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To determine General Practice (GP) recording of carer status and the number of patients self-identifying as carers, while self-completing an automated check-in screen prior to a GP consultation.
A descriptive cross-sectional study.
11 GPs in the West Midlands, England. Recruitment commenced in September 2019 and concluded in January 2020.
All patients aged 10 years and over, self-completing an automated check-in screen, were invited to participate during a 3-week recruitment period.
The current coding of carers at participating GPs and the number of patients identifying themselves as a carer were primary outcome measures. Secondary outcome measures included the number of responses attained from automated check-in screens as a research data collection tool and whether carers felt supported in their carer role.
80.3% (n=9301) of patients self-completing an automated check-in screen participated in QUantifying the identification Of carers in general practice (STATUS QUO Study) (62.6% (n=5822) female, mean age 52.9 years (10–98 years, SD=20.3)). Prior to recruitment, the clinical code used to denote a carer was identified in 2.7% (n=2739) of medical records across the participating GPs.
10.1% (n=936) of participants identified themselves as a carer. They reported feeling supported with their own health and social care needs: always 19.3% (n=150), a lot of the time 13.2% (n=102), some of the time 40.8% (n=317) and never 26.7% (n=207).
Many more participants self-identified as a carer than were recorded on participating GP lists. Improvements in the recording of the population’s caring status need to be actioned, to ensure that supportive implementation strategies for carers are effectively received. Using automated check-in facilities for research continues to provide high participation rates.
To describe ambulance clinicians' experiences of self-determination in older patients.
The study had an inductive and explorative design, guided from a life-world perspective.
Thirty-two Swedish ambulance clinicians were interviewed in six focus groups in November 2019. The data were analysed with content analysis, developing manifest categories and latent themes.
The ambulance clinicians assessed the older patients' exercise of self-determination by engaging in conversation and by being visually alert, to eventually gain an overall picture of their decision-making capacity. This assessment was used as a platform when informing older patients of their rights, thus promoting their participation in care. Having limited time and narrow guidelines counteracted ambulance clinicians' ambitions to support older patients' general desire to avoid hospitalization, which resulted in an urge to displace their responsibility to external decision-makers.
Expectations that older patients with impaired decision-making ability will give homogeneous responses mean an increased risk of ageist attitudes with a simplified view of patient autonomy. Such attitudes risk the withholding of information about options that healthcare professionals do not wish older patients to choose. When decision-making is difficult, requests for expanded guidelines may paradoxically risk alienation from the professional nursing role.
The findings show ambulance clinicians' unwillingness to shoulder their professional responsibility when encountering older patients with impaired decision-making ability. In assuming that all older patients reason in the same way, ambulance clinicians tend to adopt a simplistic and somewhat ageist approach when it comes to patient autonomy. This points to deficiencies in ethical competence, which is why increased ethics support is deemed suitable to promote and develop ethical competence. Such support can increase the ability to act as autonomous professionals in accordance with professional ethical codes.
This study adhered to COREQ guidelines.
None.
To illuminate from the perspective of nurses in ambulance services the experiences of using a web-based advisory decision support system to assess care needs and refer patients.
Inductive and descriptive approaches.
Thirteen semi-structured interviews were conducted in the spring of 2020. The data were analysed through the reflexive thematic analysis.
The Swedish web-based advisory decision support system (ADSS) was found to strengthen nurses' feelings of security when they assess patients' care needs, promote their competence and professional pride, and help them manage stress. However, the system also generated difficulties for nurses to adjust to the dynamic ambulance team and revealed a discrepancy between their professional roles and responsibilities to refer patients and provide self-care advice. The nurses thought that the support system facilitated their increased participation and helped them understand patients and significant others by offering transparency in assessment and decision making. Thus, the support system provides nurses with an opportunity to strengthen patients' independence through information and education. However, in the care relationship, nurses worked to overcome patients' expectations.
