Publications by authors named "John Brodersen"

153 Publications

Re: Hofmann et al. Overdiagnosis, one concept, three perspectives, and a model.

Eur J Epidemiol 2021 Jul 18. Epub 2021 Jul 18.

Section and Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark.

It is with great interest we have read the article "Overdiagnosis: one concept, three perspectives, and a model" by Hofmann and colleagues. We share the authors' ambition of understanding what overdiagnosis is and what it isn't. In our research, we define overdiagnosis on the basis of two interrelated phenomena: overdetection and overdefinition. Overdetection is the labelling of a person with a disease or abnormal condition, that would not have caused the person harm, e.g., symptoms or death, if left undiscovered. Overdefinition is the creation of new diagnoses by overmedicalising ordinary life experiences or expanding existing diagnoses by lowering thresholds or widening diagnostic criteria, without evidence of improved outcomes. These phenomena have different causes and thereby often different drivers. However, they have one important consequence in common: people are turned into patients unnecessarily, i.e., overdiagnosed. On a personal level, overdiagnosis cause various types of harms, including physical, psychological, social and financial harm. On a societal level, overdiagnosis may also cause harm to public health, cause resource waste, and cultural changes with overmedicalisation of normal life events. By definition, none of the aforementioned phenomena lead to any clinical benefit. Therefore, we disagree with Hofmann and colleagues' definition of overdiagnosis as diagnoses that "…on balance, do more harm than good.". We argue that introducing balance and benefits to the definition of overdiagnosis complicates the concept unnecessarily and cause problems operationalising overdiagnosis.
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http://dx.doi.org/10.1007/s10654-021-00773-1DOI Listing
July 2021

Validity of Current Assessment Tools Aiming to Measure the Affective Component of Pain: A Systematic Review.

Patient Relat Outcome Meas 2021 6;12:213-226. Epub 2021 Jul 6.

The Section of General Practice and Research Unit for General Practice in Copenhagen, Copenhagen, Denmark.

The objective of this study was to identify patient-reported outcome measures (PROMs), which aim to measure the affective component of pain and to assess their content validity, unidimensionality, measurement invariance, and Internal consistency in patients with chronic pain. The study was reported according to the PRISMA guidelines. A protocol of the review was submitted to PROSPERO before data extraction. Eligible studies were any type of study that investigated at least one of the domains: PROM development, content validity, dimensionality, internal consistency, or measurement invariance of any type of scale that claimed to measure the affective component of pain among patients with chronic pain. The databases Medline, Embase, PsycINFO, and the Cochrane Library were searched for eligible studies. The database search was supplemented by looking for relevant articles in the reference list of included studies, ie backtracking. All included studies were assessed independently by two authors according to the "COSMIN methodology on Systematic Reviews of Patient-Reported Outcome Measures". Descriptive data synthesis of the identified PROMs was conducted. The search yielded 11,242 titles of which 283 were assessed at the full-text level. Full-text screening led to the inclusion of 11 studies and an additional 28 studies were identified via backtracking, leading to the inclusion of 39 studies in total in the review. Included studies described the development and validity of 10 unique PROMs, all of which we assessed to have potentially inadequate content validity and doubtful psychometric properties. No studies reported whether the PROMs possessed invariant measurement properties. The existing PROMs measuring affective components of chronic pain potentially lack content validity and have inadequate psychometric measurement properties. There is a need for new PROMs measuring the affective component of chronic pain that possess high content validity and adequate psychometric measurement properties.
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http://dx.doi.org/10.2147/PROM.S304950DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8274708PMC
July 2021

Patients' experiences of the use of point-of-care ultrasound in general practice - a cross-sectional study.

BMC Fam Pract 2021 Jun 18;22(1):116. Epub 2021 Jun 18.

Center for General Practice, Aalborg University, Fyrkildevej 7, 13, 9220, Aalborg Øst, Denmark.

Background: The use of point-of-care ultrasonography (POCUS) performed by general practitioners (GPs) in primary care settings is increasing. Previous studies have focused on GP-reported outcomes and little is known about patients' perspectives on the use of POCUS technology within the general practice consultation. The purpose of this study was to examine patients' experiences with POCUS in general practice within the areas where GPs have indicated that POCUS affected aspects of the consultation.

Methods: A questionnaire was developed using a mixed methods sequential design. Analytical themes from interviews with GPs were converted into items in a questionnaire by the research team. The questionnaire was then further developed in several rounds of pilot tests involving both patients and GPs. The final questionnaire was used in a cohort study conducted in 18 Danish office-based general practice clinics from January 2018 to August 2018. All patients examined with POCUS were asked to complete the questionnaire on tablets immediately after their consultation.

Results: Out of 691 patients examined, 564 (81.6%) questionnaires were available for analysis. The patients reported that they were well informed about the purpose (98%) and the results (97%) of the POCUS examination; however, 29% reported that they were not informed about the difference between POCUS and an imaging-specialist's ultrasound examination. Almost all patients (99%) reported that POCUS was integrated naturally into the consultation, and 45% reported that POCUS improved the doctor-patient relationship. The majority of patients felt that they had been more thoroughly examined (92%) and taken more seriously (58%) when POCUS was part of the consultation. They felt POCUS gave them a better understanding of their health problem (82%), made them feel more secure (86%) and increased their trust in the physician's assessment (65%). Moreover, the patients reported that POCUS use improved the level of service (95%) they experienced and the quality of care (94%) in general practice.

Conclusion: We found that an examination including POCUS in general practice was a positive experience overall for the majority of patients. Future research should further explore reasons for patient confidence in POCUS and whether or not the reassuring value of POCUS is valid.

Trial Registration: ClinicalTrials.gov Identifier: NCT03416608.
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http://dx.doi.org/10.1186/s12875-021-01459-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8214303PMC
June 2021

Short and long-term psychosocial consequences of participating in a colorectal cancer screening programme: a matched longitudinal study.

BMJ Evid Based Med 2021 Jun 3. Epub 2021 Jun 3.

The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Kobenhavn, Denmark.

