Patient Related Outcome Measures

Description

An international, peer-reviewed, open access journal focusing on treatment outcomes specifically relevant to patients. All aspects of patient care are addressed within the journal and practitioners from all disciplines are invited to submit their work as well as healthcare researchers and patient support groups. Areas covered will include: Quality of life scores; Patient satisfaction audits; Treatment outcomes that focus on the patient; Research into improving patient outcomes; Hypotheses of interventions to improve outcomes; Short communications that illustrate improved outcomes; Case reports or series that show an improved patient experience; Patient journey descriptions or research.

Publications in this journal

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    ABSTRACT: Transcutaneous electrical nerve stimulation (TENS) is a noninvasive, inexpensive, self-administered technique used throughout the world to relieve pain. In Sri Lanka, physiotherapists may use TENS for their patients as they receive a small amount of education about the principles and practice of TENS in their undergraduate training. To date, there have been no data gathered about the use of TENS by physiotherapists in Sri Lanka. The aim of this study was to assess attitudes and beliefs of physiotherapists working in Sri Lanka about their use of TENS for pain management.
    Patient Related Outcome Measures 01/2014; 5:35-41.
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    ABSTRACT: Natalizumab was the first monoclonal antibody to be approved for the treatment of relapsing-remitting multiple sclerosis (RRMS) based on its short-term efficacy and overall tolerability. However, the incidence of treatment-associated progressive multifocal leukoencephalopathy (PML), an infection of the brain caused by the John Cunningham virus, jeopardized this efficacious treatment from the beginning. Eight years after licensing of natalizumab, long-term studies confirm the considerable and sustained efficacy of natalizumab, although the PML complication still threatens one of the most successful treatments available for RRMS. During these years, considerable progress has been made in identification of risk factors that allow more effective management of PML risk. In addition, long-term studies to define better when to start or stop treatment and to optimize treatment strategies after cessation of natalizumab are ongoing, and hopefully will improve management and will allow natalizumab to remain as a valuable therapeutic option for patients with highly active RRMS.
    Patient Related Outcome Measures 01/2014; 5:25-33.
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    ABSTRACT: To assess the long-term effects of prolonged-release (PR) fampridine tablets (dalfampridine extended release) in clinical practice in patients with multiple sclerosis (MS) with walking impairment. MS patients with walking impairment deemed candidates for treatment with PR-fampridine tablets were included in this case series. Clinical assessments included the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 12-item Multiple Sclerosis Walking Scale (MSWS-12), EuroQoL-5D, and the Fatigue Severity Scale (FSS). The T25FW was videotaped at each visit. Assessments were performed at baseline and after 4 weeks of treatment with PR-fampridine tablets 10 mg twice daily. Clinical benefit of treatment was defined as any improvement in T25FW or MSWS-12 score at 4 weeks. Patients who demonstrated clinical benefit continued treatment and were assessed at 3 and 6 months. Among all patients (N = 67; mean MS duration, 16.5 years; mean EDSS score, 4.8; mean T25FW, 13.9 seconds), 65, 52, and 48 completed the 4-week, 3-month, and 6-month visits, respectively. After 4 weeks, 50.7% and 32.8% of patients walked ≥10% and ≥20% faster, respectively; and in 65.7% of patients, MSWS-12 scores improved. Three patients experienced adverse events (nausea, n = 2, insomnia, n = 1) that resulted in discontinuation of treatment. After 6 months, 38.8% and 16.4% of patients walked ≥10% and ≥20% faster versus baseline, respectively; and in 59.7% of patients, MSWS-12 scores improved. Among patients who demonstrated clinical benefit of treatment at 6 months, FSS scores improved on average by 1 point and MSWS-12 scores by 10 points. Three case studies showing different outcomes of PR-fampridine treatment are detailed with a visual depiction of the changes observed. In this case series, a proportion of patients demonstrated a clinical benefit of PR-fampridine treatment on walking. Determining which patients derive benefit from PR-fampridine is an important aspect of treatment. A range of clinical and patient-reported factors should be considered when assessing the clinical benefit of PR-fampridine treatment in MS patients.
    Patient Related Outcome Measures 01/2013; 4:75-85.