Nurses using the ADSS increased their security while performing assessments and referrals and found new opportunities to provide information and promote understanding of their decisions. However, nursing care values can be threatened when new support systems are introduced, especially as ambulance services become increasingly protocol-driven.
These findings have implications for nurses' work environments and help them maintain consistency in making medical assessments and in providing equivalent self-care advice when referring patients to the different levels of care. The findings will also impact researchers and policymakers who formulate decision support systems.
Consolidated criteria for reporting qualitative research (COREQ).
None.
by William Toppen, Nam Yong Cho, Sohail Sareh, Anders Kjellberg, Anthony Medak, Peyman Benharash, Peter Lindholm
BackgroundThe role of hyperbaric oxygen therapy (HBOT) in necrotizing soft tissue infections (NSTI) is mainly based on small retrospective studies. A previous study using the 1998–2009 National Inpatient Sample (NIS) found HBOT to be associated with decreased mortality in NSTI. Given the argument of advancements in critical care, we aimed to investigate the continued role of HBOT in NSTI.
MethodsThe 2012–2020 National Inpatient Sample (NIS) was queried for NSTI admissions who received surgery. 60,481 patients between 2012–2020 were included, 600 ( Results
Age, gender, and comorbidities were similar between the two groups. On bivariate comparison, the HBOT group had lower mortality rate ( Conclusions
After correction for differences, HBOT was associated with decreased mortality, amputations, and non-home discharges in NSTI with the tradeoff of increase to costs and length of stay.
Frailty is a major geriatric syndrome that predicts increased vulnerability to minor stressor events and adverse outcomes such as falls, fractures, disability and death. The prevalence of frailty among individuals above the age of 65 varies widely with an overall weighted prevalence of 10.7%.
The purpose of this study was to examine the prevalence of prefrailty and frailty in community-dwelling older adults from the regions of Lolland-Falster, which is one of the most socioeconomically disadvantaged areas of Denmark with lower income and lower life expectancy compared with the general Danish population. Moreover, the objective was to find selected individual characteristics associated with frailty.
An observational, cross-sectional registry-based population study with data from the regions of Lolland-Falster collected between February 2016 and February 2020.
The study included 19 000 individuals. There were 10 154 above the age of 50 included for analysis. Prevalence of frailty in the age group of 50–64 years was 4.7% and 8.7% in the age group of 65 years and above.
The study demonstrates associations between frailty and high age, female gender, low education level, low income, smoking, living alone, frequency of seeing one’s children and getting help when needed. These associations are comparable with findings from other studies.
The syndrome of frailty consists of not only physiological and medical issues but also education, life conditions such as living alone and living in poverty and how you evaluate your own health.
Older adults constitute a heterogeneous group, and the focus of the individual physical exercise is often subject to the reasoning and experience of health professionals or exercise physiologists who prescribe them. Thus, this is the first effort to explicitly conceptualise the planning of individualised physical exercise training (
The concept of
Outpatient setting.
We included 115 older adults (70 females) from an outpatient setting with a median age of 74 years.
Health indicators assessing aerobic capacity, strength, balance and musculoskeletal pain/discomfort sites were collected and informed the concept of
We included 115 older adults (70 females) from an outpatient setting median age of 74 years. Approximately two-thirds of participants exceeded at least one health indicator cut-point for aerobic training. One-third of the participants exceeded the cut-point for upper extremity strength, and almost all participants >99% exceeded the cut-point for lower extremity strength. Approximately two-thirds of the participants exceeded the cut-point for functional/balance training. The most prevalent site of musculoskeletal pain was the lower extremities. Eight of 20 training combinations were used, clustering the 115 participants primarily in three main training combinations.
This study shows that older adults vary in physical functioning, indicating that exercise preferences and rehabilitation needs are individual.
This study aimed to identify factors related to changes in walking performance in individuals 3 months after a stroke or TIA.
Cross-sectional study with post hoc analysis of a randomised controlled study.
University Hospital, Sweden.
