Out-of-hours primary care (OOH-PC) has emerged as a promising solution to improve efficiency, accessibility, and quality of care and to reduce the strain on emergency departments. As this modality gains traction in diverse healthcare settings, it is increasingly important to fully assess its societal value-for-money and conduct thorough process evaluations. However, current economic evaluations mostly emphasise direct- and short-term effect measures, thus lacking a broader societal perspective.

This study offers a comprehensive overview of current effect measures in OOH-PC evaluations and proposes additional measures from the evaluation of integrated care programmes.

First, we systematically identified the effect measures from published cost-effectiveness studies and classified them as process, outcome, and resource use measures. Second, we elaborate on the incorporation of ‘productivity gains’, ‘health promotion and early intervention’, and ‘continuity of care’ as additional effects into economic evaluations of OOH-PC. Seeking care affects personal and employee time, potentially resulting in decreased productivity. Challenges in taking time off work and limited access to convenient care are often cited as barriers to accessing primary care. As such, OOH-PC can potentially reduce opportunity costs for patients. Furthermore, improving access to healthcare is important in determining whether people receive promotional and preventive services. Health promotion involves empowering people to take control of their health and its determinants. Given the unscheduled nature and the fragmented or rotational care in OOH-PC, the degree to which interventions and modalities provide continuity should be monitored, assessed, and included in economic evaluations. Continuity of care in primary care improves patient satisfaction, promotes adherence to medical advice, reduces reliance on hospitals, and reduces mortality.

Although it is essential to also address local settings and needs, the integration of broader scope measures into OOH-PC economic evaluations improves the comprehensive evaluation that aligns with welfare gains.

The goal of this pilot study was to identify changes associated with completion of a unique six-week hand exercise program in persons with carpometacarpal osteoarthritis.

Twenty-four individuals, aged 55–80, with doctor-diagnosed carpometacarpal osteoarthritis participated in the study. Movement data from standard clinical motions and complex multi-planar motions were obtained using a motion capture system at three-time points: an initial visit, after two weeks of hand exercises, and after completion of the six-week exercise program.

This exercise program produced trends of improvement in complex multi-planar motions. Specifically, joint angle changes were seen during opposition and the formation of an “okay sign” that was included as part of the exercise program.

Through the use of motion capture, changes were identified in thumb joint function after exercise. Specifically, motions associated with the more complex multi-planar tasks showed changes in individual joint contributions following the six-week exercise intervention. The results suggest that further exploration of this exercise program, particularly the inclusion of complex multi-planar tasks during osteoarthritis treatment and associated evaluations, should be considered in future clinical studies.

In difficult-to-treat depression (DTD) the outcome metrics historically used to evaluate treatment effectiveness may be suboptimal. Metrics based on remission status and on single end-point (SEP) assessment may be problematic given infrequent symptom remission, temporal instability, and poor durability of benefit in DTD.

Self-report and clinician assessment of depression symptom severity were regularly obtained over a 2-year period in a chronic and highly treatment-resistant registry sample (N = 406) receiving treatment as usual, with or without vagus nerve stimulation. Twenty alternative metrics for characterizing symptomatic improvement were evaluated, contrasting SEP metrics with integrative (INT) metrics that aggregated information over time. Metrics were compared in effect size and discriminating power when contrasting groups that did (N = 153) and did not (N = 253) achieve a threshold level of improvement in end-point quality-of-life (QoL) scores, and in their association with continuous QoL scores.

Metrics based on remission status had smaller effect size and poorer discrimination of the binary QoL outcome and weaker associations with the continuous end-point QoL scores than metrics based on partial response or response. The metrics with the strongest performance characteristics were the SEP measure of percentage change in symptom severity and the INT metric quantifying the proportion of the observation period in partial response or better. Both metrics contributed independent variance when predicting end-point QoL scores.

Revision is needed in the metrics used to quantify symptomatic change in DTD with consideration of INT time-based measures as primary or secondary outcomes. Metrics based on remission status may not be useful.

To evaluate voice intensity as the primary outcome measurement when treating unilateral vocal fold paralysis patients.

This prospective observational study comprised 34 newly diagnosed unilateral vocal fold paralysis patients undergoing surgical interventions: injection laryngoplasty or medialisation thyroplasty. Voice assessments, including maximum vocal intensity and other acoustic parameters, were performed at baseline and at one and three months post-intervention. Maximum vocal intensity was also repeated within two weeks before any surgical interventions were performed. The results were compared between different time points and between the two intervention groups.

Maximum vocal intensity showed high internal consistency. Statistically significant improvements were seen in maximum vocal intensity, Voice Handicap Index-10 and other acoustic analyses at one and three months post-intervention. A significant moderate negative correlation was demonstrated between maximum vocal intensity and Voice Handicap Index-10, shimmer and jitter. There were no significant differences in voice outcomes between injection laryngoplasty and medialisation thyroplasty patients at any time point.

