"It kind of strips down your relationship to its defining features it just kind of shone a light on what was already there": A grounded theory of the impact of postpartum psychosis on the couple's relationship.

BACKGROUND: Postpartum psychosis is a severe mental health illness following childbirth. Studies to date have developed from initial focus on experiences of women to address the role and experiences of partners, and recently to touch on the effect on their relationship. This study aimed to build on this work, by focussing directly on the impact of postpartum psychosis on the couple's relationship, from the perspectives of both the woman and her partner. METHOD: A constructivist grounded theory approach was utilised to generate a theory that explained the impact of postpartum psychosis on the couple's relationship. In-depth semi-structured interviews were completed with a sample of eight women and six partners. RESULTS: Four stages and five general categories described the processes that the couple experienced, and the impact postpartum psychosis had on their relationship. DISCUSSION: The grounded theory adds to current evidence and helps increase understanding of factors that play a role in adjustment and outcomes. New insights were identified, including postpartum psychosis amplifying existing relational patterns; and the mediating role of the pre-existing relationship and couplehood. Clinical implications and areas for further research are considered.

To Trial or Not to Trial Before Spinal Cord Stimulation for Chronic Neuropathic Pain: The Patients' View From the TRIAL-STIM Randomized Controlled Trial.

Objectives Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine suitability for a permanent implant, its evidence base is limited. The recent TRIAL-STIM study (a randomized controlled trial at three centers in the United Kingdom) found no evidence that an SCS screening trial strategy provides superior patient outcomes as compared with a no trial approach. As part of the TRIAL-STIM study, we undertook a nested qualitative study to ascertain patients' preferences in relation to undergoing a screening trial or not. Materials and Methods We interviewed 31 patients sampled from all three centers and both study arms (screening trial/no trial) prior to SCS implantation, and 23 of these patients again following implantation (eight patients were lost to follow-up). Interviews were undertaken by telephone and audio-recorded, then transcripts were subject to thematic analysis. In addition, participants were asked to state their overall preference for a one-stage (no screening trial) versus two-stage (screening trial) implant procedure on a five-point Likert scale, before and after implantation. Results Emergent themes favoured the option for a one-stage SCS procedure. Themes identified include: saving time (off work, in hospital, attending appointments), avoiding the worry about having "loose wires" in the two-stage procedure, having only one period of recovery, and saving NHS resources. Participants' rated preferences show similar support for a one-stage procedure without a screening trial. Conclusions Our findings indicate an overwhelming preference among participants for a one-stage SCS procedure both before and after the implant, regardless of which procedure they had undergone. The qualitative study findings further support the TRIAL-STIM RCT results.

Reflection for all healthcare staff: A national evaluation of Schwartz Rounds.

The emotional toll of working in healthcare is widely recognised, but staff rarely have time to reflect on their experiences. Schwartz Rounds provide an opportunity for all staff in a healthcare organisation to meet regularly and reflect on the human connections made with patients and the emotional impact of their work. They are now running in over 200 organisations across the UK & Ireland. In the first evaluation of a national sample in the UK, we review feedback received from a large sample of 402 Schwartz Rounds in a total of 47 organisations, including acute and non-acute NHS trusts and hospices. Analyses were undertaken to explore self-reported experiences of the Rounds, and differences between the proportions of professional staff groups attending. The overall experience of Schwartz Rounds was very positive across all settings. In particular, staff reported that Rounds helped them to gain insight into the working lives of their colleagues. There were no differences between the responses of clinical and non-clinical staff, indicating that all staff value a reflective space regardless of background. Healthcare staff value an opportunity to reflect on the emotional impact of their work. In increasingly overstretched and hurried services, it is a priority to provide this.

An Exploration of the Experiences and Educational Needs of Patients With Failed Back Surgery Syndrome Receiving Spinal Cord Stimulation.

