The Ultrashort Mental Health Screening Tool Is a Valid and Reliable Measure With Added Value to Support Decision-making

BACKGROUND: Mental health influences symptoms, outcomes, and decision-making in musculoskeletal healthcare. Implementing measures of mental health in clinical practice can be challenging. An ultrashort screening tool for mental health with a low burden is currently unavailable but could be used as a conversation starter, expectation management tool, or decision support tool.QUESTIONS/PURPOSES: (1) Which items of the Pain Catastrophizing Scale (PCS), Patient Health Questionnaire (PHQ-4), and Brief Illness Perception Questionnaire (B-IPQ) are the most discriminative and yield a high correlation with the total scores of these questionnaires? (2) What is the construct validity and added clinical value (explained variance for pain and hand function) of an ultrashort four-item mental health screening tool? (3) What is the test-retest reliability of the screening tool? (4) What is the response time for the ultrashort screening tool?METHODS: This was a prospective cohort study. Data collection was part of usual care at Xpert Clinics, the Netherlands, but prospective measurements were added to this study. Between September 2017 and January 2022, we included 19,156 patients with hand and wrist conditions. We subdivided these into four samples: a test set to select the screener items (n = 18,034), a validation set to determine whether the selected items were solid (n = 1017), a sample to determine the added clinical value (explained variance for pain and hand function, n = 13,061), and a sample to assess the test-retest reliability (n = 105). Patients were eligible for either sample if they completed all relevant measurements of interest for that particular sample. To create an ultrashort screening tool that is valid, reliable, and has added value, we began by picking the most discriminatory items (that is, the items that were most influential for determining the total score) from the PCS, PHQ-4, and B-IPQ using chi-square automated interaction detection (a machine-learning algorithm). To assess construct validity (how well our screening tool assesses the constructs of interest), we correlated these items with the associated sum score of the full questionnaire in the test and validation sets. We compared the explained variance of linear models for pain and function using the screening tool items or the original sum scores of the PCS, PHQ-4, and B-IPQ to further assess the screening tool's construct validity and added value. We evaluated test-retest reliability by calculating weighted kappas, ICCs, and the standard error of measurement.RESULTS: We identified four items and used these in the screening tool. The screening tool items were highly correlated with the PCS (Pearson coefficient = 0.82; p &lt; 0.001), PHQ-4 (0.87; p &lt; 0.001), and B-IPQ (0.85; p &lt; 0.001) sum scores, indicating high construct validity. The full questionnaires explained only slightly more variance in pain and function (10% to 22%) than the screening tool did (9% to 17%), again indicating high construct validity and much added clinical value of the screening tool. Test-retest reliability was high for the PCS (ICC 0.75, weighted kappa 0.75) and B-IPQ (ICC 0.70 to 0.75, standard error of measurement 1.3 to 1.4) items and moderate for the PHQ-4 item (ICC 0.54, weighted kappa 0.54). The median response time was 43 seconds, against more than 4 minutes for the full questionnaires.CONCLUSION: Our ultrashort, valid, and reliable screening tool for pain catastrophizing, psychologic distress, and illness perception can be used before clinician consultation and may serve as a conversation starter, an expectation management tool, or a decision support tool. The clinical utility of the screening tool is that it can indicate that further testing is warranted, guide a clinician when considering a consultation with a mental health specialist, or support a clinician in choosing between more invasive and less invasive treatments. Future studies could investigate how the tool can be used optimally and whether using the screening tool affects daily clinic decisions.LEVEL OF EVIDENCE: Level II, diagnostic study.</p

Tailoring and evaluating treatment with the Patient-Specific Needs Evaluation:A Patient-Centered Approach

