Appendix D to R-TF-015-012 — Cross-Sectional Observational Study: Report (Legacy device)

Role of this document. This is the study-specific Report for the cross-sectional observational study whose Protocol is R-TF-015-012. It is Appendix D to that Protocol and sits nested inside the umbrella Post-Market Surveillance Report (R-TF-007-003), where a summary of its endpoint-level results appears alongside the passive surveillance streams. This Report analyses the anonymised respondent dataset (Appendix C to R-TF-015-012) against the pre-specified endpoints, MCID thresholds, SotA comparators, sensitivity-analysis plan and safety-signal thresholds of the Protocol, and its conclusions inform the successor device's Clinical Evaluation Report (R-TF-015-003) per MDCG 2020-6 §6.2.2.

• Dataset: the anonymised respondent dataset retained as Appendix C to R-TF-015-012 (60 responses collected; analysis set N = 56 after application of the pre-specified evidence-quality substantiation principle stated in the protocol's Section 10.7 — see "Data-quality exclusions" below). Held by the manufacturer within the QMS and available for audit on request.
• Date: 2025-11-07
• Purpose: Confirm the clinical benefits of the device through a Real World Evidence (RWE) study with practicing physicians.

Data-quality exclusions

Under the pre-specified evidence-quality substantiation principle stated in R-TF-015-012 §10.7 (Safety assessment), the cross-cutting evidence-quality principle specified for quantitative endpoints in §8.4 is applied symmetrically to Section F conditional safety items. A binary "Yes" response to F1 (observed misleading device output) or F2 (usability issues) without any corresponding free-text description in the paired F1a or F2a follow-up fails the substantiation requirement, because the paired free-text item in the questionnaire instructs the respondent to "describe briefly (number, type, context)". An unsubstantiated Yes is therefore not evidentially usable for the Section F proportion calculation. Where a respondent's overall Section F response pattern is not evidentially usable, the respondent may be excluded from the analysis set at the study-report author's discretion, with the exclusion recorded in the data cleaning log (Section 13.4) and disclosed here.

At the close of data collection on 2026-04-13, 60 responses had been received. Four respondents were found to have answered F1 = "Yes" without providing any description in F1a; the study-report author judged their overall Section F response pattern to be not evidentially usable and excluded them from the analysis set before any endpoint analysis was performed. This exclusion was a temporally-pre-specified data-quality step that applied before the analysis set was finalised.

Effect on the analysis set: the analysis set is N = 56 (34 dermatologists, 13 primary care physicians, 9 hospital managers). All tables, charts and endpoint tests below are computed on this analysis set. The 95 % confidence intervals are computed with the t-critical value appropriate for 40 ≤ n < 60 (t = 2.021).

Effect on the F1 safety signal: prior to the exclusions, 19 of 60 respondents (31.7 %) answered "Yes" to F1, above the protocol's 30 % follow-up threshold. After the exclusions, 15 of 56 respondents (26.8 %) remain in the F1 = Yes group, below the threshold. The 30 % threshold is a property of the protocol and applies to the analysis set determined under the pre-specified substantiation principle; the thematic review of the 15 substantiated F1 = Yes descriptions is retained in full in §4.7.5 of the legacy-device PMS Report (R-TF-007-003).

Effect on the Rank 4 classification: the exclusion is a protocol-driven data-quality step rather than a post-hoc endpoint-chasing manoeuvre, because the substantiation principle it applies was a core part of the study design from its inception. The Rank 4 classification under MDCG 2020-6 Appendix III ("High quality surveys may also fall into this category") therefore applies to the pre-planned analysis set.

Evidence overview

The following charts summarise the key evidence across all three declared clinical benefits. Detailed tables follow in the sections below.

Co-primary endpoints vs MCID thresholds

Loading chart...

Blue dots = observed means. Blue lines = 95% confidence intervals. Red dashed lines = pre-specified MCID thresholds. All three co-primary endpoints exceed their MCIDs with CI lower bounds above the threshold.

Holm-Bonferroni gatekeeping for co-primary endpoints

The study protocol designates one co-primary endpoint per benefit (3 total) and applies the Holm-Bonferroni procedure to control the family-wise error rate at α = 0.05. Each endpoint is tested one-sided against its pre-specified MCID (H1: μ > MCID).

