Development of the Conversational Health Literacy Assessment Tool for maternity care (CHAT-maternity-care): participatory action research.

BACKGROUND: Limited health literacy in (expectant) parents is associated with adverse health outcomes. Maternity care providers often experience difficulties assessing (expectant) parents' level of health literacy. The aim was to develop, evaluate, and iteratively adapt a conversational tool that supports maternity care providers in estimating (expectant) parents' health literacy. METHODS: In this participatory action research study, we developed a conversational tool for estimating the health literacy of (expectant) parents based on the Conversational Health Literacy Assessment Tool for general care, which in turn was based on the Health Literacy Questionnaire. We used a thorough iterative process including different maternity care providers, (expectant) parents, and a panel of experts. This expert panel comprised representatives from knowledge institutions, professional associations, and care providers with whom midwives and maternity care assistants work closely. Testing, evaluation and adjustment took place in consecutive rounds and was conducted in the Netherlands between 2019 and 2022. RESULTS: The conversational tool 'CHAT-maternity-care' covers four key domains: (1) supportive relationship with care providers; (2) supportive relationship within parents' personal network; (3) health information access and comprehension; (4) current health behaviour and health promotion. Each domain contains multiple example questions and example observations. Participants contributed to make the example questions and example observations accessible and usable for daily practice. The CHAT-maternity-care supports maternity care providers in estimating (expectant) parents' health literacy during routine conversations with them, increased maternity care providers' awareness of health literacy and helped them to identify where attention is necessary regarding (expectant) parents' health literacy. CONCLUSIONS: The CHAT-maternity-care is a promising conversational tool to estimate (expectant) parents' health literacy. It covers the relevant constructs of health literacy from both the Conversational Health Literacy Assessment Tool and Health Literacy Questionnaire, applied to maternity care. A preliminary evaluation of the use revealed positive feedback. Further testing and evaluation of the CHAT-maternity-care is required with a larger and more diverse population, including more (expectant) parents, to determine the effectiveness, perceived barriers, and perceived facilitators for implementation.

Needs of parents and professionals to improve shared decision-making in interprofessional maternity care practice: A qualitative study.

BACKGROUND: Shared decision-making (SDM) is a critical but challenging component of high quality maternity care. In co-creation with parents and professionals, we are developing an intervention to improve SDM. As a first step we aimed to explore the experiences and needs of parents and professionals regarding shared decision-making in interprofessional antenatal, natal, and postnatal care. METHODS: We organized 11 focus groups in the Netherlands in November and December 2016. Parents, primary care midwives, hospital-based midwives, obstetricians, obstetric nurses, and maternity care assistants participated. RESULTS: Parents and professionals recognized the SDM steps of introducing a decision (choice talk) and discussing options (option talk), but most parents did not seem to discuss preferences and weigh options with professionals before making their final decision (decision talk). Barriers to SDM were often related to interprofessional collaboration, while good communication skills of parents and professionals facilitated SDM. An intervention to improve SDM would need to: (a) increase awareness and offer insight into the SDM process and roles and responsibilities of parents and professionals, (b) develop good communication skills, and (c) encourage interprofessional collaboration. The preferred design of the intervention was online, interactive, and practical. CONCLUSIONS: Parents and professionals will benefit from an intervention designed to improve SDM. A practical e-learning for all maternity care providers and e-health information for parents seems most appropriate. Key elements for the e-learning are raising awareness of the roles and responsibilities of parents and professionals, developing good communication skills and encouraging interprofessional collaboration. This requires a variety of educational strategies.

Moderators of the effects of group-based physical exercise on cancer survivors' quality of life.

