Janice Rattray

Essential elements of questionnaire design and development

Aims.  The aims of this paper were (1) to raise awareness of the issues in questionnaire development and subsequent psychometric evaluation, and (2) to provide strategies to enable nurse researchers to design and develop their own measure and evaluate the quality of existing nursing measures. Background.  The number of questionnaires developed by nurses has increased in recent years. While the rigour applied to the questionnaire development process may be improving, we know that nurses are still not generally adept at the psychometric evaluation of new measures. This paper explores the process by which a reliable and valid questionnaire can be developed. Methods.  We critically evaluate the theoretical and methodological issues associated with questionnaire design and development and present a series of heuristic decision-making strategies at each stage of such development. The range of available scales is presented and we discuss strategies to enable item generation and development. The importance of stating a priori the number of factors expected in a prototypic measure is emphasized. Issues of reliability and validity are explored using item analysis and exploratory factor analysis and illustrated using examples from recent nursing research literature. Conclusion.  Questionnaire design and development must be supported by a logical, systematic and structured approach. To aid this process we present a framework that supports this and suggest strategies to demonstrate the reliability and validity of the new and developing measure. Relevance to clinical practice.  In developing the evidence base of nursing practice using this method of data collection, it is vital that questionnaire design incorporates preplanned methods to establish reliability and validity. Failure to develop a questionnaire sufficiently may lead to difficulty interpreting results, and this may impact upon clinical or educational practice. This paper presents a critical evaluation of the questionnaire design and development process and demonstrates good practice at each stage of this process.

The PRaCTICaL study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial

Objectives To test the hypothesis that nurse led follow-up programmes are effective and cost effective in improving quality of life after discharge from intensive care. Design A pragmatic, non-blinded, multicentre, randomised controlled trial. Setting Three UK hospitals (two teaching hospitals and one district general hospital). Participants 286 patients aged ≥18 years were recruited after discharge from intensive care between September 2006 and October 2007. Intervention Nurse led intensive care follow-up programmes versus standard care. Main outcome measure(s) Health related quality of life (measured with the SF-36 questionnaire) at 12 months after randomisation. A cost effectiveness analysis was also performed. Results 286 patients were recruited and 192 completed one year follow-up. At 12 months, there was no evidence of a difference in the SF-36 physical component score (mean 42.0 (SD 10.6) v 40.8 (SD 11.9), effect size 1.1 (95% CI −1.9 to 4.2), P=0.46) or the SF-36 mental component score (effect size 0.4 (−3.0 to 3.7), P=0.83). There were no statistically significant differences in secondary outcomes or subgroup analyses. Follow-up programmes were significantly more costly than standard care and are unlikely to be considered cost effective. Conclusions A nurse led intensive care follow-up programme showed no evidence of being effective or cost effective in improving patients’ quality of life in the year after discharge from intensive care. Further work should focus on the roles of early physical rehabilitation, delirium, cognitive dysfunction, and relatives in recovery from critical illness. Intensive care units should review their follow-up programmes in light of these results. Trial registration ISRCTN 24294750

Predictors of emotional outcomes of intensive care

Negative emotional outcomes (anxiety, depression and post‐traumatic stress) have been identified in patients discharged from intensive care. The aims of this prospective, longitudinal study were to assess levels of and changes in emotional outcome after intensive care, and to explore how these relate to objective and subjective indicators of the intensive care experience. Emotional outcome was assessed using the Hospital Anxiety and Depression and Impact of Event Scales. Anxiety (p = 0.046) and depression (p = 0.001) were reduced subsequently, but not avoidance (p = 0.340) or intrusion (p = 0.419). Most objective (age, gender, length of ICU and hospital stay) and subjective indicators (as measured by the Intensive Care Experience Questionnaire) of the intensive care experience were related to negative emotional outcome. Subjective interpretation of the intensive care experience emerged as a consistent predictor of adverse emotional outcome, in both the short‐ and the long‐term.