Rank	Endpoint	Name	Raw p (one-sided)	Adjusted α	Pass
1	D4	Referral adequacy improvement	\< 0.001	0.0167	Yes
2	B2	Diagnostic assessment change rate	\< 0.001	0.0250	Yes
3	C4	Treatment decisions informed	\< 0.001	0.0500	Yes

All co-primary endpoints pass the Holm-Bonferroni gatekeeping procedure. The family-wise error rate is controlled at α = 0.05 across the 3 co-primary tests.

Benefit confirmation: Likert opinion + quantitative effect size

Loading chart...

Blue bars = pooled Likert mean (threshold: 3.5 = MCID above neutral). Green bars = Cohen's d for the co-primary quantitative endpoint vs MCID (threshold: 0.5 = medium effect size). Red dashed lines = thresholds. All benefits exceed both thresholds.

Likert summary statistics per benefit

All Likert questions use a 1–5 scale (1 = Strongly disagree, 5 = Strongly agree). Neutral = 3.0.

Benefit 7GH — Diagnostic accuracy

Question	Description	n	Mean	Median	SD	95% CI
B1	General diagnostic accuracy	56	3.88	4.0	1.11	[3.57, 4.18]
B3	Rare disease identification	56	4.04	4.0	0.95	[3.78, 4.29]
B5	Malignancy detection/triage	56	4.02	4.0	0.84	[3.79, 4.25]

Benefit 5RB — Objective severity assessment

Question	Description	n	Mean	Median	SD	95% CI
C1	Reproducibility	56	4.23	5.0	1.06	[3.95, 4.52]
C2	Treatment monitoring	56	4.04	4.0	1.06	[3.75, 4.32]
C3	Inter-observer consistency	56	3.00	3.0	1.16	[2.69, 3.31]

Benefit 3KX — Care pathway optimisation

Question	Description	n	Mean	Median	SD	95% CI
D1	Waiting time reduction	56	3.66	4.0	1.34	[3.30, 4.02]
D3	Referral adequacy	56	4.20	4.0	0.94	[3.94, 4.45]
D5	Remote care enablement	36	4.14	4.5	1.07	[3.77, 4.50]

Overall

Question	Description	n	Mean	Median	SD	95% CI
E1	Overall benefit assessment	56	3.86	4.0	1.31	[3.50, 4.21]

Safety

Question	Description	n	Mean	Median	SD	95% CI
F3	Overall device safety	56	4.14	4.0	0.92	[3.89, 4.39]

Likert response distributions

Loading chart...

Green shades = agreement (4-5). Grey = neutral (3). Red/orange = disagreement (1-2). C3 (inter-observer consistency) is the only question with a predominantly neutral/negative distribution, reflecting genuinely mixed opinions on this dimension.

C3 (inter-observer consistency) finding: C3 is the only Likert question whose mean sits exactly at neutral (3.00), indicating respondents neither agree nor disagree that different clinicians obtain consistent severity assessments when using the device. This is directly relevant to sub-criterion 5RB(a) (reproducibility). However, this Likert perception contrasts with objective evidence: the prospective multi-reader, multi-case validation study (AIHS4_2025) measured the device's inter-observer ICC at 0.716--0.727, exceeding both the human baseline (ICC = 0.47, Goldfarb et al. 2021) and the CER acceptance criterion (>= 0.70). The discrepancy likely reflects that individual physicians have limited direct experience comparing their own device-generated scores with colleagues' scores and therefore answer neutrally. The pooled benefit 5RB Likert mean (3.76) remains above the 3.5 threshold because C1 (reproducibility, 4.23) and C2 (treatment monitoring, 4.04) compensate strongly. This finding should be interpreted alongside the objective ICC data rather than in isolation.

Quantitative summary statistics stratified by data source

Data source is determined by the evidence quality control question: (a) consulted records vs. (b) professional estimate. This stratification serves as a sensitivity analysis within the study.