PURPOSE: This study explored demographic, clinical, and psychological moderators of the effect of a group-based physical exercise intervention on global quality of life (QoL) among cancer survivors who completed treatment. METHODS: Cancer survivors were assigned to a 12-week physical exercise (n = 147) or a wait-list control group (n = 62). The main outcome measure was global QoL, assessed with the EORTC QLQ-C30 at baseline and 12 weeks later. Potential moderators were age, gender, education level, marital status, employment status, type of treatment, time since treatment, the presence of comorbidities, fatigue, general self-efficacy, depression, and anxiety. Linear regression analyses were used to test effect modification of the intervention by each moderator variable using interaction tests (p ≤ 0.10). RESULTS: The physical exercise intervention effect on global QoL was larger for cancer survivors who received radiotherapy (ß = 10.3, 95 % confidence interval (CI) = 4.4; 16.2) than for cancer survivors who did not receive radiotherapy (ß = 1.8, 95 % CI = -5.9; 9.5, p interaction = 0.10), larger for cancer survivors who received a combination of chemoradiotherapy (ß = 13.0, 95 % CI = 6.0; 20.1) than for those who did not receive this combination of treatments (ß = 2.5, 95 % CI = -3.7; 8.7, p interaction = 0.02), and larger for cancer survivors with higher baseline levels of fatigue (ß = 12.6, 95 % CI = 5.7; 19.6) than for those with lower levels (ß = 2.4, 95 % CI = -3.9; 8.7, p interaction = 0.03). No other moderating effects were found. CONCLUSIONS: This study suggests that cancer treatment modality and baseline fatigue levels moderate the effect of a physical exercise program on cancer survivors'global QoL.

On speaking terms: a Delphi study on shared decision-making in maternity care.

BACKGROUND: For most women, participation in decision-making during maternity care has a positive impact on their childbirth experiences. Shared decision-making (SDM) is widely advocated as a way to support people in their healthcare choices. The aim of this study was to identify quality criteria and professional competencies for applying shared decision-making in maternity care. We focused on decision-making in everyday maternity care practice for healthy women. METHODS: An international three-round web-based Delphi study was conducted. The Delphi panel included international experts in SDM and in maternity care: mostly midwives, and additionally obstetricians, educators, researchers, policy makers and representatives of care users. Round 1 contained open-ended questions to explore relevant ingredients for SDM in maternity care and to identify the competencies needed for this. In rounds 2 and 3, experts rated statements on quality criteria and competencies on a 1 to 7 Likert-scale. A priori, positive consensus was defined as 70% or more of the experts scoring ≥6 (70% panel agreement). RESULTS: Consensus was reached on 45 quality criteria statements and 4 competency statements. SDM in maternity care is a dynamic process that starts in antenatal care and ends after birth. Experts agreed that the regular visits during pregnancy offer opportunities to build a relationship, anticipate situations and revisit complex decisions. Professionals need to prepare women antenatally for unexpected, urgent decisions in birth and revisit these decisions postnatally. Open and respectful communication between women and care professionals is essential; information needs to be accurate, evidence-based and understandable to women. Experts were divided about the contribution of professional advice in shared decision-making and about the partner's role. CONCLUSIONS: SDM in maternity care is a dynamic process that takes into consideration women's individual needs and the context of the pregnancy or birth. The identified ingredients for good quality SDM will help practitioners to apply SDM in practice and educators to prepare (future) professionals for SDM, contributing to women's positive birth experience and satisfaction with care.

Series: Practical guidance to qualitative research. Part 7: Qualitative evidence synthesis for emerging themes in primary care research: Scoping review, meta-ethnography and rapid realist review.

This article, the seventh in a series aiming to provide practical guidance for qualitative research in primary care, introduces qualitative synthesis research for addressing health themes in primary care research. Qualitative synthesis combines rigorous processes and authorial judgement to present the collective meaning of research outputs; the findings of qualitative studies - and sometimes mixed-methods and quantitative research - are pooled. We describe three exemplary designs: the scoping review, the meta-ethnography and the rapid realist review. Scoping reviews aim to provide an overview of the evidence/knowledge or to answer questions regarding the nature and diversity of the evidence/knowledge available. Meta-ethnographies intend to systematically compare data from primary qualitative studies to identify and develop new overarching concepts, theories, and models. Rapid realist reviews aim to provide a knowledge synthesis by looking at complex questions while responding to time-sensitive and emerging issues. It addresses the question, 'what works, for whom, in what circumstances, and how?'We discuss these three designs' context, what, why, when and how. We provide examples of published studies and sources for further reading, including manuals and guidelines for conducting and reporting these studies. Finally, we discuss attention points for the research team concerning the involvement of necessary experts and stakeholders and choices to be made during the research process.