Increased Hospital-Based Physical Rehabilitation and Information Provision After Intensive Care Unit Discharge: The RECOVER Randomized Clinical Trial

IMPORTANCE Critical illness results in disability and reduced health-related quality of life (HRQOL), but the optimum timing and components of rehabilitation are uncertain. OBJECTIVE To evaluate the effect of increasing physical and nutritional rehabilitation plus information delivered during the post-intensive care unit (ICU) acute hospital stay by dedicated rehabilitation assistants on subsequent mobility, HRQOL, and prevalent disabilities. DESIGN, SETTING, AND PARTICIPANTS A parallel group, randomized clinical trial with blinded outcome assessment at 2 hospitals in Edinburgh, Scotland, of 240 patients discharged from the ICU between December 1, 2010, and January 31, 2013, who required at least 48 hours of mechanical ventilation. Analysis for the primary outcome and other 3-month outcomes was performed between June and August 2013; for the 6- and 12-month outcomes and the health economic evaluation, between March and April 2014. INTERVENTIONS During the post-ICU hospital stay, both groups received physiotherapy and dietetic, occupational, and speech/language therapy, but patients in the intervention group received rehabilitation that typically increased the frequency of mobility and exercise therapies 2- to 3-fold, increased dietetic assessment and treatment, used individualized goal setting, and provided greater illness-specific information. Intervention group therapy was coordinated and delivered by a dedicated rehabilitation practitioner. MAIN OUTCOMES AND MEASURES The Rivermead Mobility Index (RMI) (range 0-15) at 3 months; higher scores indicate greater mobility. Secondary outcomes included HRQOL, psychological outcomes, self-reported symptoms, patient experience, and cost-effectiveness during a 12-month follow-up (completed in February 2014). RESULTS Median RMI at randomization was 3 (interquartile range [IQR], 1-6) and at 3 months was 13 (IQR, 10-14) for the intervention and usual care groups (mean difference, -0.2 [95% CI, -1.3 to 0.9; P = .71]). The HRQOL scores were unchanged by the intervention (mean difference in the Physical Component Summary score, -0.1 [95% CI, -3.3 to 3.1; P = .96]; and in the Mental Component Summary score, 0.2 [95% CI, -3.4 to 3.8; P = .91]). No differences were found for self-reported symptoms of fatigue, pain, appetite, joint stiffness, or breathlessness. Levels of anxiety, depression, and posttraumatic stress were similar, as were hand grip strength and the timed Up & Go test. No differences were found at the 6- or 12-month follow-up for any outcome measures. However, patients in the intervention group reported greater satisfaction with physiotherapy, nutritional support, coordination of care, and information provision. CONCLUSIONS AND RELEVANCE Post-ICU hospital-based rehabilitation, including increased physical and nutritional therapy plus information provision, did not improve physical recovery or HRQOL, but improved patient satisfaction with many aspects of recovery. TRIAL REGISTRATION isrctn.com Identifier: ISRCTN09412438.

People's experiences of being mechanically ventilated in an ICU: A qualitative study

OBJECTIVES In previous studies people receiving mechanical ventilation treatment have described experiencing distress over their inability to speak and feelings such as anxiety. More research is needed to improve their experience in the intensive care unit and promote recovery. The aim of this study was to describe the intensive care unit experiences of people undergoing mechanical ventilation. METHOD Qualitative, personal interviews were conducted during 2011 with eight people who were mechanically ventilated in an intensive care unit in the northern part of Sweden. Interview transcripts were analysed using qualitative content analysis. FINDINGS Two themes emerged, with four and three categories, respectively. Being dependent for survival on other people and technical medical equipment created a sense of being vulnerable in an anxious situation and a feeling of uncertainty about ones own capacity to breathe. Having lines and tubes in ones body was stressful. Being given a diary and follow-up visit to the intensive care unit after the stay were important tools for filling in the missing time, but there was also one participant who did not want to remember his stay in the intensive care unit. CONCLUSION To be dependent on other people and technical medical equipment for survival creates a sense of being delivered into the hands of others, as the people being mechanically ventilated could not trust their body to function.