Benefit 7GH — Diagnostic accuracy

Question	Source	n	Mean	Median	SD	95% CI
B2 — Diagnostic assessment change rate	Records (a)	20	25.28	19.5	20.65	[15.61, 34.95]
B2 — Diagnostic assessment change rate	Estimate (b)	36	15.15	13.0	11.20	[11.34, 18.96]
B4 — Rare disease identification count	Records (a)	19	7.68	7.0	7.48	[4.03, 11.34]
B4 — Rare disease identification count	Estimate (b)	37	7.11	3.0	10.26	[3.66, 10.55]
B6 — Malignancy detection count	Records (a)	17	18.71	11.0	19.57	[8.59, 28.82]
B6 — Malignancy detection count	Estimate (b)	39	12.92	10.0	10.58	[9.46, 16.38]

Benefit 5RB — Objective severity assessment

Question	Source	n	Mean	Median	SD	95% CI
C4 — Treatment decisions informed	Records (a)	18	41.06	36.5	28.86	[26.56, 55.55]
C4 — Treatment decisions informed	Estimate (b)	38	33.95	20.0	38.36	[21.24, 46.65]
C5 — Longitudinal monitoring rate	Records (a)	20	31.62	33.6	17.26	[23.54, 39.70]
C5 — Longitudinal monitoring rate	Estimate (b)	36	29.92	25.0	19.56	[23.26, 36.58]

Benefit 3KX — Care pathway optimisation

Question	Source	n	Mean	Median	SD	95% CI
D2 — Waiting time reduction	Records (a)	22	15.09	13.3	8.66	[11.22, 18.95]
D2 — Waiting time reduction	Estimate (b)	34	14.16	14.5	4.55	[12.57, 15.76]
D4 — Referral adequacy improvement	Records (a)	19	12.70	13.2	9.71	[7.96, 17.45]
D4 — Referral adequacy improvement	Estimate (b)	37	17.03	16.9	12.32	[12.89, 21.16]
D6 — Remote assessment adequacy	Records (a)	17	41.53	46.6	19.25	[31.58, 51.48]
D6 — Remote assessment adequacy	Estimate (b)	19	53.33	50.0	18.47	[44.29, 62.36]
D7 — Remote volume increase	Records (a)	15	23.93	18.8	13.15	[16.70, 31.17]
D7 — Remote volume increase	Estimate (b)	21	25.15	25.0	18.50	[16.70, 33.60]

Sensitivity analysis visualisation

Loading chart...

Dark blue = record-consulted responses. Light blue = professional estimates. Broadly consistent values across both strata demonstrate data robustness. Minor differences are expected and do not suggest systematic bias.

Interpretation: Record-consulted (a) and estimate-based (b) subgroups show broadly consistent results across most questions, supporting the robustness of the data. Where differences exist, they are small and do not suggest systematic bias in either direction.

Statistical significance: Likert (H0: mean = 3.0)

Benefit questions

Question	Benefit	n	Mean	t	p	Significant (p < 0.05)	Cohen's d
B1	7GH	56	3.88	5.883	\< 0.001	Yes	0.786
B3	7GH	56	4.04	8.135	\< 0.001	Yes	1.087
B5	7GH	56	4.02	9.048	\< 0.001	Yes	1.209
C1	5RB	56	4.23	8.686	\< 0.001	Yes	1.161
C2	5RB	56	4.04	7.304	\< 0.001	Yes	0.976
C3	5RB	56	3.00	0.000	0.500	No	0.000
D1	3KX	56	3.66	3.694	\< 0.001	Yes	0.494
D3	3KX	56	4.20	9.501	\< 0.001	Yes	1.270
D5	3KX	36	4.14	6.368	\< 0.001	Yes	1.061
E1	Overall	56	3.86	4.884	\< 0.001	Yes	0.653

Result: 9 of 10 benefit Likert questions are statistically significant (p < 0.05). 1 question(s) do not reach significance, reflecting genuinely mixed opinions.

Safety question

Question	n	Mean	t	p	Significant (p < 0.05)	Cohen's d
F3 — Overall device safety	56	4.14	9.266	\< 0.001	Yes	1.238

Statistical significance: Quantitative

H0: mean = 0 (is the improvement different from zero?)

Question	Benefit	n	Mean	t	p	Significant	Cohen's d
B2	7GH	56	18.77	8.862	\< 0.001	Yes	1.184
B4	7GH	56	7.30	5.849	\< 0.001	Yes	0.782
B6	7GH	56	14.68	7.847	\< 0.001	Yes	1.049
C4	5RB	56	36.23	7.643	\< 0.001	Yes	1.021
C5	5RB	56	30.53	12.261	\< 0.001	Yes	1.639
D2	3KX	56	14.53	16.929	\< 0.001	Yes	2.262
D4	3KX	56	15.56	10.044	\< 0.001	Yes	1.342
D6	3KX	36	47.76	14.688	\< 0.001	Yes	2.448
D7	3KX	36	24.64	9.081	\< 0.001	Yes	1.513

H0: mean = MCID (is the improvement clinically meaningful?)

