Methodology and Evidence Base

What We Measure, How We Aggregate, What Is Gated

Reference page for NIHR reviewers, occupational medicine researchers, ICB and employer commissioners. OccuFertility is an information and templates resource, not a medical device.

Instruments

Instruments and Licensing

Every patient-reported instrument used in OccuFertility is either public domain or licensed for commercial use. We deliberately avoid instruments that would block free embedding (for example WEMWBS commercial, EQ-5D-5L commercial) until the relevant licence is in place on a separate track.

PHQ-4 (Patient Health Questionnaire-4)

Purpose: Short anxiety and depression screen for self-reflection.
Licence: Public domain. No fee.
Role on Platform: Optional, embedded in the wellbeing check-in.

WAI-1 (Work Ability Index, single item)

Purpose: Single-item work ability self-rating (0-10).
Licence: Public domain (Finnish Institute of Occupational Health).
Role on Platform: Optional, embedded in the wellbeing check-in.

ONS-4 (Office for National Statistics personal wellbeing)

Purpose: Four-item personal wellbeing measure: life satisfaction, worthwhile, happiness, anxiety.
Licence: Open Government Licence v3.0. Free, no registration.
Role on Platform: Rolling out as a 4-weekly cadence item alongside the existing wellbeing check-in. Aggregate trend will appear on dashboards once enrolment threshold is met.

Custom work-impact items

Purpose: Plain-language items on appointment burden, side effects, disclosure choices.
Licence: Authored in-house. CC BY-NC 4.0 for re-use.
Role on Platform: Drives employer and clinic dashboard work-impact panels.

Anonymity

Aggregation and Anonymity

Dashboards never expose individual responses. Aggregates are produced by Postgres SECURITY DEFINER functions that apply k-anonymity gates before returning rows.

Employer Dashboard

Aggregates appear once 250 users have contributed to the employer's dataset. Within that, every breakdown bucket (stage, role band, age band) requires at least 50 users.

Clinic Dashboard

No fixed dataset gate (clinic cohorts are smaller). Every breakdown bucket requires at least 25 users.

Suppression

Buckets below threshold render as 'too few users to show'. Numerator and denominator are never returned to the client.

Row-Level Security

Postgres RLS ties every read to the caller's user_roles row. Employer admins can only see their own employer_id; clinic admins their own clinic_id.

Consent

Consent Model

Four separate consents. Each is per-user, versioned, and editable from Settings.

Aggregate consent (default on): permits anonymous inclusion in employer/clinic aggregates above the k-anonymity gates above. Users can opt out in Settings at any time.
Employer consent (default on for employer-redeemed users): permits sharing the employee's own employer aggregate inclusion. Independent toggle.
Research consent (default off): explicit opt-in for academic research collaborations. Captured per study with version stamp.
Email updates (default off): explicit opt-in. Marketing is never sent without it.

Governance

Governance and Regulatory Framing

OccuFertility is not a medical device, not software as a medical device (SaMD), and not a diagnostic tool. It is an information resource and a set of templates that users hand to their own GP, line manager, or occupational health team.

Data controller: Her Holistic Health Ltd, ICO registration ZB841609. Content is authored by Dr Divpreet Sacha (MBChB MRCGP DipOccMed) and reviewed against NICE fertility guidance, ACAS workplace guidance, and the Equality Act 2010. Crisis copy directs to NHS 111 (Mental Health, Option 2) and Samaritans (116 123) only.

References, source material, and methodology updates are versioned and visible at /demo/research. Source code review is available on request for academic and commissioning partners under NDA.

Researcher or Commissioner?

Send an enquiry for the methodology pack, an anonymised aggregate sample, or pilot partnership terms.

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