79 individuals, 64 (10) years, 37% women, who were acutely hospitalised because of stroke or TIA between November 2016 and December 2018. Inclusion criteria were patients aged 18 or above and the major eligibility criterion was the ability to perform the 6 min walking test.
The intervention group received standard care plus daily mobile phone text messages (short message service) with instructions to perform regular outdoor walking and functional leg exercises in combination with step counting and training diaries. The control group received standard care.
Multivariate analysis was performed and age, sex, group allocation, comorbidity, baseline 6 min walk test, body mass index (BMI), cognition and chair-stand tests were entered as possible determinants for changes in the 6 min walk test.
Multiple regression analyses showed that age (standardised beta –0.33, 95% CI –3.8 to –1.05, p
Post hoc regression analyses indicated that younger age, male sex, lower BMI and shorter 6 min walk test at baseline and possible no comorbidity contributed to improvement in walking performance at 3 months in patients with a recent stroke or TIA. These factors may be important when planning secondary prevention actions.
Traumatic shoulder dislocation is a common shoulder injury, especially among the young and active population. More than 95% of dislocations are anterior, in which the humeral head is forced beyond the anterior glenoid rim. The injury leads to increased joint laxity and recurrence rates are high. There is evidence that the shoulder biomechanics and neuromuscular control change following dislocation, but the existing literature is scarce, and it remains to be established if and how these parameters are useful in the clinical setting. The aim of this exploratory prospective cohort study is to investigate biomechanical and neuromuscular outcomes in patients with traumatic anterior shoulder instability undergoing arthroscopic Bankart repair, to test the hypothesis that examinations of these characteristics are applicable in the clinical setting to assess shoulder instability.
This is a prospective multicentre cohort study with repeated measures of 30 patients undergoing arthroscopic Bankart repair. With carefully selected and completely non-invasive examination methods, we will investigate biomechanical and neuromuscular outcomes in the affected shoulders once presurgically and twice post surgically at 6 and 12 months. Patients’ contralateral shoulders are investigated once to establish a preinjury level.
The study was approved by the Capital Region Ethics Committee (journal-no: H-21027799) and the Capital Region Knowledge Center for Data Reviews (journal-no: P-2021-842) before patient recruitment began. The study results will be published in international peer-reviewed journals, online and in other relevant media, presented at medical conventions and disseminated to clinicians and patients as appropriate.
The aim of this study was to examine population-based allostatic load (AL) indices as an indicator of community health across 14 municipalities in Denmark.
Register-based study.
Data derived from: the Lolland-Falster Health Study, the Copenhagen General Population Study and the Danish General Suburban Population Study. Nine biomarkers (systolic blood pressure, diastolic blood pressure, pulse rate, total serum cholesterol, high-density lipoprotein cholesterol, waist-to-hip ratio, triglycerides, C-reactive protein and serum albumin) were divided into high-risk and low-risk values based on clinically accepted criteria, and the AL index was defined as the average between the nine values. All-cause mortality data were obtained from Statistics Denmark.
We examined a total of 106 808 individuals aged 40–79 years.
Linear regression models were performed to investigate the association between mean AL index and cumulative mortality risk.
Mean AL index was higher in men (range 2.3–3.3) than in women (range 1.7–2.6). We found AL index to be strongly correlated with the cumulative mortality rate, correlation coefficient of 0.82. A unit increase in mean AL index corresponded to an increase in the cumulative mortality rate of 19% (95% CI 13% to 25%) for men, and 16% (95% CI 8% to 23%) for women but this difference was not statistically significant. The overall mean increase in cumulative mortality rate for both men and women was 17% (95% CI 14% to 20%).
Our findings indicate the population-based AL index to be a strong indicator of community health, and suggest identification of targets for reducing AL.
Patients with complex multimorbidity face a high treatment burden and frequently have low quality of life. General practice is the key organisational setting in terms of offering people with complex multimorbidity integrated, longitudinal, patient-centred care. This protocol describes a pragmatic cluster randomised controlled trial to evaluate the effectiveness of an adaptive, multifaceted intervention in general practice for patients with complex multimorbidity.