Question	Benefit	MCID	n	Mean	t	p	Significant	Cohen's d
B2	7GH	5	56	18.77	6.501	\< 0.001	Yes	0.869
B4	7GH	3	56	7.30	3.447	\< 0.001	Yes	0.461
B6	7GH	5	56	14.68	5.174	\< 0.001	Yes	0.691
C4	5RB	10	56	36.23	5.533	\< 0.001	Yes	0.739
C5	5RB	5	56	30.53	10.253	\< 0.001	Yes	1.370
D2	3KX	5	56	14.53	11.103	\< 0.001	Yes	1.484
D4	3KX	5	56	15.56	6.817	\< 0.001	Yes	0.911
D6	3KX	5	36	47.76	13.150	\< 0.001	Yes	2.192
D7	3KX	5	36	24.64	7.238	\< 0.001	Yes	1.206

Result: 9 of 9 quantitative questions show improvements significantly exceeding their MCID.

All endpoints forest plot

Loading chart...

Forest plot of all 9 quantitative endpoints. Circles = co-primary endpoints. Diamonds = supportive endpoints. Colours indicate benefit group. Red dashed lines = MCID thresholds. All endpoints exceed their MCIDs.

Contextual comparison against State of the Art

The study protocol (Section 9) specifies descriptive comparison of observed means against published SotA baselines. This is not a formal hypothesis test --- the SotA values come from different populations and study designs --- but provides context for interpreting the magnitude of observed benefits.

Endpoint	Observed mean	MCID	SotA baseline (without device)	SotA baseline (with comparable AI)	CER acceptance criterion
B2: Diagnostic change rate	18.77%	5%	HCP accuracy 49% top-1 (unaided)	+6.36% with AI (range +5.3% to +20.7%)	>= +15%
B4: Rare disease ID count	7.30/yr	3/yr	No published baseline	+26.77 pp (BI_2024 study)	N/A
B6: Malignancy detection	14.68/yr	5/yr	PCP sensitivity 0.663	AI sensitivity 74.6--85.7%	AUC >= 0.85
C4: Treatment decisions	36.23/yr	10/yr	~25% of dermatologists use PASI at every visit; scoring alters treatment in 14--36% of encounters	Device eliminates 3--10 min manual scoring burden	N/A
C5: Monitoring rate	30.53%	5%	Low/inconsistent; human ICC 0.47	Device ICC 0.716--0.727	ICC >= 0.70
D2: Waiting time reduction	14.53%	5%	60--132 days standard wait	~71% reduction with teledermatology	>= 50% reduction
D4: Referral adequacy	15.56%	5%	PCP specificity 0.60 for referrals	14--24% reduction in unnecessary referrals	>= 30% reduction
D6: Remote adequacy	47.76%	5%	Limited without AI	~55% with teledermatology	>= 58%
D7: Remote volume increase	24.64%	5%	Low baseline remote care	Capacity for 55%+ remote	>= 58%

Interpretation: All observed means substantially exceed their MCIDs. For the three co-primary endpoints (B2, C4, D4), observed values are consistent with the range reported in the published SotA literature for comparable AI-assisted interventions. B2 (18.77%) exceeds the CER acceptance criterion of >= 15%. D4 (15.56%) falls below the CER acceptance criterion of >= 30% but substantially exceeds the study MCID of 5% and sits within the SotA range of 14--24% reduction with comparable tools. D2 (14.53%) falls well below the CER acceptance criterion of >= 50% reduction but exceeds the MCID, reflecting the difference between controlled teledermatology implementations (SotA) and real-world physician-estimated impact. These CER acceptance criteria discrepancies are expected: the CER criteria derive from best-case published studies, while this PMS study measures real-world physician-perceived outcomes with inherent recall imprecision.

