Starting a conversation about estimands with public partners involved in clinical trials: a co-developed tool.

BACKGROUND: Clinical trials aim to draw conclusions about the effects of treatments, but a trial can address many different potential questions. For example, does the treatment work well for patients who take it as prescribed? Or does it work regardless of whether patients take it exactly as prescribed? Since different questions can lead to different conclusions on treatment benefit, it is important to clearly understand what treatment effect a trial aims to investigate-this is called the 'estimand'. Using estimands helps to ensure trials are designed and analysed to answer the questions of interest to different stakeholders, including patients and public. However, there is uncertainty about whether patients and public would like to be involved in defining estimands and how to do so. Public partners are patients and/or members of the public who are part of, or advise, the research team. We aimed to (i) co-develop a tool with public partners that helps explain what an estimand is and (ii) explore public partner's perspectives on the importance of discussing estimands during trial design. METHODS: An online consultation meeting was held with 5 public partners of mixed age, gender and ethnicities, from various regions of the UK. Public partner opinions were collected and a practical tool describing estimands, drafted before the meeting by the research team, was developed. Afterwards, the tool was refined, and additional feedback sought via email. RESULTS: Public partners want to be involved in estimand discussions. They found an introductory tool, to be presented and described to them by a researcher, helpful for starting a discussion about estimands in a trial design context. They recommended storytelling, analogies and visual aids within the tool. Four topics related to public partners' involvement in defining estimands were identified: (i) the importance of addressing questions that are relevant to patients and public in trials, (ii) involving public partners early on, (iii) a need for education and communication for all stakeholders and (iv) public partners and researchers working together. CONCLUSIONS: We co-developed a tool for researchers and public partners to use to facilitate the involvement of public partners in estimand discussions.

Exploring the care experience of patients undergoing spinal surgery: a qualitative study.

PURPOSE: This exploratory study sought to explore the patient experience of the surgical journey from decision to operate, to hospitalization, discharge and subsequent recovery. DESIGN: Patients attended one of two focus group discussions. PATIENT SAMPLE: Seven patients that had undergone surgery for spinal stenosis or disc prolapsed participated, aged between 48-75 years (mean age 59); five were male. METHODS: Patients' attitudes towards the information and care they received from the point of the decision to operate through to post-operative recovery were explored. Particular attention was paid to patients' information needs, support provided, general understanding of the processes and ways in which care could have been improved. RESULTS: Patients identified nine main 'needs' they felt played an integral part in enhancing the patient experience including the need for reduced waiting times, for better information and preparation, to be proactive, to speak up and ask questions, to feel safe and to be treated with dignity and respect; and the need for ongoing support, human contact, and; continuity of care. CONCLUSION: These findings suggest that there are several measures that could be taken to improve the patient's surgical experience. In particular, providing appropriate information to patients in a timely manner and ensuring that support and advice is easily accessible for those patients that need it are key areas for improvement.

An evaluation of a postoperative rehabilitation program after spinal surgery and its impact on outcome.

STUDY DESIGN: This study invited patients to evaluate the content and style of a rehabilitation program used as an intervention in a multicenter, factorial, randomized controlled trial of the postoperative management of spinal surgery patients. OBJECTIVE: To determine the acceptability and content of the rehabilitation program. SUMMARY OF BACKGROUND DATA: The use of rehabilitation after spinal surgery is sporadic, and the evidence for its benefit is mixed. A randomized controlled trial was conducted to determine whether functional outcome of spinal surgery could be improved by a postoperative rehabilitation program and/or an educational booklet provided at hospital discharge, each compared with usual care. METHODS: Patients randomized to postoperative rehabilitation began the course 6 weeks after surgery. At the end of the course of 12 classes, patients completed an evaluation of content, style, and length using forced choice and open questions. Patients not attending the final class completed the evaluation at their 3-month review. RESULTS: Compliance with rehabilitation was poor, with 41% of subjects failing to attend any classes and 16% attending less than half. Compliance with the evaluation was 100% for the 105 patients attending 1 or more classes. The length, content, and approach to the classes were rated positively, and patients gave the class a median rating of 9 of 10, range 5 to 10, with 91% rating the classes as 7 or above. CONCLUSION: Compliance with a postoperative rehabilitation program was disappointing, but the program was assessed positively and of benefit by those who attended. Issues were raised in relation to timing and location of classes.