Objectives: To investigate the psychosocial consequences of receiving a false-positive (no abnormalities) result or being diagnosed with polyps compared with receiving a negative result in a colorectal cancer (CRC) screening programme.

Design And Setting: This was a longitudinal study nested in the roll-out of the Danish CRC screening programme that targets all individuals aged 50-74 years.

Participants: In the inclusion period (April-September 2017), all positive screenees (n=1854) were consecutively enrolled and matched 2:1:1 on sex, age (±2 years), municipality and screening date with negative screenees (n=933) and individuals not yet invited to screening (n=933).Questionnaires were sent by mail to all eligible participants in Region Zealand, Denmark, after the screening result, 2 months and 12 months after the final result.Positive screenees who did not receive the follow-up procedure were excluded.

Main Outcome Measures: The primary outcomes were psychosocial consequences. Outcomes were measured with the CRC screening-specific questionnaire Consequences of screening in CRC with 11 outcomes after the screening result and with 21 outcomes at the two later assessments.

Results: After receiving the screening result, individuals with no abnormalities, low-risk and medium-risk and high-risk polyps scored significantly worse on 8 of 11 outcomes compared with the negative screenee group. At the 12-month follow-up, the differences were still significant in 8 of 21 outcomes (no abnormalities), 4 of 21 outcomes (low-risk polyps) and 10 of 21 outcomes (medium-risk and high-risk polyps). The negative screenee group and the group not yet invited to screening differed psychosocially on 5 of 11 outcomes after the screening result, but on none of the 21 outcomes at the 2 months and 12 months follow-up.

Conclusions: The study showed that there are both short-term and long-term psychosocial consequences associated with receiving a no abnormalities result or being diagnosed with polyps. The consequences were worst for individuals diagnosed with medium-risk and high-risk polyps.
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http://dx.doi.org/10.1136/bmjebm-2020-111576DOI Listing
June 2021

Breaking potentially bad news of cancer workup to well-informed patients by telephone versus in-person: A randomised controlled trial on psychosocial consequences.

Eur J Cancer Care (Engl) 2021 May 14:e13435. Epub 2021 May 14.

The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen K, Denmark.

Background: The use of telephone in delivering cancer care increases, but not in cancer workup. Current protocols for breaking bad news assume a single in-person meeting. Cancer workup involves multiple opportunities for patient information. We investigated the psychosocial consequences in gradually informed patients of receiving lung cancer workup results by telephone versus in-person.

Methods: A randomised, controlled, open-label, assessor-blinded, single-centre trial including patients referred for invasive workup for suspected malignancy (clinical trials no. NCT04315207). Patients were informed on probable cancer at referral, after imaging, and on the day of invasive workup (Baseline visit). Primary endpoint: change (Δ) from baseline to follow-up (4 weeks after receiving workup results) in scores of a validated, sensitive, condition-specific questionnaire (COS-LC) assessing consequences on anxiety, behaviour, dejection and sleep.

Results: Of 492 eligible patients, we randomised 255 patients (mean age: 68 years; female: 38%; malignancy diagnosed: 68%) to the telephone (n = 129) or in-person (n = 126) group. Groups were comparable at baseline and follow-up, and no between-groups difference in ΔCOS-LC was observed in the intention-to-treat population, or in subgroups diagnosed with or without malignancy.

Conclusion: Breaking final result of cancer workup by telephone is not associated with adverse psychosocial consequences compared to in-person conversation in well-informed patients.
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http://dx.doi.org/10.1111/ecc.13435DOI Listing
May 2021

Psychosocial consequences of a three-month follow-up after receiving an abnormal lung cancer CT-screening result: A longitudinal survey.

Lung Cancer 2021 05 10;155:46-52. Epub 2021 Mar 10.

The Section and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark; The Primary Health Care Research Unit, Region Zealand, Denmark.

Background: Participation in lung cancer CT-screening can be associated with a need for follow-up procedures. The screening and waiting for test results introduce the risk of experiencing psychosocial consequences. Therefore, the aims of this study were: 1) To investigate if the psychosocial consequences changed from before an annual screening round to before a three-month follow-up CT-scan in participants with a positive screening result. 2) To investigate potential differences in psychosocial consequences between false positives (FP) and true positives (TP). FP were defined as those where cancer was not confirmed in the follow-up CT-scan and TP where it was.

Materials And Methods: This longitudinal study was based on data from the Danish Lung Cancer Screening Trial (DLCST). The Consequences of Screening - Lung cancer (COS-LC) questionnaire was used to measure psychosocial consequences among 130 participants who all received an abnormal CT-screening result at their annual screening round. Eligible participants completed the COS-LC before their annual CT-screening and before the three-month follow-up.

Results: We found a statistically significant increase in negative psychosocial consequences between the annual lung cancer CT-screening and the three-month follow-up CT-scan in four of nine psychosocial scales; Sense of dejection, Self-blame, Focus on airway symptoms and Harm of smoking. Furthermore, an increase, however not statistically significant, was identified in all remaining scales, except for the scale Stigmatisation which was slightly decreased. We found no evidence of an association between psychosocial consequences and diagnostic groups, FP and TP.

Conclusions: An increase in negative psychosocial consequences was observed between the annual lung cancer CT-screening and the three-month follow-up CT-scan. Since we found no statistically significant difference between the diagnostic groups, the increase in negative psychosocial consequences is interpreted as a nocebo effect of living three months in uncertainty not knowing if one's positive CT-screening result was true or false.
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http://dx.doi.org/10.1016/j.lungcan.2021.03.003DOI Listing
May 2021

Non-specific symptoms and signs of cancer: different organisations of a cancer patient pathway in Denmark.

Scand J Prim Health Care 2021 Mar 25;39(1):23-30. Epub 2021 Feb 25.

The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.

Objective: We aimed to investigate the Non-specific Symptoms and Signs of Cancer-Cancer Patient Pathway (NSSC-CPP) in order to describe organisational and clinical practice similarities and differences in the diagnostic work-up of suspected cancer in Denmark.

Material And Methods: A questionnaire on the organisation and practice pertaining to the NSSC-CPP was completed by all 21 diagnostic units in the five healthcare regions in Denmark.