BACKGROUND: No patient-reported instrument assesses patient-specific information needs, treatment goals, and Personal Meaningful Gain (PMG, a novel construct evaluating individualized, clinically relevant improvement). This study reports the development of the Patient-Specific Needs Evaluation (PSN) and examines its discriminative validity (i.e., its ability to distinguish satisfied from dissatisfied patients) and test-retest reliability in patients with hand or wrist conditions.METHODS: A mixed-methods approach was used to develop and validate the PSN, following COSMIN guidelines, including pilot testing, a survey (pilot: n=223, final PSN: n=275), cognitive debriefing (n=16), expert input, and validation. Discriminative validity was assessed by comparing the satisfaction level of patients who did or did not achieve their PMG (n=1,985) and test-retest reliability using absolute agreement, Cohen's kappa, and ICCs (n=102). We used a sample of 2,860 patients to describe responses to the final PSN.RESULTS: The PSN has only five questions (completion time ±3 minutes) and is freely accessible online. The items and response options were considered understandable by 90-92% and complete by 84-89% of the end-users. The PSN had excellent discriminative validity (Cramer's V: 0.48, p&lt;0.001) and moderate to high test-retest reliability (Kappa: 0.46-0.68, ICCs: 0.53-0.73).CONCLUSIONS: The PSN is a freely available patient-centered decision-support tool that helps clinicians tailor their consultations to the patient's individual needs and goals. It contains the PMG, a novel construct evaluating individualized, clinically relevant treatment outcomes. The PSN may function as a conversation starter, facilitate expectation management, and aid shared decision-making. The PSN is implementation-ready and can be readily adapted to other patient populations.LEVEL OF EVIDENCE: I.</p

A standard set for outcome measurement in patients with hand and wrist conditions:Consensus by the International Consortium for Health Outcomes Measurement Hand and Wrist Working Group

Purpose: To describe the principles, process, and results of creating the International Consortium for Health Outcomes Measurement (ICHOM) standard set for hand and wrist conditions.  Methods: Following the standardized methods of ICHOM, an international working group of hand surgeons, therapists, and researchers was assembled to develop an evidence-based, patient-centered, standard set of outcome measures for patients with hand and wrist conditions. Multiple systematic reviews were performed to support our choices of outcome domains and tools for hand and wrist conditions. Fourteen video conferences were held between March 2018 and March 2020, and a modified Delphi process was used.  Results: A consensus was reached on 5 measurement tracks: the thumb, finger, wrist, nerve, and severe hand trauma tracks, with a distinction between regular and extended tracks for which specific allocation criteria applied. The standard set contains a selection of outcome tools and predefined time points for outcome measurement. Additionally, we developed a hierarchy for using the tracks when there are multiple conditions, and we selected risk-adjustment, case-mix variables.  Conclusions: The global implementation of the ICHOM standard set for hand and wrist conditions may facilitate value-based health care for patients with hand and wrist conditions.  Clinical relevance: The ICHOM standard set for hand and wrist conditions can enable clinical decision making, quality improvement, and comparisons between treatments and health care professionals

Antenatal allopurinol for reduction of birth asphyxia induced brain damage (ALLO-Trial); a randomized double blind placebo controlled multicenter study