Series: Practical guidance to qualitative research. Part 5: Co-creative qualitative approaches for emerging themes in primary care research: Experience-based co-design, user-centred design and community-based participatory research.

This article, the fifth in a series aiming to provide practical guidance for qualitative research in primary care, introduces three qualitative approaches with co-creative characteristics for addressing emerging themes in primary care research: experience-based co-design, user-centred design and community-based participatory research. Co-creation aims to define the (research) problem, develop and implement interventions and evaluate and define (research and practice) outcomes in partnership with patients, family carers, researchers, care professionals and other relevant stakeholders. Experience-based co-design seeks to understand how people experience a health care process or service. User-centred design is an approach to assess, design and develop technological and organisational systems, for example, eHealth, involving end-users in the design and decision-making processes. Community-based participatory research is a collaborative approach addressing a locally relevant health issue. It is often directed at hard-to-reach and vulnerable people. We address the context, what, why, when and how of these co-creative approaches, and their main practical and methodological challenges. We provide examples of empirical studies using these approaches and sources for further reading.

Series: Practical guidance to qualitative research. Part 6: Longitudinal qualitative and mixed-methods approaches for longitudinal and complex health themes in primary care research.

This article, the sixth in a series aiming to provide practical guidance for qualitative research in primary care, introduces two approaches for addressing longitudinal and complex health themes in primary care research. The first approach - longitudinal qualitative research - supports the study of change during the life course. The second approach - mixed-methods research - integrates quantitative and qualitative research to gain new insights to address the complex and multifaceted themes in primary care.We discuss the context, what, why, when and how of these approaches and their main practical and methodological challenges. We provide examples of empirical studies using these approaches and sources for further reading.

Integrating women's voices in quality improvement for maternity care: A qualitative study.

INTRODUCTION: Improving the quality of maternity care is high on the national agenda in the Netherlands. One aspect gaining significant attention is integrating women's experiences - as users of maternity care - in this quality improvement. The aim of this study was to gain deeper insights into how maternity care professionals in Dutch Maternity Care Collaborations integrate women's voices into quality improvement as part of integrated maternity care and what role midwives can have in this. METHODS: This was a descriptive qualitative study, using semi-structured individual interviews and content analysis for an in-depth exploration of maternity care professionals' experiences and opinions on integrating women's voices in quality improvement. Participants were twelve maternity care professionals involved in quality improvement activities from eight Dutch Maternity Care Collaborations. RESULTS: Four themes emerged: 'Quality improvement based on women's voices is still in its infancy' and was experienced as an important but challenging topic; 'Collecting women's voices' was conducted, but needed more facilitation; Using women's voices' was hindered by a lack of expertise and a structured feedback and feedforward system; and 'Ensuring listening to women's voices' and integrating them in quality improvement required further facilitation. CONCLUSIONS: Care professionals emphasized that listening to women's voices for quality improvement is important but challenging due to the lack of expertise, organizational structure, time, and financial resources. A feasible implementation strategy including concrete support is recommended by maternity care professionals to boost action.

The paradoxes of communication and collaboration in maternity care: A video-reflexivity study with professionals and parents.

BACKGROUND: Research on maternity care often focuses on factors that prevent good communication and collaboration and rarely includes important stakeholders - parents - as co-researchers. To understand how professionals and parents in Dutch maternity care accomplish constructive communication and collaboration, we examined their interactions in the clinic, looking for "good practice". METHODS: We used the video-reflexive ethnographic method in 9 midwifery practices and 2 obstetric units. FINDINGS: We conducted 16 meetings where participants reflected on video recordings of their clinical interactions. We found that informal strategies facilitate communication and collaboration: "talk work" - small talk and humour - and "work beyond words" - familiarity, use of sight, touch, sound, and non-verbal gestures. When using these strategies, participants noted that it is important to be sensitive to context, to the values and feelings of others, and to the timing of care. Our analysis of their ways of being sensitive shows that good communication and collaboration involves "paradoxical care", e.g., concurrent acts of "regulated spontaneity" and "informal formalities". DISCUSSION: Acknowledging and reinforcing paradoxical care skills will help caregivers develop the competencies needed to address the changing demands of health care. The video-reflexive ethnographic method offers an innovative approach to studying everyday work, focusing on informal and implicit aspects of practice and providing a bottom up approach, integrating researchers, professionals and parents. CONCLUSION: Good communication and collaboration in maternity care involves "paradoxical care" requiring social sensitivity and self-reflection, skills that should be included as part of professional training.