In this study, 250 recruited general practices will be randomly assigned 1:1 to either the intervention or control group. The eligible population are adult patients with two or more chronic conditions, at least one contact with secondary care within the last year, taking at least five repeat prescription drugs, living independently, who experience significant problems with their life and health due to their multimorbidity. During 2023 and 2024, intervention practices are financially incentivised to provide an extended consultation based on a patient-centred framework to eligible patients. Control practices continue care as usual. The primary outcome is need-based quality of life. Outcomes will be evaluated using linear and logistic regression models, with clustering considered. The analysis will be performed as intention to treat. In addition, a process evaluation will be carried out and reported elsewhere.
The trial will be conducted in compliance with the protocol, the Helsinki Declaration in its most recent form and good clinical practice recommendations, as well as the regulation for informed consent. The study was submitted to the Danish Capital Region Ethical Committee (ref: H-22041229). As defined by Section 2 of the Danish Act on Research Ethics in Research Projects, this project does not constitute a health research project but is considered a quality improvement project that does not require formal ethical approval. All results from the study (whether positive, negative or inconclusive) will be published in peer-reviewed journals.
To explore and describe older persons' unique experiences of care encounters with home care nurses in a real-life context.
The increasing number of older persons in society contributes to increases in age-related impairments compromising their quality of life. Future care consists of “hospitals at home” where care encounters occur in a person's private domain, partly becoming a clinical workplace. Scant research has focused on how older persons experience care encounters with home care nurses and needs to be highlighted.
Multiple-case study.
The cases relied on replication logic and five purposive sampled older persons were interviewed. Data were analysed using qualitative content analysis and differences within and between cases were explored and findings across the cases were replicated.
The cross-analysis emerged in three categories: “Nursing routine rules the care encounters”, “Lack of knowledge and information” and “Dependency on support from others”.
Our research has found that older persons face challenges while receiving home care, including limited engagement in their care and the need for enhanced support. Implementing person-centred care in homes poses ethical challenges that require careful consideration. Home care nurses should prioritise understanding each patient individually, recognising them beyond their patient role, which necessitates more thorough and time-sensitive care encounters.
Findings were reported using COREQ guidelines.
Patients were interviewed and contributed with data for this study.
This study emphasises the need to prioritise individualised care in home settings and listen to the voices of older individuals to enhance quality.
Atrial fibrillation (AF) is the most common arrhythmia and confers an increased risk of mortality, stroke, heart failure and cognitive decline. There is growing interest in AF screening; however, the most suitable population and device for AF detection remains to be elucidated. Here, we present the design of the CONSIDERING-AF (deteCtiON and Stroke preventIon by moDEl scRreenING for Atrial Fibrillation) study.
CONSIDERING-AF is a randomised, controlled, siteless, non-blinded diagnostic superiority trial with four parallel groups and a primary endpoint of identifying AF during a 6-month study period set in Region Halland, Sweden. In each group, 740 individuals aged≥65 years will be included. The primary objective is to compare the intervention of AF screening enrichment using a risk prediction model (RPM), followed by 14 days of a continuous ECG patch, with no intervention (standard care). Primary outcome is defined as the incident AF recorded in the Region Halland Information Database after 6 months as compared with standard care. Secondary endpoints include the difference in incident AF between groups enriched or not by the RPM, with and without an invitation to 14 days of continuous ECG recording, and the proportions of oral anticoagulation treatment in the four groups.
This study has ethical approval from the Swedish Ethical Review Authority. Results will be published in peer-reviewed international journals.
by Linnéa Hedman, Åsa Strinnholm, Sven-Arne Jansson, Anna Winberg
ObjectivesThe aim was to examine if a diagnostic intervention set up to assess current food allergy to cow’s milk, hen’s egg, fish, or wheat among teenagers had an impact on generic and disease specific health-related quality of life (HRQL). The study compared HRQL scoring before and two years after the intervention, and in relation to age matched controls without reported food allergy.
