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.

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

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.

SummaryNegative 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 shortand the long-term.