OBJECTIVE: To explore the experience of spinal cord stimulation (SCS) for patients with failed back surgery syndrome (FBSS). METHODS: Adults with FBSS referred for SCS underwent semistructured interviews at three time points: before their SCS trial, after the trial, and three months after receiving the SCS implant. The face-to-face interviews were audio recorded, transcribed verbatim and analyzed thematically. RESULTS: Twelve adults (8 male, 4 female, aged 38-80 years, pain duration 1-26 years) were recruited. Six themes were identified; 1) What should I expect? 2) Varied outcomes, 3) Understanding pain and this new treatment, 4) Experiences of the SCS journey, 5) Getting used to the device, and 6) Finding out what I need to know. Participants' expectations were varied and the procedures were broadly viewed as minor surgery. Participants' expectations about SCS were not limited to pain relief and included reductions in medication, better sleep, and increased physical activity. Participants' understanding of pain and how SCS purports to work was limited. Throughout the process, practical challenges were identified such as the surgical wound management and battery recharging. Participants received information from multiple sources and identified a range of key information needs including a quick-start guide on how to operate the device and a list of dos and don'ts. CONCLUSIONS: Overall, participants' understanding of SCS was limited. The value participants placed on understanding of the process varied markedly. A list of practical informational needs has been identified. Bespoke, user-friendly, informational tools should be developed from this list to enhance the patient experience of SCS.

Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain.

Spinal cord stimulation (SCS) has demonstrated effectiveness for neuropathic pain. Unfortunately, some patients report inadequate long-term pain relief. Patient selection is emphasized for this therapy; however, the prognostic capabilities and deployment strategies of existing selection techniques, including an SCS trial, have been questioned. After approval by the Board of Directors of the American Society of Regional Anesthesia and Pain Medicine, a steering committee was formed to develop evidence-based guidelines for patient selection and the role of an SCS trial. Representatives of professional organizations with clinical expertize were invited to participate as committee members. A comprehensive literature review was carried out by the steering committee, and the results organized into narrative reports, which were circulated to all the committee members. Individual statements and recommendations within each of seven sections were formulated by the steering committee and circulated to members for voting. We used a modified Delphi method wherein drafts were circulated to each member in a blinded fashion for voting. Comments were incorporated in the subsequent revisions, which were recirculated for voting to achieve consensus. Seven sections with a total of 39 recommendations were approved with 100% consensus from all the members. Sections included definitions and terminology of SCS trial; benefits of SCS trial; screening for psychosocial characteristics; patient perceptions on SCS therapy and the use of trial; other patient predictors of SCS therapy; conduct of SCS trials; and evaluation of SCS trials including minimum criteria for success. Recommendations included that SCS trial should be performed before a definitive SCS implant except in anginal pain (grade B). All patients must be screened with an objective validated instrument for psychosocial factors, and this must include depression (grade B). Despite some limitations, a trial helps patient selection and provides patients with an opportunity to experience the therapy. These recommendations are expected to guide practicing physicians and other stakeholders and should not be mistaken as practice standards. Physicians should continue to make their best judgment based on individual patient considerations and preferences.

Prospective analysis of the trial period for spinal cord stimulation treatment for chronic pain.

OBJECTIVE: To determine patient preferences regarding the duration of trial period. MATERIALS AND METHODS: Forty patients were given a trial of spinal cord stimulation. They were questioned daily if they would like to proceed to a permanent implant. Three consecutive affirmative answers implied a successful trial; three negative replies implied a failed trial. Patients rated daily the pain from the surgery, original pain, satisfaction with the stimulator, and the duration of the use of the stimulator. RESULTS: The trial duration varied from 3 to 15 days. Patients with a failed trial took longer to make a decision and also experienced prolonged surgical pain. The majority of patients with a successful trial experienced more than 50% pain reduction. The rate of infection was 7.5%, which has reduced to 2.8% after changing the dressing protocol. CONCLUSIONS: In this study, all patients could make a decision in 15 days, with successful trials requiring a shorter duration. The conversion rate was similar to rates in literature despite patients making a decision without physician input.

Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? A randomised controlled trial.

Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine whether a patient should receive permanent SCS implant, its evidence base is limited. We aimed to establish the clinical utility, diagnostic accuracy, and cost-effectiveness of an SCS screening trial. A multicentre single-blind, parallel two-group randomised controlled superiority trial was undertaken at 3 centres in the United Kingdom. Patients were randomised 1:1 to either SCS screening trial strategy (TG) or no trial screening strategy (NTG). Treatment was open label, but outcome assessors were masked. The primary outcome measure was numerical rating scale (NRS) pain at 6-month follow-up. Between June 2017 and September 2018, 105 participants were enrolled and randomised (TG = 54, NTG = 51). Mean numerical rating scale pain decreased from 7.47 at baseline (before SCS implantation) to 4.28 at 6 months in TG and from 7.54 to 4.49 in NTG (mean group difference: 0.2, 95% confidence interval [CI]: -1.2 to 0.9, P = 0.89). We found no difference between TG and NTG in the proportion of pain responders or other secondary outcomes. Spinal cord stimulation screening trial had a sensitivity of 100% (95% CI: 78-100) and specificity of 8% (95% CI: 1-25). The mean incremental cost-effectiveness ratio of TG vs NTG was £78,895 per additional quality-adjusted life-year gained. In conclusion, although the SCS screening trial may have some diagnostic utility, there was no evidence that an SCS screening TG provides superior patient outcomes or is cost-effective compared to a no trial screening approach.

Correction to: Does a Screening Trial for Spinal Cord Stimulation in Patients with Chronic Pain of Neuropathic Origin have Clinical Utility and Cost-Effectiveness? (TRIAL-STIM Study): study protocol for a randomised controlled trial.

Following publication of the original article [1], we have been notified that the final specification of randomisation implemented in the study is slightly different to that stated in the protocol and needs to be corrected as follows.

Does a Screening Trial for Spinal Cord Stimulation in Patients with Chronic Pain of Neuropathic Origin have Clinical Utility and Cost-Effectiveness? (TRIAL-STIM Study): study protocol for a randomised controlled trial.

BACKGROUND: The TRIAL-STIM Study aims to assess the diagnostic performance, clinical outcomes and cost-effectiveness of a screening trial prior to full implantation of a spinal cord stimulation (SCS) device. METHODS/DESIGN: The TRIAL-STIM Study is a superiority, parallel-group, three-centre, randomised controlled trial in patients with chronic neuropathic pain with a nested qualitative study and economic evaluation. The study will take place in three UK centres: South Tees Hospitals NHS Foundation Trust (The James Cook University Hospital); Basildon and Thurrock University Hospitals NHS Foundation Trust; and Leeds Teaching Hospitals NHS Trust. A total of 100 adults undergoing SCS implantation for the treatment of neuropathy will be included. Subjects will be recruited from the outpatient clinics of the three participating sites and randomised to undergo a screening trial prior to SCS implant or an implantation-only strategy in a 1:1 ratio. Allocation will be stratified by centre and minimised on patient age (≥ 65 or < 65 years), gender, presence of failed back surgery syndrome (or not) and use of high frequency (HF10™) (or not). The primary outcome measure is the numerical rating scale (NRS) at 6 months compared between the screening trial and implantation strategy and the implantation-only strategy. Secondary outcome measures will include diagnostic accuracy, the proportion of patients achieving at least 50% and 30% pain relief at 6 months as measured on the NRS, health-related quality-of-life (EQ-5D), function (Oswestry Disability Index), patient satisfaction (Patients' Global Impression of Change) and complication rates. A nested qualitative study will be carried out in parallel for a total of 30 of the patients recruited in each centre (10 at each centre) to explore their views of the screening trial, implantation and overall use of the SCS device. The economic evaluation will take the form of a cost-utility analysis. DISCUSSION: The TRIAL-STIM Study is a randomised controlled trial with a nested qualitative study and economic evaluation aiming to determine the clinical utility of screening trials of SCS as well as their cost-effectiveness. The nested qualitative study will seek to explore the patient's view of the screening trials, implantation and overall use of SCS. TRIAL REGISTRATION: ISRCTN, ISRCTN60778781 . Registered on 15 August 2017.

Support for compassionate care: Quantitative and qualitative evaluation of Schwartz Center Rounds in an acute general hospital.

