Evaluating Comprehensibility of 157 Patient-Reported Outcome Measures (PROMs) in the Nationwide Dutch Outcome-Based Healthcare Program: More Attention for Comprehensibility of PROMs is Needed.

INTRODUCTION: Patient-reported outcomes measures (PROMs) are increasingly prevalent in healthcare and used for shared decision-making and healthcare quality evaluation. However, the extent to which patients with varying health literacy levels can complete PROMs is often overlooked. This may lead to biased aggregated data and patients being excluded from studies or other PROM collection initiatives. This cross-sectional study evaluates the comprehensibility of 157 well-known and widely used PROM scales using a comprehensibility checklist. METHODS: Pairs of two independent raters scored 157 PROM scales designed for adults included in the 35 sets of outcome information developed as part of the Dutch Outcome-Based Healthcare Program. The PROM scales were scored on the eight comprehensibility domains of the Pharos Checklist for Questionnaires in Healthcare (PCQH). Interrater agreement of domain ratings was assessed using Intraclass Correlation Coefficients or Cohen's kappa. Subsequently, final ratings were established through discussion and used to evaluate the domain-specific comprehensibility rating for each PROM scale. RESULTS: Comprehensibility of a large number of PROM scales (n = 157), which cover a wide range of diseases and conditions across Dutch medical specialist care, was assessed. While most PROM scales were written at an accessible language level, with minimal use of medical terms, instruction clarity, number of questions, and response options emerged as significant issues, affecting a substantial proportion of PROM scales. Interrater agreement was high for most domains of the PCQH. CONCLUSION: This study highlights the need for greater attention to the comprehensibility of PROMs to ensure their accessibility to all patients, including those with low health literacy. The PCQH can be a valuable tool in PROM development in addition to qualitative methods and in selection processes enabling comparison of comprehensibility between PROMs. However, the PCQH needs further development and validation for these purposes. Enhancing the comprehensibility of PROMs is essential for their effective incorporation in healthcare evaluation and decision-making processes.

Sensory Profiles Predict Symptoms of Central Sensitization in Low Back Pain: A Predictive Model Research Study.

Background: Acute low back pain has a high prevalence, and when persisting into chronicity, it results in enormous socio-economic consequences. Sensory preferences may be key factors in predicting central sensitization as the main mechanism of nociplastic pain and chronicity. Objectives: Build a model to predict central sensitization symptoms using sensory profiles based on the PROGRESS framework. Methods: A Prognostic Model Research study was carried out to predict central sensitization symptoms at 12 weeks, using baseline sensory profiles, based on 114 patients with acute low back pain. Independent variables were sensory profiles, state and trait anxiety, age, duration, pain severity, depressive symptoms, and pain catastrophizing. Results: This model, based on continuous data, significantly predicts central sensitization symptoms at 12 weeks. It contains two significantly contributing variables: sensory profile Sensory Sensitive (unstandardized B-value = 0.42; p = 0.01) and trait anxiety (unstandardized B-value = 0.53; p ≤ 0.001). The model has a predictive value of R2 = 0.38. Conclusions: This model significantly predicts central sensitization symptoms based on sensory profile Sensory Sensitive and trait anxiety. This model may be a useful tool to intervene in a bottom-up and top-down approaches to prevent chronicity in clinical practice, including individual sensory preferences and behavioral responses to sensory stimulation in rehabilitation strategies.

Sensory profiles and their role in the persistence of central sensitization symptoms in low back pain. A prospective cohort study.

INTRODUCTION: Acute lower back pain can lead to neuroplastic changes in the central nervous system, and symptoms of central sensitization after 12 weeks. While sensory sensitivity has been shown to predict symptoms of central sensitization, trait sensory profiles may be prognostic in the persistence of central sensitization symptoms in low back pain over time. OBJECTIVE: To examine sensory profiles as prognostic symptoms of central sensitization in people with acute low back pain. METHODS: A longitudinal type 2 prognostic factor research study was performed according to the PROGRESS framework. Baseline and 12-week follow-up measures were taken using the Adolescent/Adult Sensory Profile and the Central Sensitization Inventory measures. Study participants were consecutively included from primary care physiotherapy practices. Univariable, and multivariable regression analyses were performed to adjust sensory profiles based on previous history of low back pain, baseline Central Sensitization Inventory scores, level of pain, disability, age, and duration of low back pain. RESULTS: After adjustment, the sensory profiles of Low Registration B = 0.44, 95%CI (0.18, 0.70), Sensation Seeking B = 0.38, 95%CI (0.19, 0.57), Sensory Sensitive B = 0.49, 95%CI (0.25, 0.74), Sensation Avoiding B = 0.40, 95% CI (0.15, 0.65) was significantly associated with the persistence of central sensitization symptoms (N = 103). CONCLUSION: Sensory profiles may predict symptoms of central sensitization after 12 weeks in people with acute low back pain.

