Development and preliminary validation of a tool measuring concordance and belief about performing pressure-relieving activities for pressure ulcer prevention in spinal cord injury.

OBJECTIVE: To develop and examine the reliability, and validity of a questionnaire measuring concordance for performing pressure-relief for pressure ulcer (PrU) prevention in people with Spinal Cord Injury (SCI). METHODS: Phase I included item development, content and face validity testing. In phase II, the questionnaire was evaluated for preliminary acceptability, reliability and validity among 48 wheelchair users with SCI. RESULTS: Thirty-seven items were initially explored. Item and factor analysis resulted in a final 26-item questionnaire with four factors reflecting concordance, perceived benefits, perceived negative consequences, and personal practical barriers to performing pressure-relief activities. The internal consistency reliability for four domains were very good (Cronbach's α = 0.75-.89). Pearson correlation coefficient on a test-retest of the same subjects yielded significant correlations in concordance (r2 = 0.91, p = .005), perceived benefit (r2 = 0.71, p < .04), perceived negative consequences (r2 = 0.98, p < .0001), personal barriers (r2 = 0.93, p= .002). Participants with higher levels of concordance reported a greater amount of pressure-relieving performed. Individuals viewing PrU as a threatening illness were associated with higher scores of concordance and tended to report a greater amount of pressure-relieving performance which provides evidence of criterion related validity. CONCLUSION: The new questionnaire demonstrated good preliminary reliability and validity in people with SCI. Further evaluation is necessary to confirm these findings using larger samples with follow-up data for predictive validity. Such a questionnaire could be used by clinicians to identify high risk of patients and to design individualised education programme for PrU prevention.

The Effects of Adding Transcutaneous Spinal Cord Stimulation (tSCS) to Sit-To-Stand Training in People with Spinal Cord Injury: A Pilot Study.

Spinal cord stimulation may enable recovery of volitional motor control in people with chronic Spinal Cord Injury (SCI). In this study we explored the effects of adding SCS, applied transcutaneously (tSCS) at vertebral levels T10/11, to a sit-to-stand training intervention in people with motor complete and incomplete SCI. Nine people with chronic SCI (six motor complete; three motor incomplete) participated in an 8-week intervention, incorporating three training sessions per week. Participants received either tSCS combined with sit-to-stand training (STIM) or sit-to-stand training alone (NON-STIM). Outcome measures were carried out before and after the intervention. Seven participants completed the intervention (STIM N = 5; NON-STIM N = 2). Post training, improvements in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor scores were noted in three STIM participants (range 1.0-7.0), with no change in NON-STIM participants. Recovery of volitional lower limb muscle activity and/or movement (with tSCS off) was noted in three STIM participants. Unassisted standing was not achieved in any participant, although standing with minimal assistance was achieved in one STIM participant. This pilot study has shown that the recruitment of participants, intervention and outcome measures were all feasible in this study design. However, some modifications are recommended for a larger trial.

Ambulatory urodynamic monitoring assessment of dorsal genital nerve stimulation for suppression of involuntary detrusor contractions following spinal cord injury: a pilot study.

STUDY DESIGN: A prospective interventional pilot study using within-individual comparisons. OBJECTIVES: To assess the effect of dorsal genital nerve stimulation (DGNS) on urine-storage parameters in participants with spinal cord injury (SCI) and neurogenic detrusor overactivity (NDO) during natural bladder filling. SETTING: The London Spinal Cord Injuries Centre at the Royal National Orthopaedic Hospital, Stanmore, UK. METHODS: Ambulatory urodynamic monitoring (AUM) was carried out with and without DGNS, before and after a week of using DGNS at home. DGNS was applied on-demand by four participants with bladder sensation, and both continuously and intermittently by one participant with absent sensation. A Wilcoxon sign-rank test was used to test paired results of changes within an AUM session. RESULTS: Urodynamic outcomes were improved using DGNS. Bladder capacity was increased from 244 ± 59 to 346 ± 61 ml (p = 0.0078), a mean change of 46 ± 25%. Maximum detrusor pressure was decreased from 58 ± 18 to 47 ± 18 cmH2O (p = 0.0156), a change of 17 ± 13%, and average peak detrusor pressure was decreased from 56 ± 16 to 31 ± 128 cmH2O (p = 0.0156), a mean reduction of 50 ± 19%. There was an increase in the number of detrusor contractions from the first involuntary detrusor contraction to a strong desire, urgency or incontinence, from 1.5 ± 1.4 to 4.3 ± 1.7, and an increase in time of 23 ± 22 min. There were no changes in baseline outcomes following home use of DGNS. CONCLUSIONS: DGNS may be applied on-demand, intermittently or continuously, to increase bladder capacity, decrease storage pressures and provide extra time. Improvements were made in addition to existing antimuscarinic medication regimes.