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    ABSTRACT: Additional catheter-directed thrombolysis (CDT) for acute deep vein thrombosis (DVT) reduces long-term postthrombotic syndrome and is likely to represent a cost-effective alternative treatment compared to the standard treatment of anticoagulation and elastic compression stockings. Accelerated thrombus resolution has also been suggested to improve symptoms and patient function in the acute phase. We aimed to investigate whether additional CDT led to fewer symptoms and job absenteeism during the first 6 months after initiation of DVT treatment compared to standard treatment alone. The Catheter-directed Venous Thrombolysis (CaVenT) study was a multicenter open label, randomized controlled trial of patients ages 18 years to 75 years with a verified high proximal DVT, <21 days of symptoms, and no apparent bleeding risk. Patients were allocated to additional CDT or to standard treatment only. Symptoms were assessed at baseline and at 6 months using items from the generic and disease-specific quality of life questionnaires EQ-5D and VEINES-QOL/Sym, respectively. Individual data on sickness benefits related to venous thromboembolic disease were obtained from the national welfare service. A total of 90 patients allocated additional CDT and 99 control patients completed long-term follow-up and were included in the analyses. Twenty-four in the CDT arm and 40 controls received sick leave (P = 0.046). When considering working patients only (54 in the CDT arm and 72 controls) this difference was no longer statistically significant. Mean duration of job absenteeism was 86.4 days (95% confidence interval 59.4-113.5) in the CDT arm and 60.1 days (95% confidence interval 42.3-77.8) in controls (P = 0.072). After 6 months, more controls experienced frequent swelling of the leg compared with those allocated to CDT (47 [49.0%] patients versus 25 [29.4%] patients, respectively, [P = 0.007]). There are limitations to our data, but the findings indicate improved symptom relief and less frequent job absenteeism in patients treated with additional CDT; this expands upon previously established benefits from this treatment.
    Patient Related Outcome Measures 01/2013; 4:55-59.
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    ABSTRACT: The Western Ontario Osteoarthritis of the Shoulder (WOOS) index is a patient-reported, disease-specific questionnaire for the measurement of the quality-of-life in patients with osteoarthritis. The purpose of this study was to describe the process used to translate the WOOS into Danish and to test the translation in a Danish population, in terms of validity, reliability, and responsiveness. The translation of the WOOS was done according to international standardized guidelines. The psychometric properties were tested in 20 consecutive patients. The eligibility criteria were: a diagnosis of osteoarthritis without symptomatic rotator cuff pathology and treated with primary shoulder replacement. Patients were excluded only in the case of other pathology of the upper extremity or in the case of cognitive or linguistic impairment compromising the ability to complete the questionnaires. The Pearson's correlation coefficient between the WOOS and the Constant-Murley score (CMS), preoperatively was 0.62 (P = 0.004) and the correlation between the changes of score for the WOOS and CMS was 0.73 (P < 0.001). The correlation coefficient between the WOOS and the CMS, SF-36, and the Oxford Shoulder Score postoperatively was 0.82 (P < 0.001), 0.48 (P = 0.03), and 0.82 (P < 0.001), respectively. There were no floor and ceiling effects. The Cronbach's alpha was 0.98. The intraclass correlation coefficient between test and retest was 0.96. The standardized response mean was 1.41, and effect size was 2.32. We have shown that the Danish version of the WOOS, translated according to international standardized guidelines, has substantial statistical and clinical psychometric properties at the same level as was described for the original version.
    Patient Related Outcome Measures 01/2013; 4:49-54.
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    ABSTRACT: Migraine is a common and potentially disabling disorder for patients, with wide-reaching implications for health care services, society, and the economy. Nausea and vomiting during migraine attacks are common symptoms that affect at least 60% of patients suffering from migraines. These symptoms are often more disabling than the headache itself, causing a great burden on the patient's life. Nausea and vomiting may delay the use of oral abortive medication or interfere with oral drug absorption. Therefore, they can hinder significantly the management and treatment of migraine (which is usually given orally). The main treatment of pain-associated symptoms of migraine (such as nausea and vomiting) is to stop the migraine attack itself as soon as possible, with the effective drugs at the effective doses, seeking if necessary alternative routes of