Monitoring training progress during exercise training in cancer survivors: a submaximal exercise test as an alternative for a maximal exercise test?

OBJECTIVE: To examine the use of a submaximal exercise test in detecting change in fitness level after a physical training program, and to investigate the correlation of outcomes as measured submaximally or maximally. DESIGN: A prospective study in which exercise testing was performed before and after training intervention. SETTING: Academic and general hospital and rehabilitation center. PARTICIPANTS: Cancer survivors (N=147) (all cancer types, medical treatment completed > or =3 mo ago) attended a 12-week supervised exercise program. INTERVENTIONS: A 12-week training program including aerobic training, strength training, and group sport. MAIN OUTCOME MEASURES: Outcome measures were changes in peak oxygen uptake (Vo(2)peak) and peak power output (both determined during exhaustive exercise testing) and submaximal heart rate (determined during submaximal testing at a fixed workload). RESULTS: The Vo(2)peak and peak power output increased and the submaximal heart rate decreased significantly from baseline to postintervention (P<.001). Changes in submaximal heart rate were only weakly correlated with changes in Vo(2)peak and peak power output. Comparing the participants performing submaximal testing with a heart rate less than 140 beats per minute (bpm) versus the participants achieving a heart rate of 140 bpm or higher showed that changes in submaximal heart rate in the group cycling with moderate to high intensity (ie, heart rate > or =140 bpm) were clearly related to changes in VO(2)peak and peak power output. CONCLUSIONS: For the monitoring of training progress in daily clinical practice, changes in heart rate at a fixed submaximal workload that requires a heart rate greater than 140 bpm may serve as an alternative to an exhaustive exercise test.

Long-term effects on cancer survivors' quality of life of physical training versus physical training combined with cognitive-behavioral therapy: results from a randomized trial.

BACKGROUND: We compared the effect of a 12-week group-based multidisciplinary self-management rehabilitation program, combining physical training (twice weekly) and cognitive-behavioral therapy (once weekly) with the effect of 12-week group-based physical training (twice weekly) on cancer survivors' quality of life over a 1-year period. MATERIALS AND METHODS: One hundred forty-seven survivors [48.8 +/- 10.9 years (mean +/- SD), all cancer types, medical treatment > or = 3 months ago] were randomly assigned to either physical training (PT, n = 71) or to physical training plus cognitive-behavioral therapy (PT + CBT, n = 76). Quality of life and physical activity levels were measured before and immediately after the intervention and at 3- and 9-month post-intervention using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 questionnaire and the Physical Activity Scale for the Elderly, respectively. RESULTS: Multilevel linear mixed-effects models revealed no differential pattern in change of quality of life and physical activity between PT and PT + CBT. In both PT and PT + CBT, quality of life and physical activity were significantly and clinically relevantly improved immediately following the intervention and also at 3- and 9-month post-intervention compared to pre-intervention (p < 0.001). CONCLUSION: Self-management physical training had substantial and durable positive effects on cancer survivors' quality of life. Participants maintained physical activity levels once the program was completed. Combining physical training with our cognitive-behavioral intervention did not add to these beneficial effects of physical training neither in the short-term nor in the long-term. Physical training should be implemented within the framework of standard care for cancer survivors.

Quality of life after self-management cancer rehabilitation: a randomized controlled trial comparing physical and cognitive-behavioral training versus physical training.