<p>Abstract</p> <p>Background</p> <p>Hypoxic-ischaemic encephalopathy is associated with development of cerebral palsy and cognitive disability later in life and is therefore one of the fundamental problems in perinatal medicine. The xanthine-oxidase inhibitor allopurinol reduces the formation of free radicals, thereby limiting the amount of hypoxia-reperfusion damage. In case of suspected intra-uterine hypoxia, both animal and human studies suggest that maternal administration of allopurinol immediately prior to delivery reduces hypoxic-ischaemic encephalopathy.</p> <p>Methods/Design</p> <p>The proposed trial is a randomized double blind placebo controlled multicenter study in pregnant women at term in whom the foetus is suspected of intra-uterine hypoxia.</p> <p>Allopurinol 500 mg IV or placebo will be administered antenatally to the pregnant woman when foetal hypoxia is suspected. Foetal distress is being diagnosed by the clinician as an abnormal or non-reassuring foetal heart rate trace, preferably accompanied by either significant ST-wave abnormalities (as detected by the STAN-monitor) or an abnormal foetal blood scalp sampling (pH < 7.20).</p> <p>Primary outcome measures are the amount of S100B (a marker for brain tissue damage) and the severity of oxidative stress (measured by isoprostane, neuroprostane, non protein bound iron and hypoxanthine), both measured in umbilical cord blood. Secondary outcome measures are neonatal mortality, serious composite neonatal morbidity and long-term neurological outcome. Furthermore pharmacokinetics and pharmacodynamics will be investigated.</p> <p>We expect an inclusion of 220 patients (110 per group) to be feasible in an inclusion period of two years. Given a suspected mean value of S100B of 1.05 ug/L (SD 0.37 ug/L) in the placebo group this trial has a power of 90% (alpha 0.05) to detect a mean value of S100B of 0.89 ug/L (SD 0.37 ug/L) in the 'allopurinol-treated' group (z-test_2-sided). Analysis will be by intention to treat and it allows for one interim analysis.</p> <p>Discussion</p> <p>In this trial we aim to answer the question whether antenatal allopurinol administration reduces hypoxic-ischaemic encephalopathy in neonates exposed to foetal hypoxia.</p> <p>Trial registration number</p> <p>Clinical Trials, protocol registration system: NCT00189007</p

Postoperative rehabilitation following thumb base surgery: A systematic review of the literature

WOS: 000433381200016PubMed ID: 29030095Objective: To provide an overview of rehabilitation for patients who underwent first carpometacarpal joint (CMC-1) arthroplasty, with emphasis on early active mobilization. Data Sources: PubMed/MEDLINE, Embase, CINAHL, and Cochrane were searched. Study Selection: Articles written in English that described the postoperative regimen (including immobilization period/method and/or description of exercises/physical therapy, follow-up 6wk) on CMC-1 arthroplasty were included. Data Extraction: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement was used as guidance in this review, and methodological quality was assessed using the Effective Public Health Practice Project quality assessment tool. Randomized studies were additionally scored using the Physiotherapy Evidence Database scale. Data Synthesis: Twenty-seven studies were included consisting of 1015 participants, in whom 1118 surgical procedures were performed. A summary of the components of postoperative rehabilitation used in the included studies of CMC-1 osteoarthritis is presented for different surgical interventions. We found that early active recovery (including short immobilization, early initiation of range of motion and strength exercises) provides positive outcomes for pain, limitations in activities of daily living, and grip and pinch strength, but comparative studies are lacking. Furthermore, 3 postoperative exercises/therapy phases were identified in the literature-the acute phase, the unloaded phase, and the functional phase-but again comparative studies are lacking. Conclusions: Early active recovery is used more often in the literature and does not lead to worse outcomes or more complications. This systematic review provides guidance for clinicians in the content of postoperative rehabilitation for CMC-1 arthroplasty. The review also clearly identifies the almost complete lack of high-quality comparative studies on postoperative rehabilitation after CMC-1 arthroplasty

Incision techniques for trigger thumb release:a comparison of outcomes of four types of skin incision

Although trigger thumb release is commonly performed, there is no consensus on the optimal skin incision. This study aimed to compare outcomes of four incision techniques, including V-shaped, oblique, transverse and longitudinal incisions. Outcomes included the Michigan Hand Outcomes Questionnaire, satisfaction with the treatment and postoperative complications. The results of 875 patients who underwent trigger thumb release were assessed. All groups demonstrated improvement in self-reported hand function (range of 10-14 points), pain (25-27 points) and aesthetics (4-7 points) from baseline to 3 months postoperatively with no differences between incision techniques. Of the patients, 76% reported good or excellent satisfaction with the outcome of treatment. Satisfaction and complication rates of the different incision techniques were similar. These findings imply that there is no clear benefit of one type of incision over another for trigger thumb release, suggesting that surgeons may use the technique of their preference.Level of evidence: II

Long-Term Outcomes of Nonsurgical Treatment of Thumb Carpometacarpal Osteoarthritis:A Cohort Study

