Jens Gaab’s research while affiliated with University of Basel and other places

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Publications (225)


A dose of doubt: a qualitative study on placebo regulations
  • Article
  • Full-text available

June 2025

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1 Read

Mélina Richard

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Manuela Ganz

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Bernice S. Elger

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Jens Gaab

Introduction Placebo use is common in primary care, yet ethical and legal concerns persist, and few qualitative studies have explored physicians’ views on placebo regulation. Methods We conducted semi-structured interviews with 10 primary care physicians from 2 German-speaking Swiss cantons to explore their definitions of placebos, usage in clinical practice, knowledge of existing regulations, and attitudes toward potential regulatory frameworks. Participants were recruited from a publicly available physician registry, yielding a 4.9% response rate. Results Participants consistently reported using at least impure placebos in their practice, while references to the use of pure placebos were relatively uncommon. A distinction between pure and impure placebos emerged, with the latter generally viewed as more ethically acceptable. Risk-benefit evaluation was emphasized as the primary justification for placebo use. Most participants had not actively sought legal information, and knowledge about current regulations varied considerably. While clear support for specific regulation was rare, most participants did not perceive it as necessary, often citing distrust in regulatory systems or concerns that formal rules could restrict therapeutic flexibility. Expert bodies such as the Swiss Medical Association were mentioned as potential sources of guidance. Discussion The findings highlight a practice-oriented, risk-benefit-driven approach to placebo use, shaped by skepticism toward regulation and limited legal awareness. Despite frequent use, physicians operate in a legally ambiguous space and express limited demand for regulatory clarity, suggesting a need for targeted professional discourse rather than strict formal regulation.

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Expatriation stressors and the well-being of accompanying partners: a commonality analysis approach

Introduction This cross-sectional study aims to explore the unique and shared effects of non-work expatriation stressors on the well-being of expatriate partners and spouses who relocate on a regular basis. Methods A cohort of 207 internationally mobile adults was recruited through international associations, foreign ministries, social media, and personal networks. Participants completed a quantitative online questionnaire that assessed various psychological factors. We employed commonality analysis to evaluate the unique and joint impact of perceived stress, perceived social support, isolation, and perceived cultural distance on partner well-being, using validated psychological scales. Results Perceived stress proved to be the most impactful unique contributor to partner well-being, while isolation emerged as the second strongest unique predictor. Perceived social support showed the most substantial combined effect with stress and isolation. The variance explained by perceived cultural distance was marginal, suggesting that stress and isolation are more influential factors in this population. The control variables (age, gender, duration of residence in the host country, and frequency of relocation) showed no significant contribution in combination with the stressors. Discussion Building on the findings of existing research, these results provide further support for the need for tailored interventions to promote the well-being of expatriate partners. Practical implications include involving partners in pre-assignment screening processes, investing in structured social support systems to reduce isolation, and developing comprehensive, culturally sensitive policies that address the range of challenges faced by expatriate partners.


PRISMA flowchart overview.
A systematic qualitative review of ethical issues in open label placebo in published research

Open-label placebos (OLPs), which are transparently administered inert treatments, have gained increasing attention in the research community. They have the potential to harness placebo effects without deceiving the patient. The purpose of this study was to examine and synthesize prior research discussing ethical issues in OLPs. A systematic qualitative literature review was conducted (last search on January 2023) across multiple databases (e.g., MEDLINE, Embase, PsycInfo) using keywords related to OLPs. Publications were screened and assessed for eligibility. Seventeen articles explicitly addressing OLP ethics were included. Data were extracted and thematically analyzed following established qualitative content analysis procedures. 37 distinct ethical issues were identified, grouped into five overarching themes: (1) Sociocultural and Contextual Factors, (2) Implementation and Logistics, (3) Informed Consent, (4) Patient Health Behavior and Dynamics, and (5) Therapeutic Relationship. Frequently mentioned concerns focused on uncertainty of OLP efficacy, the need for further research, and complexities of dose-extending OLPs. The effective integration of OLPs into healthcare necessitates thoughtful consideration and responsible communication. This analysis shows that demonstrating the efficacy of OLPs becomes pivotal for their widespread adoption, underscoring the necessity for additional research to validate their effectiveness. This review was pre-registered on January 26th, 2023, in the Open Science Framework Registry under the identifier: DOI https://doi.org/10.17605/OSF.IO/R6NKG.