MethodsThe study was performed within the Obstructive Lung Disease in Northern Sweden (OLIN) studies where a cohort study on asthma and allergic diseases among 8-year-old schoolchildren was initiated in 2006. At age 12 years, the 125/2612 (5%) children who reported allergy to cow’s milk, hen’s egg, fish, or wheat were invited to a diagnostic intervention including clinical examination, blood tests and evaluation by a pediatric allergist. Of 94 participants, 79 completed generic and disease specific HRQL questionnaires. Additionally, a random sample of 200 (62% of invited) children without food allergy from the OLIN cohort answered the generic HRQL questionnaire. The respondents of the HRQL questionnaires were re-examined two years later and 57 teenagers with and 154 without reported allergy participated.
ResultsThere were no significant differences in generic HRQL scores between teenagers with and without reported food allergy at study entry, or after the intervention. Among those with reported food allergy, we found a significant improvement in disease specific HRQL after the intervention (mean values: 3.41 vs 2.80, p Conclusion
The diagnostic intervention showed a long-term improvement of disease specific HRQL but not generic HRQL.
by Linnéa Ekman, Lars B. Dahlin, Gert S. Andersson, Eero Lindholm
AimThe aim was to assess the use of multi-frequency vibrometry (MFV) in detecting diabetic peripheral neuropathy (DPN) in type 1 diabetes in comparison to nerve conduction studies (NCS) and neurothesiometer (NT). Our objectives were to examine how VPTs correlated with NCS parameters, evaluate the efficacy of MFV in distinguishing DPN as well as to investigate whether MFV procedure could be based on fewer frequencies.
MethodsAdults with type 1 diabetes with previous MFV examinations were recruited at Skåne University Hospital in Malmö, Sweden, between 2018 and 2020. Participants were examined regarding nerve function in the lower limbs through MFV, NT and NCS.
ResultsA total of 66 participants (28 women and 38 men) with a median age of 50 (39 to 64) years were included in the study. Through NCS assessment, 33 participants (50%) were diagnosed with DPN. We found negative correlations between VPTs and all NCS parameters, where the strongest correlation was found between sural nerve amplitude and the 125 Hz frequency of MFV. A combination of four frequencies, two low (4 and 8 Hz) and two high (125 and 250 Hz), showed the highest classification efficacy (AUC 0.83, 95% CI 0.73–0.93).
ConclusionWe conclude that a strong correlation exists between the sural nerve amplitude and the VPTs at 125 Hz and that VPT testing with MFV can be focused on only four frequencies instead of seven, thus shortening test time, to distinguish DPN in the lower limb.
It is well-known that the implementation of evidence into clinical practice is complex and challenging. The integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework conceptualizes successful implementation of evidence into practice. As the implementation of the mentoring programme proved to be a challenge, it seemed valuable to retrospectively study the implementation process using a framework like the i-PARIHS.
The aim of this study was to evaluate implementation of a multifaceted mentoring programme for bedside nurses using the i-PARIHS framework, to identify factors that influenced the implementation.
A secondary analysis of qualitative data using the i-PARIHS framework as the theoretical lens.
A directed content analysis was performed, driven theoretically by the i-PARIHS framework. The analysis focused separately on (a) characteristics of the innovation and (b) successful and hindering factors in the implementation process.
The results showed that successful factors influencing implementation of the mentoring programme included supportive and actively involved formal leaders and supervisors at the unit level. A major hindering factor was lack of resources in the form of personnel, time and money. A lack of facilitators, particularly experienced facilitators, throughout the organization hindered implementation. The i-PARIHS framework offered a structured how-to guide to identify factors that influenced the implementation process.
Implementation of the mentoring programme was a challenge for the organization. Investment into implementation should continue, with a more structured facilitation process. A structured and prioritized management system, including supportive leadership at the unit level, should be established by the hospital board.
There is a need for experienced facilitators throughout the organization. This is crucial to achieve sustainability in the mentoring programme and ensure that the large investments of staff resources and money do not fizzle out.