Evaluating sensory profiles in nociplastic chronic low back pain: a cross-sectional validation study.

BACKGROUND: Sensory profiles (SPs) may be useful in classifying patients based on sensory sensitivity and behavioral responses to stimuli to develop personalized treatments for nonspecific chronic low back pain (CLBP). The Adolescent/Adult Sensory Profile (AASP) identifies four sensitivity and behavioral response-related quadrants: Sensory Sensitive, Sensation Avoiding, Low Registration, and Sensation Seeking. It is an appropriate questionnaire for evaluating SPs; however, it has not been validated in CLBP. OBJECTIVES: To assess the internal consistency, test-retest reliability, agreement, and construct validity of the AASP in a CLBP population with nociplastic pain in primary care physiotherapy. DESIGN: Two evaluations were performed at a 2-week interval in this non-experimental cross-sectional study. PARTICIPANTS: Patients with CLBP. METHODS: Questionnaires were used to compare outcomes with the AASP. Reliability was evaluated by assessing internal consistency and test-retest reliability. Construct validity was evaluated in response to the a priori hypothesis. RESULTS: Ninety patients with CLBP were included. Internal consistency was excellent for all SPs (Cronbach's alpha, 0.91-0.92). Test-retest reliability Intraclass Correlation Coefficient (ICC (3,2)) 0.82-0.87, for the SPs (95% CI 0.74-0.91, p< .001). Construct validity correlated positively with Low Registration, Sensory Sensitive, and Sensation Avoiding and negatively with Sensation Seeking. CONCLUSION: The AASP is suitable for evaluating SPs in primary care CLBP patients.

Illness perceptions as an independent predictor of chronic low back pain and pain-related disability: a prospective cohort study.

OBJECTIVES: To investigate whether illness perceptions, measured with the Brief Illness Perception Questionnaire, are an independent predictor of chronic low back pain and pain-related disability at 12 weeks. DESIGN: A prospective, observational cohort study. SETTING: 26 outpatient primary care physiotherapy practices throughout the Netherlands. PARTICIPANTS: Acute nonspecific low back pain patients between the age of 18 and 60 years, with or without radiating pain, and a pain-free episode of at least three months before onset. INTERVENTIONS: Standard physiotherapy care according to Dutch clinical practice guidelines. OUTCOME MEASURE: Chronic low back pain defined as pain ≥3/10 on the Numeric Pain Rating Scale and as pain-related disability ≥19/70 on the Pain Disability Index measured after 12 weeks. RESULTS: Two hundred and four people with acute nonspecific low back pain completed both assessments. In the multivariable analyses, adjusted for pain intensity, disability, duration, radiating pain, depressed mood, associations of illness perceptions were OR 1.04 (95% CI: 1.01 to 1.08) for pain and 1.04 (95% CI: 0.99 to 1.09) for pain-related disability. CONCLUSIONS: Illness perceptions independently predicted chronic low back pain but not pain-related disability at 12 weeks. The added predictive value of illness perceptions was relatively low.

Psychological assessments by manual physiotherapists in the Netherlands in patients with nonspecific low back pain.

Background: Clinical Practice Guidelines for low back pain emphasize implementing assessment and addressing of psychosocial context. It is unknown to what extent manual physiotherapists incorporate psychological factors in their diagnostic management of patients with nonspecific low back pain.Methods: An online survey among Dutch manual physiotherapists was conducted exploring the use of 10 psychological constructs. Frequencies of attention to psychological factors during history-taking and use of questionnaires were calculated. Associations between therapists characteristics and use of psychological questionnaires were analyzed using Spearmans rank correlation coefficient (r s) and logistic regression. In addition, a retrospective patient record review was conducted.Results: One hundred and twelve manual physiotherapists returned completed surveys. Although respondents indicated psychological factors were assessed, they rarely used psychological questionnaires. Significant but negligible associations were found for age and working hours and the use of specific questionnaires. From 95 patient records reviewed, seven were identified that mentioned one psychological factor each during history taking.Conclusions: Dutch MPTs, regardless of their age and work characteristics, rarely use psychological questionnaires in patients with LBP, although they report addressing these constructs implicitly during history taking. Educational and implementation strategies are needed to warrant the use of psychological constructs and validated psychological questionnaires at all phases of the clinical reasoning process.

State anxiety improves prediction of pain and pain-related disability after 12 weeks in patients with acute low back pain: a cohort study.

