Clare Harley

The development, assessment, and selection of questionnaires.

Patient-reported outcome measurement has become accepted as an important component of comprehensive outcomes research. Researchers wishing to use a patient-reported measure must either develop their own questionnaire (called an instrument in the research literature) or choose from the myriad of instruments previously reported. This article summarizes how previously developed instruments are best assessed using a systematic process and we propose a system of quality assessment so that clinicians and researchers can determine whether there exists an appropriately developed and validated instrument that matches their particular needs. These quality assessment criteria may also be useful to guide new instrument development and refinement. We welcome debate over the appropriateness of these criteria as this will lead to the evolution of better quality assessment criteria and in turn better assessment of patient-reported outcomes.

Individual differences in deductive reasoning

Three studies are reported, which examined individual differences in deductive reasoning as a function of intellectual ability and thinking style. Intellectual ability was a good predictor of logical performance on syllogisms, especially where there was a conflict between logic and believability. However, in the first two experiments there was no link between ability and performance on indicative selection tasks, in sharp contrast to previous research. This correlation did, however, return in the final study. Our data are consistent with the claim that the correlation with logical accuracy on abstract selection tasks is found primarily with participants of relatively high ability. At lower levels, pragmatically cued responses are given but those of slightly higher ability divorce the rule from the scenario and respond consistently (though incorrectly) across problems. Self-report questionnaires were generally poor predictors of performance, but a measure of the ability to generate alternative representations proved an excellent predictor. These results are consistent with a mental models approach to reasoning and also have implications for the debate about human rationality.

Stepping over obstacles: Attention demands and aging

Older adults have been shown to trip on obstacles despite taking precautions to step carefully. It has been demonstrated in dual-task walking that age-related decline in cognitive and attentional mechanisms can compromise postural management. This is yet to be substantiated during obstacle negotiation when walking. Forty-six healthy volunteers (aged 20-79 years) stepped over obstacles in their path whilst walking and performing a verbal fluency task. Using 3D kinematic analysis we compared obstacle crossing during single-task (obstacle crossing only) and dual-task (obstacle crossing with verbal task) conditions. We grouped the participants into three age groups and examined age-related changes to cognitive interference on obstacle crossing. During dual-task trials, the 20-29 and 60-69 groups stepped closer to the obstacles prior to crossing, increased vertical toe-obstacle clearance, and had reduced gait variability. In these two groups there was a small dual-task decrease in verbal output. The 70-79 group applied similar dual-task stepping strategies during pre-crossing. However, during crossing they showed reduced vertical toe-to-obstacle clearance and increased variability of obstacle-to-heel distance. Additionally, this group did not show any significant change to verbal output across trials. These results suggest that with advanced age, increased cognitive demands are more likely to have a detrimental impact on motor performance, leading to compromised safety margins and increased variability in foot placement. We conclude that younger adults utilise a posture-preserving strategy during complex tasks but the likelihood of this strategy being used decreases with advanced age.

Discussion of emotional and social impact of cancer during outpatient oncology consultations

Objective: Following publication of national guidelines on detection and management of psychosocial problems in oncology, this study explores frequency of discussion of emotional and social issues in outpatient oncology consultations.

Interventions for sexual problems following treatment for breast cancer: a systematic review.

Sexual functioning is an important element of quality of life. Many women experience sexual problems as a result of a breast cancer diagnosis and its treatment. Little is known about the availability and the effectiveness of interventions for sexual problems in this patient population. Six electronic databases were searched using Medical Subject Headings and keywords. Additional hand searching of the references of relevant papers was also conducted. The searches were conducted between October 2010 and January 2011. Papers were included if they evaluated interventions for sexual problems caused as a result of breast cancer or its treatment. Studies were only included if sexual functioning was reported using a patient-reported outcome questionnaire. Studies were excluded if sexual functioning was measured but improving sexual problems was not one of the main aims of the intervention. 3514 papers were identified in the initial search. 21 papers were selected for inclusion. Studies were of mixed methodological quality; 15 randomised trials were identified, many included small sample sizes and the use of non-validated questionnaires. Three main types of interventions were identified: Exercise (2), medical (2) and psycho-educational (17). The psycho-educational interventions included skills-based training such as problem-solving and communication skills, counselling, hypnosis, education and specific sex-therapies. Interventions were delivered to individual patients, patients and their partners (couple-based) and groups of patients. The widespread methodological variability hinders the development of a coherent picture about which interventions work for whom. Tentative findings suggest the most effective interventions are couple-based psycho-educational interventions that include an element of sexual therapy. More methodologically strong research is needed before any intervention can be recommended for clinical practice. Improved screening and classification of sexual problems will ensure interventions can be more effectively targeted to suit individual patient needs.