Results: The questionnaire responses revealed regional and intraregional differences in the organisation and clinical practice of the NSSC-CPP. CT scan was the most often used imaging in the NSSC-CPP but there was no consensus whether the CT scan should be ordered and evaluated by general practitioners (GPs) or by the diagnostic units. Two regions were consistent but had different modalities regarding referrals from GPs. Three regions had intra-regional differences. The units reported on different types and frequency of forum for patient plan discussion and how to end a NSSC-CPP.

Conclusion: The NSSC-CPP is implemented with great regional and intra-regional differences in Denmark. GPs face different requirements when referring to the NSSC-CPP, which indicates that the division of role and responsibility between GPs and the diagnostic units is not well defined.KEY POINTSIn Denmark, the cancer patient pathway for non-specific symptoms and signs of cancer (NSSC-CPP) has been implemented with variations, but little is known about these different modalities. This study showed that both at a regional and an intra-regional level:•General practitioners meet different implementation of national guidelines in the diagnostic units when referring to the NSSCP-CPP•The suitable patient group for the NSSC-CPP is not well defined•Quality criteria are needed to monitor, evaluate and improve the diagnostic work-up for patients with non-specific symptoms and signs of cancer.
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http://dx.doi.org/10.1080/02813432.2021.1880094DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7971193PMC
March 2021

Psychosocial consequences of invitation to colorectal cancer screening: a matched cohort study.

J Epidemiol Community Health 2021 Feb 23. Epub 2021 Feb 23.

The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.

Background: Psychosocial consequences of colorectal cancer (CRC) screening can arise anywhere in the screening cascade. Previous studies have investigated the consequences of participating in CRC screening; however, we have not identified any studies investigating the psychosocial consequences of receiving the invitation. Therefore, the objective of this study was to investigate psychosocial consequences of invitation to CRC screening.

Methods: The study was a longitudinal study performed in Region Zealand, Denmark. Participants included in this study were a random sample of 1000 CRC screening invitees and 1000 control persons, not invited to screening, matched in a 1:1 design on sex, age and municipality. We assessed psychosocial consequences before and after invitation in both study groups concurrently. The primary outcomes were psychosocial consequences measured with the condition-specific questionnaire Consequences of Screening in ColoRectal Cancer.

Results: Preinvitation response rates were 575 (57.5%) and 610 (61.0%) for the invitation group and control group, respectively. Postinvitation response rates were 442 (44.2%) for the invitation group and 561 (56.1%) for the control group.No differences in mean change in scale score were seen except for the scale 'Change in body perception'. The invitation group had a 0.39 lower change (99% CI (-0.78 to -0.004), p=0.009) in mean score than the control group in the direction of a less negative body perception after invitation.

Conclusions: This study did not identify an association between invitation to CRC screening and negative psychosocial consequences.
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http://dx.doi.org/10.1136/jech-2019-213360DOI Listing
February 2021

Psychometric properties of a condition-specific PROM for the psychosocial consequences of Labelling hypertension by using Rasch analysis.

J Patient Rep Outcomes 2021 Feb 4;5(1):19. Epub 2021 Feb 4.

Department of Public Health, Section of General Practice and Research Unit for General Practice, University of Copenhagen, Øster Farimagsgade 5, building 24, P.O. Box 2099, 1014, Copenhagen K, Denmark.

Background: A previous qualitative assessment of the psychosocial consequences of labelling hypertension describes the diagnosis of hypertension as a labelling event with potential unintended negative long-term psychosocial consequences (labelling effects). Until now, the benefits of diagnosing hypertension have been far more reported than the harms. To obtain the net result of the preventive interventions for cardiovascular disease, such as diagnosing and treating mild hypertension, assessing benefits and harms in the most comprehensive way possible is necessary, including the psychosocial consequences of labelling. When measuring psychosocial consequences of labelling hypertension, a questionnaire with high content validity and adequate psychometric properties is needed.

Objectives: The aim of this study was to describe the psychometric parameters of face and content-validated pool of items. Other objectives were also to screen the item pool by using Rasch model analysis and confirmatory factor analysis (CFA) for identifying such items with sufficient fit to the hypothesised models.

Methods: We surveyed the pool of items as a draft questionnaire to Brazilians recruited via social networks, sending e-mails, WhatsApp® messages and posting on Facebook®. The inclusion criteria were to be older than 18 years old, to be healthy and to have only hypertension. We used Rasch model analysis to screen the item pool, discarding items that did not fit the hypothesised domain. We searched for local dependence and differential item functioning. We used CFA to confirm the derived measurement models and complementarily assessed reliability using Cronbach's coefficient alpha.

Results: The validation sample consisted of 798 respondents. All 798 respondents completed Part I, whereas 285 (35.7%)-those with hypertension-completed Part II. A condition-specific questionnaire with high content validity and adequate psychometric properties was developed for people labelled with hypertension. This measure is called 'Consequences of Labelling Hypertension Questionnaire' and covers the psychosocial consequences of labelling hypertension in two parts, encompassing a total of 71 items in 15 subscales and 11 single items.

Conclusion: We developed a tool that can be used in future research involving hypertension, especially in scenarios of screening, prevention, population strategies and in intervention studies. Future use and testing of the questionnaire may still be required.
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http://dx.doi.org/10.1186/s41687-021-00291-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7862460PMC
February 2021

A catalogue of PROMs in sports science: Quality assessment of PROM development and validation.

Scand J Med Sci Sports 2021 May 4;31(5):991-998. Epub 2021 Mar 4.