A Pragmatic Randomised, Controlled Trial of Intensive Care follow up programmes in improving Longer-term outcomes from critical illness. The PRACTICAL study

BackgroundA number of intensive care (ICU) patients experience significant problems with physical, psychological, and social functioning for some time after discharge from ICU. These problems have implications not just for patients, but impose a continuing financial burden for the National Health Service. To support recovery, a number of hospitals across the UK have developed Intensive Care follow-up clinics. However, there is a lack of evidence base to support these, and this study aims to test the hypothesis that intensive care follow up programmes are effective and cost-effective at improving physical and psychological quality of life in the year after intensive care discharge.Methods/DesignThis is a multi-centre, pragmatic, randomised controlled trial. Patients (n = 270) will be recruited prior to hospital discharge from three intensive care units in the UK, and randomised to one of two groups. The control group will receive standard in-hospital follow-up and the intervention group will participate in an ICU follow-up programme with clinic appointments 2–3 and 9 months after ICU discharge.The primary outcome measure is Health-related Quality of Life (HRQoL) 12 months after ICU discharge as measured by the Short Form-36. Secondary measures include: HRQoL at six months; Quality-adjusted life years using EQ-5D; posttraumatic psychopathology as measured by Davidson Trauma Scale; and anxiety and depression using the Hospital Anxiety and Depression Scale at both six and twelve months after ICU discharge. Contacts with health services in the twelve months after ICU discharge will be measured as part of the economic analysis.DiscussionThe provision of intensive care follow-up clinics within the UK has developed in an ad hoc manner, is inconsistent in both the number of hospitals offering such a service or in the type of service offered. This study provides the opportunity to evaluate such services both in terms of patient benefit and cost-effectiveness. The results of this study therefore will inform clinical practice and policy with regard to the appropriate development of such services aimed at improving outcomes after intensive care.Trial RegistrationISRCTN24294750.

Exploring the relationship between coping, social support and health-related quality of life for prostate cancer survivors: A review of the literature

OBJECTIVE Men affected by prostate cancer can experience profound physical and psychological sequalae; and unmet support needs are prevalent in men affected by this disease. Social support has been linked to improved health-related quality of life (HRQoL) and coping strategies, but little is known about the relationship between social support, coping and HRQoL for prostate cancer survivors. This review aims to identify the mechanism through which social support influences the relationship between coping and HRQoL for prostate cancer survivors. METHODS A literature review was conducted from the earliest date available to January 2013. Medline, CINAHL, PsycInfo, and ASSIA databases were searched using terms relevant to coping, social support and prostate cancer. Studies that explored the relationship between coping, social support and HRQoL were included. RESULTS 175 studies were assessed for potential inclusion with 11 publications included in this review. Studies predominately reported main effects of perceived social support on HRQoL, and few studies assessed moderation and mediation effects of coping and social support on HRQoL. Perceived social support was frequently assessed, but few studies evaluated the effects of received social support or satisfaction with social support on HRQoL. CONCLUSIONS The evidence base is under-developed at present. Future research should use a multidimensional inventory of the social support constructs to examine how each of the constructs influences the relationship between coping and HRQoL over time. This may facilitate the development of appropriately targeted social support interventions that are theoretically driven to address the unmet support needs of prostate cancer survivors.

The use of diaries in psychological recovery from intensive care

Intensive care patients frequently experience memory loss, nightmares, and delusional memories and some may develop symptoms of anxiety, depression, and post-traumatic stress. The use of diaries is emerging as a putative tool to ‘fill the memory gaps’ and promote psychological recovery. In this review, we critically analyze the available literature regarding the use and impact of diaries for intensive care patients specifically to examine the impact of diaries on intensive care patients’ recovery. Diversity of practice in regard to the structure, content, and process elements of diaries for intensive care patients exists and emphasizes the lack of an underpinning psychological conceptualization. The use of diaries as an intervention to aid psychological recovery in intensive care patients has been examined in 11 studies, including two randomized controlled trials. Inconsistencies exist in sample characteristics, study outcomes, study methods, and the diary intervention itself, limiting the amount of comparison that is possible between studies. Measurement of the impact of the diary intervention on patient outcomes has been limited in both scope and time frame. Furthermore, an underpinning conceptualization or rationale for diaries as an intervention has not been articulated or tested. Given these significant limitations, although findings tend to be positive, implementation as routine clinical practice should not occur until a body of evidence is developed to inform methodological considerations and confirm proposed benefits.