Use of single-vision eyeglasses improves stepping precision and safety when elderly habitual multifocal wearers negotiate a raised surface.

justed for age, activities of daily living, mental status, skin condition, and 20 medical diagnoses, including organic psychotic disorders, Parkinson’s disease, and diabetes mellitus. After adjustments, the residents catheterized for 76% or more of days were three times as likely to die, be hospitalized, or require antibiotics. Excess deaths attributed to Foley catheters are apparently related to infection and kidney damage. Additional concerns include to the ‘‘one-point immobilization’’ mentioned in the Holroyd-Leduc article, as well as a potential need for restraints and sedation to avoid catheterrelated trauma or removal with an inflated bulb. Urinary catheters provide a biofilm-laden conduit for skin and bowel flora to enter the bladder. The catheter may become a sharp-edged instrument coated with encrusted bacterial biofilm and struvite crystals that can abrade and even lacerate the mucosa if differing forces are applied to the torso and drainage system. Self-manipulation with trauma, especially removal with the bulb inflated or catheter obstruction, are dangerous and may be associated with fatal bacteremia. In one case series, 13 consecutive admissions with urosepsis had catheter obstruction, traumatic manipulation, or removal with an inflated balloon within the previous 72 hours. There is also some evidence that men have more problems with urethral catheters, because the catheter may interfere with drainage of seminal secretions. Urethral catheterization in men is associated with epididymitis, orchitis, scrotal abscess, prostatitis, and prostatic abscess, conditions not present in women. I would appreciate if the authors could check their database to determine whether excess deaths were more prominent in men.

Disruption of sitting balance after stroke: influence of spoken output

Objectives: To identify the extent of dual task interference between cognitive and motor tasks, (cognitive motor interference (CMI)) in sitting balance during recovery from stroke; to compare CMI in sitting balance between stroke and non-stroke groups; and to record any changes to CMI during sitting that correlate with functional recovery. Method: 36 patients from stroke rehabilitation settings in three NHS trusts. Healthy control group: 21 older volunteers. Measures of seated postural sway were taken in unsupported sitting positions, alone, or concurrently with either a repetitive utterance task or an oral word category generation task. Outcome measures were variability of sway area, path length of sway, and the number of valid words generated. Results: Stroke patients were generally less stable than controls during unsupported sitting tasks. They showed greater sway during repetitive speech compared with quiet sitting, but did not show increased instability to posture between repetitive speech and word category generation. When compared with controls, stroke patients experienced greater dual task interferences during repetitive utterance but not during word generation. Sway during repetitive speech was negatively correlated with concurrent function on the Barthel ADL index. Conclusions: The stroke patients showed postural instability and poor word generation skills. The results of this study show that the effort of verbal utterances alone was sufficient to disturb postural control early after stroke, and the extent of this instability correlated with concomitant Barthel ADL function.

Levels of State and Trait Anxiety in Patients Referred to Ophthalmology by Primary Care Clinicians: A Cross Sectional Study

Purpose There is a high level of over-referral from primary eye care leading to significant numbers of people without ocular pathology (false positives) being referred to secondary eye care. The present study used a psychometric instrument to determine whether there is a psychological burden on patients due to referral to secondary eye care, and used Rasch analysis to convert the data from an ordinal to an interval scale. Design Cross sectional study. Participants and Controls 322 participants and 80 control participants. Methods State (i.e. current) and trait (i.e. propensity to) anxiety were measured in a group of patients referred to a hospital eye department in the UK and in a control group who have had a sight test but were not referred. Response category analysis plus infit and outfit Rasch statistics and person separation indices were used to determine the usefulness of individual items and the response categories. Principal components analysis was used to determine dimensionality. Main Outcome Measure Levels of state and trait anxiety measured using the State-Trait Anxiety Inventory. Results State anxiety scores were significantly higher in the patients referred to secondary eye care than the controls (p<0.04), but similar for trait anxiety (p>0.1). Rasch analysis highlighted that the questionnaire results needed to be split into “anxiety-absent” and “anxiety-present” items for both state and trait anxiety, but both subscales showed the same profile of results between patients and controls. Conclusions State anxiety was shown to be higher in patients referred to secondary eye care than the controls, and at similar levels to people with moderate to high perceived susceptibility to breast cancer. This suggests that referral from primary to secondary eye care can result in a significant psychological burden on some patients.

Asking the right questions to get the right answers: using cognitive interviews to review the acceptability, comprehension and clinical meaningfulness of patient self-report adverse event items in oncology patients.