Section for Sports Traumatology M51, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

Choosing the most adequate PROM for a study is a non-trivial process. The aim of this study was to provide a catalogue with analyses of content and construct validity of PROMs relevant to research in sports science, including all published local translations. The most commonly used PROMs in sports research were selected from a PubMed search "patient reported outcome measures sports", identifying 439 articles and 194 different PROMs. Articles describing development of the 61 selected PROMs were assessed for content validity, and all articles regarding construct validity of each PROM and all published translations (in total 622 articles) were analyzed. A catalogue with assessments of the 61 PROMs was produced. The majority were of inferior validity, with few exceptions. The most common reason for this was that the PROM had not been developed by methods that ensure high content validity. Another major reason for inferior validity was that construct validity had not been secured by adequate statistical methods. In conclusion, this catalogue provides a tool for researchers to facilitate choosing the most valid PROM for studies in sports research. Furthermore, it shows for popular PROMs where further validation is needed, and for fields in musculoskeletal medicine where valid PROMs are lacking. It is suggested that a targeted effort is made to develop valid PROMs for major conditions in musculoskeletal research. The current method is easier to practice compared with assessment after COSMIN guidelines.
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http://dx.doi.org/10.1111/sms.13923DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8251933PMC
May 2021

Factors associated with a clinically relevant reduction in menopausal symptoms of a standardized acupuncture approach for women with bothersome menopausal symptoms.

BMC Complement Med Ther 2021 Jan 13;21(1):29. Epub 2021 Jan 13.

The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.

Background: Little is known about factors associated with a clinically relevant reduction in menopausal symptoms through a brief acupuncture approach for women with moderate-to-severe menopausal symptoms.

Methods: Post hoc analysis of a randomized controlled trial where participants were allocated to early versus late standardized acupuncture. Both the early group and the late group are included in this study. The late group got an identical intervention parallel staged by 6 weeks. By means of the relative importance, the effect was evaluated for both early versus late women with a 6-week follow-up. We included four symptom subscales from the validated MenoScores Questionnaire: hot flushes, day and night sweats, general sweating, menopausal-specific sleeping problems, as well as an overall score, which is the sum of the four outcomes in the analysis.

Results: 67 women with moderate to severe menopausal symptoms were included of whom 52 (77.6%) experienced a clinically relevant reduction in any of the four surveyed symptom subscales or overall score. 48 (71.6%) women experienced a clinically relevant reduction in any of the vasomotor symptom subscales: hot flushes, day and night sweats, general sweating. Women with vocational education were most likely to experience improvement compared to women with higher education. Beyond education, other factors of some importance for a clinically relevant reduction were no alcohol consumption, two or more births and urinary incontinence.

Conclusions: Level of education was the most consistent factor associated with improvement. Beyond education, other factors of some importance were no alcohol consumption, two or more births and urinary incontinence.

Trial Registration: This study was registered in ClinicalTrials.gov at April 21, 2016. The registration number is NCT02746497 .
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http://dx.doi.org/10.1186/s12906-021-03208-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7805030PMC
January 2021

Consequences of screening in colorectal cancer (COS-CRC): development and dimensionality of a questionnaire.

BMC Psychol 2021 Jan 7;9(1). Epub 2021 Jan 7.

The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Oester Farimagsgade 5, 1514, Copenhagen, Denmark.

Background: Harms of colorectal cancer (CRC) screening include psychosocial consequences. We have not identified studies using a participant-relevant questionnaire with adequate measurement properties to investigate these harms. However, Brodersen et al. have previously developed a core questionnaire consequences of screening (COS) for use in screening for life-threatening diseases. Therefore, the objectives were: (1) To investigate content validity of COS in a CRC screening setting and in case of gaps in content coverage (2) generate new items and themes and (3) test the possibly extended version of COS for dimensionality and differential item functioning (DIF) using Rasch Models.

Methods: We performed two-part-focus-groups with CRC screenees. Screenees were recruited by strategic sampling. In the first part 16 screenees with false-positive results (n = 7) and low-risk polyps (n = 9) were interviewed about their CRC screening experiences and in the second part COS was examined for content validity. When new information was developed in the focus groups, new items covering this topic were generated. Subsequently, new items were, together with COS, tested in the subsequent interviews. A random subsample (n = 410) from a longitudinal questionnaire study, not yet published, was used to form the data for this paper. We analysed multidimensionality and uniform DIF with Andersen's conditional likelihood ratio test. We assessed individual item fit to the model. We also analysed Local Dependence (LD) and DIF by partial gamma coefficients using Rasch Models.

Results: COS was found relevant in a CRC screening setting. However, new information was discovered in the focus groups, covered by 18 new CRC screening-specific items. The Rasch analyses only revealed minor problems in the COS-scales. The 18 new items were distributed on four new CRC screening-specific dimensions and one single item.

Conclusion: An extended version of COS specifically for use in a CRC screening setting has been developed. The extended part encompasses four new scales and one new single item. The original COS with the CRC-screening specific extension is called consequences of screening in colorectal cancer (COS-CRC). COS-CRC possessed reliability, unidimensionality and invariant measurement.
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http://dx.doi.org/10.1186/s40359-020-00504-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7792180PMC
January 2021

Choosing the most appropriate PROM for clinical studies in sports medicine.

Scand J Med Sci Sports 2021 Jun 12;31(6):1209-1215. Epub 2021 Jan 12.

Section for Sports Traumatology M51, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

Choosing the most appropriate patient-reported outcome measure (PROM) for a clinical study is essential in order to achieve trustworthy results. This choice will depend on (a) the objective of the study and hence the research question; (b) the choice of a theoretical framework, such as the World Health Organization's International Classification of Functioning, Disability, and Health (ICF); (c) whether there currently is a PROM that possesses high content validity and high construct validity for the specific patient group and objective, and if not; (d) the decision on whether to use a suboptimal PROM or develop and validate a new PROM. This paper presents the steps that should be followed in order to assess the relevance of PROMs and suggests ways to enhance the choice depending on the goal of the study.
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http://dx.doi.org/10.1111/sms.13906DOI Listing
June 2021

Psychometric validation of PROM instruments.

Scand J Med Sci Sports 2021 Jun 22;31(6):1225-1238. Epub 2021 Jan 22.

Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.

