bots and manual participant deception. Automated “bots” (short for “robots”) [This is not a new issue, and previous remote studies have encountered bots and detailed management techniques, such as differentiating between automated strategies embedded into electronic surveys and manual plans during recruitment [This paper reports a case study of a remotely conducted randomized controlled trial of an alcohol reduction app, | PMC10540014 | |
Methods | CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines [ | PMC10540014 | ||
Trial Context | RECRUITMENT | The iDEAS trial aimed to evaluate the effectiveness of The original recruitment plan prepandemic was to place posters in NHS Primary Care services, but this has to be moved to web-based media when face-to-face appointments became remote appointments. Because recruitment occurred at this time, when many people were at home, people may have had more motivation and time to engage in deception.The 21-month trial recruitment period ran from July 13, 2020, to March 31, 2022, with a monthly target of 265 (total recruitment target, n=5562). Minimal advertising on Twitter (a tweet from the University and a promotion from the funder) occurred in July. The study began advertising on Facebook and Google in September 2020 (Figures S1 in After completing a baseline eligibility survey on Qualtrics, participants were randomized to 1 of 2 conditions (either the From the outset of recruitment, problems were experienced with participant deception. Enrollment decision tree. | PMC10540014 | |
Bot Deception | PMC10540014 | |||
Definition | Bots were identified as (1) an entry enrolling in a cluster (multiple entries in the same hour, with a similar style of email address) who (2) provided postcodes that did not match international street names entered and provided international phone numbers. | PMC10540014 | ||
Identification of the Problem | RECRUITMENT | Within the first 19 days of recruitment, with minimal advertising that was expected to have low reach (a tweet from the university and a promotion from the funder), the monthly recruitment target of 265 participants had been surpassed with 870 randomized participants (15.6% of the overall study target). The anticipated rate of recruitment was based on previous experience (an earlier factorial trial of | PMC10540014 | |
Management | There were 2 main stages to the management process. | PMC10540014 | ||
Postcode Checks | All randomized participants’ postcodes were checked (enrollments had now risen to n=915) to assess whether they matched with the first line of an address provided by Royal Mail Postcode Finder [Different options were considered to avoid future bot responses, including Qualtrics’ fraud detection software options, such as a reporting tool to indicate whether a response is likely to be a bot [A second round of checks on participants (n=196) were reviewed to identify whether any bots had enrolled (1) since the original checks but before the addition of the CAPTCHA and (2) following its addition. A further 181 suspicious entries were identified as enrolling (in the intervening period between the original checks and the addition of the CAPTCHA). | PMC10540014 | ||
Telephone Checks | To further avoid the likelihood of including fraudulent entries, every participant who enrolled before the CAPTCHA had been added was contacted by phone. A participant was classified as a bot if either (1) the number provided was false or (2) it was confirmed the participant was not known at that number.To minimize bias in removing participants after randomization, decisions erred on the side of inclusion, and unless there was proof that participants were not real, they remained in the study. For example, a participant remained in the study even if nobody answered the phone after 2 attempts. An additional 121 bots were identified and emailed as before, allowing 24 hours to respond with verified contact information. | PMC10540014 | ||
Manual Participant Deception | Monthly data checks from October 2020 (Dates and changes to procedures in response to problems arising. CAPTCHA: Completely Automated Public Turing Test to Tell Computers and Humans Apart. | PMC10540014 | ||
Definition | Manual participant deception was defined as when a participant signed up for the trial and provided false contact information, confirmed by verification checks. This comprised either (1) invalid contact numbers where participants were not known, (2) an address where the postcode did not match the first line of the address, or (3) the same landline number provided by multiple respondents with different geographical postal addresses (where the likelihood of the number being shared was slim). | PMC10540014 | ||
Identification | Manual participant deception was first identified during October 2020, relating to a participant randomized in August, with postcode checks [This issue was distinctive mainly through the use of landline phone numbers or the addresses of large companies. Examples included web-based estate agents, London hotels and restaurants, charities, and even funeral homes. As described, part of the procedure was to verify all addresses using Royal Mail’s website [ | PMC10540014 | ||
Management | RECRUITMENT | The management procedure is shown in In an attempt to mitigate against participant deception, the mention of the financial compensation was removed from social media advertising (Figure S2 in When we spoke to a genuine participant (whose name matched the person we reached on the phone), we explained we had called to confirm the details provided, and they remained in the study. From December 2020 onward, a percentage of participants were called at random each month to verify their details.In March 2021, we amended the social media advertising to reinclude the mention of the financial compensation but reduce the prominence of the financial compensation available, in addition to targeting Facebook advertising so it could only be viewed by males to try and achieve a more representative sample. This compromise was a balance between reducing the rate of participant deception and minimizing the impact on genuine recruitment, leading to a fall in the rate of manual participant deception. The advertising had specific parameters in terms of who it was displayed to at this time, which reduced the audience it was displayed to on Facebook. This second advertisement, which ran on social media for 90 days, was replaced by a final edit (Figure S3 in The other method we employed was an additional attention check on the baseline survey. One had been placed in the survey initially, a question: “Just checking that you are a human, please select ‘weekly’ as your answer to this question”. If they did not, they were screened out (62/7300, 0.8%). To further protect against manual deception, in November 2020, a second check was added, asking participants to enter their age, then, after a few further blocks of questions, to enter their age again. If these responses did not match, the participants were screened out (135/7300, 1.85%).One of the difficulties during this process was balancing the need to recruit large numbers of participants to detect small but meaningful effects while avoiding encouraging many attempts at fraud by making incentives too prominent. We were also mindful of trying to recruit a representative sample while also ensuring that participants were genuine. We were fortunate to have the support of NHS Digital in placing an advertisement (At each stage, a problem was identified, the core research team discussed the issue and how best to resolve it, and these decisions were checked with the full trial team, the Data Monitoring and Trial Steering Committees. The approach was flexible and reactive, depending on how the problem manifested. The decisions described in the case study were made on the basis of inclusion, with participants included in the study unless we could confirm that there was participant deception. Despite the issues experienced, the iDEAS trial successfully recruited participants to time and target. | PMC10540014 | |
Ethics Approval | Ethical approval for this study was obtained from the UCL Research Ethics Committee (16799/001). | PMC10540014 | ||
Results | PMC10540014 |
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