Table 2, Review protocol: Patient information - Evidence review for patient information

Field	Content
Review question	What information is useful for people with primary hyperparathyroidism?
Type of review question	Views and experiences (qualitative) A review of health economic evidence related to the same review question was conducted in parallel with this review. For details see the health economic review protocol for this NICE guideline.
Objective of the review	To determine what information should be provided to people with PHPT.
Eligibility criteria – population	Adults (18 years or over) with primary hyperparathyroidism Strata: Post-diagnosis, pre-surgery, post-surgery, people on pharmacological treatment Exclude people: with secondary and tertiary HPT with multiple endocrine neoplasia with familial hyperparathyroidism with parathyroid carcinoma
Eligibility criteria – context	Any type of information described by studies. Content of information and how this information is delivered Information to include pre- and post-surgery Timing of information and support
Eligibility criteria – comparator(s)	N/A
Outcomes and prioritisation	Synthesis of qualitative research: thematic analysis – information synthesised into main review findings. Results presented in a detailed narrative and in table format with summary statements of main review findings.
Eligibility criteria – study design	Qualitative studies (for example, interviews, focus groups, observations)
Other inclusion exclusion criteria	Non-English language studies Conference abstracts
Proposed sensitivity / subgroup analysis, or meta-regression	N/A
Selection process – duplicate screening / selection / analysis	Studies are sifted by title and abstract. Potentially significant publications obtained in full text are then assessed against the inclusion criteria specified in this protocol.
Data management (software)	CERQual will be used to synthesise data from qualitative studies. Endnote for bibliography, citations, sifting and reference management Data extractions performed using EviBase, a platform designed and maintained by the National Guideline Centre (NGC)
Information sources – databases and dates	Clinical search databases to be used: Medline, Embase, CINAHL and PsycINFO Date: all years Language: Restrict to English only Supplementary search techniques: backward citation searching Key papers: Not known
Identify if an update	N/A
Author contacts	https://www.nice.org.uk/guidance/indevelopment/gid-ng10051
Highlight if amendment to previous protocol	For details please see section 4.5 of Developing NICE guidelines: the manual.
Search strategy – for one database	[For details please see appendix B
Data collection process – forms / duplicate	A standardised evidence table format will be used, and published as appendix D of the evidence report.
Data items – define all variables to be collected	For details please see evidence tables in appendix D (clinical evidence tables) or H (health economic evidence tables).
Methods for assessing bias at outcome / study level	Standard study checklists will be used to critically appraise individual studies. For details please see section 6.2 of Developing NICE guidelines: the manual. The risk of bias across all available evidence will be evaluated for each outcome using an adaptation of the ‘Grading of Recommendations Assessment, Development and Evaluation (GRADE) toolbox’ developed by the international GRADE working group http://www.gradeworkinggroup.org/
Criteria for quantitative synthesis	For details please see section 6.4 of Developing NICE guidelines: the manual.
Methods for quantitative analysis – combining studies and exploring (in)consistency	For details please see the separate Methods report for this guideline.
Meta-bias assessment – publication bias, selective reporting bias	For details please see section 6.2 of Developing NICE guidelines: the manual.
Confidence in cumulative evidence	For details please see sections 6.4 and 9.1 of Developing NICE guidelines: the manual.
Rationale / context – what is known	For details please see the introduction to the evidence review.
Describe contributions of authors and guarantor	A multidisciplinary committee developed the evidence review. The committee was convened by the National Guideline Centre (NGC) and chaired by Jonathan Mant in line with section 3 of Developing NICE guidelines: the manual. Staff from the NGC undertook systematic literature searches, appraised the evidence, conducted meta-analysis and cost-effectiveness analysis where appropriate, and drafted the evidence review in collaboration with the committee. For details please see Developing NICE guidelines: the manual.
Sources of funding / support	The NGC is funded by NICE and hosted by the Royal College of Physicians.
Name of sponsor	The NGC is funded by NICE and hosted by the Royal College of Physicians.
Roles of sponsor	NICE funds the NGC to develop guidelines for those working in the NHS, public health and social care in England.
PROSPERO registration number	Not registered

Field

Content

Review question

What information is useful for people with primary hyperparathyroidism?

Type of review question

Views and experiences (qualitative)

A review of health economic evidence related to the same review question was conducted in parallel with this review. For details see the health economic review protocol for this NICE guideline.