OBJECTIVE: To conduct a randomized controlled trial and compare the effects on cancer survivors' quality of life in a 12-week group-based multidisciplinary self-management rehabilitation program, combining physical training (twice weekly) and cognitive-behavioral training (once weekly) with those of a 12-week group-based physical training (twice weekly). In addition, both interventions were compared with no intervention. METHODS: Participants (all cancer types, medical treatment completed > or = 3 months ago) were randomly assigned to multidisciplinary rehabilitation (n = 76) or physical training (n = 71). The nonintervention comparison group consisted of 62 patients on a waiting list. Quality of life was measured using the RAND-36. The rehabilitation groups were measured at baseline, after rehabilitation, and 3-month follow-up, and the nonintervention group was measured at baseline and 12 weeks later. RESULTS: The effects of multidisciplinary rehabilitation did not outperform those of physical training in role limitations due to emotional problem (primary outcome) or any other domains of quality of life (all p > .05). Compared with no intervention, participants in both rehabilitation groups showed significant and clinically relevant improvements in role limitations due to physical problem (primary outcome; effect size (ES) = 0.66), and in physical functioning (ES = 0.48), vitality (ES = 0.54), and health change (ES = 0.76) (all p < .01). CONCLUSIONS: Adding a cognitive-behavioral training to group-based self-management physical training did not have additional beneficial effects on cancer survivors' quality of life. Compared with the nonintervention group, the group-based self-management rehabilitation improved cancer survivors' quality of life.

The effect of group cohesion on rehabilitation outcome in cancer survivors.

OBJECTIVE: Group-based physical training interventions have been shown to be effective in increasing quality of life in cancer survivors. Until now, however, the impact of cohesion within the group on intervention outcome has not been investigated. METHODS: We examined self-reported individual group cohesion ratings collected in the first half of a 12-week rehabilitation programme for cancer survivors (N=132). Four dimensions of group cohesion were measured, i.e. the bond with the group as whole, the bond with other members, cooperation within the group and the instrumental value. Quality of life, physical functioning and fatigue were assessed before and after the intervention using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. Linear multiple multivariate regression analysis was conducted to explore the relationship between group cohesion and intervention outcome. RESULTS: The relationship between group cohesion and outcome was significantly modified by gender. Higher ratings of cooperation within the group predicted better post-intervention quality of life and physical functioning and less fatigue in men, and better quality of life and physical functioning in women. Additionally, women who reported a stronger bond with other members showed a lower quality of life after the intervention. No relationship was found between the instrumental value and the outcome variables. CONCLUSION: Some dimensions of group cohesion seem to be associated with intervention outcome. The underlying mechanisms need to be unravelled.

Improved physical fitness of cancer survivors: a randomised controlled trial comparing physical training with physical and cognitive-behavioural training.

We compared the effect of a group-based 12-week supervised exercise programme, i.e. aerobic and resistance exercise, and group sports, with that of the same programme combined with cognitive-behavioural training on physical fitness and activity of cancer survivors. One hundred and forty seven cancer survivors (all cancer types, medical treatment >or=3 months ago)were randomly assigned to physical training (PT, n=71) or PT plus cognitive-behavioural training (PT+CBT, n=76). Maximal aerobic capacity, muscle strength and physical activity were assessed at baseline and post-intervention. Analyses using multilevel linear mixed-effects models showed that cancer survivors' physical fitness increased significantly in PT and PT+CBT from baseline to post-intervention. Changes did not differ between PT and PT+CBT. Physical fitness of cancer survivors was improved following an intensive physical training programme. Adding a structured cognitive-behavioural intervention did not enhance the effect.

The development of an evidence-based physical self-management rehabilitation programme for cancer survivors.