QUESTION: Do measures of state anxiety and trait anxiety in people with acute low back pain (ALBP) improve prediction of chronic low back pain (CLBP), defined as pain or pain-related disability at 12 weeks? DESIGN: Observational multi-centre prospective cohort study in primary physiotherapy care with measurements at baseline and at 12 weeks of state and trait anxiety, as well as other established prognostic factors for CLBP. PARTICIPANTS: People with nonspecific ALBP, aged 18 to 60 years, who had been pain free for ≥ 3 months before their current ALBP, and who were being treated according the Dutch clinical guidelines. OUTCOME MEASURES AND ANALYSIS: CLBP was defined as a pain score ≥ 3/10 on the Numerical Pain Rating Scale (primary outcome), and as a pain-related disability score ≥ 19/70 on the Pain Disability Inventory. Univariate and multivariate logistic regression analyses estimated how the risk of CLBP differed with state and trait anxiety and other established prognostic factors. RESULTS: Most (204 of 225) participants completed both assessments. State anxiety was an independent predictor of CLBP, whether defined as pain or pain-related disability at 12 weeks, in contrast to trait anxiety. State anxiety improved the predictive performance of the model, with area under the curve (AUC) increasing from 0.64 (95% CI 0.56 to 0.71) to 0.75 (95% CI 0.68 to 0.82) and Nagelkerke's R2 increasing from 0.08 to 0.24 for the primary outcome measure, pain. For the secondary outcome measure, pain-related disability: AUC 0.63 (95% CI 0.54 to 0.72) improved to 0.73 (95% CI 0.65 to 0.82) and Nagelkerke's R2 increased from 0.05 to 0.16. Adding trait anxiety to the prognostic model for pain improved the AUC from 0.64 (95% CI 0.56 to 0.71) to 0.70 (95% CI 0.62 to 0.77) and Nagelkerke's R2 from 0.08 to 0.15. CONCLUSION: State anxiety in patients with ALBP improved prediction of CLBP, defined as pain and pain-related disability at 12 weeks.

Pilot testing a stretching regimen for prevention of night time nocturnal leg cramps.

Nocturnal leg cramps (NLC) are painful, involuntary muscle contractions that affect the quality of sleep. The aim of this study was to examine the feasibility and effectiveness of a stretching regimen in frail older adults aged over 75 years with NLC. The experimental group (n = 15) received an intervention, which they were instructed to perform three daily exercises to stretch the calves and hamstrings. After six weeks, frequency and pain intensity of NLC were both significantly decreased in the experimental group compared to the control group. A paired samples t-test reveals a statistically significant decrease in cramp frequency (t = 2.2, df 28, P = 0.04) and cramp intensity (t = 2.7, df 28, P = 0.01). Therefore, a six-week stretching regimen is likely to reduce the frequency and pain intensity of NLC in frail older adults aged over 75 years.

Criteria in diagnosing nocturnal leg cramps: a systematic review.

BACKGROUND: Up to 33% of the general population over 50 years of age are affected by nocturnal leg cramps. Currently there are no generally accepted clinical characteristics, which identify nocturnal leg cramps. This study aims to identify these clinical characteristics and to differentiate between them and the characteristics of restless leg syndrome and periodic limb disorder. METHOD: A systematic literature study was executed from December 2015 to May 2016. This study comprised of a systematic literature review of randomized clinical trials, observational studies on nocturnal and rest cramps of legs and other muscles, and other systematic and narrative reviews. Two researchers independently extracted literature data and analyzed this using a standardized reviewing protocol. Modified versions of the Cochrane Collaboration tools assessed the risk of bias. A Delphi study was conducted to assess agreement on the characteristics of nocturnal leg cramps. RESULTS: After systematic and manual searches, eight randomized trials and ten observational studies were included. On the basis of these we identified seven diagnostic characteristics of nocturnal leg cramps: intense pain, period of duration from seconds to maximum 10 minutes, location in calf or foot, location seldom in thigh or hamstrings, persistent subsequent pain, sleep disruption and distress. CONCLUSION: The seven above characteristics will enhance recognition of the condition, and help clinicians make a clear distinction between NLC and other sleep-related musculoskeletal disorder among older adults.

A note of caution with respect to the Low Back Pain Perception Scale in primary care physiotherapy.

BACKGROUND: The predictive validity of the Low Back Pain Perception Scale is determined in two studies in general practice and showed sufficient discriminative ability, although the psychometric properties of the scale have never been established until now. OBJECTIVE: To determine the reliability and validity of the Low Back Pain Perception Scale in acute nonspecific low back pain patients. METHODS: The Low Back Pain Perception Scale has been authorized translated into Dutch by two bilingual content experts. A sample of 84 acute low back pain patients in physiotherapy primary care, mean age (SD) age 42 (12) years participated in this study. Internal reliability and a test-retest procedure within one-week interval were evaluated. RESULTS: The internal consistency Cronbach α=0.38 (95% CI 0.09 to 0.56) and test - retest reliability within one week Intra Class Correlation coefficient=0.50 (95% CI 0.31 to 0.64). Minimal Detectable Change was measured 1.95. The concurrent validity demonstrates Pearson's r=0.35 (95% CI 0.14 to 0.53). CONCLUSIONS: The Low Back Pain Perception Scale demonstrates poor internal consistency and reliability and moderate concurrent validity. Extreme high or low scores may be clinical relevant therefore the scale can be used as a first screening instrument.