Maximum vocal intensity can be applied as a treatment outcome measure in unilateral vocal fold paralysis patients; it can demonstrate the effectiveness of treatment and moderately correlates with self-reported outcome measures.

Alzheimer’s disease (AD) studies are increasingly targeting earlier (pre)clinical populations, in which the expected degree of observable cognitive decline over a certain time interval is reduced as compared to the dementia stage. Consequently, endpoints to capture early cognitive changes require refinement. We aimed to determine the sensitivity to decline of widely applied neuropsychological tests at different clinical stages of AD as outlined in the National Institute on Aging – Alzheimer’s Association (NIA-AA) research framework.

Amyloid-positive individuals (as determined by positron emission tomography or cerebrospinal fluid) with longitudinal neuropsychological assessments available were included from four well-defined study cohorts and subsequently classified among the NIA-AA stages. For each stage, we investigated the sensitivity to decline of 17 individual neuropsychological tests using linear mixed models.

1103 participants (age = 70.54 ± 8.7, 47% female) were included: n = 120 Stage 1, n = 206 Stage 2, n = 467 Stage 3 and n = 309 Stage 4. Neuropsychological tests were differentially sensitive to decline across stages. For example, Category Fluency captured significant 1-year decline as early as Stage 1 (β = −.58, p < .001). Word List Delayed Recall (β = −.22, p < .05) and Trail Making Test (β = 6.2, p < .05) became sensitive to 1-year decline in Stage 2, whereas the Mini-Mental State Examination did not capture 1-year decline until Stage 3 (β = −1.13, p < .001) and 4 (β = −2.23, p < .001).

We demonstrated that commonly used neuropsychological tests differ in their ability to capture decline depending on clinical stage within the AD continuum (preclinical to dementia). This implies that stage-specific cognitive endpoints are needed to accurately assess disease progression and increase the chance of successful treatment evaluation in AD.

Placements within high secure forensic hospitals consist of wards providing various different levels of relational security. They should form a coherent pathway through secure care, based on individual patient risks and needs. Moves to less secure wards within high secure forensic hospitals and moves on to lower secure hospital settings have rarely been systematically studied.

The aim of this study was to ascertain if placements within Broadmoor High Secure Hospital and moves from Broadmoor to medium secure hospitals corresponded to measures of violence risk, programme completion and recovery.

A 13-month prospective cohort study was completed. Patients (n = 142) were rated at baseline for violence risk (Historical, Clinical and Risk – 20), therapeutic programme completion and recovery (DUNDRUM tool) and overall functioning (Global Assessment of Functioning). Placements on the care pathway and moves on to medium secure hospitals were observed.

Placements on the care pathway within the high secure hospital were associated with dynamic violence risk (F = 16.324, P<0.001), therapeutic programme completion (F = 4.167, P = 0.003), recovery (F = 2.440, P = 0.050) with better scores on these measures being found in the rehabilitation wards and the poorest scores on the highest levels of dependency. Moves to medium secure hospitals were associated with better scores on dynamic risk of violence (F = 33.199, P<0.001), therapeutic programme completion (F = 9.237 P<0.001), recovery (F = 6.863, P = 0.001).

Placements within Broadmoor Hospital formed a coherent pathway through high secure care. Moves to less secure places were influenced by more than reduction in violence risk. Therapeutic programme completion and recovery in a broad sense were also important.

Using the data of a positive d.b.c.t. comparing an hypericum extract (W55570) to placebo in depressed patients we explored whether the Ham D6 was unidimentional and in case of a positive answer whether the total score was as sensitive as the total score of the Ham D17.

The study was a 6 weeks double blind placebo controlled trial comparing 300 mg of hypericum t.i.d (n = 186), to placebo (n = 189), in patients with a single or recurrent depression according to DSM-IV. Superiority of hypericum versus placebo on the main outcome criterion (HDRS 17) was already published.

The unidimensionality of the Hamilton depression scale 6 and 17 items were tested using a Mokken scale analysis. The effect size according to the initial severity of depression was calculated on the ITT last observation carried forward population.

The Ham D6, covering the core symptoms of depression was unidimensional, implying that improving this score reflects a true antidepressant effect. The Ham D17 was not unidimensional.

Hypericum was an effective antidepressant in patients with a pre-treatment score of 12 or more (n = 208) on the Ham D6, the effect size was 0.46. No difference with placebo was observed for those with a score of less than 12 (n = 167).

For the evaluation of an antidepressant effect, because of its specificity and sensitivity, the Ham D6 should be used as a primary outcome measure rather than the Ham D17.