A systematic review of qualitative research into people's experiences of living with venous leg ulcers.

AIM: To systematically identify, evaluate and synthesize qualitative research that examined the symptoms and health-related quality of life themes that are important from the perspective of patients with venous leg ulceration. BACKGROUND: Venous leg ulceration is a common chronic condition; the symptoms and associated treatments have a negative effect on health-related quality of life. Qualitative research methods can provide insight into the personal experiences of patients with venous leg ulceration. DESIGN: Qualitative evidence synthesis (using framework synthesis). DATA SOURCES: Multiple electronic databases including MEDLINE, EMBASE, PsycINFO and CINAHL were comprehensively searched from inception to November 2015. REVIEW METHODS: Systematic identification, quality assessment and synthesis of existing qualitative research were performed; framework synthesis was conducted on included studies. An inductive approach was used and emergent themes were identified. The final stage in the synthesis involved the development of new interpretations. RESULTS: Thirteen studies met the inclusion criteria; the overall quality of the included studies was good. Four overarching themes were identified; physical impact, psychological impact, social impact and treatment and, in these, further subthemes were identified. Ulcer and treatment-related pain, as well as odour and exudate appeared to have significant and direct negative effects on quality of life, with additional and cumulative effects on sleep, mobility and mood. CONCLUSION: The themes identified in this review should be considered by professionals providing services, care and treatment for venous leg ulcer patients and in the selection, or development, of patient-reported outcome measures for use with this population.

Patient-reported outcome measures in patients with peripheral arterial disease: a systematic review of psychometric properties.

BACKGROUND: Peripheral arterial disease (PAD) is generally associated with considerable morbidity and reduced quality of life. Patient-reported outcome measures (PROMs) provide important information about the burden of disease and impact of treatment in affected patients. OBJECTIVES: The objective of the review was to identify and appraise studies reporting the psychometric evaluation of PROMs administered to a specified population of patients with PAD with a view to recommending suitable PROMs. METHODS: A systematic review of peer-reviewed English language articles was undertaken to identify primary studies reporting psychometric properties of PROMs in English-speaking patients with various stages of PAD. Comprehensive searches were completed up until January 2015. Study selection, data extraction and quality assessment were undertaken independently by at least two researchers. Findings were presented as tabular and narrative summaries based on accepted guidance. RESULTS: Psychometric evaluation of 6 generic and 7 condition-specific PROMs reported in 14 studies contributed data to the review. The frequently reported measure was the SF-36 (n = 11 studies); others included the Walking Impairment Questionnaire (n = 8 studies), EQ-5D (n = 5 studies) and the Vascular Quality of Life Questionnaire (n = 3 studies). Studies included a diverse PAD population and varied in methodology, including approach to validation of PROMs. CONCLUSIONS: Various PROMs have been validated in patients with PAD but no study provided evidence of a full psychometric evaluation in the patient population. Careful selection is required to identify reliable and valid PROMs to use in clinical and research settings.

The relationship between psychological distress and multiple tender points across the adult lifespan.

Multiple tender points are common in the population and, in studies of mid-life adults, are strongly associated with high levels of psychological distress. Whether this relationship occurs in older adults is unclear. This cross-sectional study investigated whether high levels of psychological distress would be associated with a high tender point count and whether the relationship would be moderated by age. Three thousand three hundred and seventy-nine individuals were mailed a questionnaire which included the Hospital Anxiety and Depression (HAD) scale, the Pain Catastrophising Scale (PCS), the Brief Illness Perception Questionnaire (Brief IPQ), and the Pittsburgh Sleep Quality Index (PSQI). A random sample of approximately 10% of subjects who returned the questionnaire undertook a physical assessment, including a manual tender point count assessment. A total of 2385 (71%) subjects completed the questionnaire, of whom 798 (33%) were invited to take part in the physical assessment and 290 (12%) participated. Of the 290 participants the median age was 64 years (range 34-97) and 63% were female. The median HAD score was 9 (IQR 5-14) and the median number of tender points was 3 (range 0-7). Increasing HAD score was positively and significantly associated with tender point count, but this relationship was not moderated by age. In a final multivariable model, sex, HAD score and PSQI score were independent predictors of multiple tender points. Psychological distress was associated with multiple tender points independent of age. Psychological distress and trouble sleeping were important, potentially modifiable factors associated with the outcome.

A rapid review indicated higher recruitment rates in treatment trials than in prevention trials.

OBJECTIVES: To test the hypothesis that the percentage of patients screened that randomize differs between prevention and therapy trials. STUDY DESIGN AND SETTING: Rapid review of randomized controlled trials (RCTs) identified through published systematic reviews in August 2013. Individually randomized, parallel group controlled RCTs were eligible if they evaluated metformin monotherapy or exercise for the prevention or treatment of type 2 diabetes. Numbers of patients screened and randomized were extracted by a single reviewer. Percentages were calculated for each study for those randomized: as a function of those approached, screened, and eligible. Percentages (95% confidence intervals) from each individual study were weighted according to the denominator and pooled rates calculated. Statistical heterogeneity was assessed using I(2). RESULTS: The percentage of those screened who subsequently randomized was 6.2% (6.0%, 6.4%; 3 studies, I(2) = 100.0%) for metformin prevention trials; 50.7% (49.9%, 51.4%; 21 studies, I(2) = 99.6%) for metformin treatment trials; 4.8% (4.7%, 4.8%; 14 studies, I(2) = 99.9%) for exercise prevention trials; and 43.3% (42.6%, 43.9%; 28 studies, I(2) = 99.8%) for exercise treatment trials. CONCLUSION: This study provides qualified support for the hypothesis that prevention trials recruit a smaller proportion of those screened than treatment trials. Statistical heterogeneity associated with pooled estimates and other study limitations is discussed.

'Putting Life in Years' (PLINY) telephone friendship groups research study: pilot randomised controlled trial.

BACKGROUND: Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. METHODS: Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. RESULTS: We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). CONCLUSIONS: Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For the voluntary sector to recruit sufficient volunteers to match demand for telephone befriending created by trial recruitment would require the study to be run in more than one major population centre, and/or involve dedicated management of volunteers. TRIAL REGISTRATION: ISRCTN28645428.