Kate Morrow Guthrie

Qualitative Research in Emergency Care Part I: Research Principles and Common Applications.

Qualitative methods are increasingly being used in emergency care research. Rigorous qualitative methods can play a critical role in advancing the emergency care research agenda by allowing investigators to generate hypotheses, gain an in-depth understanding of health problems or specific populations, create expert consensus, and develop new intervention and dissemination strategies. This article, Part I of a two-article series, provides an introduction to general principles of applied qualitative health research and examples of its common use in emergency care research, describing study designs and data collection methods most relevant to our field, including observation, individual interviews, and focus groups. In Part II of this series, we will outline the specific steps necessary to conduct a valid and reliable qualitative research project, with a focus on interview-based studies. These elements include building the research team, preparing data collection guides, defining and obtaining an adequate sample, collecting and organizing qualitative data, and coding and analyzing the data. We also discuss potential ethical considerations unique to qualitative research as it relates to emergency care research.

Interview-based Qualitative Research in Emergency Care Part II: Data Collection, Analysis and Results Reporting

Qualitative methods are increasingly being used in emergency care research. Rigorous qualitative methods can play a critical role in advancing the emergency care research agenda by allowing investigators to generate hypotheses, gain an in-depth understanding of health problems or specific populations, create expert consensus, and develop new intervention and dissemination strategies. In Part I of this two-article series, we provided an introduction to general principles of applied qualitative health research and examples of its common use in emergency care research, describing study designs and data collection methods most relevant to our field (observation, individual interviews, and focus groups). Here in Part II of this series, we outline the specific steps necessary to conduct a valid and reliable qualitative research project, with a focus on interview-based studies. These elements include building the research team, preparing data collection guides, defining and obtaining an adequate sample, collecting and organizing qualitative data, and coding and analyzing the data. We also discuss potential ethical considerations unique to qualitative research as it relates to emergency care research.

The promise of intravaginal rings for prevention: User perceptions of biomechanical properties and implications for prevention product development

Intravaginal rings (IVRs) are currently under investigation as devices for the delivery of agents to protect against the sexual transmission of HIV and STIs, as well as pregnancy. To assist product developers in creating highly acceptable rings, we sought to identify characteristics that intravaginal ring users consider when making decisions about ring use or non-use. We conducted four semi-structured focus groups with 21 women (aged 18–45) who reported using an IVR in the past 12 months. Participants manipulated four prototype rings in their hands, discussed ring materials, dimensionality, and “behavior,” and shared perceptions and appraisals. Five salient ring characteristics were identified: 1) appearance of the rings’ surfaces, 2) tactile sensations of the cylinder material, 3) materials properties, 4) diameter of the cylinder, and 5) ring circumference. Pliability (or flexibility) was generally considered the most important mechanical property. Several ring properties (e.g., porousness, dimensionality) were associated with perceptions of efficacy. Women also revealed user behaviors that may impact the effectiveness of certain drugs, such as removing, rinsing and re-inserting the ring while bathing, and removing the ring during sexual encounters. As product developers explore IVRs as prevention delivery systems, it is critical to balance product materials and dimensions with use parameters to optimize drug delivery and the user experience. It is also critical to consider how user behaviors (e.g., removing the ring) might impact drug delivery.

Unplanned pregnancy and contraceptive use in Hull and East Yorkshire

OBJECTIVE This study has two aims. The first is to assess the proportion of unplanned pregnancies among women attending antenatal clinics (ANCs) and those undergoing induced abortion (IA). The second is to assess both their previous contraceptive use and contraceptive intention, with particular focus on the use or consideration of any long-acting reversible contraceptives in Hull and East Riding in order to inform service redesign. STUDY DESIGN Consecutive women attending their first ANC appointment and women attending a gynecology clinic undergoing IA were asked to complete a two-page questionnaire that contained a validated pregnancy intendedness questionnaire [the London Measure of Unplanned Pregnancy (LMUP)] and questions to establish contraceptive use and access prior to this index pregnancy. RESULTS The overall response rate was 69%. We received 648 evaluable questionnaires for women undergoing IA. Of these pregnancies, 75.8% [95% confidence interval (CI), 72.3%-79.0%] were unplanned (LMUP, score 0-3). We received 1001 evaluable questionnaires from women booking at ANCs. Of these pregnancies, 5.5% (95% CI, 4.2%-7.0%) were unplanned. Among those with unplanned pregnancies who were not using contraception, 31% reported that they were unable to obtain the method they wanted. Among those using a method immediately prior to the index unplanned pregnancy, 33% stated that it was not the method they wanted; of these, 75% would have preferred sterilization, the implant, injectable or intrauterine contraceptive. CONCLUSION Unplanned pregnancies in this population are common among women undergoing IA but are uncommon among women attending an ANC. About a third of women not using contraception reported that they were unable to obtain the method they wanted, and about a third of women using contraception stated that they were not using the method they would have preferred. IMPLICATIONS Opportunities to prevent unplanned pregnancies are missed when staff in primary and secondary care looking after women do not knowledgeably inform, discuss and offer contraception in a timely manner, particularly the most effective long-acting reversible contraceptive methods. Services should be deliverable where women are: this includes within pregnancy care services. Seeking patient experience is an essential component of service redesign.