The conceptual relevance of assessment measures in patients with mild/mild-moderate Alzheimer's disease.

INTRODUCTION: This study aims to evaluate the conceptual relevance of four measures of disease activity in patients with mild/mild-moderate Alzheimer's disease (AD): (1) the Alzheimer's Disease Assessment Scale-Cognitive Subscale; (2) the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory; (3) the Neuropsychiatry Inventory; and (4) the Dependence Scale. METHODS: A conceptual model depicting patient experience of mild AD was developed via literature review; concepts were compared with the items of the four measures. Relevance of the concepts included in the four measures was evaluated by patients with mild AD in a survey and follow-up interviews. RESULTS: The four measures assessed few of the symptoms/impacts of mild AD identified within the literature. Measured items addressing emotional impacts were deemed most relevant by participants but were included in the measures only superficially. DISCUSSION: The four assessment measures do not appear to capture the concepts most relevant to/important to patients with mild/mild-moderate AD.

Patients' experience of recurrent/metastatic head and neck squamous cell carcinoma and their perspective on the EORTC QLQ-C30 and QLQ-H&N35 questionnaires: a qualitative study.

BACKGROUND: Head and neck squamous cell carcinoma (HNSCC) and its associated treatments may affect all aspects of patients' health-related quality of life (HRQoL). Although the EORTC QLQ-H&N35 is regularly administered to patients with HNSCC, there is a paucity of studies re-assessing the conceptual relevance of this patient-reported outcome (PRO) measure from a patient perspective. Furthermore, the content validity of the EORTC QLQ-C30 has not been widely documented in patients with recurrent and/or metastatic HNSCC. The objectives of this study were to understand patients' experiences of recurrent/metastatic HNSCC and its treatments, and to evaluate the conceptual relevance and acceptability of the EORTC QLQ-C30 and QLQ-H&N35 from a patient perspective for use in clinical trials. METHODS: A literature review and clinician interviews were conducted to inform in-depth semi-structured telephone interviews with US patients who had received treatment for recurrent and/or metastatic HNSCC in the preceding 12 months. Interview transcripts were analysed thematically using ATLAS.ti v7; patient quotes were coded to identify concepts and themes to develop a conceptual model of HNSCC experience. RESULTS: Fourteen patients were interviewed (71% male, aged 35-84 years). Patients reported few symptoms pre-diagnosis including neck lump/swelling (n = 7/14, 50%) and/or difficulty swallowing (n = 3/14, 21%). Treatments generally comprised surgery and chemotherapy and/or radiotherapy. A number of side effects from all treatments were reported. Numbness, difficulty speaking and pain were the most reported side effects of surgery (n = 4/8, 50%); weight loss and fatigue were the most reported side effects of chemotherapy and/or radiotherapy (n = 8/13, 61%). All side effects negatively impacted patients' HRQoL. Patients generally found the QLQ-C30 and QLQ H&N35 content to be understandable and conceptually relevant; excessive mucous production and neuropathic symptoms were among the suggested additions. CONCLUSIONS: HNSCC and its diverse symptoms and treatments have a negative impact on many aspects of patients' lives. A number of reported symptoms including difficulty speaking and swallowing, localised pain and fatigue may be important for treatment benefit evaluation in clinical trials from a patient perspective. The QLQ-C30 and QLQ-H&N35 are generally relevant and suitable for use in clinical trials. However, some items could be amended/added to ensure conceptual comprehensiveness of these measures.