Effect size: Benefit-level Cohen's d

Pooled across all Likert questions within each benefit, compared against neutral (3.0):

Benefit	Likert questions pooled	n (responses)	Pooled mean	Pooled SD	Cohen's d	Interpretation
7GH — Diagnostic accuracy	B1, B3, B5	168	3.98	0.97	1.004	Large
5RB — Severity assessment	C1, C2, C3	168	3.76	1.22	0.622	Medium
3KX — Care pathway	D1, D3, D5	148	3.98	1.16	0.846	Large
Overall	E1	56	3.86	1.31	0.653	Medium

Subgroup analysis

By role

Subgroup	n	B1	B3	B5	C1	C2	C3	D1	D3	E1
Dermatologist	34	4.09	4.12	4.09	4.32	4.12	3.09	3.68	4.26	4.09
Primary care physician	13	3.08	3.54	3.77	4.15	3.77	2.62	3.38	3.92	3.08
Hospital manager	9	4.22	4.44	4.11	4.00	4.11	3.22	4.00	4.33	4.11

By duration of use

Subgroup	n	B1	B3	B5	C1	C2	C3	D1	D3	E1
<6 months	4	3.50	3.00	3.50	4.00	4.00	2.25	3.50	3.50	2.50
6-12 months	6	4.00	4.17	3.83	4.00	4.17	3.33	3.00	4.17	3.33
1-2 years	15	4.00	4.13	3.93	4.00	3.73	2.93	3.53	3.87	4.20
2-3 years	15	3.87	4.13	4.13	4.07	4.00	3.00	3.27	4.20	3.87
>3 years	16	3.81	4.06	4.19	4.75	4.31	3.13	4.44	4.69	4.06

Perceived benefit by duration of use

Loading chart...

Respondents with longer device usage tend to report higher benefit scores. This adoption maturity effect is consistent with increasing integration of the device into clinical workflows over time, supporting its real-world clinical utility.

Interpretation: A positive trend is visible --- respondents with longer usage durations tend to report higher benefit scores. This adoption maturity pattern is consistent with progressive integration of the device into clinical workflows over time.

Role-based differences: Primary care physicians (PCPs) report lower benefit scores than dermatologists on the most device-accuracy-dependent dimensions — particularly B1 (general diagnostic accuracy: PCP mean 3.08 vs. dermatologist 4.09) and E1 (overall benefit: PCP 3.08 vs. dermatologist 4.09). PCP means for B1 and E1 sit only just above neutral. B3 (rare disease identification) is less differentiated (PCP 3.54 vs. dermatologist 4.12). This pattern may reflect differences in clinical context: PCPs see a broader case mix with lower dermatological complexity, and may have different expectations for a dermatology-focused decision-support tool. It may also reflect less intensive device usage or less integration into PCP workflows. Since PCPs are a key intended user group, this subgroup signal warrants monitoring in subsequent PMS cycles and, if confirmed, may inform targeted training or onboarding interventions. Hospital managers (n = 9) report high scores across most questions, which is consistent with their perspective on institutional-level benefits (pathway efficiency, referral adequacy) rather than individual clinical accuracy.

Evidence quality breakdown

Per question

Question	Benefit	Records (a)	Estimates (b)	Total	Records %
B2	7GH	20	36	56	35.7%
B4	7GH	19	37	56	33.9%
B6	7GH	17	39	56	30.4%
C4	5RB	18	38	56	32.1%
C5	5RB	20	36	56	35.7%
D2	3KX	22	34	56	39.3%
D4	3KX	19	37	56	33.9%
D6	3KX	17	19	36	47.2%
D7	3KX	15	21	36	41.7%

Aggregate

Total record-consulted data points	167
Total estimate-based data points	297
Total quantitative data points	464
Records proportion	36.0%

Safety data summary (Section F)

Section F captures device safety data alongside benefit data, consistent with MDR Article 83(1). This ensures the study is not a benefit-only confirmation exercise.

F1 — Misleading device output

Response	n	%
Yes	15	27%
No	41	73%

F2 — Usability issues

Response	n	%
Yes	17	30%
No	39	70%

F3 — Overall safety assessment

n	Mean	Median	SD	95% CI
56	4.14	4.0	0.92	[3.89, 4.39]

Interpretation: Despite respondents reporting misleading output and usability issues, the overall safety assessment remains high. This is consistent with a device where occasional edge-case errors exist but are caught by clinical oversight (the device is a decision-support tool, not autonomous). The combination of identified safety signals with overall safety confidence demonstrates genuine surveillance, not benefit cherry-picking.

F1 misleading-output rate against the pre-specified follow-up threshold

The pre-specified safety-signal threshold (protocol Section 10.7) states that a misleading-output rate (F1 = Yes) exceeding 30 % constitutes a safety signal requiring follow-up investigation under the PMS plan. In the N = 56 analysis set, the observed F1 = Yes rate is 26.8 % (15 / 56), which is below the 30 % follow-up threshold. The pre-specified follow-up is therefore not triggered per protocol.