Background:Although nonsurgical treatment of thumb carpometacarpal (CMC-1) osteoarthritis (OA) provides short-term improvement, the durability of these effects beyond 1 year is unknown. In this study, we investigated patient-reported pain and limitations in activities of daily living (ADL) at &amp; gt;5 years following nonsurgical treatment (i.e., exercise therapy and use of an orthosis) for CMC-1 OA. We hypothesized that pain and limitations in ADL would not worsen after 12 months. Secondary outcomes were satisfaction with treatment results and health-related quality of life at &amp; gt;5 years of follow-up and the rate of conversion to surgery.Methods:This was a multicenter, prospective cohort study using 2 overlapping samples. The change in the Michigan Hand Outcomes Questionnaire (MHQ) subscales of pain and ADL between 12 months and &amp; gt;5 years was the primary outcome as measured in the first sample (n = 170), which consisted of patients who did not undergo conversion to surgery. Additional measurement time points included baseline and 3 months. We evaluated conversion to surgery in a second sample, which included all patients who responded to the invitation for this follow-up study (n = 217).Results:At a median follow-up of 6.6 years (range, 5.1 to 8.7 years), the score on the MHQ pain subscale did not differ significantly from that at 12 months. The score on the MHQ ADL improved by 4.4 points (95% confidence interval [CI],1.5 to 7.2) compared with 12 months, but this was not clinically relevant. At &amp; gt;5 years, 5% of the patients rated their satisfaction as &amp; quot;poor,&amp; quot; 14% as &amp; quot;moderate,&amp; quot; 26% as &amp; quot;fair,&amp; quot; 39% as &amp; quot;good,&amp; quot; and 16% as &amp; quot;excellent.&amp; quot; The median EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) index score was 0.852 (range, 0.135 to 1). The rate of conversion to surgery was 22% (95% CI,16.4% to 27.7%) at a median follow-up of 7 years (range, 5.5 to 9.0 years).Conclusions:We found positive outcomes at &amp; gt;5 years of follow-up for nonsurgical treatment of CMC-1 OA, with no worsening of pain or of limitations in ADL after 12 months. Our findings support nonsurgical treatment as the first treatment choice and suggest that treatment effects are sustainable.Level of evidence:Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.</p

CRISPR/Cas9 generated human CD46, CD55 and CD59 knockout cell lines as a tool for complement research

To prevent unwanted complement activation and subsequent damage, complement activation must be tightly regulated on healthy host cells. Dysregulation of the complement system contributes to the pathology of diseases like Paroxysmal Nocturnal Hemoglobinuria and atypical Hemolytic Uremic Syndrome. To investigate complement regulator deficiencies, primary patient cells may be used, but access to patient cells may be limited and cells are heterogeneous between different patients. To inhibit regulator function on healthy host cells, blocking antibodies can be used, though it may be difficult to exclude antibody-mediated effects. To circumvent these issues, we created single and combined complement regulator human knockout cells to be able to in vitro investigate complement activation and regulation on human cells. CRISPR/Cas9 was used to knockout (KO) complement regulatory proteins CD46, CD55 and/or CD59 in human HAP1 cells. Single cell derived cell lines were profiled by Sanger sequencing and flow cytometry. To confirm the lack of complement regulatory function, the cells were exposed to complement in normal human serum and subsequently C3 and C4 deposition on the cell surface were detected by using flow cytometry. We created single KO cell lines that completely lacked CD46, CD55 or CD59. We additionally generated double CD46/CD55, CD46/CD59 and CD55/CD59 KOs and triple CD46/CD55/CD59 KOs. Upon classical pathway activation, deletion of CD46 resulted in increased C3 and C4 deposition, while deleting CD55 mainly resulted to increased C3 deposition, confirming their reported function in complement regulation. Upon alternative pathway activation, C3 deposition was only observed on the triple CD46/CD55/CD59 KO cells and not on any of the other cell lines, suggesting that human cells are resistant to spontaneous complement activation and suggesting a role for CD59 in C3 regulation. The generation of complement regulator KO cell lines provides a relevant tool for future in vitro investigations of complement activation and regulation on human cells. Furthermore, these cell lines may also be helpful to evaluate therapeutic complement inhibitors and may shed light on novel roles of complement regulatory proteins as we here observed for CD5