administration. In some cases, intravenous antiemetic drugs are able to relieve a migraine attack and associated symptoms like nausea and vomiting. We performed an exhaustive PubMed search of the English literature to find studies about management of migraine and its associated symptoms. Search terms were migraine, nausea, and vomiting. We did not limit our search to a specific time period. We focused on clinical efficacy and tolerance of the various drugs and procedures based on data from human studies. We included the best available studies for each discussed drug or procedure. These ranged from randomized controlled trials for some treatments to small case series for others. Recently updated books and manuals on neurology and headache were also consulted. We herein review the efficacy of the different approaches in order to manage nausea and vomiting for migraine patents.
    Patient Related Outcome Measures 01/2013; 4:61-73.
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    ABSTRACT: Patient-related outcomes measures could provide important information for the current state of the art in medical care and even have an impact on macrodecisions in the health care system. Patient-related outcomes were initially defined as subjective health indicators that allow disability and illness to be assessed, based on patient, caregiver, or physician self-reports. As illness involves psychological and behavioral complex processes of care, a multidisciplinary approach in measuring patient-reported outcomes should be recommended, such as quality of life questionnaires. Patient-related outcomes measures should correspond to specific clinical situations and bring opportunities to improve quality of care. Objective measurements enable quantitative data to be collected and analyzed. Depending on the aim of the research, investigators can use existing methods or develop new tools. This publication presents a methodology for developing patient-related outcomes measures, based on a multistage procedure. The proper definition of specific study objectives and the methodology of instrument development are crucial for successfully transferring the study concept. The model of instrument development is the process of starting from the preliminary phase and includes questionnaire design and scaling, pilot testing (cognitive debriefing), revision of the preliminary version, evaluation of the new tool, and implementation. Validation of the new instrument includes reliability, reproducibility, internal consistency, and responsiveness. The process of designing the new tool should involve a panel of experts, including clinicians, psychologists (preliminary phase), and statisticians (scale development and scoring), and patients (cognitive debriefing). Implementation of a new tool should be followed by evaluation study - assessment of the tool's usefulness in clinical practice. An instrument must show not only the expected methodological properties and performance but also a positive contribution to care. The necessity of implementation of direct patient-reporting methods has been highlighted by both the Food and Drug Administration and the European Medicines Agency.
    Patient Related Outcome Measures 07/2012; 3:1-7.
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    ABSTRACT: To determine the short-term effects of physiotherapy triage assessments on self-reported pain, functioning, and general well-being and quality of life in people with low back-related disorders. Participants with low back-related complaints were recruited from those referred to a spinal triage assessment program delivered by physiotherapists (PTs). Before undergoing the triage assessment, the participants completed a battery of questionnaires covering a range of sociodemographic, clinical, and psychosocial features. The study used the Numeric Pain Rating Scale (NPRS), the Oswestry Disability Index (ODI), and the Medical Outcomes Survey 36-item short-form version 2 (SF-36v2) to assess self-reported pain, function, and quality of life. Baseline measures and variables were analyzed using a descriptive analysis method (ie, proportions, means, medians). Paired samples t-tests or Wilcoxon matched-pair signed-rank tests were used to analyze the overall group differences between the pretest and posttest outcome measures where appropriate. A total of 108 out of 115 (93.9%) participants completed the posttest survey. The Physical Component Summary of the SF36v2 was the only measure that demonstrated significant improvement (P < 0.001). A spinal triage assessment program delivered by PTs can be viewed as a complex intervention that may have the potential to affect a wide range of patient-related outcomes. Further research is needed to examine the long-term outcomes and explore potential mechanisms of improvement using a biopsychosocial framework.
    Patient Related Outcome Measures 07/2012; 3:9-19.

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