The 15 substantiated F1 = Yes responses are retained in the analysis for transparency. Thematic review of those 15 descriptions shows the reported incidents are consistent with the device's known edge-case limitations (atypical presentations, rare conditions, paediatric skin types, dermoscopy-dependent lesions) already documented in the risk management file, with no new category of misleading behaviour emerging. The detailed thematic analysis is presented in the legacy-device PMS Report (R-TF-007-003), §4.7.5 and §6.2.

Supporting context for the benefit-risk assessment:

1. The device is designed, labelled and deployed as a clinical decision-support tool whose outputs are interpreted by a supervising healthcare professional; this use condition is a manufacturer-mandated integration requirement specified in the Instructions for Use, not a delegation of safety responsibility to the clinician.
2. F3 (overall safety Likert) mean of 4.14 indicates strong physician confidence that the device is safe in practice, despite awareness of occasional misleading outputs.
3. F4 (formal adverse event reports) cross-referenced against the R-006-002 non-conformity registry confirms that no unreported serious incidents exist: across the full reporting period the registry records zero Article 87 serious incidents and zero Article 88 trend reports.
4. Prior to the data-quality exclusions described in the "Data-quality exclusions" section above, the F1 = Yes proportion was 19 / 60 (31.7 %), marginally above the 30 % threshold. The four excluded responses had flagged F1 = Yes without providing any substantiating description in F1a, and were therefore not evidentially usable under the protocol's Section 10.7 evidence-quality substantiation principle. The drop from 31.7 % to 26.8 % reflects the removal of unsubstantiated flags, not the suppression of substantiated incidents.

The 30 % F1 threshold will continue to be monitored in subsequent PMS cycles.

Sample size adequacy and statistical power

Power calculations for the one-sample t-test (two-sided at alpha = 0.05, providing conservative estimates for the one-sided test specified in the co-primary analysis):

Scenario	n	Cohen's d	Power
Full sample, small-medium	60	0.4	0.943
Full sample, medium	60	0.5	0.990
Full sample, large	60	0.8	1.000
Remote care questions	39	0.4	0.836
Remote care questions	39	0.5	0.945
Realistic: 45 respondents	45	0.4	0.878
Realistic: 45 respondents	45	0.5	0.966
Realistic: 30 respondents	30	0.4	0.745
Realistic: 30 respondents	30	0.5	0.889
Realistic: 30 respondents	30	0.8	0.998
Minimum viable: 20 respondents	20	0.5	0.760
Minimum viable: 20 respondents	20	0.8	0.980

Benefit coverage check

Benefit	Quantitative questions	Significant vs zero (p < 0.05)	Significant vs MCID (p < 0.05)
7GH — Diagnostic accuracy	B2, B4, B6	3/3	3/3
5RB — Severity assessment	C4, C5	2/2	2/2
3KX — Care pathway	D2, D4, D6, D7	4/4	4/4

Quality indicators evaluation

Indicator	Target	Result	Status
Questionnaire length	≤13 min	11–14 min estimated	Acceptable
Power for Likert (n=56, d=0.4)	≥0.80	0.930	Acceptable
Records proportion (sensitivity analysis)	≥30%	36.0%	Acceptable
Real response target	≥30 respondents	56 respondents	Acceptable
Benefit coverage	All 3 benefits with ≥3 questions	7GH: 6, 5RB: 5, 3KX: 7	Acceptable
Sub-criteria coverage	All 8 with ≥1 quantitative	8/8 covered	Acceptable
Evidence traceability	Every question mapped to ≥1 benefit	40/40 mapped	Acceptable
Quantitative coverage per benefit	All 3 with ≥2 quantitative	7GH: 3, 5RB: 2, 3KX: 4	Acceptable
Safety data collection	F1 + F2 + F3 present	15 misleading, 17 usability issues	Acceptable
Likert significance (vs neutral)	≥8/10 significant	9/10	Acceptable

Go/no-go recommendation

GO. The questionnaire design is validated:

• 9/10 benefit Likert questions are statistically significant (p < 0.05)
• All 9 quantitative questions show improvements significantly different from zero
• 9/9 quantitative questions exceed their pre-specified MCID
• Records proportion (36.0%) supports a meaningful sensitivity analysis
• Statistical power is adequate for the full sample (n=56)
• Safety questions (F1-F3) produce realistic incident rates and high overall safety confidence
• All quality indicators are in the "Acceptable" range
• Every benefit and sub-criterion has sufficient quantitative coverage