Nurse-led telephone consultation and outpatient local anaesthetic abortion: a pilot project.

Objectives The study objectives were to improve access to earlier and safer abortion and to offer women a wider choice of method of termination of pregnancy (TOP). Methods The study comprised two pilot projects conducted in a teaching hospital to assess the feasibility of (1) a telephone booking clinic and (2) a local anaesthetic outpatient surgical termination of pregnancy (LA-STOP) service. The main outcome measures were the uptake of services by referrers and patients, staff acceptability and cost. Results Demand from referrers for the telephone booking clinic was greater than could be accommodated by the service. Telephone consultation was popular with patients as it was carried out at their convenience in their homes, and with staff as it reduced clinic assessment time. Some staff members felt that consulting over the telephone affected their assessment of the patients emotional status. Outpatient LA-STOP seemed well accepted by both staff and patients as it offered patients a convenient and safe method of early abortion. A preliminary costing indicated a net saving plus increased service capacity. Conclusions The pilots suggest that the introduction of a telephone booking clinic and LA-STOP service into existing hospital services is feasible and cost effective. Further research is required to evaluate the potential for reducing waiting times and the gestations at which terminations are carried out.

User input in iterative design for prevention product development: leveraging interdisciplinary methods to optimize effectiveness

The development of HIV-preventive topical vaginal microbicides has been challenged by a lack of sufficient adherence in later stage clinical trials to confidently evaluate effectiveness. This dilemma has highlighted the need to integrate translational research earlier in the drug development process, essentially applying behavioral science to facilitate the advances of basic science with respect to the uptake and use of biomedical prevention technologies. In the last several years, there has been an increasing recognition that the user experience, specifically the sensory experience, as well as the role of meaning-making elicited by those sensations, may play a more substantive role than previously thought. Importantly, the role of the user—their sensory perceptions, their judgements of those experiences, and their willingness to use a product—is critical in product uptake and consistent use post-marketing, ultimately realizing gains in global public health. Specifically, a successful prevention product requires an efficacious drug, an efficient drug delivery system, and an effective user. We present an integrated iterative drug development and user experience evaluation method to illustrate how user-centered formulation design can be iterated from the early stages of preclinical development to leverage the user experience. Integrating the user and their product experiences into the formulation design process may help optimize both the efficiency of drug delivery and the effectiveness of the user.

Lessons from the Contraceptive CHOICE Project: the Hull long-acting reversible contraception (LARC) initiative

Aim To discover whether a hand-out explaining the benefits of intrauterine contraceptives (IUCs) and implants could increase their uptake in Hull, UK. Methods We developed a simple double-sided A4 hand-out. On one side was a script with pictures of copper and levonorgestrel IUCs next to a 20 pence coin and of an implant beside a hairgrip. On the other side was the three-tiered effectiveness chart published in the textbook Contraceptive Technology. We implemented the project in family planning (FP), abortion and antenatal clinics and general practitioner (GP) surgeries. The plan was that the receptionist would give the hand-out to every woman and ask her to read it before seeing a clinician. We evaluated the hand-out in FP clinics and GP practices because routine electronic monitoring reports were available only for these locations. Results There was no impact in GP practices. There was no overall impact in FP clinics, with the exception of the service hub, in which there was an increase in the proportion of women receiving IUCs or implants of 15.0% between the periods October 2011–April 2012 and May 2012–November 2012 (p=0.0002). This clinic is open 6 days per week and has permanent sexual health staff on the reception desk. The proportion of women receiving IUCs or implants returned to baseline in December 2012–November 2013, when a change in clinic procedure to reduce waiting times caused staff to stop dispensing hand-outs. Conclusions This was not a formal study, so there was no research coordinator to monitor the project. We think that there was no impact among GPs because the project was not implemented by them. The project was poorly implemented at the four satellite FP clinics. Only the service hub implemented the project, where it had a clear impact. We conclude that when implemented as intended, this simple, very low-cost long-acting reversible contraception intervention was highly effective and also extremely cost effective.