Routinely-Collected Outcomes of Proximal Row Carpectomy

Purpose: To describe patient-reported pain and function 12 months after proximal row carpectomy (PRC). Secondary outcomes included return to work, grip strength, range of wrist motion, satisfaction with treatment results, and complications. Methods: This cohort study was part of the British Society for Surgery of the Hand Studyathon 2021, using ongoing routinely-collected data of 304 eligible patients who underwent PRC (73% scapholunate advanced collapse, 11% scaphoid nonunion advanced collapse wrist; 11% Kienböck, 5% other indications) from Xpert Clinics, the Netherlands between 2012–2020. The primary outcome was the Patient Rated Wrist/Hand Evaluation total score (range, 0–100, lower scores indicate better performance). Results: Of the 304 patients, the primary outcome was available in 217 patients. The total Patient Rated Wrist/Hand Evaluation score improved from 60 (95% confidence interval [CI], 57–63) to 38 (95% CI, 35–41) at 3 months, and 26 (95% CI, 23–29) at 12 months. The pain and function subscales improved by 18 (95% CI, 17–20) and 16 (95% CI, 14–18) points, respectively. At 12 months, 82% had returned to work at a median time of 12 (95% CI, 9–14) weeks following PRC. Grip strength did not improve. Wrist flexion and extension demonstrated a clinically irrelevant decrease. Satisfaction with treatment result was excellent in 27% of patients, good in 42%, fair in 20%, moderate in 6%, and poor in 5%. Complications occurred in 11% of patients, and conversion to wrist arthroplasty occurred in 2 patients. Conclusion: A clinically relevant improvement in patient-reported pain and function was observed at 3 months after PRC, with continued improvement to 12 months. These data can be used for shared-decision making and expectation management

Exercise Therapy in Addition to an Orthosis Reduces Pain More Than an Orthosis Alone in Patients With Thumb Base Osteoarthritis: A Propensity Score Matching Study

Item does not contain fulltextOBJECTIVE: To compare the effect of exercises and orthotics with orthotics alone on pain and hand function in patients with first carpometacarpal joint (CMC-1) osteoarthritis (OA) and to predict outcomes on pain and hand function of exercises and orthotics. DESIGN: Prospective cohort study with propensity score matching. SETTING: Data collection took place in 13 outpatient clinics for hand surgery and hand therapy in The Netherlands. PARTICIPANTS: A consecutive, population-based sample of patients with CMC-1 OA (N=173) was included in this study, of which 84 were matched on baseline demographics and baseline primary outcomes. INTERVENTIONS: Exercises and orthotics versus orthotics alone. MAIN OUTCOME MEASURES: Primary outcomes included pain and hand function at 3 months, measured using visual analog scale (VAS, 0-100) and the Michigan Hand Outcomes Questionnaire (MHQ, 0-100). RESULTS: A larger decrease in VAS pain at rest (11.1 points difference; 95% confidence interval, 1.9-20.3; P=.002) and during physical load (22.7 points difference; 95% confidence interval, 13.6-31.0; P<.001) was found in the exercise + orthotic group compared to the orthotic group. In addition, larger improvement was found for the MHQ subscales pain, work performance, aesthetics, and satisfaction in the exercise + orthotic group. No differences were found on other outcomes. Baseline scores of metacarpophalangeal flexion, presence of scaphotrapeziotrapezoid OA, VAS pain at rest, heavy physical labor, and MHQ total predicted primary outcomes for the total exercise + orthotic group (N=131). CONCLUSIONS: Non-surgical treatment of patients with CMC-1 OA should include exercises, since there is a relatively large treatment effect compared to using an orthosis alone. Future research should study exercises and predictors in a more standardized setting to confirm this finding