Figure 1 CONSORT flow diagram. CONSORT, Consolidated Standards of Reporting Trials.
Figure 2 Study design overview. MC, menstrual cycle; PMS, premenstrual syndrome.
Figure 3 Observed reduction in PMS symptom intensity (A) and interference (B). OLP−, open label placebo without rationale; OLP+, open label placebo with rationale; PMS, premenstrual syndrome; TAU, treatment as usual.
Baseline sociodemographic and PMS-related characteristics of participants
Efficacy of open-label placebos for premenstrual syndrome: a randomised controlled trial

March 2025

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58 Reads

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1 Citation

BMJ evidence-based medicine

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Jens Gaab

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Bojana Degen

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[...]

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Objective To investigate the efficacy and safety of open-label placebos (OLP) in premenstrual syndrome (PMS). Design Randomised controlled trial. Setting Switzerland, 2018–2020. Participants 150 women (18–45 years of age) with PMS or premenstrual dysphoric disorder. Intervention Random assignment (1:1:1) to treatment as usual (TAU), OLP without treatment rationale (OLP–), or OLP with treatment rationale (OLP+). OLP consisted of two placebo pills per day for 6 weeks. Main outcome measures Primary outcomes were PMS symptom intensity and interference between groups across three menstrual cycles (MC1–MC3); adverse events (ie, safety) were measured at weeks 3 and 6 after the start of the intervention. Secondary outcomes were psychological and somatic subscales of PMS symptom intensity, and adherence. Results From 2 August 2018 to 3 December 2020, 150 women were randomly allocated to TAU (n=50), OLP– (n=50), and OLP+ (n=50), of whom 145 (96.7%) completed trial participation. Groups differed in symptom intensity (F(4)=4.419, p=0.002, r ² =0.16) and interference (F(4)=3.159, p=0.014, r ² =0.13) across three MCs. Mean symptom intensity at MC3 was lower for OLP+ compared to TAU (b=–9.97, SE=2.85, t(412)=3.50, p<0.001, d=0.90) and to OLP– (b=–6.10, SE=2.89, t(411)=2.11, p=0.036, d=0.55), but OLP– and TAU did not differ (b=–3.87, SE=2.87, t(411)=1.35, p=0.177, d=0.35). Mean interference at MC3 was lower for OLP+ compared to TAU (b=–1.23, SE=0.54, t(443)=2.30, p=0.022, d=0.55) and to OLP– (b=–1.10, SE=0.54, t(442)=2.02, p=0.044, d=0.48), but OLP– and TAU did not differ (b=–0.14, SE=0.54, t(442)=0.26, p=0.799, d=0.06). Four non-serious adverse events were reported in OLP– (n=1) and OLP+ (n=3). Improvement in psychological and somatic symptom intensity was comparable to primary outcomes. Adherence to the OLP intervention was high (93.18±18.95%), with no difference between groups. Conclusions The results of our clinical trial indicate that OLP provided with a treatment rationale is an effective, safe, and acceptable treatment for PMS. Trial registration ClinicalTrials.gov NCT03547661 (submitted 2 May 2018).