The aim was to provide an overview of the different statistical methods for validation of patient-reported outcome measures, ranging from simple statistical methods available in all software packages to advanced statistical models that require specialized software. A non-technical summary of classical test theory (CTT) and modern test theory (MTT) is provided. Specifically, confirmatory factor analysis, item response theory, and Rasch analysis is outlined. One CTT and three MTT methods were used to validate the two subscales (Symptoms and Quality of Life) from the Knee Injury and Osteoarthritis Outcome Score (KOOS). For each methodology, two analyses were considered: (i) a unidimensional analysis ignoring the pre-specified dimensionality, and (ii) a two-dimensional analysis using the pre-specified dimensionality. While CTT did not adequately address central issues regarding the validity of the KOOS subscales, the three MTT methods yielded very similar results. In conclusion, MTT methods offer analysis of all relevant properties related to the validity of patient-reported outcome measures, while this is not the case for CTT. Claims about sufficient validity based on CTT methods are inadequate and should not be trusted.
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http://dx.doi.org/10.1111/sms.13908DOI Listing
June 2021

'You should see a doctor', said the robot: Reflections on a digital diagnostic device in a pandemic age.

Scand J Public Health 2021 Feb 18;49(1):33-36. Epub 2020 Dec 18.

Department of Public Health, University of Copenhagen, Denmark.

Aims: In three days at the beginning of the COVID-19 pandemic, the Copenhagen Emergency Medical Services developed a digital diagnostic device. The purpose was to assess and triage potential COVID-19 symptoms and to reduce the number of calls to public health-care helplines. The device was used almost 150,000 times in a few weeks and was described by politicians and administrators as a solution and success. However, high usage cannot serve as the sole criterion of success. What might be adequate criteria? And should digital triage for citizens by default be considered low risk?

Methods: This paper reflects on the uncertain aspects of the performance, risks and issues of accountability pertaining to the digital diagnostic device in order to draw lessons for future improvements. The analysis is based on the principles of evidence-based medicine (EBM), the EU and US regulations of medical devices and the taxonomy of uncertainty in health care by Han et al.

Results: Lessons for future digital devices are (a) the need for clear criteria of success, (b) the importance of awareness of other severe diseases when triaging, (c) the priority of designing the device to collect data for evaluation and (d) clear allocation of responsibilities.

Conclusions: A device meant to substitute triage for citizens according to its own criteria of success should not by default be considered as low risk. In a pandemic age dependent on digitalisation, it is therefore important not to abandon the ethos of EBM, but instead to prepare the ground for new ways of building evidence of effect.
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http://dx.doi.org/10.1177/1403494820980268DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7859581PMC
February 2021

Are adequate PROMs used as outcomes in randomized controlled trials? an analysis of 54 trials.

Scand J Med Sci Sports 2021 May 3;31(5):972-981. Epub 2021 Jan 3.

Section for Sports Traumatology M51, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

Results by patient-reported outcome measures (PROMs) from randomized controlled trials (RCTs) in musculoskeletal research often influence healthcare strategies. We aimed to evaluate to which extent these RCTs use adequate PROMs, and how this influences the results and conclusions. We identified RCTs of sports research relevance with PROMs as primary outcomes published in 13 preselected journals between January 1, 2008, and November 1, 2019; all journals regularly publish results from musculoskeletal research. Five journals have a high impact factor (>15), and eight with lower impact factors are widely read journals. It was assessed whether the RCTs had used PROMs with high content validity and whether the most adequate PROMs were used (ie, the most well developed and well validated for the patients enrolled in the study). We registered journal impact factor, year of publication, existence of a registered protocol, and whether the study showed significant difference between interventions. A total of 54 RCTs with 56 primary outcomes comprising 26 different PROMs were identified. For 13 RCTs (24%), a protocol was not published. In only 24 of RCTs (44%), the most appropriate PROM had been used as primary outcome, independent of a registered protocol, ranking of the journal, and year of publication. In seven cases, PROMs were used to evaluate a condition that they had not been developed for. RCTs that used the most adequate PROM showed significantly more often (46%) difference in outcomes in contrast to RCTs that used inadequate PROMs (22%) (P = 0.0483). In conclusion, in the majority of RCTs, the most adequate PROM had not been used. Studies, in which the most adequate PROM had been used as outcome, were significantly more likely to show significant difference between interventions. The extent to which protocols were not available was surprisingly high. Journals should request that adequate PROMs are used in RCTs, and if this is not the case that it is discussed how it might influence the results and conclusions. Likewise, it should be requested that a protocol is published or registered.
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http://dx.doi.org/10.1111/sms.13896DOI Listing
May 2021

What is a PROM and why do we need it?

Scand J Med Sci Sports 2021 May 25;31(5):967-971. Epub 2020 Dec 25.

Section for Sports Traumatology M51, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

The purpose of this article was to introduce the reader to the nature of patient-reported outcome measures (PROMs) and pitfalls in their use. PROMs collect subjective information directly from the patient regarding specific or general conditions and add to clinical and functional outcomes, and turn unmeasurable subjective qualities into quantitative measures. PROMs are questionnaires consisting of items: questions or statements with predefined response options. The items in an adequate PROM have been developed by involvement of patients with the condition in focus, and the PROM has been validated for these patients using suitable statistical methods. An adequate well-targeted PROM is more responsive than an inadequate PROM. Unfortunately, many studies use inadequate PROMs as outcomes. The methods used to generate PROMs should be described as thoroughly as those used to develop any other types of measurement instruments, and the choice of PROM should always be explained and thereby justified. If the PROM used is not adequate, the consequences for the interpretation of the results should be discussed. In many cases, an adequate PROM does not exist. If the best available PROM is chosen, there are methods to validate the adequacy of the chosen PROM, which make an interpretation of the study results possible.
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http://dx.doi.org/10.1111/sms.13892DOI Listing
May 2021

Psychosocial consequences of potential overdiagnosis in prostate cancer a qualitative interview study.

Scand J Prim Health Care 2020 Dec 26;38(4):439-446. Epub 2020 Nov 26.

Department of Public Health, University of Copenhagen Faculty of Health Sciences, Section of General Practice & Research Unit for General Practice, Copenhagen, Denmark.

Background: Prostate cancer is a frequently diagnosed cancer and made up 6% of male cancer deaths globally in 2008. Its incidence varies more than 25-fold worldwide, which is primarily attributed to the implementation of the prostate-specific antigen (PSA) test in developed countries. To reduce harm of overdiagnosis, most international guidelines recommend surveillance programmes. However, this approach can entail negative psychosocial consequences from being under surveillance for an (over)diagnosed prostate cancer.

