Le biais de sélection par rapport au sexe (ou biais de sexe) représente une différence systématique des proportions d’hommes et de femmes entre un échantillon de participants et leur population, ce qui peut miner la validité d’une étude. La recherche sur le stress humain est susceptible au biais de sexe étant donné la présence de facteurs y étant généralement associés, principalement les protocoles invasifs – contenant des éléments douloureux, inconfortables ou menaçants pour les participants. La présente étude a vérifié si les proportions d’hommes et de femmes des études sur le stress varient selon 1) le niveau d’invasion d’une étude en stress (invasif ou non invasif) et selon 2) des facteurs exploratoires (p. ex. pays, méthode de recrutement). Deux domaines hors stress possédant des protocoles invasifs (douleur expérimentale) et non invasifs (mémoire) ont été utilisés comme domaines contrôles. Dans cette enquête transversale de la littérature, les proportions d’hommes et de femmes ont été recueillies dans 324 études contenant des protocoles invasifs ou non invasifs, représentant un total de 23 611 participants, dont 42,18 % d’hommes. La représentativité des sexes a varié selon le niveau d’invasion dans les domaines du stress et hors stress, les hommes davantage représentés dans les études invasives que dans les études non invasives. Les résultats indiquent que les facteurs exploratoires analysés peuvent tous être associés au sexe. Cette étude a identifié la présence de facteurs pouvant provoquer un biais de sexe en recherche sur le stress humain, ouvrant la voie aux recherches souhaitant approfondir la généralisation des résultats. / Sex selection bias (or sex bias) refers to a systematic difference in the proportions of men and women between a sample of participants and their population, which may undermine the validity of a study. Human stress research is vulnerable to sex bias, given the presence of factors typically associated with it, primarily invasive protocols — containing painful, uncomfortable, or threatening elements for participants. The present study has verified whether the proportions of men and women in stress studies differ by 1) the invasiveness of a study (invasive or non-invasive) and by 2) exploratory factors (e.g. country, recruitment method). Two non-stress domains with invasive (experimental pain) and non-invasive (memory) protocols were used as control domains. In a cross-sectional survey of the literature, the proportions of men and women were collected from 324 studies containing invasive or non-invasive protocols, representing a total of 23 611 participants, 42,18 % of whom were men. Sex representativeness differed across invasiveness levels in both the stress and non-stress domains with men being more represented in invasive than in non-invasive studies. Results indicate that the exploratory factors analyzed may all be associated with sex. This study identified the presence of factors that may cause sex bias in human stress research, opening the door to research wishing to further investigate the generalizability of results.

Background: There is a great need for effective treatments for mental health problems. Randomised controlled trials are the gold standard for evaluating treatments, however recruitment into trials is challenging, highlighting a clear need for evidence-based recruitment strategies. This thesis aimed to systematically develop a recruitment intervention and evaluate its effectiveness for improving the recruitment of participants into mental health trials. Methods: A mixed-methods approach, adopting the Medical Research Council’s complex interventions framework: 1) a systematic review to identify the evidence base and describe the factors affecting recruitment into depression trials; 2) a qualitative study to understand patients’ decision-making process in declining to enrol in a depression trial; 3) development of a recruitment intervention, using Participatory Design methods; and 4) evaluation of the recruitment intervention, using a randomised controlled trial, embedded in an ongoing mental health trial (the EQUIP trial). The primary outcome was the proportion of participants enrolled in EQUIP. Results: From the systematic review, a conceptual framework of factors influencing the decision to participate was developed, which highlighted that the decision to enrol involves a judgement between risk and reward. Findings suggested that patient and public involvement in research (PPIR) might be advertised to potential participants to reduce such perceived risk. The qualitative study found positive views of trials. Interviewees’ decision making resembled a four-stage process; in each stage they either decided to decline or progressed to the next stage. In Stage 1, those with an established position of declining trials opted out – they are termed ‘prior decliners’. In Stage 2, those who opted out after judging themselves ineligible are termed ‘self-excluders’. In Stage 3, those who decided they did not need the trial therapy and opted out are termed ‘treatment decliners’. In Stage 4, those who opted out after judging that disadvantages outweighed advantages are termed ‘trial decliners’. While ‘prior decliners’ are unlikely to respond to trial recruitment initiatives, the factors leading others to decline are amenable to amelioration as they do not arise from a rejection of trials. We recruited a host mental health trial (EQUIP), and worked with key stakeholders, including mental health service users and carers, to develop an intervention using a leaflet to advertise the nature and function of the PPIR in EQUIP to potential trial participants. 34 community mental health teams were randomised and 8182 patients invited. For the primary outcome, 4% of patients in the PPIR group were enrolled versus 5.3% of the control group. The intervention was not effective for improving recruitment rates (adjusted OR= 0.75, 95% CI= 0.53 to 1.07, p=0.113). Conclusions: This thesis reports the largest ever trial to evaluate the impact of a recruitment intervention. It also reports the largest trial of a PPIR intervention and makes a contribution to the evidence base on trial recruitment as well as to that assessing the impact of PPIR. Two further embedded trials are underway to evaluate the effectiveness of different versions of the recruitment intervention in different trial contexts and patient populations. This will also allow the results to be pooled to generate a more precise estimate of effect; to evaluate the impact of the intervention on trial retention; and to explore patient experiences of receiving the intervention.

This work considers the theoretical, epistemological and methodological criteria for a hermeneutic phenomenological approach to the study of spiritual experience founded within a qualitative paradigm. Spirituality is noted to be of increasing significance in society and as a developing discipline within the academy and spiritual experience is offered as an opening to greater understanding and appreciation of an individual's understandings of their spirituality. The methodology provides an interpretative approach towards an opportunity for resonance, identification and empathy between individual and reader through richly descriptive narratives offering insights into such experiences and developing themes and threads of particular interest prior to seeking universal and semi universal traits between or amongst narratives. Practical methods for applying the methodology are considered, including ethical and researcher reflexive issues. The assessment of the methodology includes its application to a case study, located within contemporary Christianity in the Roman Catholic Archdiocese of St Andrews and Edinburgh, Scotland, which due to limitations of space focuses particularly on the notion of the Gift and assists in the determination of the efficacy and validity of hermeneutic phenomenology in the study of spiritual experience.