Orthostatic hypotension following spinal cord injury: impact on the use of standing apparatus.

INTRODUCTION: Upright posture confers numerous medical and social benefits to a spinal cord injured (SCI) patient. Doing so is limited by symptoms of orthostatic hypotension. This is a common secondary impairment among tetraplegic sufferers. OBJECTIVE: Establish the proportion of SCI patients who are restricted from using standing apparatus, such as standing frames and standing wheelchairs, because of inducing symptomatic orthostatic hypotension or the fear of developing these disabling symptoms. STUDY DESIGN: Survey conducted by Internet-accessible electronic questionnaire. Questionnaire validated for reliability and accuracy. RESULTS: 293 respondents. Mean age 44.6; 76% male. Median time from injury: 7 years. 38% suffered with orthostatic hypotension; majority were complete injuries and all (except one - T12) were T5 or above level. 52% replied that they were using standing wheelchairs or frames. Of these, 59 (20% of total) stated that orthostatic hypotension symptoms were limiting the use of their upright apparatus. Of those who did not use standing wheelchairs or frames, 16 (5.5% of total) reported that this was because of the fear of worsening their orthostatic hypotension. CONCLUSION: Orthostatic hypotension restricts standing apparatus use in a large proportion (a total of 25.5% of respondents in this survey) of SCI patients.

Interface pressure and cutaneous hemoglobin and oxygenation changes under ischial tuberosities during sacral nerve root stimulation in spinal cord injury.

Noninvasive functional magnetic stimulation (FMS) of the sacral nerve roots can activate gluteal muscles. We propose the use of sacral anterior root stimulator (SARS) implants to prevent ischial pressure ulcers in the spinal cord injury (SCI) population. In this study, we (1) investigated the acute effects of sacral FMS on ischial pressure, skin blood content, and oxygenation changes in people with SCI and demonstrated the utility of FMS as an assessment tool, and (2) showed that similar effects are possible with electrical stimulation via a SARS implant. Results indicated that sacral nerve root stimulation, either by FMS or implanted electrical stimulation, induced sufficient gluteus maximus contraction to significantly change subjects' ischial pressures and cutaneous hemoglobin and oxygenation during sitting. In addition to these beneficial acute effects, chronic stimulation via a SARS implant may build gluteal muscle bulk and prevent or reduce pressure ulcers in the SCI population.

Pressure changes under the ischial tuberosities of seated individuals during sacral nerve root stimulation.

Neuromuscular stimulation via the sacral nerve roots is proposed for prevention of ischial pressure ulcers following a spinal cord injury (SCI). Acute effects of sacral functional magnetic stimulation (FMS) on seat interface pressure changes were investigated in five nondisabled volunteers. Similar effects were demonstrated with functional electrical stimulation in people with SCI who used a sacral anterior root stimulator implant. The results indicated that sacral nerve root stimulation, either by FMS or implanted electrical stimulation, induced gluteus maximus contraction and mild pelvic tilt sufficient for clinically significant reductions in ischial pressures during sitting.

A new artificial urinary sphincter with conditional occlusion for stress urinary incontinence: preliminary clinical results.

OBJECTIVES: To perform a preliminary clinical investigation to determine the safety and efficacy of a novel artificial urinary sphincter (AUS) with conditional occlusion for the treatment of stress urinary incontinence. METHODS: Male patients with urodynamically proven stress urinary incontinence after a prostatectomy were implanted with the novel AUS. They were followed up over a period of 12 months and the device tested for efficacy by using objective measurements of urinary leakage and continence. We derived a new measure for continence called the Continence Index. RESULTS: We have demonstrated that the patients receiving the new AUS showed a reduction of greater than 10-fold in mean daily leakage volume from 770.6 ml to 55.1 ml. There was an overall improvement in the Continence Index from 54% to 97%. CONCLUSIONS: The new AUS with conditional occlusion provides good continence rates and enables adjustment of regulating pressure in situ.