Generative AI in Primary Care: A qualitative study of UK General Practitioners’ Views (Preprint)

March 2025

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7 Reads

BACKGROUND The potential for generative AI (GenAI) to assist with clinical tasks is the subject of ongoing debate within biomedical informatics and related fields. OBJECTIVE This study aimed to explore general practitioners’ (GPs’) opinions about GenAI on primary care. METHODS In January 2025, we conducted a Web-based survey of 1005 UK GPs’ experiences and opinions of GenAI in clinical practice. This study involved a qualitative descriptive analysis of a written response (“comments”) to an open-ended question in the survey. RESULTS Comments were classified into 3 major themes and 8 subthemes in relation to GenAI in clinical practice. The major themes were: (1) unfamiliarity, (2) ambivalence and anxiety, and (3) role in clinical tasks. ‘Unfamiliarity’ encompassed lack of experience and knowledge, and the need for training on GenAI. ‘Ambivalence and anxiety’ included mixed expectations among GPs in relation to these tools, beliefs about diminished human connection, and skepticism about AI accountability. Finally, commenting on the role of GenAI in clinical tasks, GPs believed it would help with documentation. However, respondents questioned AI’s clinical judgment and raised concerns about operational uncertainty concerning these tools. CONCLUSIONS This study provides timely insights into GPs’ perspectives on the role, impact, and limitations of GenAI in primary care. A majority reported limited experience and training with these tools; however, many GPs perceived potential benefits of GenAI and ambient AI for documentation. Notably, two years after the widespread introduction of GenAI, GPs’ persistent lack of understanding and training remains a critical concern. More extensive qualitative work would provide a more in-depth understanding of GPs’ views.


Open-labelplacebofornon-specific pain in the emergency department (OLP EM): study protocol for a mixed-method randomised control feasibility study in Switzerland

March 2025

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6 Reads

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1 Citation

BMJ Open

Introduction: Non-specific pain (NSP), defined as pain without a clear pathological cause, is a common presentation in the emergency department (ED). There is no universally accepted analgesic strategy, but non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen are often prescribed. However, the established efficacy of NSAIDs for NSP is limited. Additionally, NSAIDs are associated with an increased risk of upper gastrointestinal bleeding, acute kidney injury and cardiovascular events, such as myocardial infarction and stroke. There is increasing evidence supporting the analgesic effects of open-label placebo (OLP), defined as placebo administered to patients without deception, in a broad variety of settings. Accordingly, OLP could be a safer, effective analgesic treatment option for NSP. To our knowledge, this is the first study investigating the feasibility of OLP for NSP in the ED. Therefore, our primary objective is to assess whether OLP is a feasible treatment option in this setting. Methods and analysis: Patients diagnosed with acute NSP will be prospectively recruited at discharge in the ED at the University Hospital of Basel, Switzerland. Patients treated with pain medication for >7 days prior to ED visit or with chronic pain will be excluded. Patients will be randomised to receive either OLP (intervention) or ibuprofen (control). Rescue medication will be ibuprofen in both groups. Daily online self-assessment will take place during the first 7 days after the baseline visit as well as on day 30. A qualitative interview will be conducted on day 30. The primary outcome is feasibility, consisting of acceptability, adherence to the protocol and patient satisfaction. Clinical outcomes will focus on pain intensity and interference according to the Brief Pain Inventory Short Form as well as adverse events. Ethics and dissemination: The study protocol has received approval from the ethics committee for Northwestern and central Switzerland (EKNZ; project ID 2024-00089). The results will be disseminated in peer-reviewed journals and at scientific conferences. Trial registration number: Swiss National Clinical Trials Portal (SNCTP000005852); Clinicaltrial.gov (NCT06408519). Keywords: ACCIDENT & EMERGENCY MEDICINE; Feasibility Studies; PAIN MANAGEMENT.