Intensive care diaries to promote recovery for patients and families after critical illness: A Cochrane Systematic Review

OBJECTIVES To assess the effect of an intensive care unit (ICU) diary versus no ICU diary on patients, and their caregivers or families, during the patients recovery from admission to an ICU. DESIGN Systematic review of randomized controlled trials (RCTs) and clinical controlled trials. DATA SOURCES CENTRAL, MEDLINE, CINAHL, EMBASE, PsycINFO, PILOT; Web of Science Conference Proceedings, clinical trial registries and reference lists of identified trials. REVIEW METHODS Studies evaluated the effectiveness of patient diaries, when compared to no ICU diary, for patients or family members to promote recovery after admission to ICU were included. Outcome measures for describing recovery from ICU included the risk of post-traumatic stress disorder (PTSD), anxiety, depression and post-traumatic stress symptomatology, health-related quality of life and costs. We used standard methodological approaches as expected by The Cochrane Collaboration. Two review authors independently reviewed titles for inclusion, extracted data and undertook risk of bias according to pre-specified criteria. RESULTS We identified three eligible studies; two describing ICU patients (N=358), and one describing relatives of ICU patients (N=30). No study adequately reported on risk of PTSD as described using a clinical interview, family or caregiver anxiety or depression, health-related quality of life or costs. Within a single study there was no clear evidence of a difference in risk for developing anxiety (RR 0.29, 95% CI 0.07-1.19) or depression (RR 0.38, 95% CI 0.12-1.19) in participants who received ICU diaries, in comparison to those that did not receive a patient diary. Within a single study there was no evidence of difference in median post-traumatic stress symptomatology scores (diaries 24, SD 11.6; no diary 24, SD 11.6) and delusional ICU memory recall (RR 1.04, 95% CI 0.84-1.28) between the patients recovering from ICU admission who received patient diaries, and those who did not. One study reported reduced post-traumatic stress symptomatology in family members of patients recovering from admission to ICU who received patient diaries (median 19; range 14-28), in comparison to no diary (median 28; range 14-38). CONCLUSIONS Currently there is minimal evidence from RCTs of the benefits or harms of patient diaries for patients and their caregivers or family members. A small study has described their potential to reduce post-traumatic stress symptomatology in family members. However, there is currently inadequate evidence to support their effectiveness in improving psychological recovery after critical illness for patients and their family members.

What is the relationship between elements of ICU treatment and memories after discharge in adult ICU survivors

OBJECTIVES Patients admitted to an intensive care unit (ICU) often experience distressing memories during recovery that have been associated with poor psychological and cognitive outcomes. The aim of this literature review was to synthesise the literature reporting on relationships between elements of ICU treatment and memories after discharge in adult ICU survivors. REVIEW METHOD USED Integrative review methods were used to systematically search, select, extract, appraise and summarise current knowledge from the available research and identify gaps in the literature. DATA SOURCES The following electronic databases were systematically searched: PubMed, Ovid EMBASE, EBSCOhost CINAHL, PsycINFO and Cochrane Central Register of Controlled Trials. Additional studies were identified through searches of bibliographies. Original quantitative research articles written in English that were published in peer-review journals were included. REVIEW METHODS Data extracted from studies included authors, study aims, population, sample size and characteristics, methods, ICU treatments, ICU memory definitions, data collection strategies and findings. Study quality assessment was based on elements of the Critical Appraisal Skills Programme using the checklists developed for randomised controlled trials and cohort studies. RESULTS Fourteen articles containing data from 13 studies met the inclusion criteria and were included in the final analysis. The relatively limited evidence about the association between elements of ICU treatment and memories after ICU discharge suggest that deep sedation, corticoids and administration of glucose 50% due to hypoglycaemia contribute to the development of delusional memories and amnesia of ICU stay. CONCLUSIONS The body of literature on the relationship between elements of ICU treatment and memories after ICU discharge is small and at its early stages. Larger studies using rigorous study design are needed in order to evaluate the effects of different elements of ICU treatment on the development of memories of the ICU during recovery.