Objective of the review

To determine what information should be provided to people with PHPT.

Eligibility criteria – population

Adults (18 years or over) with primary hyperparathyroidism

Strata:

Post-diagnosis, pre-surgery, post-surgery, people on pharmacological treatment

Exclude people:

with secondary and tertiary HPT
with multiple endocrine neoplasia
with familial hyperparathyroidism
with parathyroid carcinoma

Eligibility criteria – context

Any type of information described by studies.

Content of information and how this information is delivered
Information to include pre- and post-surgery
Timing of information and support

Eligibility criteria – comparator(s)

N/A

Outcomes and prioritisation

Synthesis of qualitative research: thematic analysis – information synthesised into main review findings. Results presented in a detailed narrative and in table format with summary statements of main review findings.

Eligibility criteria – study design

Qualitative studies (for example, interviews, focus groups, observations)

Other inclusion exclusion criteria

Non-English language studies
Conference abstracts

Proposed sensitivity / subgroup analysis, or meta-regression

N/A

Selection process – duplicate screening / selection / analysis

Studies are sifted by title and abstract. Potentially significant publications obtained in full text are then assessed against the inclusion criteria specified in this protocol.

Data management (software)

CERQual will be used to synthesise data from qualitative studies.

Endnote for bibliography, citations, sifting and reference management
Data extractions performed using EviBase, a platform designed and maintained by the National Guideline Centre (NGC)

Information sources – databases and dates

Clinical search databases to be used: Medline, Embase, CINAHL and PsycINFO

Date: all years

Language: Restrict to English only

Supplementary search techniques: backward citation searching

Key papers: Not known

Identify if an update

N/A

Author contacts

https://www.nice.org.uk/guidance/indevelopment/gid-ng10051

Highlight if amendment to previous protocol

For details please see section 4.5 of Developing NICE guidelines: the manual.

Search strategy – for one database

[For details please see appendix B

Data collection process – forms / duplicate

A standardised evidence table format will be used, and published as appendix D of the evidence report.

Data items – define all variables to be collected

For details please see evidence tables in appendix D (clinical evidence tables) or H (health economic evidence tables).

Methods for assessing bias at outcome / study level

Standard study checklists will be used to critically appraise individual studies. For details please see section 6.2 of Developing NICE guidelines: the manual.

The risk of bias across all available evidence will be evaluated for each outcome using an adaptation of the ‘Grading of Recommendations Assessment, Development and Evaluation (GRADE) toolbox’ developed by the international GRADE working group http://www.gradeworkinggroup.org/

Criteria for quantitative synthesis

For details please see section 6.4 of Developing NICE guidelines: the manual.

Methods for quantitative analysis – combining studies and exploring (in)consistency

For details please see the separate Methods report for this guideline.

Meta-bias assessment – publication bias, selective reporting bias

For details please see section 6.2 of Developing NICE guidelines: the manual.

Confidence in cumulative evidence

For details please see sections 6.4 and 9.1 of Developing NICE guidelines: the manual.

Rationale / context – what is known

For details please see the introduction to the evidence review.

Describe contributions of authors and guarantor

A multidisciplinary committee developed the evidence review. The committee was convened by the National Guideline Centre (NGC) and chaired by Jonathan Mant in line with section 3 of Developing NICE guidelines: the manual.

Staff from the NGC undertook systematic literature searches, appraised the evidence, conducted meta-analysis and cost-effectiveness analysis where appropriate, and drafted the evidence review in collaboration with the committee. For details please see Developing NICE guidelines: the manual.

Sources of funding / support

The NGC is funded by NICE and hosted by the Royal College of Physicians.

Name of sponsor

The NGC is funded by NICE and hosted by the Royal College of Physicians.

Roles of sponsor

NICE funds the NGC to develop guidelines for those working in the NHS, public health and social care in England.

PROSPERO registration number

Not registered

From: Evidence review for patient information

Cover of Evidence review for patient information

Evidence review for patient information: Hyperparathyroidism (primary): diagnosis, assessment and initial management: Evidence review K.

NICE Guideline, No. 132.

National Guideline Centre (UK).

London: National Institute for Health and Care Excellence (NICE); 2019 May.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Table 2Review protocol: Patient information