OBJECTIVE: To evaluate the impact of Schwartz Center Rounds, a multi-disciplinary forum to reflect on the emotional consequences of working in healthcare, on the staff of a large acute general hospital over a three-year period. DESIGN: Evaluation data following each Round were collected routinely from all staff attending over this period and analysed quantitatively and qualitatively. SETTING: An integrated university teaching trust with both acute hospital and community services in the North East of England. PARTICIPANTS: Over the three-year period of the study, 795 participant evaluation forms were returned by staff attending the Rounds. MAIN OUTCOME MEASURES: A standard evaluation form completed at the end of each Round by those present, including ratings on a five-point scale against each of eight statements and an opportunity to offer additional free text comments. RESULTS: The findings show a very positive response to all aspects of the Rounds by staff who attended. The most highly rated statement was: 'I have gained insight into how others think/feel in caring for patients'. This was reinforced by the qualitative analysis in which the primary theme was found to be Insight. There were no significant differences between disciplines/staff groups, indicating that all staff whether clinical or non-clinical responded to the Rounds equally positively. CONCLUSIONS: Schwartz Rounds are highly valued by staff from all disciplines, and by managers and other non-clinicians as well as clinicians. They appear to have the potential to increase understanding between different staff, and so to reduce isolation and provide support.

Can compassionate healthcare be measured? The Schwartz Center Compassionate Care Scale™.

OBJECTIVE: Assess psychometric characteristics of an instrument to measure patient ratings of treating physicians' compassionate care in a recent hospitalization. METHODS: We used Cronbach's alpha to examine scale reliability, exploratory and confirmatory factor analysis to examine scale structure of two sets of items on compassionate care. We used Mokken analysis to determine if items in each set belonged to a unidimensional scale. RESULTS: Results indicated that both sets of items had strong reliability when used to rate individual physicians (Cronbach's α=.97 and .95). A one factor model was a good fit to both sets of items. Mokken analysis supported unidimensional scales. Both sets of items correlated with an overall measure of patient satisfaction with physicians and even more strongly with an item measuring emotional support. CONCLUSIONS: A patient-rated scale reliably measured hospital physicians' compassion and correlated significantly with an item measuring overall patient satisfaction and a specific measure of satisfaction with emotional support. Measurement of compassionate healthcare should be included in research, educational assessment, and quality improvement programs. PRACTICE IMPLICATIONS: Clinicians should participate in efforts to enhance their ability to demonstrate compassionate care including eliciting and sharing information and acting collaboratively to ameliorate patients' socioemotional concerns and needs.

Spinal Cord Independence Measure, version III: applicability to the UK spinal cord injured population.

OBJECTIVE: To examine the validity, reliability and usefulness of the Spinal Cord Independence Measure for the UK spinal cord injury population. DESIGN: Multi-centre cohort study. SETTING: Four UK regional spinal cord injury centres. SUBJECTS: Eighty-six people with spinal cord injury. INTERVENTIONS: Spinal Cord Independence Measure and Functional Independence Measure on admission analysed using inferential statistics, and Rasch analysis of Spinal Cord Independence Measure. MAIN OUTCOME MEASURES: Internal consistency, inter-rater reliability, discriminant validity; Spinal Cord Independence Measure subscale match between distribution of item difficulty and patient ability measurements; reliability of patient ability measures; fit of data to Rasch model; unidimensionality of subscales; hierarchical ordering of categories within items; differential item functioning across patient groups. RESULTS: Scale reliability (kappa coefficients range 0.491-0.835; (p < 0.001)), internal consistency (Cronbach's alpha 0.770 and 0.780 for raters), and validity (Pearson correlation; p < 0.01) were all significant. Spinal Cord Independence Measure subscales compatible with stringent Rasch requirements; mean infit indices high; distinct strata of abilities identified; most thresholds ordered; item hierarchy stable across clinical groups and centres. Misfit and differences in item hierarchy identified. Difficulties assessing central cord injuries highlighted. CONCLUSION: Conventional statistical and Rasch analyses justify the use of the Spinal Cord Independence Measure in clinical practice and research in the UK. Cross-cultural validity may be further improved.