Aim: To explore men's feelings and experiences in a surveillance programme.

Design And Setting: Qualitative study with Danish men diagnosed with asymptomatic prostate cancer Gleason score ≤ 6, who are in a surveillance programme.

Methods: 12 semi-structured, individual interviews were conducted and analysed with systematic text condensation and selected theories.

Results: Most informants reported that they were astonished at the time of diagnosis. They were aware of the small likelihood of dying from cancer, but in some cases, the uncertainty created ambivalence between knowing and not knowing. The men expressed their risk awareness in different ways: a realization that life does not last forever, uncertainty towards the future, a feeling of powerlessness, and a need for control.

Conclusions: The men in this study had substantial psychosocial consequences from being labelled with a cancer diagnosis. Bearing these men's high risk of overdiagnosis in mind, it is important to discuss whether the harms of this diagnosis outweigh the benefits. The psychosocial consequences of being in a prostate cancer surveillance programme should be explored further. KEY POINTS Current awareness: The number of men living with an asymptomatic prostate cancer has increased the last 20 years after the implementation of the PSA test. Main Statements: Men living with an asymptomatic, low-risk prostate cancer experience negative psychocosial consequences GPs should consider the possible negative psychosocial consequences in their decision-making of measuring the PSA level.
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http://dx.doi.org/10.1080/02813432.2020.1843826DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7781953PMC
December 2020

Potential problems in the use of patient reported outcome measures (PROMs) and reporting of PROM data in sports science.

Scand J Med Sci Sports 2021 Jun 30;31(6):1249-1258. Epub 2020 Dec 30.

Section for Sports Traumatology M51, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

To use an inadequate patient reported outcome measure (PROM) or use a PROM in an inappropriate way potentially influences the quality of measurement. The objectives of this study were to define potential inadequate uses of PROMs in sports research studies and estimate how often they occur. A consensus group consisting of medical researchers, statisticians, and psychometricians identified and defined potentially irregular applications of PROMs. Occurrence of these in 349 consecutive articles in sports medicine in which PROMs were used as primary outcomes was reviewed. In all, 14 different potential problems were defined, and one or several occurred in 172 of the articles (49%). These were as follows: using a PROM that was developed for a different patient group (100 cases), using two or more PROMs with identical questions (94), aggregation of domain sum scores (82), combinations of subjective and objective measures (27), using a PROM to diagnose or evaluate the individual patient (7), using a PROM for a single limb (3), recall bias (3), exclusion of domains or items (3), construction of a PROM for a specific occasion (2), categorization of the scale (2), and mixing different versions of a PROM (1). Adaption of scale scores (e. g., to percentage) when results are reported (144) carries a risk of miscalculation and distorted impression of results. Data related to uncertainty about completing the PROM and the handling of missing data were not provided in the manuscripts. In conclusion, potential problems in the use and reporting of PROMs are common in sports research, and this can influence the validity of reported results.
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http://dx.doi.org/10.1111/sms.13888DOI Listing
June 2021

Are PROMs used adequately in sports research? An analysis of 54 randomized controlled trials with PROMs as endpoint.

Scand J Med Sci Sports 2021 May 14;31(5):982-990. Epub 2020 Dec 14.

Section for Sports Traumatology M51, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

Deviations from adequate use and reporting of PROMs may be problematic and misleading. The aim of this study was to investigate the extent of such problems in randomized clinical trials (RCTs). RCTs involving sports medicine research that used PROMs as primary outcomes were identified in 13 preselected journals. The articles were reviewed for nine potential problems related to how the PROM was used and how the data had been reported. The potential problems were as follows: aggregating subscale scores; combining patient-reported scores with physical, clinical, or para-clinical measures; using a PROM to diagnose or evaluate the individual patient; using a PROM for one leg or arm; selectively excluding domains or items; constructing a PROM for the specific occasion; mixing PROM formats (ie, digital, paper, telephone, e-mail, in person); ambiguous instructions for how the PROM should be completed; and recall bias. As covariates, we registered journal impact factor, year of publication, and existence of a registered protocol. In 29 (53.7%) of 54 identified RCTs, at least one potential problem was identified, the most common being aggregation of domain scores. This was not different with a published protocol or dependent on journal rankings, except for exclusion of domains, which was most common in high-ranking journals. Aggregation of domain scores was significantly less common in recently published articles compared with older articles (P = .03). Potential problematic use of PROMs and reporting of PROM data are common in RCTs, also in high-ranking journals, but less so in more recent articles.
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http://dx.doi.org/10.1111/sms.13880DOI Listing
May 2021

How to develop a condition-specific PROM.

Scand J Med Sci Sports 2021 Jun 22;31(6):1216-1224. Epub 2020 Nov 22.

Section for Sports Traumatology M51, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

Developing new patient-reported outcome measures (PROMs) for application in clinical studies can be necessary if an adequate PROM does not exist. For adequate measurement, it is essential that the PROM has face validity (ie, is perceived to be relevant by clinicians and researchers) and has high content validity (ie, content relevance and content coverage for the targeted patient group). The steps needed to create PROMs that possess face and content validity for a specific condition are described in this paper. Face validity is achieved by item identification and generation through literature review. Content validity is confirmed through repetitive cognitive interviews of patients from the targeted patient group in order to generate a consensus-based pilot-version of the new PROM. This qualitative process ensures that items are appropriately worded, understandable, and minimizes doubts about how items should be answered. A practical example of this process is presented, which shows the development of the Knee Numeric-Entity Evaluation Score (KNEES-ACL), a condition-specific PROM for patients with deficiency of the anterior cruciate ligament (ACL).
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http://dx.doi.org/10.1111/sms.13868DOI Listing
June 2021

User experiences on implementation of patient reported outcome measures (PROMs)in a Haematological outpatient clinic.

J Patient Rep Outcomes 2020 Oct 28;4(1):87. Epub 2020 Oct 28.

Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.