Abstract Background: Standardized reporting of treatment-related adverse events (AE) is essential in clinical trials, usually achieved by using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) reported by clinicians. Patient-reported adverse events (PRAE) may add value to clinician assessments, providing patient perspective on subjective toxicity. We developed an online patient symptom report and self-management system for real-time reporting and managing AE during cancer treatment integrated with electronic patient records (eRAPID). As part of this program we developed a patient version of the CTCAE (version 4.0), rephrasing terminology into a self-report format. We explored patient understanding of these items via cognitive interviews. Material and method: Sixty patients (33 female, 27 male) undergoing treatment were purposively sampled by age, gender and tumor group (median age 61.5, range 35–84, 12 breast, 12 gynecological, 13 colorectal, 12 lung and 11 renal). Twenty-one PRAE items were completed on a touch-screen computer. Subsequent audio-recorded cognitive interviews and thematic analysis explored patients’ comprehension of items via verbal probing techniques during three interview rounds (n = 20 patients/round). Results: In total 33 item amendments were made; 29% related to question comprehension, 68% response option and 3% order effects. These amendments to phrasing and language improved patient understanding but maintained CTCAE grading and key medical information. Changes were endorsed by members of a patient advisory group (N = 11). Conclusion: Item adaptations resulted in a bank of consistently interpreted self-report AE items for use in future research program. In-depth analysis of items through cognitive interviews is an important step towards developing an internationally valid system for PRAE, thus improving patient safety and experiences during cancer treatment.

Breast Cancer, Sexuality, and Intimacy: Addressing the Unmet Need.

To the Editor: Breast cancer is the most commonly diagnosed female cancer with more than 1.7 million new cases in 2012 (1). Sexuality and intimacy problems caused by breast cancer diagnosis and treatment affect large proportions of women (2). Some problems are expected to resolve after treatment (3) while others last for many years (4,5). Sexual activity may not be a priority for all women, particularly during treatment (6) but sexuality and intimacy are an important element of quality of life (7). Despite recognition of the importance of sexual issues to patients, there is a lack of effective support services and interventions (8). The aim of this qualitative study was to: explore the extent of sexual problems in terms of their severity for individuals; examine coping mechanisms and existing support services and determine how patients’ experiences might be improved. Leeds West NHS Research Ethics Committee provided ethical approval. Eleven women with current or previous experience of breast cancer-related sexuality or intimacy problems were recruited. Participants’ age ranged from 33 to 56, the majority (n = 6) were married and had early breast cancer (n = 8). All participants had received surgery (2 mastectomy, 3 mastectomy with reconstruction, and 6 wide local excision). The majority of participants (n = 9) had also received at least one other form of treatment. A researcher (ST) conducted semistructured interviews (19–39 minutes, median 33 minutes) examining: medical background and diagnosis; relationship and family background; impact of diagnosis and treatment; impact on sexuality and intimacy; and access to support. Interviews were audio-recorded and transcribed verbatim. Thematic analysis identified four themes. 1. Sexuality and intimacy problems. Body image concerns were prevalent regardless of the type of surgery women had received. I wasn’t sure if I could deal with what I’m now left with which is sort of a lumpy breast and loads of scars. Body image seemed less important to women with advanced disease. Women who had received endocrine therapy experienced vaginal dryness making sexual intercourse painful or sometimes impossible. Additional complications were loss of breast sensation, inability to orgasm, or reduced libido. 2. Impact on emotions and relationships. Women felt angry and sad about their changed bodies and the impact on their sexual function I just feel that the way I wanted to do it is no longer possible and I’m pi**ed off, I’m not pi**ed off I’m very sad. Some women’s experiences were so severe and had such a profound impact on their lives; they considered potentially risky treatment changes to improve their sexual function. Many participants experienced a relationship breakdown. Women expressed a need to focus on survival or felt they were protecting themselves from the pain of not being sexually active. 3. Coping mechanisms. Some women felt the most effective coping mechanisms were to deal with the issue themselves. Others, sought medical advice from GPs, oncologists or specialist nurses and occasionally, women were referred to more specialist services. I talk to my oncologist. . .and he admitted that he. . . didn’t know what to offer to help so he referred me to the menopause clinic. The majority of participants had accessed services such as counseling, holistic treatments, and therapies and some had seen psychologists or psychotherapists. These services focused on emotional experiences rather than sex or intimacy. 4. How can experiences be improved? Participants felt their experiences could be improved with: more information; increased availability of support services; a designated sexuality and intimacy contact within the clinical team. Breast cancer and its treatment can have a devastating effect on sexuality. A striking finding from this research Address correspondence and reprint requests to: Sally Taylor, PhD, Academic Unit of Palliative Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, West Yorkshire, UK, or e-mail: s.s.taylor@leeds.ac.uk Joint senior authors.