Implementing a mentoring programme for nurses in a large university hospital proved to be a challenge. Therefore, it seemed valuable to retrospectively study the implementation process using a framework like the i-PARIHS.
A lack of facilitators, particularly experienced facilitators, throughout the organization hindered the implementation. The i-PARIHS framework offered a structured how-to guide to identify factors that influenced the implementation process.
Our findings are important for leaders on all levels in a hospital setting, including the hospital board, heads of departments and nurse managers.
Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups is used.
No patient or public contribution.
by Jonas Sundén-Cullberg, Puran Chen, Henrike Häbel, Paul Skorup, Helena Janols, Johan Rasmuson, Katarina Niward, Åse Östholm Balkhed, Katerina Chatzidionysiou, Hilmir Asgeirsson, Ola Blennow, Åsa Parke, Anna-Karin Svensson, Jagadeeswara Rao Muvva, Hans-Gustav Ljunggren, Karolinska KI/K COVID-19 Treatment Working Group , Anna-Carin Horne, Ulrika Ådén, Jan-Inge Henter, Anders Sönnerborg, Jan Vesterbacka, Piotr Nowak, Jon Lampa
BackgroundAnakinra and tocilizumab are used for severe Covid-19, but only one previous randomized controlled trial (RCT) has studied both. We performed a multi-center RCT comparing anakinra or tocilizumab versus usual care (UC) for adults at high risk of deterioration.
MethodsThe study was conducted June 2020 to March 2021. Eligibility required ≥ 5 liters/minute of Oxygen to maintain peripheral oxygen saturation at ≥ 93%, CRP > 70 mg/L, ferritin > 500 μg/L and at least two points where one point was awarded for lymphocytes 9/L; D-dimer ≥ 0.5 mg/L and; lactate dehydrogenase ≥ 8 microkatal/L. Patients were randomly assigned 1:1:1 to receive either a single dose of tocilizumab (8 mg/kg) or anakinra 100 mg IV QID for seven days or UC alone. The primary outcome was time to recovery.
ResultsRecruitment was ended prematurely when tocilizumab became part of usual care. Out of a planned 195 patients, 77 had been randomized, 27 to UC, 28 to anakinra and 22 to tocilizumab. Median time to recovery was 15, 15 and 11 days. Rate ratio for recovery for UC vs anakinra was 0.91, 0.47 to 1.78, 95% [CI], p = 0.8 and for UC vs tocilizumab 1.13, 0.55 to 2.30; p = 0.7. There were non-significant trends favoring tocilizumab (and to limited degree anakinra) vs UC for some secondary outcomes. Safety profiles did not differ significantly.
ConclusionPremature closure of trial precludes firm conclusions. Anakinra or tocilizumab did not significantly shorten time to clinical recovery compared to usual care. (IMMCoVA, NCT04412291, EudraCT: 2020–00174824).
To engage children who have experienced cancer, childhood cancer survivors, their families and professionals to systematically identify and prioritise research questions about childhood cancer to inform the future research agenda.
James Lind Alliance Priority Setting Partnership.
UK health service and community.
A steering group oversaw the initiative. Potential research questions were collected in an online survey, then checked to ensure they were unanswered. Shortlisting via a second online survey identified the highest priority questions. A parallel process with children was undertaken. A final consensus workshop was held to determine the Top 10 priorities.
Children and survivors of childhood cancer, diagnosed before age 16, their families, friends and professionals who work with this population.
Four hundred and eighty-eight people submitted 1299 potential questions. These were refined into 108 unique questions; 4 were already answered and 3 were under active study, therefore, removed. Three hundred and twenty-seven respondents completed the shortlisting survey. Seventy-one children submitted questions in the children’s surveys, eight children attended a workshop to prioritise these questions. The Top 5 questions from children were taken to the final workshop where 23 questions in total were discussed by 25 participants (young adults, carers and professionals). The top priority was ‘can we find effective and kinder (less burdensome, more tolerable, with fewer short and long-term effects) treatments for children with cancer, including relapsed cancer?’