Background: PROMs can help healthcare professionals gain an improved understanding of patients' physical burdens, functional levels, and (health-related) quality of life throughout disease and medical treatment. The aim of this study was to investigate the barriers and potential opportunities PROMs may present in a haematological outpatient clinic from three different perspectives: patients, nurses and haematologists.

Methods: The present study synthesizes three previously published studies that separately explored the experiences of patients, nurses and haematologists when implementing PROMs. The studies were all guided by the qualitative methodology Interpretive Description, including a focused ethnographic approach, to develop implications for future practice.

Results: The overall themes that emerged from the analysis were "Structural similarities influence the adoption of PROMs" and "Different perspectives on the potential of PROMs."

Conclusion: Across the different user groups in the haematological outpatient clinic, the use of PROMs was thwarted due to an unquestioned commitment to biomedical knowledge and the system's rationality and norms: PROM data was not used in patient consultations. Nurses and haematologists expressed different preferences related to potential future PROMs and different objectives for PROMs in clinical practice. From the different perspectives of the patients, nurses and haematologists, PROMs were not compatible with clinical practice. Further research is recommended to develop PROMs validated for use in haematological outpatient clinics. Moreover, implementation strategies adjusted to the structural barriers of the system are crucial.
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http://dx.doi.org/10.1186/s41687-020-00256-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7593370PMC
October 2020

How to translate and locally adapt a PROM. Assessment of cross-cultural differential item functioning.

Scand J Med Sci Sports 2021 May 5;31(5):999-1008. Epub 2020 Nov 5.

Section for Sports Traumatology M51, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

Translating patient-reported outcome measures (PROMs) can alter the meaning of items and undermine the PROM's psychometric properties (quantified as cross-cultural differential item functioning [DIF]). The aim of this paper was to present the theoretical background for PROM translation, adaptation, and cross-cultural validation, and assess how PROMs used in sports medicine research have been translated and adapted. We also assessed DIF for the Knee Injury and Osteoarthritis Outcome Score (KOOS) across Danish, Norwegian, and Swedish versions. We conducted a search in PubMed and Scopus to identify the method of translation, adaptation, and validation of PROMs relevant to musculoskeletal research. Additionally, 150 preoperative KOOS questionnaires were obtained from the Scandinavian knee ligament reconstruction registries, and cross-cultural DIF was evaluated using confirmatory factor analysis and Rasch analysis. There were 392 studies identified, describing the translation of 61 PROMs. Ninety-four percent were performed with forward-backward technique. Forty-nine percent used cognitive interviews to ensure appropriate wording, understandability, and adaptation to the target culture. Only two percent were validated according to modern test theory. No study assessed cross-cultural DIF. One KOOS subscale showed no cross-cultural DIF, two had DIF with respect to some (but not all) items, and thus conversion tables could be constructed, and two KOOS subscales could not be pooled. Most PROM translations are of undocumented quality, despite the common conclusion that they are valid and reliable. Scores from three of five KOOS subscales can be pooled across the Danish, Norwegian, and Swedish versions, but two of these must be adjusted for DIF.
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http://dx.doi.org/10.1111/sms.13854DOI Listing
May 2021

Responsiveness, minimal important difference, minimal relevant difference, and optimal number of patients for a study.

Scand J Med Sci Sports 2021 Jun 5;31(6):1239-1248. Epub 2020 Nov 5.

Section for Sports Traumatology M51, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

Several terms are used to describe changes in PROM scores in relation to treatments. Whether the change is small, large, or relevant is defined in different ways, yet these change scores are used to recommend or oppose treatments. They are also used to calculate the necessary number of patients for a study. This article offers a theoretical explanation behind the terms responsiveness, minimal important difference (MID), minimal important change (MIC), minimal relevant difference (MIREDIF), and threshold of clinical importance. It also gives instructions on how these and the optimal number of patients for a study are calculated. Responses to two domains of the Knee Injury and Osteoarthritis Outcome Score (KOOS), before and 1 year after reconstruction of the anterior cruciate ligament of 164 patients, are used to illustrate the calculations. This paper presents the most common methods used to calculate and interpret MID. Results vary substantially across domains, patient location on the scale, and health conditions. The optimal number of patients depends on the minimal relevant difference (MIREDIF), the standard error of the measure (SEM), the desired statistical power for the measurement, and the responsiveness of the measurement instrument (the PROM). There is often uncertainty surrounding the calculation and interpretation of responsiveness, MID, and MIREDIF, as these concepts are complex. When MID is used to evaluate research results, authors should specify how the MID was calculated, and its relevance for the study population. These measures should only be used after thorough consideration to justify healthcare decisions.
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http://dx.doi.org/10.1111/sms.13855DOI Listing
June 2021

Use and impact of point-of-care ultrasonography in general practice: a prospective observational study.

BMJ Open 2020 09 17;10(9):e037664. Epub 2020 Sep 17.

Center for General Practice, Aalborg University, Aalborg, Denmark.

Objectives: To describe how general practitioners (GPs) use point-of-care ultrasonography (POCUS) and how it influences the diagnostic process and treatment of patients.

Design: Prospective observational study using an online questionnaire before and after POCUS.

Setting: Office-based general practice.

Participants: Twenty GPs consecutively recruited all patients examined with POCUS in 1 month.

Primary And Secondary Outcome Measures: We estimated the use of POCUS through the indication for use, the frequency of use, the time consumption, the extent of modification of the examination and the findings.The influence on the diagnostic process was estimated through change in the tentative diagnoses, change in confidence, the ability to produce ultrasound images and the relationship between confidence and organs scanned or tentative diagnoses.The influence of POCUS on patient treatment was estimated through change in plan for the patient, change in patient's treatment and the relationship between such changes and certain findings.

Results: The GPs included 574 patients in the study. POCUS was used in patient consultations with a median frequency of 8.6% (IQR: 4.9-12.6). Many different organs were scanned covering more than 100 different tentative diagnoses. The median time taken to perform POCUS was 5 min (IQR: 3-8). Across applications and GPs, POCUS entailed a change in diagnoses in 49.4% of patients; increased confidence in a diagnosis in 89.2% of patients; a change in the management plan for 50.9% of patients including an absolute reduction in intended referrals to secondary care from 49.2% to 25.6%; and a change in treatment for 26.5% of patients.