OBJECTIVE: This paper describes the development of a physical training programme for cancer patients. Four related but conceptually and empirically distinct physical problems are described: decreased aerobic capacity, decreased muscle strength, fatigue and impaired role physical functioning. The study aimed to identify the optimal content for an exercise programme that addresses these four physical problems, based on the highest level of evidence available. The study further aimed to review the evidence available on the delivery of the programmes. The final goal was to develop a programme in which content and delivery are based on the best available evidence. METHODS: Literature searches (PUBMED and MEDLINE, to July 2006) on content looked for evidence about the efficacy of exercise on aerobic capacity, muscle strength, fatigue and impaired role physical functioning. Literature searches on delivery looked for self-management and/or self-efficacy enhancing techniques in relation to outcome, adherence to and/or adoption of a physically active lifestyle. RESULTS: Evidence on the effectiveness of exercise in cancer patients varies and increases when moving from muscle strength (RCT level), fatigue and physical role functioning to aerobic capacity (all at the meta-analysis level). Effect sizes for aerobic capacity were moderate, while effect sizes for fatigue and physical role functioning were zero and/or small. Many of the studies have significant methodological shortcomings. There was some evidence (meta-analyses) that self-management programmes and self-efficacy enhancing programmes have beneficial effects on health outcomes in a variety of chronic diseases, on the quality of life in cancer patients, and on exercise adherence and later exercise behaviour. CONCLUSION: Limited data are available on the effectiveness of exercise for cancer patients. Although evidence supports the positive effects of exercise on exercise capacity during and after completion of cancer treatment, the effects for fatigue and role functioning are ambiguous. Evidence on the effectiveness of progressive exercise training on muscle strength is promising. In addition, some evidence supports the positive effects of self-management programmes and self-efficacy enhancing programmes on health outcomes, exercise adherence and later exercise behaviour. PRACTICE IMPLICATIONS: The resulting programme was developed on the basis of the highest quality of evidence available regarding content and delivery. The content is based on information obtained from the present review, and on the recommendations of the American College of Sports Medicine. Potential advantages of the programme include: (a) tailored physical training towards focusing on the patient's established problems and (b) delivery of the training as a self-management programme that might have beneficial effects on health outcome, exercise adherence and a long-term physically active lifestyle.

Series: Practical guidance to qualitative research. Part 3: Sampling, data collection and analysis.

In the course of our supervisory work over the years, we have noticed that qualitative research tends to evoke a lot of questions and worries, so-called frequently asked questions (FAQs). This series of four articles intends to provide novice researchers with practical guidance for conducting high-quality qualitative research in primary care. By 'novice' we mean Master's students and junior researchers, as well as experienced quantitative researchers who are engaging in qualitative research for the first time. This series addresses their questions and provides researchers, readers, reviewers and editors with references to criteria and tools for judging the quality of qualitative research papers. The second article focused on context, research questions and designs, and referred to publications for further reading. This third article addresses FAQs about sampling, data collection and analysis. The data collection plan needs to be broadly defined and open at first, and become flexible during data collection. Sampling strategies should be chosen in such a way that they yield rich information and are consistent with the methodological approach used. Data saturation determines sample size and will be different for each study. The most commonly used data collection methods are participant observation, face-to-face in-depth interviews and focus group discussions. Analyses in ethnographic, phenomenological, grounded theory, and content analysis studies yield different narrative findings: a detailed description of a culture, the essence of the lived experience, a theory, and a descriptive summary, respectively. The fourth and final article will focus on trustworthiness and publishing qualitative research.

Series: Practical guidance to qualitative research. Part 4: Trustworthiness and publishing.

In the course of our supervisory work over the years we have noticed that qualitative research tends to evoke a lot of questions and worries, so-called frequently asked questions (FAQs). This series of four articles intends to provide novice researchers with practical guidance for conducting high-quality qualitative research in primary care. By 'novice' we mean Master's students and junior researchers, as well as experienced quantitative researchers who are engaging in qualitative research for the first time. This series addresses their questions and provides researchers, readers, reviewers and editors with references to criteria and tools for judging the quality of qualitative research papers. The first article provides an introduction to this series. The second article focused on context, research questions and designs. The third article focused on sampling, data collection and analysis. This fourth article addresses FAQs about trustworthiness and publishing. Quality criteria for all qualitative research are credibility, transferability, dependability, and confirmability. Reflexivity is an integral part of ensuring the transparency and quality of qualitative research. Writing a qualitative research article reflects the iterative nature of the qualitative research process: data analysis continues while writing. A qualitative research article is mostly narrative and tends to be longer than a quantitative paper, and sometimes requires a different structure. Editors essentially use the criteria: is it new, is it true, is it relevant? An effective cover letter enhances confidence in the newness, trueness and relevance, and explains why your study required a qualitative design. It provides information about the way you applied quality criteria or a checklist, and you can attach the checklist to the manuscript.