Flowchart of the search process on PubMed for articles on legal aspects with placebo.
Flowchart of the search process on PubMed for articles on ethical aspects with placebo.
Flowchart of the search strategy for legal regulations, codes of conduct, and guidelines.
Noble Humbug? Hard and soft laws on clinical placebo use

March 2025

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10 Reads

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1 Citation

Despite the widespread historical and contemporary use of placebos in medicine, legal regulations addressing their administration remain limited in many countries. This paper examines the legal landscape of clinical placebo use, focusing on key jurisdictions such as France, Germany, Switzerland, the United Kingdom, and the United States. Given the ethical and legal complexities surrounding placebo use, a critical assessment of existing regulatory frameworks is essential. This study employs a multidisciplinary approach, analyzing both binding laws (“hard laws”) and non-binding principles (“soft laws”) related to placebo administration. Data were collected from legal statutes, health institution guidelines, and professional medical codes to map the regulatory environment governing placebos in different legal systems. The results indicate significant variations in how placebos are addressed legally. For instance in Germany and the UK, no specific laws regulate placebo use, but statutes on informed consent implicitly cover their administration. In the United States, the American Medical Association provides ethical guidelines permitting placebo use under strict conditions emphasizing patient welfare and transparency. Across all examined jurisdictions, unauthorized placebo use may lead to legal consequences such as medical fraud allegations or violations of patient rights. These findings highlight the need for explicit regulatory guidelines to ensure that placebo use adheres to ethical and legal standards. The growing acceptance of open-label placebos (OLPs), which demonstrate efficacy without deception, presents a potential avenue for aligning legal frameworks with evolving medical practices. Future regulatory developments should address the ethical and legal challenges associated with placebos, ensuring patient autonomy and informed consent remain central to their use in clinical practice.


Region of GPs' Practice. Sample (n = 1,005)
General Practitioners’ Experiences with Generative Artificial Intelligence in the UK: An Online Survey

March 2025

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37 Reads

Background Following the launch of ChatGPT in November 2022, interest in large language model-powered chatbots has soared with increasing focus on the clinical potential of these tools. Building on a previous survey conducted in 2024, we sought to gauge general practitioners’ (GPs) adoption of this new generation of chatbots to assist with any aspect of clinical practice in the UK. Methods An online survey was disseminated in January 2025 to a non-probability sample of GPs registered with the clinician marketing platform Doctors.net.uk. The research was conducted as part of a scheduled monthly 'omnibus survey,' designed to achieve a fixed sample size of 1,000 participants. Results Of the 1,005 respondents, 50% respondents were men, 54% were 46 years or older. 25% reported using generative artificial intelligence (GenAI) tools in clinical practice; of these, 35% reported using these tools to generate documentation after patient appointments, 27% to suggest a differential diagnosis, 24 % for treatment options, and 24% for referrals. Of the 249 GPs who used generative AI for clinical tasks, 71% said that in general these tools reduced work burdens. In the last 12 months, 85% reported that their employer had not encouraged them to use GenAI tools, but only 3% said their employer had prohibited them from using GenAI tools in their work; 95% reported they had no professional training in using GenAI tools in their work. Conclusions This survey suggests that doctors’ use of GenAI in clinical practice may be growing in the UK. Findings suggest that UK GPs may benefit from these tools, especially for administrative tasks and clinical reasoning support, and after adopting them, most users reported a decrease in work burdens. Continued absence of reported training remains a concern.