Conclusions: The clinical utilisation of POCUS was highly variable among the GPs included in this study in terms of the indication for performing POCUS, examined scanning modalities and frequency of use. Overall, using POCUS altered the GPs' diagnostic process and clinical decision-making in nearly three out of four consultations.

Trial Registration Number: NCT03375333.
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http://dx.doi.org/10.1136/bmjopen-2020-037664DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7500300PMC
September 2020

Categories of systematic influences applied to increase cancer screening participation: a literature review and analysis.

Eur J Public Health 2021 02;31(1):200-206

The Research Unit for General Practice, Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen K, Denmark.

Background: Health authorities can influence citizens in subtle ways that render them more likely to participate in cancer screening programmes, and thereby possibly increase the beneficial effects. If the influences become too severe, the citizens' ability to make a personal choice may be lost on the way. The purpose of this analysis was to identify and categorize the influences while questioning whether they still permit the citizens to make their own choices regarding participation.

Methods: A two-stringed approach was used to obtain empirical examples of systematic influences that aim to raise participation rates in cancer screening programmes: First, a systematic literature search was conducted on three databases. Second, relevant experts were contacted via internationally based e-mail lists and asked for examples of systematic influences in cancer screening. The present analysis was based on direct, conventional content analysis to address different categories of systematic influences.

Results: The literature search yielded 19 included articles and the expert inquiry yielded 11 empirical examples of which content analysis of the empirical examples generated six major categories of systematic influence: (i) misleading presentation of statistics, (ii) misrepresentation of harms vs. benefits, (iii) opt-out systems, (iv) recommendation of participation, (v) fear appeals and (vi) influencing the general practitioners and other healthcare professionals.

Conclusion: The six categories of identified influences work through psychological biases and personal costs and are still in widely use. The use of these types of influence remains ethically questionable in cancer screening programmes since they might compromise informed decision making.
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http://dx.doi.org/10.1093/eurpub/ckaa158DOI Listing
February 2021

Sustained effects of a brief and standardised acupuncture approach on menopausal symptoms: post hoc analysis of the ACOM randomised controlled trial.

Acupunct Med 2020 12 9;38(6):396-406. Epub 2020 Jun 9.

The Research Unit for General Practice, Department of Public Health, University of Southern Denmark, Copenhagen, Denmark.

Background: Our objective was to investigate whether the effect of a brief and standardised acupuncture approach persists after the end of the acupuncture treatment (post-treatment effect) and whether the anticipation of future acupuncture treatment affects menopausal symptoms (pre-treatment effect).

Method: This study is a post hoc analysis of data from a randomised controlled trial where women with moderate to severe menopausal symptoms were offered weekly acupuncture treatment over five consecutive weeks and randomised (1:1) to an early intervention group that received treatment immediately and a late intervention group with a 6-week delay. The acupuncture style was Western medical, administered at CV3, CV4 and bilateral LR8, SP6 and SP9. Acupuncturists were general practitioners. The effect was evaluated repeatedly during and after the interventions using scales from the validated MenoScores Questionnaire (MSQ) for hot flushes (HF), day and night sweats (DNS), general sweating (GS) and menopausal-specific sleeping problems (MSSP) with a 26-week follow-up period (corresponding to 21 or 15 weeks post-treatment for the early and late intervention groups, respectively). Multivariable linear mixed models were used to analyse the extent and duration of effects.

Results: Seventy participants were included in the study. Four participants dropped out. Furthermore, one participant was excluded from the short- and long-term follow-up analyses after the insertion of a hormonal intrauterine device, and nine participants were excluded from the long-term follow-up analysis due to the initiation of co-interventions. For each of the four outcomes, the effect was sustained up to 21 weeks post-treatment with an effect size that was only slightly diminished. A small, but significant, pre-treatment effect was observed in the HF scale scores. The same trend, although not significant, was observed in the DNS and MSSP scale scores. No serious harms were reported.

Conclusion: This study demonstrated that the overall effect of a brief and standardised acupuncture treatment on menopause-relevant outcomes was sustained up to 21 weeks post-treatment and that there was a small pre-treatment effect.
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http://dx.doi.org/10.1177/0964528420920280DOI Listing
December 2020

Psychosocial consequences of false positives in the Danish Lung Cancer CT Screening Trial: a nested matched cohort study.

BMJ Open 2020 06 4;10(6):e034682. Epub 2020 Jun 4.

The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.

Objectives: Lung cancer CT screening can reduce lung cancer mortality, but high false-positive rates may cause adverse psychosocial consequences. The aim was to analyse the psychosocial consequences of false-positive lung cancer CT screening using the lung cancer screening-specific questionnaire, Consequences of Screening in Lung Cancer (COS-LC).

Design And Setting: This study was a matched cohort study, nested in the randomised Danish Lung Cancer Screening Trial (DLCST).

Participants: Our study included all 130 participants in the DLCST with positive CT results in screening rounds 2-5, who had completed the COS-LC questionnaire. Participants were split into a true-positive and a false-positive group and were then matched 1:2 with a control group (n=248) on sex, age (±3 years) and the time of screening for the positive CT groups or clinic visit for the control group. The true positives and false positives were also matched 1:2 with participants with negative CT screening results (n=252).

Primary Outcomes: Primary outcomes were psychosocial consequences measured at five time points.

Results: False positives experienced significantly more negative psychosocial consequences in seven outcomes at 1 week and in three outcomes at 1 month compared with the control group and the true-negative group (mean ∆ score >0 and p<0.001). True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group. No long-term psychosocial consequences were identified either in false positives or true positives.

Conclusions: Receiving a false-positive result in lung cancer screening was associated with negative short-term psychosocial consequences. These findings contribute to the evidence on harms of screening and should be taken into account when considering implementation of lung cancer screening programmes.

Trial Registration Number: NCT00496977.
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http://dx.doi.org/10.1136/bmjopen-2019-034682DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7279658PMC
June 2020