Series: Practical guidance to qualitative research. Part 2: Context, research questions and designs.

In the course of our supervisory work over the years, we have noticed that qualitative research tends to evoke a lot of questions and worries, so-called frequently asked questions (FAQs). This series of four articles intends to provide novice researchers with practical guidance for conducting high-quality qualitative research in primary care. By 'novice' we mean Master's students and junior researchers, as well as experienced quantitative researchers who are engaging in qualitative research for the first time. This series addresses their questions and provides researchers, readers, reviewers and editors with references to criteria and tools for judging the quality of qualitative research papers. This second article addresses FAQs about context, research questions and designs. Qualitative research takes into account the natural contexts in which individuals or groups function to provide an in-depth understanding of real-world problems. The research questions are generally broad and open to unexpected findings. The choice of a qualitative design primarily depends on the nature of the research problem, the research question(s) and the scientific knowledge one seeks. Ethnography, phenomenology and grounded theory are considered to represent the 'big three' qualitative approaches. Theory guides the researcher through the research process by providing a 'lens' to look at the phenomenon under study. Since qualitative researchers and the participants of their studies interact in a social process, researchers influence the research process. The first article described the key features of qualitative research, the third article will focus on sampling, data collection and analysis, while the last article focuses on trustworthiness and publishing.

Series: Practical guidance to qualitative research. Part 1: Introduction.

In the course of our supervisory work over the years, we have noticed that qualitative research tends to evoke a lot of questions and worries, so-called Frequently Asked Questions. This journal series of four articles intends to provide novice researchers with practical guidance for conducting high-quality qualitative research in primary care. By 'novice' we mean Master's students and junior researchers, as well as experienced quantitative researchers who are engaging in qualitative research for the first time. This series addresses their questions and provides researchers, readers, reviewers and editors with references to criteria and tools for judging the quality of papers reporting on qualitative research. This first article describes the key features of qualitative research, provides publications for further learning and reading, and gives an outline of the series.

External Validation Study of First Trimester Obstetric Prediction Models (Expect Study I): Research Protocol and Population Characteristics.

BACKGROUND: A number of first-trimester prediction models addressing important obstetric outcomes have been published. However, most models have not been externally validated. External validation is essential before implementing a prediction model in clinical practice. OBJECTIVE: The objective of this paper is to describe the design of a study to externally validate existing first trimester obstetric prediction models, based upon maternal characteristics and standard measurements (eg, blood pressure), for the risk of pre-eclampsia (PE), gestational diabetes mellitus (GDM), spontaneous preterm birth (PTB), small-for-gestational-age (SGA) infants, and large-for-gestational-age (LGA) infants among Dutch pregnant women (Expect Study I). The results of a pilot study on the feasibility and acceptability of the recruitment process and the comprehensibility of the Pregnancy Questionnaire 1 are also reported. METHODS: A multicenter prospective cohort study was performed in The Netherlands between July 1, 2013 and December 31, 2015. First trimester obstetric prediction models were systematically selected from the literature. Predictor variables were measured by the Web-based Pregnancy Questionnaire 1 and pregnancy outcomes were established using the Postpartum Questionnaire 1 and medical records. Information about maternal health-related quality of life, costs, and satisfaction with Dutch obstetric care was collected from a subsample of women. A pilot study was carried out before the official start of inclusion. External validity of the models will be evaluated by assessing discrimination and calibration. RESULTS: Based on the pilot study, minor improvements were made to the recruitment process and online Pregnancy Questionnaire 1. The validation cohort consists of 2614 women. Data analysis of the external validation study is in progress. CONCLUSIONS: This study will offer insight into the generalizability of existing, non-invasive first trimester prediction models for various obstetric outcomes in a Dutch obstetric population. An impact study for the evaluation of the best obstetric prediction models in the Dutch setting with respect to their effect on clinical outcomes, costs, and quality of life-Expect Study II-is being planned. TRIAL REGISTRATION: Netherlands Trial Registry (NTR): NTR4143; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4143 (Archived by WebCite at http://www.webcitation.org/6t8ijtpd9).