Pain induces a rapid characteristic metabolic signature detectable in breath

February 2025

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19 Reads

The objectification of pain presents a significant clinical challenge, particularly in children, elderly individuals, patients with disabilities and unconscious patients. It is critically important to accurately assess pain in these populations due to the heightened risk of undertreatment. Using the cold pressor test (CPT) as a pain induction model, we combined real-time breath metabolomics with pathway analysis to uncover metabolic shifts. Exhaled breath was analyzed in a discovery cohort (n=19) and validated in an independent cohort (n=21) using secondary electrospray ionization-high-resolution mass spectrometry (SESI-HRMS). Within 15 minutes of CPT, over 400 conserved mass spectral features were significantly altered across both cohorts. Pathway analysis highlighted shifts in aminoacyl-tRNA biosynthesis, cysteine/methionine metabolism, butanoate metabolism, and arginine/proline metabolism. Arginine and glutamate, key contributors to nitric oxide production and nociceptive signaling, exhibited consistent upregulation. Neural network classifiers achieved robust differentiation between pre- and post-CPT profiles (AUC=0.856), showcasing breath metabolomics as a promising observer independent, and objective tool for real-time pain assessment. To validate universal mechanistic relevance of the findings, we compared them to findings of chronic pain studies revealing consistencies in amino acid and neurotransmitter-related pathways. This study provides novel insights into the metabolic basis of acute pain and positions breath metabolomics as a viable approach for dynamic, observer independent monitoring pain in vulnerable patient groups. Future research must determine if these new insights into mechanistic pathways can inform patient- and disease-specific pain management strategies.


Participant characteristics
Psychological stressors of imprisonment and coping of older incarcerated persons: a qualitative interview study

January 2025

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58 Reads

BMC Public Health

Background Imprisonment has a major impact on a person’s psychological well-being. The proportion of older imprisoned persons is dramatically increasing worldwide, and they are likely to have greater physical and mental health needs compared to younger persons in prisons. However, there is currently a lack of research on the psychological stressors and the coping strategies of older imprisoned persons. This study therefore aims to explore the key psychological stressors experienced by older imprisoned persons and their coping strategies. Methods Individual semi-structured qualitative interviews were conducted between April 2017 and December 2018 with a purposive sample of 79 participants from 2 different groups in Switzerland: older imprisoned persons (n = 50) and mental health professionals (n = 29) with experience working in prisons. Transcripts were analysed using conventional content analysis. Results This study has identified various ways in which the prison environment not only undermines older incarcerated persons´ psychological well-being, but also their ability to manage the stress they are experiencing. Two overarching psychological stressors identified were a lack of physical and emotional closeness in social relationships (with prison staff, with other incarcerated persons, and outside of prison), and the loss of autonomy in prison. Participants reported five main ways that older incarcerated persons coped with the psychological stressors in prison: 1) recognising a lack of control over situation, 2) withdrawing and isolating, 3) self-improvement, 4) staying connected to the outside world, and 5) self-expression. Conclusions To improve the psychological well-being of older incarcerated persons, there is a need for: specialised training of prison staff regarding hardships that elderly persons can face in prison relationships, encouragement and enablement of social contacts with the outside world, and increasing possibilities for autonomy, new challenges, and thus stimuli within a limited setting.


Citations (61)


... The exploration of OLPs within the systematic review highlighted a nuanced spectrum of implementation and logistical considerations critical to their integration into medical practice. Acceptability was a pivotal concern, with intervention preference varying widely; some patients exhibited a readiness to embrace OLPs as an extension of their current treatment regimen (Publications: 2,3,4,5,6,7,8,9). However, the potential for OLPs to serve as a dose extending OLP alongside active medication was met with both intrigue and scepticism, prompting calls for more definitive evidence to validate this application (Publications: 2, 3,4,8,9,11,13,15,17). ...

Reference:

A systematic qualitative review of ethical issues in open label placebo in published research
Noble Humbug? Hard and soft laws on clinical placebo use

... These AI systems can interact with patients through text or speech, providing information, monitoring symptoms, offering support, and fulfilling other roles historically provided by human healthcare professionals (HCPs) [3]. It has also been reported that 20% of UK general practitioners (GPs) now use generative AI like ChatGPT for tasks such as assistance with writing patient correspondence [4]. However, despite the growing use of these technologies [5], there are concerns about whether AI chatbots can be as empathic as human HCPs [6], and thus leverage the benefits of empathic care for patients [7]. ...

Generative artificial intelligence in primary care: an online survey of UK general practitioners

... Training on how to write clinical notes in the context of ORA could help HCPs navigate the changing role of the EHR. Recent survey of psychotherapy trainees found that 9 out of 10 believed education on open notes should be part of the curriculum [77]. ...