Vaginal film for prevention of HIV: using visual and tactile evaluations among potential users to inform product design

Abstract Topical prevention of HIV and other STIs is a global health priority. To provide options for users, developers have worked to design safe, effective and acceptable vaginal dissolving film formulations. We aimed to characterize user experiences of vaginal film size, texture and color, and their role in product-elicited sensory perceptions (i.e. perceptibility), acceptability and willingness to use. In the context of a user-centered product evaluation study, we elicited users’ ‘first impressions’ of various vaginal film formulation designs via visual and tactile prototype inspection during a qualitative user evaluation interview. Twenty-four women evaluated prototypes. Participants considered size and texture to be important for easy insertion. Color was more important following dissolution than prior to insertion. When asked to combine and balance all properties to arrive at an ideal film, previously stated priorities for individual characteristics sometimes shifted, with the salience of some individual characteristics lessening when multiple characteristics were weighted in combination. While first impressions alone may not drive product uptake, users’ willingness to initially try a product is likely impacted by such impressions. Developers should consider potential users’ experiences and preferences in vaginal film design. This user-focused approach is useful for characterizing user sensory perceptions and experiences relevant to early design of prevention technologies.

User evaluations offer promise for pod-intravaginal ring as a drug delivery platform: A mixed methods study of acceptability and use experiences

Background Effective HIV prevention requires efficient delivery of safe and efficacious drugs and optimization of user adherence. The user’s experiences with the drug, delivery system, and use parameters are critical to product acceptability and adherence. Prevention product developers have the opportunity to directly control a drug delivery system and its impact on acceptability and adherence, as well as product efficacy. Involvement of potential users during preclinical design and development can facilitate this process. We embedded a mixed methods user evaluation study into a safety and pharmacokinetics (PK) trial of a pod-intravaginal ring delivering antiretroviral agents. Methodology Women enrolled in two cohorts, ultimately evaluating the safety/PK of a pod-IVRs delivering TDF-alone, TDF-FTC, and/or TDF-FTC-MVC. A 7-day use period was targeted for each pod-IVR, regardless of drug or drug combination. During the clinical study, participants provided both quantitative (i.e., survey) and qualitative (i.e., in-depth interview) data capturing acceptability, perceptibility, and adherence behaviors. Initial sexual and reproductive health history surveys, daily diaries, a final acceptability and willingness to use survey, and a qualitative in-depth interview comprised the user evaluation data for each pod-IVR experienced by the participants. Findings Overall, the majority of participants (N = 10) reported being willing to use the pod-IVR platform for HIV prevention should it advance to market. Confidence to use the pod-IVR (e.g., insertion, removal) was high. There were no differences noted in the user experience of the pod-IVR platform; that is, whether the ring delivered TDF-alone, TDF-FTC, or TDF-FTC-MVC, users’ experiences of the ring were similar and acceptable. Participants did report specific experiences, both sensory and behavioral, that impacted their use behaviors with respect to the ring, and which could ultimately impact acceptability and adherence. These experiences, and user evaluations elicited by them, could both challenge use or be used to leverage use in future trials and product rollout once fully articulated. Conclusions High willingness-to-use data and lack of salient differences in user experiences related to use of the pod-IVR platform (regardless of agents delivered) suggests that the pod-IVR is a feasible and acceptable drug delivery device in and of itself. This finding holds promise both for an anti-HIV pod-IVR and, potentially, a multipurpose prevention pod-IVR that could deliver both prevention for sexually transmitted infections (STIs) including HIV and contraception. Given the very early clinical trial context, further acceptability, perceptibility, and adherence data should continue to be explored, in the context of longer use periods (e.g., 28-day ring use), and in the contexts of sexual activity and menses. Using early design and development contexts to gain insights into potential challenges and facilitators of drug delivery systems such as the pod-IVR could save valuable resources and time as a potential biomedical technology moves through the clinical trial pipeline and into real-world use.

Cardiovascular Risk Reduction in Persons Living With HIV: Treatment Development, Feasibility, and Preliminary Results

&NA; Persons living with HIV (PLWH) have elevated risks for cardiovascular disease (CVD). Our goal was to develop and pilot test a tailored intervention to improve CVD risk perception and the adoption of heart‐healthy behaviors. In‐depth qualitative interviews were conducted with 30 PLWH participants to examine learning needs and preferences. An intervention manual was developed and tested in an open pilot with eight participants. Participants were stable on antiretroviral therapy and were recruited from two urban HIV clinics in the northeastern United States. Thematic analysis identified five major themes: (a) tailored structure and design for PLWH, (b) learning needs (specific to HIV), (c) desire for prompts/reminders (to exercise), (d) importance of participant resources, and (e) need for personal evaluation and goal setting. Feasibility and acceptability of the intervention were demonstrated with high session attendance and treatment satisfaction. Further testing is warranted.