We have identified research priorities for children’s cancer from the perspectives of children, survivors, their families and the professionals who care for them. Questions reflect the breadth of the cancer experience, including diagnosis, relapse, hospital experience, support during/after treatment and the long-term impact of cancer. These should inform funding of future research as they are the questions that matter most to the people who could benefit from research.
The Finnish Retirement and Aging (FIREA) Study was set up to study changes in health behavioural and cardiometabolic risk factors across retirement transition, and to examine the long-term consequences of work and retirement on health and functioning with advancing age.
Public sector workers whose estimated statutory retirement date was in 2014–2019 were invited to participate by sending them a questionnaire 18 months prior to their estimated retirement date. In the first phase of the FIREA Study, participants were followed up with annual surveys, accelerometer and clinical measurements during retirement transition into post-retirement years. The FIREA survey cohort includes 6783 participants, of which 908 belong also to the activity substudy and 290 to the clinical substudy.
Collected data include survey measures about health, lifestyle factors, psychosocial distress, work-related factors as well as retirement intentions. Accelerometer and GPS devices are used to measure 24-hour movement behaviours. Clinical examination includes blood and hair sample, measurements of anthropometry, cardiovascular function, physical fitness, physical and cognitive function. Our results suggest that in general retirement transition seems to have beneficial influence on health behaviours as well as on physical and mental health, but there are large individual differences, and certain behaviours such as sedentariness tend to increase especially among those retiring from manual occupations.
The second phase of the FIREA Study will be conducted during 2023–2025, when participants are 70 years old. The FIREA Study welcomes research collaboration proposals that fall within the general aims of the project.
Gonadotropin-releasing hormone agonists (GnRHa) cotreatment used to transiently suppress ovarian function during chemotherapy to prevent ovarian damage and preserve female fertility is used globally but efficacy is debated. Most clinical studies investigating a beneficial effect of GnRHa cotreatment on ovarian function have been small, retrospective and uncontrolled. Unblinded randomised studies on women with breast cancer have suggested a beneficial effect, but results are mixed with lack of evidence of improvement in markers of ovarian reserve. Unblinded randomised studies of women with lymphoma have not shown any benefit regarding fertility markers after long-term follow-up and no placebo-controlled study has been conducted so far. The aim of this study is to investigate if administration of GnRHa during cancer treatment can preserve fertility in young female cancer patients in a double-blind, placebo-controlled clinical trial.
A prospective, randomised, double-blinded, placebo-controlled, phase III study including 300 subjects with breast cancer. In addition, 200 subjects with lymphoma, acute leukemias and sarcomas will be recruited. Women aged 14–42 will be randomised 1:1 to treatment with GnRHa (triptorelin) or placebo for the duration of their gonadotoxic chemotherapy. Follow-up until 5 years from end of treatment (EoT). The primary endpoint will be change in anti-Müllerian hormone (AMH) recovery at follow-up 12 months after EoT, relative to AMH levels at EoT, comparing the GnRHa group and the placebo group in women with breast cancer.
This study is designed in accordance with the principles of Good Clinical Practice (ICH-GCP E6 (R2)), local regulations (ie, European Directive 2001/20/EC) and the ethical principles of the Declaration of Helsinki. Within 6 months of study completion, the results will be analysed and the study results shall be reported in the EudraCT database.
The National Institutional review board in Sweden dnr:2021–03379, approval date 12 October 2021 (approved amendments 12 June 2022, dnr:2022-02924-02 and 13 December 2022, dnr:2022-05565-02). The Swedish Medical Product Agency 19 January 2022, Dnr:5.1-2021-98927 (approved amendment 4 February 2022). Manufacturing authorisation for authorised medicinal products approved 6 December 2021, Dnr:6.2.1-2020-079580. Stockholm Medical Biobank approved 22 June 2022, RBC dnr:202 253.
NCT05328258; EudraCT number:2020-004780-71.
FreshRSS 