Measurement of acute nonspecific low back pain perception in primary care physical therapy: reliability and validity of the brief illness perception questionnaire.

BACKGROUND: The eight-item Brief Illness Perception Questionnaire is used as a screening instrument in physical therapy to assess mental defeat in patients with acute low back pain, besides patient perception might determine the course and risk for chronic low back pain. However, the psychometric properties of the Brief Illness Perception Questionnaire in common musculoskeletal disorders like acute low back pain have not been adequately studied. Patients' perceptions vary across different populations and affect coping styles. Thus, our aim was to determine the internal consistency, test-retest reliability and validity of the Dutch language version of the Brief Illness Perception Questionnaire in acute non-specific low back pain patients in primary care physical therapy. METHODS: A non-experimental cross-sectional study with two measurements was performed. Eighty-four acute low back pain patients, in multidisciplinary health care center in Dutch primary care with a sample mean (SD) age of 42 (12) years, participated in the study. Internal consistency (Cronbach's α) and test-retest procedures (Intraclass Correlation Coefficients and limits of agreement) were evaluated at a one-week interval. The concurrent validity of the Brief Illness Perception Questionnaire was examined by using the Mental Health Component of the Short Form 36 Health Survey. RESULTS: The Cronbach's α for internal consistency was 0.73 (95% CI, 0.67 - 0.83); and the Intraclass Correlation Coefficient test-retest reliability was acceptable: 0.72 (95% CI, 0.53 - 0.82), however, the limits of agreement were large. The Intraclass Correlation Coefficient measuring concurrent validity 0.65 (95% CI, 0.46 - 0.80). CONCLUSION: The Dutch version of the Brief Illness Perception Questionnaire is an appropriate instrument for measuring patients' perceptions in acute low back pain patients, showing acceptable internal consistency and reliability. Concurrent validity is adequate, however, the instrument may be unsuitable for detecting changes in low back pain perception over time.

Expectations about recovery from acute non-specific low back pain predict absence from usual work due to chronic low back pain: a systematic review.

QUESTION: Do negative expectations in patients after the onset of acute low back pain increase the odds of absence from usual work due to progression to chronic low back pain? DESIGN: Systematic review with meta-analysis of prospective inception cohort studies. PARTICIPANTS: Adults with acute or subacute non-specific low back pain. OUTCOME MEASURE: Absence from usual work at a given time point greater than 12 weeks after the onset of pain due to ongoing pain. RESULTS: Ten studies involving 4683 participants were included in the review. Participants with acute or subacute pain and negative expectations about their recovery had significantly greater odds of being absent from usual work at a given time point more than 12 weeks after the onset of pain: OR 2.17 (95% CI 1.61 to 2.91). The exclusion of five studies with the greatest risk of bias showed that the result was similar when more rigorous quality criteria were applied: OR 2.52 (95% CI 1.47 to 4.31). CONCLUSION: The odds that adults with acute or subacute non-specific low back pain and negative recovery expectations will remain absent from work due to progression to chronic low back pain are two times greater than for those with more positive expectations. These results were consistent across the included studies despite variations in the risk of bias.

Stretching before sleep reduces the frequency and severity of nocturnal leg cramps in older adults: a randomised trial.

QUESTION: In adults who experience nocturnal leg cramps, does stretching of the calf and hamstring muscles each day just before sleep reduce the frequency and severity of the cramps? DESIGN: A randomised trial with concealed allocation and intention-to-treat analysis. PARTICIPANTS: Eighty adults aged over 55 years with nocturnal leg cramps who were not being treated with quinine. INTERVENTION: The experimental group performed stretches of the calf and hamstring muscles nightly, immediately before going to sleep, for six weeks. The control group performed no specific stretching exercises. Both groups continued other usual activities. OUTCOME MEASURES: Participants recorded the frequency of nocturnal leg cramps in a daily diary. Participants also recorded the severity of the pain associated with nocturnal leg cramps on a 10-cm visual analogue scale. Adverse events were also recorded. RESULTS: All participants completed the study. At six weeks, the frequency of nocturnal leg cramps decreased significantly more in the experimental group, mean difference 1.2 cramps per night (95% CI 0.6 to 1.8). The severity of the nocturnal leg cramps had also decreased significantly more in the experimental group than in the control group, mean difference 1.3 cm (95% CI 0.9 to 1.7) on the 10-cm visual analogue scale. CONCLUSION: Nightly stretching before going to sleep reduces the frequency and severity of nocturnal leg cramps in older adults. TRIAL REGISTRATION: NCT01421628.