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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 adm... | 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. Seco... | 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... | 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 8... | 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. Participa... | 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 a... | 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, ... | 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 ... | 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... | 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... | 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 ... | 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-indu... | 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 ... | 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 ... | 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 psychot... | 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 ... | 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, dif... | 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 phase... | 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 e... | 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 m... | 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 e... | 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 ... | 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 ... | 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 (PI... | 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’—... | 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 t... | 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 medici... | 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 practitio... | 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 reside... | PMC10619113 | |
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 ... | PMC10619113 | |
Data collection | The process evaluation semistructured interview guide drew on outcomes from the earlier feasibility study
| PMC10619113 | ||
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 al... | PMC10619113 | ||
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. I... | 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 er... | 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 ... | 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... | 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... | 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, th... | 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 mee... | 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... | 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 ... | 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... | 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, b... | 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 expert... | 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 ... | 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 ... | 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 v... | 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... | 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 c... | 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 ... | 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 h... | 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... | 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 a... | 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 bia... | 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 addr... | 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 resta... | 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 co... | 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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