Open notes in psychotherapy: An exploratory mixed methods survey of psychotherapy students in Switzerland

... A minority of patients (13.7%) reported that they felt that sensitive topics were discussed during the round. They were asked whether they encountered any topics during the ward round they considered sensitive, and if so, asked for details on those topics [16]. ...

Occurrence of sensitive topics during ward round: an ancillary analysis of the BEDSIDE-OUTSIDE trial

... Most of the studies had two groups, one experimental and one comparator. Placebo was usually the comparator except in Koban et al. (2017) and Stumpp et al. (2023), where it was employed as the experimental treatment. Unlike other studies, Slavich et al. (2019) had 3 groups; an active group that received acetaminophen, a placebo group that received a pill but it wasn't acetaminophen, and a control group that did not receive any intervention. ...

Effects of an open-label placebo intervention on reactions to social exclusion in healthy adults: a randomized controlled trial

... In most studies, school students made up the majority of the samples. Four studies reported the relationship between age and perceived stress (Beranbaum et al., 2023;Długosz, 2022;Jones et al., 2023;Takeuchi et al., 2022), but only two of them present statistical evidence. Only one study reported age as a significant predictor of perceived stress (Jones et al., 2023). ...

Stress, mental health and sociocultural adjustment in third culture kids: exploring the mediating roles of resilience and family functioning

... Previous research has relied primarily on quantitative methods, limiting the understanding of physicians' attitudes and regulatory needs. The rise in placebo research and media coverage, along with evidence supporting open-label placebos (16,17), highlights the evolving context of placebo use (18). ...

The roles of expectation, comparator, administration route, and population in open-label placebo effects: a network meta-analysis

... Whilst these are not easily tackled, long-term advocacy should still be pursued. In particular, stigma is hugely influential, with past research consistently revealing the 'double stigma' attached to previous incarceration status and age, that creates significant barriers for post-release support [62]. ...

Stigma management during reintegration of older incarcerated adults with mental health issues: A qualitative analysis
  • Citing Article
  • June 2023

International Journal of Law and Psychiatry

... Whereas resilience theory and research have focused on maintenance or recovery of functioning (Bonanno, 2021;Carver, 1998;Lunansky et al., 2024;Southwick et al., 2015), to date, resilience theory with regard to research on COVID-19 and cancer has generally only been used to provide a broad framework for studies. That is, these studies were not designed to specifically test or elaborate upon resilience theory, but instead merely included resilience resource variables, for example, as (a) a mediating variable (Galindo-Domínguez et al., 2020;Oviedo et al., 2023;Reed et al., 2023), (b) an independent variable in mediational model testing (Karademas et al., 2023), or (c) a variable in correlational studies with coping, distress, or quality-of-life outcomes (Clarke et al., 2019;Fritzson et al., 2024;Macía et al., 2021;Tamura et al., 2021;Ulibarri-Ochoa et al., 2024). Closer to theory are longitudinal studies that tested maintenance of functioning across time (Park et al., 2021); however, even these studies did not examine the complex relationship between resilience resources and coping or the impact of differing levels of stress/adversity. ...

Exploring resilience as a mediator and moderator in the relationship between cultural intelligence and sociocultural adjustment: A study of expatriates in Switzerland

International Journal of Intercultural Relations

... The chance-corrected agreement between raters after the full-text screening in the updated search was substantial (κ = 0.78) 63 . We included two individual studies reported in one article meeting the eligibility criteria 55 Additionally, two trials investigated the impact of OLPs on cognitive performance 35,81 , and two on test anxiety 44,54 . The impact of OLPs on promoting bene cial behaviors such as Progressive Muscle Relaxation 95 and Acts of Kindnes 96 was investigated in two trials and one experiment explored effects on experimentally induced acute stress 45 . ...

Imaginary pills and open-label placebos can reduce test anxiety by means of placebo mechanisms